CA2735280A1 - Pharmaceutical safety dosage forms - Google Patents
Pharmaceutical safety dosage forms Download PDFInfo
- Publication number
- CA2735280A1 CA2735280A1 CA2735280A CA2735280A CA2735280A1 CA 2735280 A1 CA2735280 A1 CA 2735280A1 CA 2735280 A CA2735280 A CA 2735280A CA 2735280 A CA2735280 A CA 2735280A CA 2735280 A1 CA2735280 A1 CA 2735280A1
- Authority
- CA
- Canada
- Prior art keywords
- pharmaceutical
- dosage form
- safety dosage
- antagonist
- microdosage
- 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.)
- Abandoned
Links
- 239000002552 dosage form Substances 0.000 title claims abstract 38
- 239000005557 antagonist Substances 0.000 claims abstract 24
- 239000002895 emetic Substances 0.000 claims abstract 8
- 239000008280 blood Substances 0.000 claims abstract 7
- 210000004369 blood Anatomy 0.000 claims abstract 7
- 239000000150 Sympathomimetic Substances 0.000 claims abstract 6
- 230000001975 sympathomimetic effect Effects 0.000 claims abstract 6
- 239000003795 chemical substances by application Substances 0.000 claims abstract 4
- 239000012530 fluid Substances 0.000 claims 9
- 230000002496 gastric effect Effects 0.000 claims 9
- 239000011324 bead Substances 0.000 claims 4
- 239000011248 coating agent Substances 0.000 claims 4
- 238000000576 coating method Methods 0.000 claims 4
- 239000008185 minitablet Substances 0.000 claims 4
- 239000003826 tablet Substances 0.000 claims 4
- 229940079593 drug Drugs 0.000 claims 3
- 239000003814 drug Substances 0.000 claims 3
- VYFYYTLLBUKUHU-UHFFFAOYSA-N dopamine Chemical compound NCCC1=CC=C(O)C(O)=C1 VYFYYTLLBUKUHU-UHFFFAOYSA-N 0.000 claims 2
- AQHHHDLHHXJYJD-UHFFFAOYSA-N propranolol Chemical compound C1=CC=C2C(OCC(O)CNC(C)C)=CC=CC2=C1 AQHHHDLHHXJYJD-UHFFFAOYSA-N 0.000 claims 2
- 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 1
- 239000005541 ACE inhibitor Substances 0.000 claims 1
- 229940127291 Calcium channel antagonist Drugs 0.000 claims 1
- 244000284152 Carapichea ipecacuanha Species 0.000 claims 1
- 239000009471 Ipecac Substances 0.000 claims 1
- UCTWMZQNUQWSLP-UHFFFAOYSA-N adrenaline Chemical compound CNCC(O)C1=CC=C(O)C(O)=C1 UCTWMZQNUQWSLP-UHFFFAOYSA-N 0.000 claims 1
- 230000001800 adrenalinergic effect Effects 0.000 claims 1
- 239000000443 aerosol Substances 0.000 claims 1
- 229940044094 angiotensin-converting-enzyme inhibitor Drugs 0.000 claims 1
- 239000002876 beta blocker Substances 0.000 claims 1
- 229940097320 beta blocking agent Drugs 0.000 claims 1
- 239000000480 calcium channel blocker Substances 0.000 claims 1
- 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 1
- 229960004166 diltiazem Drugs 0.000 claims 1
- 229960003638 dopamine Drugs 0.000 claims 1
- 238000000605 extraction Methods 0.000 claims 1
- 229940029408 ipecac Drugs 0.000 claims 1
- 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 1
- 229960002237 metoprolol Drugs 0.000 claims 1
- IUBSYMUCCVWXPE-UHFFFAOYSA-N metoprolol Chemical compound COCCC1=CC=C(OCC(O)CNC(C)C)C=C1 IUBSYMUCCVWXPE-UHFFFAOYSA-N 0.000 claims 1
- 229960001597 nifedipine Drugs 0.000 claims 1
- 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 1
- 229960000227 nisoldipine Drugs 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 229960003712 propranolol Drugs 0.000 claims 1
- 239000012453 solvate Substances 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 238000013268 sustained release Methods 0.000 claims 1
- 239000012730 sustained-release form Substances 0.000 claims 1
- 229960005221 timolol maleate Drugs 0.000 claims 1
- 239000004615 ingredient Substances 0.000 abstract 2
- 230000000694 effects Effects 0.000 abstract 1
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
The invention provides a pharmaceutical safety dosage form comprising a pharmaceutical and an antagonist for said pharmaceutical wherein said antagonist comprises an emetic agent and has bioavailability only when said pharmaceutical safety dosage form is disrupted, and wherein the pharmaceutical is a blood pressure-lowering agent and the antagonist optionally further comprises a sympathomimetic. The invention also provides a pharmaceutical safety dosage form comprising a pharmaceutical and an antagonist for said pharmaceutical wherein said antagonist has bioavailability only when said pharmaceutical safety dosage form is disrupted, and wherein the pharmaceutical is a blood pressure-lowering agent and the antagonist is a sympathomimetic. The pharmaceutical safety dosage forms of the present invention are useful for providing pharmaceutical ingredients in forms which can minimize the effects of abusive or otherwise inappropriate use of the pharmaceutical ingredients.
Claims (29)
1. A pharmaceutical safety dosage form comprising a pharmaceutical and an antagonist for said pharmaceutical wherein said antagonist comprises an emetic agent and has bioavailability only when said pharmaceutical safety dosage form is disrupted, and wherein the pharmaceutical is a blood pressure-lowering agent and the antagonist optionally further comprises a sympathomimetic.
2. A pharmaceutical safety dosage form comprising a pharmaceutical and an antagonist for said pharmaceutical wherein said antagonist has bioavailability only when said pharmaceutical safety dosage form is disrupted, and wherein the pharmaceutical is a blood pressure-lowering agent and the antagonist is a sympathomimetic.
3. The pharmaceutical safety dosage of claim 1 or 2, wherein said pharmaceutical is adapted for time-release, or said antagonist further comprises an insoluble coating, or both.
4. The pharmaceutical safety dosage form of claim 1 or 2, wherein said bioavailability occurs upon mechanical disruption.
5. The pharmaceutical safety dosage form of claim 1 or 2, wherein said bioavailability occurs upon extraction by a chemical.
6. The pharmaceutical safety dosage form of claim 1 or 2, adapted to be administered orally.
7. The pharmaceutical safety dosage form of claim 1 or 2, adapted to be administered rectally, parenterally, vaginally, transdermally, intranasally, or via aerosol.
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 or 2, wherein said pharmaceutical comprises a blood pressure-lowering medication.
10. The pharmaceutical safety dosage form of claim 9, wherein said blood pressure-lowering medication is an adrenergic beta blocker, a calcium channel blocker, or an ACE inhibitor.
11. The pharmaceutical safety dosage form of claim 9 wherein said blood pressure-lowering medication is propranolol, metoprolol, nifedipine, diltiazem, nisoldipine, timolol maleate, derivatives thereof, or combinations thereof.
12. The pharmaceutical safety dosage form of claim 1 wherein said antagonist further comprises a sympathomimetic.
13. The pharmaceutical safety dosage form of claim 1 or 2, wherein said sympathomimetic is dopamine, epinepherine, derivatives thereof, or combinations thereof.
14. The pharmaceutical safety dosage form of any one of claims 1 to 13, wherein the pharmaceutical is contained within a first microdosage form, said first microdosage form being adapted for release of said pharmaceutical within a patient, and the antagonist for said pharmaceutical, said antagonist comprising an emetic agent, is contained within a second microdosage form, said second microdosage form being substantially insoluble in gastric fluid.
15. The pharmaceutical safety dosage form of claim 14, 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.
16. The pharmaceutical safety dosage form of claim 14, wherein said first microdosage form comprises beads, tablets, mini tablets, or combinations thereof; or said second microdosage forms comprises beads, tablets, mini tablets, or combinations thereof; or both.
17. The pharmaceutical safety dosage form of any one of claims 1 to 13, wherein the pharmaceutical is contained within a first plurality of particulated forms, said first particulated forms being adapted for release of said pharmaceutical within a patient, and the antagonist for said pharmaceutical, said antagonist comprising the emetic agent, is contained within a second plurality of particulated forms, said second particulated forms being substantially insoluble in gastric fluid.
18. The pharmaceutical safety dosage form of claim 17, 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.
19. The pharmaceutical safety dosage form of claim 17, wherein said first plurality of particulated forms comprises a sustained-release powder.
20. The pharmaceutical safety dosage form of any one of claims 1 to 13, wherein the pharmaceutical is contained within a microdosage form, said microdosage form being adapted for release of said pharmaceutical within a patient, and the antagonist for said pharmaceutical, said antagonist comprising the emetic agent is contained within a plurality of particulated dosage forms, said particulated dosage forms being substantially insoluble in gastric fluid.
21. The pharmaceutical safety dosage form of claim 20, 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.
22. The pharmaceutical safety dosage form of claim 20, wherein said microdosage form comprises beads, tablets, mini tablets, or combinations thereof.
23. The pharmaceutical safety dosage form of any one of claims 1 to 13, wherein the pharmaceutical is contained within a plurality of particulated forms, said particulated forms being adapted for release of said pharmaceutical within a patient, and the antagonist for said pharmaceutical, said antagonist comprising the emetic agent, is contained within a microdosage form, said microdosage form being substantially insoluble in gastric fluid.
24. The pharmaceutical safety dosage form of claim 23, 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.
25. The pharmaceutical safety dosage form of claim 23, wherein said microdosage form comprises beads, tablets, mini tablets, or combinations thereof.
26. The pharmaceutical safety dosage form according to any one of claims 1 to 13, wherein the pharmaceutical is in a first form adjacent to an antagonist for said pharmaceutical in a second form wherein said antagonist comprises the emetic agent and has bioavailability only when said pharmaceutical safety dosage form is disrupted.
27. The pharmaceutical safety dosage of claim 26, wherein said first form is time-release, or said second form comprises an insoluble coating, or both.
28. The pharmaceutical safety dosage form of claim 26, wherein said first form is substantially layered over said second form.
29. The pharmaceutical safety dosage form of claim 26, wherein said second form is substantially layered over said first form.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/339,977 | 2003-01-10 | ||
| US10/339,977 US7524515B2 (en) | 2003-01-10 | 2003-01-10 | Pharmaceutical safety dosage forms |
| CA2505661A CA2505661C (en) | 2003-01-10 | 2003-12-18 | Pharmaceutical safety dosage forms |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2505661A Division CA2505661C (en) | 2003-01-10 | 2003-12-18 | Pharmaceutical safety dosage forms |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2735280A1 true CA2735280A1 (en) | 2004-07-29 |
Family
ID=23331375
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| 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 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2505661A Expired - Fee Related CA2505661C (en) | 2003-01-10 | 2003-12-18 | Pharmaceutical safety dosage forms |
Country Status (7)
| Country | Link |
|---|---|
| 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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| CA2452871C (en) * | 2001-07-06 | 2011-10-04 | Endo Pharmaceuticals, Inc. | Oxymorphone controlled release formulations |
| US8329216B2 (en) * | 2001-07-06 | 2012-12-11 | Endo Pharmaceuticals Inc. | Oxymorphone controlled release formulations |
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| AU2002337686B2 (en) * | 2001-09-26 | 2008-05-15 | Penwest Pharmaceuticals Company | Opioid formulations having reduced potential for abuse |
| AU2003270778B2 (en) | 2002-09-20 | 2009-10-08 | Alpharma Pharmaceuticals, Llc | Sequestering subunit and related compositions and methods |
| US7524515B2 (en) * | 2003-01-10 | 2009-04-28 | Mutual Pharmaceuticals, Inc. | Pharmaceutical safety dosage forms |
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| CA2536816A1 (en) * | 2003-08-12 | 2005-03-03 | Endo Pharmaceuticals, Inc. | Method for deterring abuse of opioids by combination with non-release formulation of emetic |
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-
2003
- 2003-01-10 US US10/339,977 patent/US7524515B2/en active Active
- 2003-12-18 AU AU2003299826A patent/AU2003299826A1/en not_active Abandoned
- 2003-12-18 CA CA2735280A patent/CA2735280A1/en not_active Abandoned
- 2003-12-18 EP EP03800100A patent/EP1581188A4/en not_active Ceased
- 2003-12-18 JP JP2004566589A patent/JP2006514067A/en active Pending
- 2003-12-18 WO PCT/US2003/040990 patent/WO2004062642A1/en active Application Filing
- 2003-12-18 CA CA2505661A patent/CA2505661C/en not_active Expired - Fee Related
-
2004
- 2004-01-09 TW TW093100493A patent/TWI265812B/en not_active IP Right Cessation
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2009
- 2009-03-16 US US12/404,372 patent/US7919120B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| US20030124061A1 (en) | 2003-07-03 |
| US7524515B2 (en) | 2009-04-28 |
| CA2505661A1 (en) | 2004-07-29 |
| CA2505661C (en) | 2011-06-14 |
| AU2003299826A1 (en) | 2004-08-10 |
| TWI265812B (en) | 2006-11-11 |
| EP1581188A4 (en) | 2006-04-05 |
| US7919120B2 (en) | 2011-04-05 |
| WO2004062642A1 (en) | 2004-07-29 |
| JP2006514067A (en) | 2006-04-27 |
| EP1581188A1 (en) | 2005-10-05 |
| TW200505506A (en) | 2005-02-16 |
| WO2004062642B1 (en) | 2004-10-21 |
| US20090175950A1 (en) | 2009-07-09 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |
Effective date: 20141218 |