CA2505661A1 - Pharmaceutical safety dosage forms - Google Patents
Pharmaceutical safety dosage forms Download PDFInfo
- Publication number
- CA2505661A1 CA2505661A1 CA002505661A CA2505661A CA2505661A1 CA 2505661 A1 CA2505661 A1 CA 2505661A1 CA 002505661 A CA002505661 A CA 002505661A CA 2505661 A CA2505661 A CA 2505661A CA 2505661 A1 CA2505661 A1 CA 2505661A1
- Authority
- CA
- Canada
- Prior art keywords
- pharmaceutical
- dosage form
- safety dosage
- pharmaceutical safety
- antagonist
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000002552 dosage form Substances 0.000 title claims abstract 289
- 239000005557 antagonist Substances 0.000 claims abstract 107
- 238000000034 method Methods 0.000 claims abstract 52
- 239000003814 drug Substances 0.000 claims abstract 31
- 239000000150 Sympathomimetic Substances 0.000 claims 71
- 230000001975 sympathomimetic effect Effects 0.000 claims 71
- 230000001800 adrenalinergic effect Effects 0.000 claims 44
- 239000002876 beta blocker Substances 0.000 claims 44
- 229940097320 beta blocking agent Drugs 0.000 claims 44
- KWTSXDURSIMDCE-QMMMGPOBSA-N (S)-amphetamine Chemical compound C[C@H](N)CC1=CC=CC=C1 KWTSXDURSIMDCE-QMMMGPOBSA-N 0.000 claims 36
- 239000012530 fluid Substances 0.000 claims 36
- 230000002496 gastric effect Effects 0.000 claims 36
- AQHHHDLHHXJYJD-UHFFFAOYSA-N propranolol Chemical group C1=CC=C2C(OCC(O)CNC(C)C)=CC=CC2=C1 AQHHHDLHHXJYJD-UHFFFAOYSA-N 0.000 claims 36
- 229940079593 drug Drugs 0.000 claims 30
- 239000008280 blood Substances 0.000 claims 28
- 210000004369 blood Anatomy 0.000 claims 28
- 229940025084 amphetamine Drugs 0.000 claims 27
- 230000002218 hypoglycaemic effect Effects 0.000 claims 23
- 239000002895 emetic Substances 0.000 claims 22
- 230000003533 narcotic effect Effects 0.000 claims 20
- GUGOEEXESWIERI-UHFFFAOYSA-N Terfenadine Chemical compound C1=CC(C(C)(C)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 GUGOEEXESWIERI-UHFFFAOYSA-N 0.000 claims 18
- 230000001387 anti-histamine Effects 0.000 claims 18
- 239000003472 antidiabetic agent Substances 0.000 claims 18
- 239000000739 antihistaminic agent Substances 0.000 claims 18
- VYFYYTLLBUKUHU-UHFFFAOYSA-N dopamine Chemical compound NCCC1=CC=C(O)C(O)=C1 VYFYYTLLBUKUHU-UHFFFAOYSA-N 0.000 claims 18
- 239000000864 hyperglycemic agent Substances 0.000 claims 18
- 229940126904 hypoglycaemic agent Drugs 0.000 claims 18
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 claims 18
- IUBSYMUCCVWXPE-UHFFFAOYSA-N metoprolol Chemical compound COCCC1=CC=C(OCC(O)CNC(C)C)C=C1 IUBSYMUCCVWXPE-UHFFFAOYSA-N 0.000 claims 18
- 229960002237 metoprolol Drugs 0.000 claims 18
- 229960003712 propranolol Drugs 0.000 claims 18
- UCTWMZQNUQWSLP-UHFFFAOYSA-N adrenaline Chemical compound CNCC(O)C1=CC=C(O)C(O)=C1 UCTWMZQNUQWSLP-UHFFFAOYSA-N 0.000 claims 17
- 239000011324 bead Substances 0.000 claims 16
- 239000011248 coating agent Substances 0.000 claims 16
- 238000000576 coating method Methods 0.000 claims 16
- OROGSEYTTFOCAN-DNJOTXNNSA-N codeine Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)=C[C@H](O)[C@@H]1OC1=C2C3=CC=C1OC OROGSEYTTFOCAN-DNJOTXNNSA-N 0.000 claims 16
- 239000008185 minitablet Substances 0.000 claims 16
- 239000003826 tablet Substances 0.000 claims 16
- 239000000443 aerosol Substances 0.000 claims 10
- BALXUFOVQVENIU-KXNXZCPBSA-N pseudoephedrine hydrochloride Chemical compound [H+].[Cl-].CN[C@@H](C)[C@@H](O)C1=CC=CC=C1 BALXUFOVQVENIU-KXNXZCPBSA-N 0.000 claims 10
- METKIMKYRPQLGS-GFCCVEGCSA-N (R)-atenolol Chemical compound CC(C)NC[C@@H](O)COC1=CC=C(CC(N)=O)C=C1 METKIMKYRPQLGS-GFCCVEGCSA-N 0.000 claims 9
- WLRMANUAADYWEA-NWASOUNVSA-N (S)-timolol maleate Chemical compound OC(=O)\C=C/C(O)=O.CC(C)(C)NC[C@H](O)COC1=NSN=C1N1CCOCC1 WLRMANUAADYWEA-NWASOUNVSA-N 0.000 claims 9
- 239000005541 ACE inhibitor Substances 0.000 claims 9
- 229940127291 Calcium channel antagonist Drugs 0.000 claims 9
- ZKLPARSLTMPFCP-UHFFFAOYSA-N Cetirizine Chemical group C1CN(CCOCC(=O)O)CCN1C(C=1C=CC(Cl)=CC=1)C1=CC=CC=C1 ZKLPARSLTMPFCP-UHFFFAOYSA-N 0.000 claims 9
- 102000004877 Insulin Human genes 0.000 claims 9
- 108090001061 Insulin Proteins 0.000 claims 9
- DUGOZIWVEXMGBE-UHFFFAOYSA-N Methylphenidate Chemical compound C=1C=CC=CC=1C(C(=O)OC)C1CCCCN1 DUGOZIWVEXMGBE-UHFFFAOYSA-N 0.000 claims 9
- 229940044094 angiotensin-converting-enzyme inhibitor Drugs 0.000 claims 9
- 229960002274 atenolol Drugs 0.000 claims 9
- 239000000480 calcium channel blocker Substances 0.000 claims 9
- 229960001803 cetirizine Drugs 0.000 claims 9
- 229960000632 dexamfetamine Drugs 0.000 claims 9
- HSUGRBWQSSZJOP-RTWAWAEBSA-N diltiazem Chemical compound C1=CC(OC)=CC=C1[C@H]1[C@@H](OC(C)=O)C(=O)N(CCN(C)C)C2=CC=CC=C2S1 HSUGRBWQSSZJOP-RTWAWAEBSA-N 0.000 claims 9
- 229960004166 diltiazem Drugs 0.000 claims 9
- 229960003638 dopamine Drugs 0.000 claims 9
- RWTNPBWLLIMQHL-UHFFFAOYSA-N fexofenadine Chemical compound C1=CC(C(C)(C(O)=O)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 RWTNPBWLLIMQHL-UHFFFAOYSA-N 0.000 claims 9
- 229960003592 fexofenadine Drugs 0.000 claims 9
- 229960001381 glipizide Drugs 0.000 claims 9
- ZJJXGWJIGJFDTL-UHFFFAOYSA-N glipizide Chemical compound C1=NC(C)=CN=C1C(=O)NCCC1=CC=C(S(=O)(=O)NC(=O)NC2CCCCC2)C=C1 ZJJXGWJIGJFDTL-UHFFFAOYSA-N 0.000 claims 9
- 229940125396 insulin Drugs 0.000 claims 9
- XZWYZXLIPXDOLR-UHFFFAOYSA-N metformin Chemical compound CN(C)C(=N)NC(N)=N XZWYZXLIPXDOLR-UHFFFAOYSA-N 0.000 claims 9
- 229960003105 metformin Drugs 0.000 claims 9
- 229960001252 methamphetamine Drugs 0.000 claims 9
- MYWUZJCMWCOHBA-VIFPVBQESA-N methamphetamine Chemical compound CN[C@@H](C)CC1=CC=CC=C1 MYWUZJCMWCOHBA-VIFPVBQESA-N 0.000 claims 9
- VKQFCGNPDRICFG-UHFFFAOYSA-N methyl 2-methylpropyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate Chemical compound COC(=O)C1=C(C)NC(C)=C(C(=O)OCC(C)C)C1C1=CC=CC=C1[N+]([O-])=O VKQFCGNPDRICFG-UHFFFAOYSA-N 0.000 claims 9
- 229960001344 methylphenidate Drugs 0.000 claims 9
- 229960001597 nifedipine Drugs 0.000 claims 9
- HYIMSNHJOBLJNT-UHFFFAOYSA-N nifedipine Chemical compound COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1[N+]([O-])=O HYIMSNHJOBLJNT-UHFFFAOYSA-N 0.000 claims 9
- 229960000227 nisoldipine Drugs 0.000 claims 9
- 229960005221 timolol maleate Drugs 0.000 claims 9
- 244000284152 Carapichea ipecacuanha Species 0.000 claims 8
- 102000051325 Glucagon Human genes 0.000 claims 8
- 108060003199 Glucagon Proteins 0.000 claims 8
- 239000009471 Ipecac Substances 0.000 claims 8
- WJBLNOPPDWQMCH-MBPVOVBZSA-N Nalmefene Chemical compound N1([C@@H]2CC3=CC=C(C=4O[C@@H]5[C@](C3=4)([C@]2(CCC5=C)O)CC1)O)CC1CC1 WJBLNOPPDWQMCH-MBPVOVBZSA-N 0.000 claims 8
- BRUQQQPBMZOVGD-XFKAJCMBSA-N Oxycodone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C BRUQQQPBMZOVGD-XFKAJCMBSA-N 0.000 claims 8
- 229960004126 codeine Drugs 0.000 claims 8
- XLMALTXPSGQGBX-GCJKJVERSA-N dextropropoxyphene Chemical compound C([C@](OC(=O)CC)([C@H](C)CN(C)C)C=1C=CC=CC=1)C1=CC=CC=C1 XLMALTXPSGQGBX-GCJKJVERSA-N 0.000 claims 8
- 229960004193 dextropropoxyphene Drugs 0.000 claims 8
- 229960004580 glibenclamide Drugs 0.000 claims 8
- MASNOZXLGMXCHN-ZLPAWPGGSA-N glucagon Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(O)=O)C(C)C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](C)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CO)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](N)CC=1NC=NC=1)[C@@H](C)O)[C@@H](C)O)C1=CC=CC=C1 MASNOZXLGMXCHN-ZLPAWPGGSA-N 0.000 claims 8
- 229960004666 glucagon Drugs 0.000 claims 8
- ZNNLBTZKUZBEKO-UHFFFAOYSA-N glyburide Chemical compound COC1=CC=C(Cl)C=C1C(=O)NCCC1=CC=C(S(=O)(=O)NC(=O)NC2CCCCC2)C=C1 ZNNLBTZKUZBEKO-UHFFFAOYSA-N 0.000 claims 8
- OROGSEYTTFOCAN-UHFFFAOYSA-N hydrocodone Natural products C1C(N(CCC234)C)C2C=CC(O)C3OC2=C4C1=CC=C2OC OROGSEYTTFOCAN-UHFFFAOYSA-N 0.000 claims 8
- 229940029408 ipecac Drugs 0.000 claims 8
- 229960005297 nalmefene Drugs 0.000 claims 8
- UZHSEJADLWPNLE-GRGSLBFTSA-N naloxone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4CC=C UZHSEJADLWPNLE-GRGSLBFTSA-N 0.000 claims 8
- 229960004127 naloxone Drugs 0.000 claims 8
- 229960002085 oxycodone Drugs 0.000 claims 8
- VOKSWYLNZZRQPF-GDIGMMSISA-N pentazocine Chemical compound C1C2=CC=C(O)C=C2[C@@]2(C)[C@@H](C)[C@@H]1N(CC=C(C)C)CC2 VOKSWYLNZZRQPF-GDIGMMSISA-N 0.000 claims 8
- 229960005301 pentazocine Drugs 0.000 claims 8
- 238000000605 extraction Methods 0.000 claims 6
- 239000000126 substance Substances 0.000 claims 6
- 239000000843 powder Substances 0.000 claims 4
- 239000012453 solvate Substances 0.000 claims 4
- 238000013268 sustained release Methods 0.000 claims 4
- 239000012730 sustained-release form Substances 0.000 claims 4
- 238000004519 manufacturing process Methods 0.000 claims 2
- 239000003887 narcotic antagonist Substances 0.000 claims 2
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Abstract
Pharmaceutical safety dosage forms are provided which include a pharmaceutical and an antagonist to the pharmaceutical. The safety dosage forms are such that the antagonist has no significant bioavailability when the pharmaceutical safety dosage form is administered as intended. However, the antagonist is released and becomes bioavailable if the dosage form is disrupted. Methods of administering pharmaceuticals by providing pharmaceutical safety dosage forms are also provided.
Claims (315)
1. A pharmaceutical safety dosage form comprising a pharmaceutical and an antagonist for said pharmaceutical wherein said antagonist comprises an emetic agent and has significant bioavailability only when said pharmaceutical safety dosage form is disrupted.
2. The pharmaceutical safety dosage of claim 1 wherein said pharmaceutical is adapted for time-release, or said antagonist further comprises an insoluble coating, or both.
3. The pharmaceutical safety dosage form of claim 1 wherein said bioavailability occurs upon mechanical disruption.
4. The pharmaceutical safety dosage form of claim 1 wherein said bioavailability occurs upon extraction by a chemical.
5. The pharmaceutical safety dosage form of claim 1 adapted to be administered orally.
6. The pharmaceutical safety dosage form of claim 1 adapted to be administered rectally, parenterally, vaginally, transdermally, intranasally, or via aerosol.
7. (Canceled)
8. The pharmaceutical safety dosage form of claim 1 wherein said emetic agent is ipecac or derivatives thereof.
9. The pharmaceutical safety dosage form of claim 1 wherein said pharmaceutical comprises a narcotic.
10. The pharmaceutical safety dosage form of claim 9 wherein said narcotic is codeine, oxycodone, propoxyphene, pentazocine, derivatives thereof, or combinations thereof.
11. The pharmaceutical safety dosage form of claim 9 wherein said antagonist further comprises naloxone, nalmefene, derivatives thereof, or combinations thereof.
12. The pharmaceutical safety dosage form of claim 1 wherein said pharmaceutical comprises a sympathomimetic.
13. The pharmaceutical safety dosage form of claim 12 further comprising an antihistamine.
14. The pharmaceutical safety dosage form of claim 13 wherein said sympathomimetic is pseudoephedrine HCl or derivatives thereof, and said antihistamine is cetirizine HCl, fexofenadine HCl, derivatives thereof, or combinations thereof.
15. The pharmaceutical safety dosage form of claim 13 wherein said antagonist further comprises an adrenergic beta blocker.
16. The pharmaceutical safety dosage form of claim 12 wherein said sympathomimetic comprises methylphenidate.
17. The pharmaceutical safety dosage form of claim 16 wherein said antagonist further comprises an adrenergic beta blocker.
18. The pharmaceutical safety dosage form of claim 12 wherein said sympathomimetic comprises an amphetamine.
19. The pharmaceutical safety dosage form of claim 18 wherein said amphetamine is methamphetamine, amphetamine, dextroamphetamine, derivatives thereof, or combinations thereof.
20. The pharmaceutical safety dosage form of claim 18 wherein said antagonist further comprises an adrenergic beta blocker.
21. The pharmaceutical safety dosage form of claim 20 wherein said adrenergic beta blocker is propranolol, atenolol, metoprolol, derivatives thereof, or combinations thereof.
22. The pharmaceutical safety dosage form of claim 1 wherein said pharmaceutical comprises a blood pressure-lowering medication.
23. The pharmaceutical safety dosage form of claim 22 wherein said blood pressure-lowering medication is an adrenergic beta blocker, a calcium channel blocker, or an ACE
inhibitor.
inhibitor.
24. The pharmaceutical safety dosage form of claim 23 wherein said blood pressure-lowering medication is propranolol, metoprolol, nifedipine, diltiazem, nisoldipine, timolol maleate, derivatives thereof, or combinations thereof.
25. The pharmaceutical safety dosage form of claim 22 wherein said antagonist further comprises a sympathomimetic.
26. The pharmaceutical safety dosage form of claim 25 wherein said sympathomimetic is dopamine, epinepherine, derivatives thereof, or combinations thereof.
27. The pharmaceutical safety dosage form of claim 1 wherein said pharmaceutical comprises a hypoglycemic agent.
28. The pharmaceutical safety dosage form of claim 27 wherein said hypoglycemicagent is insulin, metformin, glipizide, glyburide, derivatives thereof, or combinations thereof.
29. The pharmaceutical safety dosage form of claim 27 wherein said antagonist further comprises a hyperglycemic agent.
30. The pharmaceutical safety dosage form of claim 29 wherein said hyperglycemic agent is epinepherine, glucagon, derivatives thereof, or combinations thereof.
31. A pharmaceutical safety dosage form comprising a pharmaceutical contained within a first microdosage form, said first microdosage form being adapted for release of said pharmaceutical within a patient, together with an antagonist for said pharmaceutical, said antagonist comprising an emetic agent and being contained within a second microdosage form, said second microdosage form being substantially insoluble in gastric fluid.
32. The pharmaceutical safety dosage form of claim 31 wherein said pharmaceutical is adapted for time-release, or said second microdosage form comprises a coating which is substantially insoluble in gastric fluid, or both.
33. The pharmaceutical safety dosage form of claim 31 wherein said first microdosage form comprises beads, tablets, mini tablets, or combinations thereof; or second microdosage forms comprises beads, tablets, mini tablets, or combinations thereof; or both.
34. The pharmaceutical safety dosage form of claim 31 adapted to be administered orally.
35. The pharmaceutical safety dosage form of claim 31 adapted to be administered rectally, parenterally, vaginally, transdermally, intranasally, or via aerosol.
36. (Canceled)
37. The pharmaceutical safety dosage form of claim 31 wherein said emetic agent is ipecac or derivatives thereof.
38. The pharmaceutical safety dosage form of claim 31 wherein said pharmaceutical comprises a narcotic.
39. The pharmaceutical safety dosage form of claim 38 wherein said narcotic is codeine, oxycodone, propoxyphene, pentazocine, derivatives thereof, or combinations thereof.
40. The pharmaceutical safety dosage form of claim 38 wherein said antagonist further comprises naloxone, nalmefene, derivatives thereof, or combinations thereof.
41. The pharmaceutical safety dosage form of claim 31 wherein said pharmaceutical comprises a sympathomimetic.
42. The pharmaceutical safety dosage form of claim 41 further comprising an antihistamine.
43. The pharmaceutical safety dosage form of claim 42 wherein said sympathomimetic is pseudoephedrine HCl or derivatives thereof, and said antihistamine is cetirizine HCI, fexofenadine HCI, derivatives thereof, or combinations thereof.
44. The pharmaceutical safety dosage form of claim 42 wherein said antagonist further comprises an adrenergic beta blocker.
45. The pharmaceutical safety dosage form of claim 41 wherein said sympathomimetic comprises methylphenidate.
46. The pharmaceutical safety dosage form of claim 45 wherein said antagonist further comprises an adrenergic beta blocker.
47. The pharmaceutical safety dosage form of claim 41 wherein said sympathomimetic comprises an amphetamine.
48. The pharmaceutical safety dosage form of claim 47 wherein said amphetamine is methamphetamine, amphetamine, dextroamphetamine, derivatives thereof, or combinations thereof.
49. The pharmaceutical safety dosage form of claim 47 wherein said antagonist further comprises an adrenergic beta blocker.
50. The pharmaceutical safety dosage form of claim 49 wherein said adrenergic beta blocker is propranolol, atenolol, metoprolol, derivatives thereof, or combinations thereof.
51. The pharmaceutical safety dosage form of claim 31 wherein said pharmaceutical comprises a blood pressure-lowering medication.
52. The pharmaceutical safety dosage form of claim 51 wherein said blood pressure-lowering medication is an adrenergic beta blocker, a calcium channel blocker, or an ACE
inhibitor.
inhibitor.
53. The pharmaceutical safety dosage form of claim 52 wherein said blood pressure-lowering medication is propranolol, metoprolol, nifedipine, diltiazem, nisoldipine, timolol maleate, derivatives thereof, or combinations thereof.
54. The pharmaceutical safety dosage form of claim 51 wherein said antagonist further comprises a sympathomimetic.
55. The pharmaceutical safety dosage form of claim 54 wherein said sympathomimetic is dopamine, epinepherine, derivatives thereof, or combinations thereof.
56. The pharmaceutical safety dosage form of claim 31 wherein said pharmaceutical comprises a hypoglycemic agent.
57. The pharmaceutical safety dosage form of claim 56 wherein said hypoglycemic agent is insulin, metformin, glipizide, glyburide, derivatives thereof, or combinations thereof.
58. The pharmaceutical safety dosage form of claim 56 wherein said antagonist further comprises a hyperglycemic agent.
59. The pharmaceutical safety dosage form of claim 58 wherein said hyperglycemic agent is epinepherine, glucagon, derivatives thereof, or combinations thereof.
60. A pharmaceutical safety dosage form comprising a pharmaceutical contained within a first plurality of particulated forms, said first particulated forms being adapted for release of said pharmaceutical within a patient, together with an antagonist for said pharmaceutical, said antagonist comprising an emetic agent and being contained within a second plurality of particulated forms, said second particulated forms being substantially insoluble in gastric fluid.
61. The pharmaceutical safety dosage form of claim 60 wherein said pharmaceutical is adapted for time-release, or said second plurality of particulated forms comprise a polymorph or a solvate which is substantially insoluble in gastric fluid, or both.
62. The pharmaceutical safety dosage form of claim 61 wherein said first plurality of particulated forms comprises a sustained-release powder.
63. The pharmaceutical safety dosage form of claim 60 adapted to be administered orally.
64. The pharmaceutical safety dosage form of claim 60 adapted to be administered rectally, parenterally, vaginally, transdermally, intranasally, or via aerosol.
65. (Canceled)
66. The pharmaceutical safety dosage form of claim 60 wherein said emetic agent is ipecac or derivatives thereof.
67. The pharmaceutical safety dosage form of claim 60 wherein said pharmaceutical comprises a narcotic.
68. The pharmaceutical safety dosage form of claim 67 wherein said narcotic is codeine, oxycodone, propoxyphene, pentazocine, derivatives thereof, or combinations thereof.
69. The pharmaceutical safety dosage form of claim 67 wherein said antagonist further comprises naloxone, nalmefene, derivatives thereof, or combinations thereof.
70. The pharmaceutical safety dosage form of claim 60 wherein said pharmaceutical comprises a sympathomimetic.
71. The pharmaceutical safety dosage form of claim 70 further comprising an antihistamine.
72. The pharmaceutical safety dosage form of claim 71 wherein said sympathomimetic is pseudoephedrine HCl or derivatives thereof, and said antihistamine is cetirizine HCI, fexofenadine HCl, derivatives thereof, or combinations thereof.
73. The pharmaceutical safety dosage form of claim 71 wherein said antagonist further comprises an adrenergic beta blocker.
74. The pharmaceutical safety dosage form of claim 70 wherein said sympathomimetic comprises methylphenidate.
75. The pharmaceutical safety dosage form of claim 74 wherein said antagonist further comprises an adrenergic beta blocker.
76. The pharmaceutical safety dosage form of claim 70 wherein said sympathomimetic comprises an amphetamine.
52 -77. The pharmaceutical safety dosage form of claim 76 wherein said amphetamine is methamphetamine, amphetamine, dextroamphetamine, derivatives thereof, or combinations thereof.
78. The pharmaceutical safety dosage form of claim 76 wherein said antagonist further comprises an adrenergic beta blocker.
79. The pharmaceutical safety dosage form of claim 78 wherein said adrenergic beta blocker is propranolol, atenolol, metoprolol, derivatives thereof, or combinations thereof.
80. The pharmaceutical safety dosage form of claim 60 wherein said pharmaceutical comprises a blood pressure-lowering medication.
81. The pharmaceutical safety dosage form of claim 80 wherein said blood pressure-lowering medication is an adrenergic beta blocker, a calcium channel blocker, or an ACE
inhibitor.
inhibitor.
82. The pharmaceutical safety dosage form of claim 81 wherein said blood pressure-lowering medication is propranolol, metoprolol, nifedipine, diltiazem, nisoldipine, timolol maleate, derivatives thereof, or combinations thereof.
83. The pharmaceutical safety dosage form of claim 80 wherein said antagonist further comprises a sympathomimetic.
84. The pharmaceutical safety dosage form of claim 83 wherein said sympathomimetic is dopamine, epinepherine, derivatives thereof, or combinations thereof.
85. The pharmaceutical safety dosage form of claim 60 wherein said pharmaceutical comprises a hypoglycemic agent.
86. The pharmaceutical safety dosage form of claim 85 wherein said hypoglycemic agent is insulin, metformin, glipizide, glyburide, derivatives thereof, or combinations thereof.
87. The pharmaceutical safety dosage form of claim 85 wherein said antagonist further comprises a hyperglycemic agent.
88. The pharmaceutical safety dosage form of claim 87 wherein said hyperglycemic agent is epinepherine, glucagon, derivatives thereof, or combinations thereof.
89. A pharmaceutical safety dosage form comprising a pharmaceutical contained within a microdosage form, said microdosage form being adapted for release of said pharmaceutical within a patient, together with an antagonist for said pharmaceutical, said antagonist comprising an emetic agent and being contained within a plurality of particulated dosage forms, said particulated dosage forms being substantially insoluble in gastric fluid.
90. The pharmaceutical safety dosage form of claim 89 wherein said pharmaceutical is adapted for time-release, or said plurality of particulated forms comprise a polymorph which is substantially insoluble in gastric fluid, or both.
91. The pharmaceutical safety dosage form of claim 89 wherein said microdosage form comprises beads, tablets, mini tablets, or combinations thereof.
92. The pharmaceutical safety dosage form of claim 89 adapted to be administered orally.
93. The pharmaceutical safety dosage form of claim 89 adapted to be administered rectally, parenterally, vaginally, transdermally, intranasally, or via aerosol.
94. (Canceled)
95. The pharmaceutical safety dosage form of claim 89 wherein said emetic agent is ipecac or derivatives thereof.
96. The pharmaceutical safety dosage form of claim 89 wherein said pharmaceutical comprises a narcotic.
97. The pharmaceutical safety dosage form of claim 96 wherein said narcotic is codeine, oxycodone, propoxyphene, pentazocine, derivatives thereof, or combinations thereof.
98. The pharmaceutical safety dosage form of claim 96 wherein said antagonist further comprises naloxone, nalmefene, derivatives thereof, or combinations thereof.
99. The pharmaceutical safety dosage form of claim 89 wherein said pharmaceutical comprises a sympathomimetic.
100. The pharmaceutical safety dosage form of claim 99 further comprising an antihistamine.
101. The pharmaceutical safety dosage form of claim 100 wherein said sympathomimetic is pseudoephedrine HCl or derivatives thereof, and said antihistamine is cetirizine HCI, fexofenadine HCl, derivatives thereof, or combinations thereof.
102. The pharmaceutical safety dosage form of claim 100 wherein said antagonist further comprises an adrenergic beta blocker.
103. The pharmaceutical safety dosage form of claim 99 wherein said sympathomimetic comprises methylphenidate.
104. The pharmaceutical safety dosage form of claim 103 wherein said antagonist further comprises an adrenergic beta blocker.
105. The pharmaceutical safety dosage form of claim 99 wherein said sympathomimetic comprises an amphetamine.
106. The pharmaceutical safety dosage form of claim 105 wherein said amphetamine is methamphetamine, amphetamine, dextroamphetamine, derivatives thereof, or combinations thereof.
107. The pharmaceutical safety dosage form of claim 105 wherein said antagonist further comprises an adrenergic beta blocker.
108. The pharmaceutical safety dosage form of claim 107 wherein said adrenergic beta blocker is propranolol, atenolol, metoprolol, derivatives thereof, or combinations thereof.
109. The pharmaceutical safety dosage form of claim 89 wherein said pharmaceutical comprises a blood pressure-lowering medication.
110. The pharmaceutical safety dosage form of claim 109 wherein said blood pressure-lowering medication is an adrenergic beta blocker, a calcium channel blocker, or an ACE
inhibitor.
inhibitor.
111. The pharmaceutical safety dosage form of claim 110 wherein said blood pressure-lowering medication is propranolol, metoprolol, nifedipine, diltiazem, nisoldipine, timolol maleate, derivatives thereof, or combinations thereof.
112. The pharmaceutical safety dosage form of claim 109 wherein said antagonist further comprises a sympathomimetic.
113. The pharmaceutical safety dosage form of claim 112 wherein said sympathomimetic is dopamine, epinepherine, derivatives thereof, or combinations thereof.
114. The pharmaceutical safety dosage form of claim 89 wherein said pharmaceutical comprises a hypoglycemic agent.
115. The pharmaceutical safety dosage form of claim 114 wherein said hypoglycemic agent is insulin, metformin, glipizide, glyburide, derivatives thereof, or combinations thereof.
116. The pharmaceutical safety dosage fore of claim 114 wherein said antagonist further comprises a hyperglycemic agent.
117. The pharmaceutical safety dosage form of claim 116 wherein said hyperglycemic agent is epinepherine, glucagon, derivatives thereof, or combinations thereof.
118. A pharmaceutical safety dosage form comprising a pharmaceutical contained within a plurality of particulated forms, said particulated forms being adapted for release of said pharmaceutical within a patient, together with an antagonist for said pharmaceutical, said antagonist comprising an emetic agent and being contained within a microdosage form, said microdosage form being substantially insoluble in gastric fluid.
119. The pharmaceutical safety dosage form of claim 118 wherein said plurality of particulated forms comprise a polymorph which is substantially insoluble in gastric fluid, or said microdosage form comprises a coating which is substantially insoluble in gastric fluid, or both.
120. The pharmaceutical safety dosage form of claim 118 wherein said microdosage form comprises beads, tablets, mini tablets, or combinations thereof.
121. The pharmaceutical safety dosage form of claim 118 adapted to be administered orally.
122. The pharmaceutical safety dosage form of claim 118 adapted to be administered rectally, parenterally, vaginally, transdermally, intranasally, or via aerosol.
123. (Canceled)
124. The pharmaceutical safety dosage form of claim 118 wherein said emetic agent is ipecac or derivatives thereof.
125. The pharmaceutical safety dosage form of claim 118 wherein said pharmaceutical comprises a narcotic.
126. The pharmaceutical safety dosage form of claim 125 wherein said narcotic is codeine, oxycodone, propoxyphene, pentazocine, derivatives thereof, or combinations thereof.
127. The pharmaceutical safety dosage form of claim 125 wherein said antagonist further comprises naloxone, nalmefene, derivatives thereof, or combinations thereof.
128. The pharmaceutical safety dosage form of claim 118 wherein said pharmaceutical comprises a sympathomimetic.
129. The pharmaceutical safety dosage form of claim 128 further comprising an antihistamine.
130. The pharmaceutical safety dosage fore of claim 129 wherein said sympathomimetic is pseudoephedrine HCl or derivatives thereof, and said antihistamine is cetirizine HCl, fexofenadine HCl, derivatives thereof, or combinations thereof.
131. The pharmaceutical safety dosage form of claim 129 wherein said antagonist further comprises an adrenergic beta blocker.
132. The pharmaceutical safety dosage form of claim 128 wherein said sympathomimetic comprises methylphenidate.
133. The pharmaceutical safety dosage form of claim 132 wherein said antagonist further comprises an adrenergic beta blocker.
134. The pharmaceutical safety dosage form of claim 128 wherein said sympathomimetic comprises an amphetamine.
135. The pharmaceutical safety dosage form of claim 134 wherein said amphetamine is methamphetamine, amphetamine, dextroamphetamine, derivatives thereof, or combinations thereof.
136. The pharmaceutical safety dosage form of claim 134 wherein said antagonist further comprises an adrenergic beta blocker.
137. The pharmaceutical safety dosage form of claim 136 wherein said adrenergic beta blocker is propranolol, atenolol, metoprolol, derivatives thereof, or combinations thereof.
138. The pharmaceutical safety dosage form of claim 118 wherein said pharmaceutical comprises a blood pressure-lowering medication.
139. The pharmaceutical safety dosage form of claim 138 wherein said blood pressure-lowering medication is an adrenergic beta blocker, a calcium channel blocker, or an ACE
inhibitor.
inhibitor.
140. The pharmaceutical safety dosage form of claim 139 wherein said blood pressure-lowering medication is propranolol, metoprolol, nifedipine, diltiazem, nisoldipine, timolol maleate, derivatives thereof, or combinations thereof.
141. The pharmaceutical safety dosage form of claim 138 wherein said antagonist further comprises a sympathomimetic.
142. The pharmaceutical safety dosage form of claim 141 wherein said sympathomimetic is dopamine, epinepherine, derivatives thereof, or combinations thereof.
143. The pharmaceutical safety dosage form of claim 118 wherein said pharmaceutical comprises a hypoglycemic agent.
144. The pharmaceutical safety dosage form of claim 143 wherein said hypoglycemic agent is insulin, metformin, glipizide, glyburide, derivatives thereof, or combinations thereof.
145. The pharmaceutical safety dosage form of claim 143 wherein said antagonist further comprises a hyperglycemic agent.
146. The pharmaceutical safety dosage form of claim 145 wherein said hyperglycemic agent is epinepherine, glucagon, derivatives thereof, or combinations thereof.
147. A pharmaceutical safety dosage form comprising a pharmaceutical in a first form adjacent to an antagonist for said pharmaceutical in a second form wherein said antagonist comprises an emetic agent and has significant bioavailability only when said pharmaceutical safety dosage form is disrupted.
148. The pharmaceutical safety dosage of claim 147 wherein said first form is time-release, or said second form comprises an insoluble coating, or both.
149. The pharmaceutical safety dosage form of claim 147 wherein said first form is substantially layered over said second form.
150. The pharmaceutical safety dosage form of claim 147 wherein said second form is substantially layered over said first form.
151. The pharmaceutical safety dosage form of claim 147 wherein said bioavailability occurs upon mechanical disruption.
152. The pharmaceutical safety dosage form of claim 147 wherein said bioavailability occurs upon extraction by a chemical.
153. The pharmaceutical safety dosage form of claim 147 adapted to be administered orally.
154. The pharmaceutical safety dosage form of claim 147 adapted to be administered rectally, parenterally, vaginally, transdermally, intranasally, or via aerosol.
155. (Canceled)
156. The pharmaceutical safety dosage form of claim 147 wherein said emetic agent is ipecac or derivatives thereof.
157. The pharmaceutical safety dosage form of claim 147 wherein said pharmaceutical comprises a narcotic.
158. The pharmaceutical safety dosage form of claim 157 wherein said narcotic is codeine, oxycodone, propoxyphene, pentazocine, derivatives thereof, or combinations thereof.
159. The pharmaceutical safety dosage form of claim 157 wherein said antagonist further comprises naloxone, nalmefene, derivatives thereof, or combinations thereof.
160. The pharmaceutical safety dosage form of claim 147 wherein said pharmaceutical comprises a sympathomimetic.
161. The pharmaceutical safety dosage form of claim 160 further comprising an antihistamine.
162. The pharmaceutical safety dosage form of claim 161 wherein said sympathomimetic is pseudoephedrine HCl or derivatives thereof, and said antihistamine is cetirizine HCl, fexofenadine HCl, derivatives thereof, or combinations thereof.
163. The pharmaceutical safety dosage form of claim 161 wherein said antagonist further comprises an adrenergic beta blocker.
164. The pharmaceutical safety dosage form of claim 160 wherein said sympathomimetic comprises methylphenidate.
165. The pharmaceutical safety dosage form of claim 164. wherein said antagonist further comprises an adrenergic beta blocker.
166. The pharmaceutical safety dosage form of claim 160 wherein said sympathomimetic comprises an amphetamine.
167. The pharmaceutical safety dosage form of claim 166 wherein said amphetamine is methamphetamine, amphetamine, dextroamphetamine, derivatives thereof, or combinations thereof.
168. The pharmaceutical safety dosage form of claim 166 wherein said antagonist further comprises an adrenergic beta blocker.
169. The pharmaceutical safety dosage form of claim 168 wherein said adrenergic beta blocker is propranolol, atenolol, metoprolol, derivatives thereof, or combinations thereof.
170. The pharmaceutical safety dosage form of claim 147 wherein said pharmaceutical comprises a blood pressure-lowering medication.
171. The pharmaceutical safety dosage form of claim 170 wherein said blood pressure-lowering medication is an adrenergic beta blocker, a calcium channel blocker, or an ACE
inhibitor.
inhibitor.
172. The pharmaceutical safety dosage form of claim 171 wherein said blood pressure-lowering medication is propranolol, metoprolol, nifedipine, diltiazem, nisoldipine, timolol maleate, derivatives thereof, or combinations thereof.
173. The pharmaceutical safety dosage form of claim 170 wherein said antagonist further comprises a sympathomimetic.
174. The pharmaceutical safety dosage form of claim 173 wherein said sympathomimetic is dopamine, epinepherine, derivatives thereof, or combinations thereof.
175. The pharmaceutical safety dosage form of claim 147 wherein said pharmaceutical comprises a hypoglycemic agent.
176. The pharmaceutical safety dosage form of claim 175 wherein said hypoglycemic agent is insulin, metformin, glipizide, derivatives thereof, or combinations thereof.
177. The pharmaceutical safety dosage form of claim 175 wherein said antagonist further comprises a hyperglycemic agent.
178. The pharmaceutical safety dosage form of claim 177 wherein said hyperglycemic agent is epinepherine, glucagon, derivatives thereof, or combinations thereof.
179. A method of administering a pharmaceutical comprising:
providing a pharmaceutical safety dosage form comprising a pharmaceutical in a first form, said first form providing a prescribed bioavailability; and providing an antagonist for said pharmaceutical in a second form, said antagonist comprising an emetic agent and said second form providing insignificant bioavailability when administered; and wherein disruption to said pharmaceutical safety dosage form may result in significant bioavailability of said antagonist.
providing a pharmaceutical safety dosage form comprising a pharmaceutical in a first form, said first form providing a prescribed bioavailability; and providing an antagonist for said pharmaceutical in a second form, said antagonist comprising an emetic agent and said second form providing insignificant bioavailability when administered; and wherein disruption to said pharmaceutical safety dosage form may result in significant bioavailability of said antagonist.
180. The method of claim 179 wherein said significant bioavailability occurs upon mechanical disruption.
181. The method of claim 179 wherein said significant bioavailability occurs upon extraction by a chemical.
182. The method of claim 179 wherein said pharmaceutical safety dosage form is adapted to be administered orally.
183. The method of claim 179 wherein said pharmaceutical safety dosage form is adapted to be administered rectally, parenterally, vaginally, transdermally, intranasally, or via aerosol.
184. (Canceled)
185. The method of claim 179 wherein said emetic agent is ipecac or derivatives thereof.
186. The method of claim 179 wherein said pharmaceutical comprises a narcotic.
187. The method of claim 186 wherein said narcotic is codeine, oxycodone, propoxyphene, pentazocine, derivatives thereof, or combinations thereof.
188. The method of claim 186 wherein said antagonist further comprises naloxone, nalmefene, derivatives thereof, or combinations thereof.
189. The method of claim 179 wherein said pharmaceutical comprises a sympathomimetic.
190. The method of claim 189 wherein said pharmaceutical safety dosage form further comprises an antihistamine.
191. The method of claim 190 wherein said sympathomimetic is pseudoephedrine HCl or derivatives thereof, and said antihistamine is cetirizine HCl, fexofenadine HCl, derivatives thereof, or combinations thereof.
192. The method of claim 190 wherein said antagonist further comprises an adrenergic beta blocker.
193. The method of claim 189 wherein said sympathomimetic comprises methylphenidate.
194. The method of claim 193 wherein said antagonist further comprises an adrenergic beta blocker.
195. The method of claim 189 wherein said sympathomimetic comprises an amphetamine.
196. The method of claim 195 wherein said amphetamine is methamphetamine, amphetamine, dextroamphetamine, derivatives thereof, or combinations thereof.
197. The method of claim 196 wherein said antagonist further comprises an adrenergic beta blocker.
198. The method of claim 197 wherein said adrenergic beta blocker is propranolol, atenolol, metoprolol, derivatives thereof, or combinations thereof.
199. The method of claim 179 wherein said pharmaceutical comprises a blood pressure-lowering medication.
200. The method of claim 199 wherein said blood pressure-lowering medication is an adrenergic beta blocker, a calcium channel blocker, or an ACE inhibitor.
201. The method of claim 200 wherein said blood pressure-lowering medication is propranolol, metoprolol, nifedipine, diltiazem, nisoldipine, timolol maleate, derivatives thereof, or combinations thereof.
202. The method of claim 199 wherein said antagonist further comprises a sympathomimetic.
203. The method of claim 202 wherein said sympathomimetic is dopamine, epinepherine, derivatives thereof, or combinations thereof.
204. The method of claim 179 wherein said pharmaceutical comprises a hypoglycemic agent.
205. The method of claim 204 wherein said hypoglycemic agent is insulin, metformin, glipizide, glyburide, derivatives thereof, or combinations thereof.
206. The method of claim 204 wherein said antagonist further comprises a hyperglycemic agent.
207. The method of claim 206 wherein said hyperglycemic agent is epinepherine, glucagon, derivatives thereof, or combinations thereof.
208. A method of delivering a drug to a patient comprising placing said drug into a pharmaceutical safety dosage form further comprising an antagonist for said drug, said antagonist comprising an emetic agent and being insubstantially bioavailable when said dosage form is not disrupted; and administering said safety dosage form to the patient.
209. (Canceled)
210. The method of claim 208 wherein said emetic agent is ipecac or derivatives thereof.
211. A method of delivering a narcotic to a patient comprising placing said narcotic into a pharmaceutical safety dosage form further comprising a narcotic antagonist and an emetic agent, said narcotic antagonist and said emetic agent being insubstantially bioavailable when said dosage form is not disrupted; and administering said safety dosage form to the patient.
212. The method of claim 211 wherein said narcotic is codeine, oxycodone, propoxyphene, pentazocine, derivatives thereof, or combinations thereof.
213. The method of claim 211 wherein said antagonist further comprises naloxone, nalmefene, derivatives thereof, or combinations thereof.
214. A method of delivering a sympathomimetic to a patient comprising placing said sympathomimetic into a pharmaceutical safety dosage form comprising an adrenergic beta blocker, said adrenergic beta blocker being insubstantially bioavailable when said dosage form is not disrupted; and administering said safety dosage form to the patient.
215. The method of claim 214 further delivering an antihistamine along with said sympathomimetic.
216. The method of claim 215 wherein said sympathomimetic and said antihistamine are cetirizine HCl/pseudoephedrine HCl, fexofenadine HCl/pseudoephedrine HCl, derivatives thereof, or combinations thereof.
217. The method of claim 214 wherein said sympathomimetic comprises methylphenidate.
218. The method of claim 214 wherein said sympathomimetic comprises an amphetamine.
219. The method of claim 218 wherein said amphetamine is methamphetamine, amphetamine, dextroamphetamine, derivatives thereof, or combinations thereof.
220. The method of claim 219 wherein said adrenergic beta blocker is propranolol, atenolol, metoprolol, derivatives thereof, or combinations thereof.
221. A method of delivering a blood pressure-lowering medication to a patient comprising placing said blood pressure-lowering medication into a pharmaceutical safety dosage form comprising a sympathomimetic, said sympathomimetic being insubstantially bioavailable when said dosage form is not disrupted; and administering said safety dosage form to the patient.
222. The method of claim 221 wherein said blood pressure-lowering medication is an adrenergic beta blocker, a calcium channel blocker, or an ACE inhibitor.
223. The method of claim 222 wherein said blood pressure-lowering medication is propranolol, metoprolol, nifedipine, diltiazem, nisoldipine, timolol maleate, derivatives thereof, or combinations thereof.
224. The method of claim 221 wherein said sympathomimetic is dopamine, epinepherine, derivatives thereof, or combinations thereof.
225. A method of delivering a hypoglycemic agent to a patient comprising placing said hypoglycemic agent into a pharmaceutical safety dosage form comprising a hyperglycemic agent, said hyperglycemic agent being insubstantially bioavailable when said dosage form is not disrupted; and administering said safety dosage form to the patient.
226. The method of claim 225 wherein said hypoglycemic agent is insulin, metformin, glipizide, glyburide, derivatives thereof, or combinations thereof.
227. The method of claim 225 wherein said hyperglycemic agent is epinepherine, glucagon, derivatives thereof, or combinations thereof.
228. A method of making a pharmaceutical safety dosage form comprising a pharmaceutical and an antagonist for said pharmaceutical wherein said antagonist comprises.
an emetic agent that has significant bioavailability only when said pharmaceutical safety dosage form is disrupted.
an emetic agent that has significant bioavailability only when said pharmaceutical safety dosage form is disrupted.
229. The method of claim 214 wherein said antagonist comprises an emetic agent.
230. The method of claim 221 wherein said antagonist comprises an emetic agent.
231. The method of claim 225 wherein said antagonist comprises an emetic agent.
232. A pharmaceutical safety dosage form comprising a sympathomimetic pharmaceutical and an antagonist for said pharmaceutical wherein said antagonist has significant bioavailability only when said pharmaceutical safety dosage form is disrupted.
233. The pharmaceutical safety dosage of claim 232 wherein said pharmaceutical is adapted for time-release, or said antagonist comprises an insoluble coating, or both.
234. The pharmaceutical safety dosage form of claim 232 wherein said bioavailability occurs upon mechanical disruption.
235. The pharmaceutical safety dosage form of claim 232 wherein said bioavailability occurs upon extraction by a chemical.
236. The pharmaceutical safety dosage form of claim 232 adapted to be administered orally.
237. The pharmaceutical safety dosage form of claim 232 adapted to be administered rectally, parenterally, vaginally, transdermally, intranasally, or via aerosol.
238. The pharmaceutical safety dosage form of claim 232 further comprising an antihistamine.
239. The pharmaceutical safety dosage form of claim 238 wherein said sympathomimetic is pseudoephedrine HCl or derivatives thereof, and said antihistamine is cetirizine HCl, fexofenadine HCl, derivatives thereof, or combinations thereof.
240. The pharmaceutical safety dosage form of claim 238 wherein said antagonist comprises an adrenergic beta blocker.
241. The pharmaceutical safety dosage form of claim 232 wherein said sympathomimetic comprises methylphenidate.
242. The pharmaceutical safety dosage form of claim 241 wherein said antagonist comprises an adrenergic beta blocker.
243. The pharmaceutical safety dosage form of claim 232 wherein said sympathomimetic comprises an amphetamine.
244. The pharmaceutical safety dosage form of claim 243 wherein said amphetamine is methamphetamine, amphetamine, dextroamphetamine, derivatives thereof, or combinations thereof.
245. The pharmaceutical safety dosage form of claim 244 wherein said antagonist comprises an adrenergic beta blocker.
246. The pharmaceutical safety dosage form of claim 245 wherein said adrenergic beta blocker is propranolol, atenolol, metoprolol, derivatives thereof, or combinations thereof.
247. The pharmaceutical safety dosage form of claim 232 wherein said sympathomimetic pharmaceutical is contained within a first microdosage form, said first microdosage form being adapted for release of said sympathomimetic pharmaceutical within a patient and said antagonist is contained within a second microdosage form, said second microdosage form being substantially insoluble in gastric fluid.
248. The pharmaceutical safety dosage form of claim 247 wherein said sympathomimetic pharmaceutical is adapted for time-release, or said second microdosage form comprises a coating which is substantially insoluble in gastric fluid, or both.
249. The pharmaceutical safety dosage form of claim 247 wherein said first microdosage form comprises beads, tablets, mini tablets, or combinations thereof; or second microdosage forms comprises beads, tablets, mini tablets, or combinations thereof; or both.
250. The pharmaceutical safety dosage form of claim 232 wherein said sympathomimetic pharmaceutical is contained within a first plurality of particulated forms, said first particulated forms being adapted for release of said sympathomimetic pharmaceutical within a patient and said antagonist is contained within a second plurality of particulated forms, said second particulated forms being substantially insoluble in gastric fluid.
251. The pharmaceutical safety dosage form of claim 250 wherein said sympathomimetic pharmaceutical is adapted for time-release, or said second plurality of particulated forms comprise a polymorph or a solvate which is substantially insoluble in gastric fluid, or both.
252. The pharmaceutical safety dosage form of claim 251 wherein said first plurality of particulated forms comprises a sustained-release powder.
253. The pharmaceutical safety dosage form of claim 232 wherein said sympathomimetic pharmaceutical is contained within a microdosage form, said microdosage form being adapted for release of said sympathomimetic pharmaceutical within a patient said antagonist is contained within a plurality of particulated dosage forms, said particulated dosage forms being substantially insoluble in gastric fluid.
254. The pharmaceutical safety dosage form of claim 253 wherein said sympathomimetic pharmaceutical is adapted for time-release, or said plurality of particulated forms comprise a polymorph which is substantially insoluble in gastric fluid, or both.
255. The pharmaceutical safety dosage form of claim 253 wherein said microdosage form comprises beads, tablets, mini tablets, or combinations thereof.
256. The pharmaceutical safety dosage form of claim 232 wherein said sympathomimetic pharmaceutical is contained within a plurality of particulated forms, said particulated forms being adapted for release of said sympathomimetic pharmaceutical within a patient and said antagonist is contained within a microdosage form, said microdosage form being substantially insoluble in gastric fluid.
257. The pharmaceutical safety dosage form of claim 256 wherein said plurality of particulated forms comprise a polymorph which is substantially insoluble in gastric fluid, or said microdosage form comprises a coating which is substantially insoluble in gastric fluid, or both.
258. The pharmaceutical safety dosage fore of claim 256 wherein said microdosage form comprises beads, tablets, mini tablets, or combinations thereof.
259. The pharmaceutical safety dosage form of claim 232 wherein said sympathomimetic pharmaceutical is in a first form adjacent to said antagonist, said antagonist being in a second form.
260. The pharmaceutical safety dosage of claim 259 wherein said first form is time-release, or said second form comprises an insoluble coating, or both.
261. The pharmaceutical safety dosage form of claim 259 wherein said first form is substantially layered over said second form.
262. The pharmaceutical safety dosage form of claim 259 wherein said second form is substantially layered over said first form.
263. A pharmaceutical safety dosage form comprising a blood pressure-lowering pharmaceutical and an antagonist for said pharmaceutical wherein said antagonist has significant bioavailability only when said pharmaceutical safety dosage form is disrupted.
264. The pharmaceutical safety dosage of claim 263 wherein said pharmaceutical is adapted for time-release, or said antagonist comprises an insoluble coating, or both.
265. The pharmaceutical safety dosage form of claim 263 wherein said bioavailability occurs upon mechanical disruption.
266. The pharmaceutical safety dosage form of claim 263 wherein said bioavailability occurs upon extraction by a chemical.
267. The pharmaceutical safety dosage form of claim 263 adapted to be administered orally.
268. The pharmaceutical safety dosage form of claim 263 adapted to be administered rectally, parenterally, vaginally, transdermally, intranasally, or via aerosol.
269. The pharmaceutical safety dosage form of claim 263 wherein said blood pressure-lowering medication is an adrenergic beta blocker, a calcium channel blocker, or an ACE
inhibitor.
inhibitor.
270. The pharmaceutical safety dosage form of claim 269 wherein said blood pressure-lowering medication is propranolol, metoprolol, nifedipine, diltiazem, nisoldipine, timolol maleate, derivatives thereof, or combinations thereof.
271. The pharmaceutical safety dosage form of claim 263 wherein said antagonist comprises a sympathomimetic.
272. The pharmaceutical safety dosage form of claim 271 wherein said sympathomimetic is dopamine, epinepherine, derivatives thereof, or combinations thereof.
273. The pharmaceutical safety dosage form of claim 263 wherein said hypoglycemic pharmaceutical is contained within a first microdosage form, said first microdosage form being adapted for release of said sympathomimetic pharmaceutical within a patient and said antagonist is contained within a second microdosage form, said second microdosage form being substantially insoluble in gastric fluid.
274. The pharmaceutical safety dosage form of claim 273 wherein said hypoglycemic pharmaceutical is adapted for time-release, or said second microdosage form comprises a coating which is substantially insoluble in gastric fluid, or both.
275. The pharmaceutical safety dosage form of claim 273 wherein said first microdosage form comprises beads, tablets, mini tablets, or combinations thereof; or second microdosage forms comprises beads, tablets, mini tablets, or combinations thereof; or both.
276. The pharmaceutical safety dosage form of claim 263 wherein said hypoglycemic pharmaceutical is contained within a first plurality of particulated forms, said first particulated forms being adapted for release of said hypoglycemic pharmaceutical within a patient and said antagonist is contained within a second plurality of particulated forms, said second particulated forms being substantially insoluble in gastric fluid.
277. The pharmaceutical safety dosage form of claim 276 wherein said hypoglycemic pharmaceutical is adapted for time-release, or said second plurality of particulated forms comprise a polymorph or a solvate which is substantially insoluble in gastric fluid, or both.
278. The pharmaceutical safety dosage form of claim 277 wherein said first plurality of particulated forms comprises a sustained-release powder.
279. The pharmaceutical safety dosage form of claim 263 wherein said hypoglycemic pharmaceutical is contained within a microdosage form, said microdosage form being adapted for release of said hypoglycemic pharmaceutical within a patient said antagonist is contained within a plurality of particulated dosage forms, said particulated dosage forms being substantially insoluble in gastric fluid.
280. The pharmaceutical safety dosage form of claim 279 wherein said hypoglycemic pharmaceutical is adapted for time-release, or said plurality of particulated forms comprise a polymorph which is substantially insoluble in gastric fluid, or both.
281. The pharmaceutical safety dosage form of claim 279 wherein said microdosage form comprises beads, tablets, mini tablets, or combinations thereof.
282. The pharmaceutical safety dosage form of claim 263 wherein said hypoglycemic pharmaceutical is contained within a plurality of particulated forms, said particulated forms being adapted for release of said hypoglycemic pharmaceutical within a patient and said antagonist is contained within a microdosage form, said microdosage form being substantially insoluble in gastric fluid.
283. The pharmaceutical safety dosage form of claim 282 wherein said plurality of particulated forms comprise a polymorph which is substantially insoluble in gastric fluid, or said microdosage form comprises a coating which is substantially insoluble in gastric fluid, or both.
284. The pharmaceutical safety dosage form of claim 282 wherein said microdosage form comprises beads, tablets, mini tablets, or combinations thereof.
285. The pharmaceutical safety dosage form of claim 263 wherein said hypoglycemic pharmaceutical is in a first form adjacent to said antagonist, said antagonist being in a second form.
286. The pharmaceutical safety dosage of claim 285 wherein said first form is time-release, or said second form comprises an insoluble coating, or both.
287. The pharmaceutical safety dosage form of claim 285 wherein said first form is substantially layered over said second form.
288. The pharmaceutical safety dosage form of claim 285 wherein said second form is substantially layered over said first form.
289. A pharmaceutical safety dosage form comprising a hypoglycemic pharmaceutical and an antagonist for said pharmaceutical wherein said antagonist has significant bioavailability only when said pharmaceutical safety dosage form is disrupted.
290. The pharmaceutical safety dosage of claim 289 wherein said pharmaceutical is adapted for time-release, or said antagonist comprises an insoluble coating, or both.
291. The pharmaceutical safety dosage form of claim 289 wherein said bioavailability occurs upon mechanical disruption.
292. The pharmaceutical safety dosage form of claim 289 wherein said bioavailability occurs upon extraction by a chemical.
293. The pharmaceutical safety dosage form of claim 289 adapted to be administered orally.
294. The pharmaceutical safety dosage form of claim 289 adapted to be administered rectally, parenterally, vaginally, transdermally, intranasally, or via aerosol.
295. The pharmaceutical safety dosage form of claim 289 wherein said hypoglycemic agent is insulin, metformin, glipizide, glyburide, derivatives thereof, or combinations thereof.
296. The pharmaceutical safety dosage form of claim 289 wherein said antagonist comprises a hyperglycemic agent.
297. The pharmaceutical safety dosage form of claim 289 wherein said hypoglycemic pharmaceutical is contained within a first microdosage form, said first microdosage form being adapted for release of said sympathomimetic pharmaceutical within a patient and said antagonist is contained within a second microdosage form, said second microdosage form being substantially insoluble in gastric fluid.
298. The pharmaceutical safety dosage form of claim 297 wherein said hypoglycemic pharmaceutical is adapted for time-release, or said second microdosage form comprises a coating which is substantially insoluble in gastric fluid, or both.
299. The pharmaceutical safety dosage form of claim 297 wherein said first microdosage form comprises beads, tablets, mini tablets, or combinations thereof; or second microdosage forms comprises beads, tablets, mini tablets, or combinations thereof; or both.
300. The pharmaceutical safety dosage form of claim 289 wherein said hypoglycemic pharmaceutical is contained within a first plurality of particulated forms, said first particulated forms being adapted for release of said hypoglycemic pharmaceutical within a patient and said antagonist is contained within a second plurality of particulated forms, said second particulated forms being substantially insoluble in gastric fluid.
301. The pharmaceutical safety dosage form of claim 300 wherein said hypoglycemic pharmaceutical is adapted for time-release, or said second plurality of particulated forms comprise a polymorph or a solvate which is substantially insoluble in gastric fluid, or both.
302. The pharmaceutical safety dosage form of claim 301 wherein said first plurality of particulated forms comprises a sustained-release powder.
303. The pharmaceutical safety dosage form of claim 289 wherein said hypoglycemic pharmaceutical is contained within a microdosage form, said microdosage form being adapted for release of said hypoglycemic pharmaceutical within a patient said antagonist is contained within a plurality of particulated dosage forms, said particulated dosage forms being substantially insoluble in gastric fluid.
304. The pharmaceutical safety dosage form of claim 303 wherein said hypoglycemic pharmaceutical is adapted for time-release, or said plurality of particulated forms comprise a polymorph which is substantially insoluble in gastric fluid, or both.
305. The pharmaceutical safety dosage form of claim 303 wherein said microdosage form comprises beads, tablets, mini tablets, or combinations thereof.
306. The pharmaceutical safety dosage form of claim 289 wherein said hypoglycemic pharmaceutical is contained within a plurality of particulated forms, said particulated forms being adapted for release of said hypoglycemic pharmaceutical within a patient and said antagonist is contained within a microdosage form, said microdosage form being substantially insoluble in gastric fluid.
307. The pharmaceutical safety dosage form of claim 306 wherein said plurality of particulated forms comprise a polymorph which is substantially insoluble in gastric fluid, or said microdosage form comprises a coating which is substantially insoluble in gastric fluid, or both.
308. The pharmaceutical safety dosage form of claim 306 wherein said microdosage form comprises beads, tablets, mini tablets, or combinations thereof.
309. The pharmaceutical safety dosage form of claim 289 wherein said hypoglycemic pharmaceutical is in a first form adjacent to said antagonist, said antagonist being in a second form.
310. The pharmaceutical safety dosage of claim 309 wherein said first form is time-release, or said second form comprises an insoluble coating, or both.
311. The pharmaceutical safety dosage form of claim 309 wherein said first form is substantially layered over said second form.
312. The pharmaceutical safety dosage form of claim 309 wherein said second form is substantially layered over said first form.
313. A pharmaceutical safety dosage form comprising a pharmaceutical which is substantially free of a narcotic and an antagonist for said pharmaceutical wherein said antagonist has significant bioavailability only when said pharmaceutical safety dosage form is disrupted.
314. A method of administering a pharmaceutical comprising providing a pharmaceutical safety dosage form comprising a pharmaceutical in a first form, said pharmaceutical being substantially free of a narcotic and said first form providing a prescribed bioavailability; and providing an antagonist for said pharmaceutical in a second form, said second form providing insignificant bioavailability when administered; and wherein disruption to said pharmaceutical safety dosage form may result in significant bioavailability of said antagonist.
315. A method of making a pharmaceutical safety dosage form comprising a pharmaceutical which is substantially free of a narcotic and an antagonist for said pharmaceutical wherein said antagonist has significant bioavailability only when said pharmaceutical safety dosage form is disrupted.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CA2735280A CA2735280A1 (en) | 2003-01-10 | 2003-12-18 | Pharmaceutical safety dosage forms |
Applications Claiming Priority (3)
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US10/339,977 US7524515B2 (en) | 2003-01-10 | 2003-01-10 | Pharmaceutical safety dosage forms |
US10/339,977 | 2003-01-10 | ||
PCT/US2003/040990 WO2004062642A1 (en) | 2003-01-10 | 2003-12-18 | Pharmaceutical safety dosage forms |
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CA2735280A Division CA2735280A1 (en) | 2003-01-10 | 2003-12-18 | Pharmaceutical safety dosage forms |
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CA2505661A1 true CA2505661A1 (en) | 2004-07-29 |
CA2505661C CA2505661C (en) | 2011-06-14 |
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CA2735280A Abandoned CA2735280A1 (en) | 2003-01-10 | 2003-12-18 | Pharmaceutical safety dosage forms |
CA2505661A Expired - Fee Related CA2505661C (en) | 2003-01-10 | 2003-12-18 | Pharmaceutical safety dosage forms |
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CA2735280A Abandoned CA2735280A1 (en) | 2003-01-10 | 2003-12-18 | Pharmaceutical safety dosage forms |
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US (2) | US7524515B2 (en) |
EP (1) | EP1581188A4 (en) |
JP (1) | JP2006514067A (en) |
AU (1) | AU2003299826A1 (en) |
CA (2) | CA2735280A1 (en) |
TW (1) | TWI265812B (en) |
WO (1) | WO2004062642A1 (en) |
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