CA2566793A1 - A novel dosage form - Google Patents

A novel dosage form Download PDF

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Publication number
CA2566793A1
CA2566793A1 CA002566793A CA2566793A CA2566793A1 CA 2566793 A1 CA2566793 A1 CA 2566793A1 CA 002566793 A CA002566793 A CA 002566793A CA 2566793 A CA2566793 A CA 2566793A CA 2566793 A1 CA2566793 A1 CA 2566793A1
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CA
Canada
Prior art keywords
vehicle according
sodium
vehicle
pharmaceutical composition
gellan gum
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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
Application number
CA002566793A
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French (fr)
Other versions
CA2566793C (en
Inventor
Daniel Bar-Shalom
Lillian Slot
Gina Fischer
Pernille Hoyrup Hemmingsen
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Adare Pharma Solutions Inc
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Individual
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Publication of CA2566793A1 publication Critical patent/CA2566793A1/en
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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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0015—Devices specially adapted for taking medicines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0015—Devices specially adapted for taking medicines
    • A61J7/0023—Spoons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0015—Devices specially adapted for taking medicines
    • A61J7/0046—Cups, bottles or bags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

Abstract

A novel dosage form. The dosage form is presented in particulate form and before oral ingestion the particulate material is subjected to an aqueous medium, whereby it is converted to a semi-solid form by swelling or gelling of one or more of the components, especially of a gellan gum, of the particulate matter. The invention also relates to a vehicle for oral administration of one or more active substances, the vehicle comprising a gellan gum arranged in a configuration allowing optimal water diffusion so that upon addition of a predetermined amount of an aqueous medium, without the necessity of applying shear forces or other mixing forces, within a time period of 5 minutes or less swells and/or gels and the texture of the swelled vehicle being similar to that of a soft pudding and having a viscosity of at least about 10,000 cps as measured by a Brookfield Viscometer with a #4 LV spindle at 6 rpm and at 20-25~C. In one embodiment of the invention, the particulate matter can be moulded into a desired shape or pressed onto a dispensing unit such as a spoon.

Claims (58)

1. A vehicle for oral administration of one or more active substances, the vehicle comprising a gellan gum arranged in a configuration allowing optimal water diffusion so that upon addition of a predetermined amount of an aqueous medium, without the necessity of applying shear forces or other mixing forces, within a time period of 5 minutes or less swells and/or gels and the texture of the swelled vehicle being similar to that of a soft pudding and having a viscosity of at least about 10,000 cps as measured by a Brookfield Viscometer with a #4 LV spindle at 6 rpm and at 20-25 °C.
2. A vehicle according to claim 1, wherein the viscosity is in a range from about 10,000 to about 99,000 cps.
3. A vehicle according to claim 1 or 2 further comprising a swelling and/or gelling agent selected from hydrocolloids and hydrogelling agents such as alginic acid, sodium alginate, potassium alginate, ammonium alginate, calcium alginate, propane-1,2-diol alginate, agar, carrageenan, processed eucheuma seaweed, locust bean gum, guar gum, tragacanth, acacia gum, xanthan gum, karaya gum, tara gum, konjac, pectins, cellulose derivatives such as: methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl methyl cellulose, carboxy methyl cellulose, sodium carboxy methyl cellulose, crosslinked sodium carboxy methyl cellulose, enzymatically hydrolysed carboxy methyl cellulose, gelatine, or mixtures thereof.
4. A vehicle according to any of the preceding claims, wherein the gellan gum has a mean particle size within 25 mesh to 300 mesh.
5. A vehicle according to any of the preceding claims, wherein the gellan gum is acylated within a degree of 0 to 4 per every two repeats of the glucose-rhamnose-glucose-glucuronic acid unit of the polymer.
6. A vehicle according to claim 5, wherein the gellan gum has a degree of acylation of one glycerate per repeat and one acetate per every two repeats.
7. A vehicle according to any of the preceding claims, which - when contacted with water - forms a micro-porous hydrogel having a pore size of at the most 4 A.
8. A vehicle according to any of claims 1-6, which - when contacted with water - forms a macro-porous hydrogel having a pore size of from about 4 to about 15 A.
9. A vehicle according to any of the preceding claims further comprising an agent that improves swelling of the gellan gum.
10. A vehicle according to claim 9, wherein the agent is a hydrophilic agent selected from the group consisting of electrolytes, organic acids and osmotic agents, and mixtures thereof.
11. A vehicle according to claim 9 or 10, wherein the agent is an osmotic agent selected from the group consisting of hydrophilic vinyl and acryl polymers, poly saccharides, PEO, PEG, PPG, poly(2-hydroxyethyl methacrylate), poly(acrylic)acid, poly(methacrylic)acid, PVP, PVA, PVA/PVP copolymers, HEC, HPC, HPMC, CMC, CEC, sodium alginate, polycarbophil, gelatine and sodium starch glycolate, and mixtures thereof.
12. A vehicle according to any of claims 9-11, wherein the agent is an osmotic agent selected from the group consisting of PEO, PEG, PVP, HPMC and polyacrylic acid, and mixtures thereof.
13. A vehicle according to any of claims 9-12, wherein the agent is an osmotic agent selected from the group consisting of magnesium sulfate, magnesium chloride, calcium chloride, sodium chloride, lithium chloride, potassium sulfate, sodium carbonate, sodium sulfite, lithium sulfate, potassium chloride, sodium sulfate, mannitol, xylitol, urea, sorbitol, inositol, raffinose, sucrose, glucose, fructose, lactose, inulin, instant sugar, citric acid, succinic acid, tartaric acid, and mixtures thereof.
14. A vehicle according to any of claims 9-13, wherein the agent is an osmotic agent selected from the group consisting of glucose, lactose, sucrose, mannitol, xylitol and sodium chloride, and mixtures thereof.
15. A vehicle according to claim 9, wherein the agent is an electrolyte is a ionizable substance that is selected from the group consisting of monovalent, divalent, or multivalent ionizable salts.
16. A vehicle according to claim 15, wherein the salt is selected from inorganic salts, including various alkali metal and/or alkaline earth metal sulfates, chlorides, borates, bromides, etc., and ionizable alkaline earth organic salts such as citrates, acetates, lactates, etc.
17. A vehicle according to claim 16, wherein the salt is selected from calcium sulfate, sodium chloride, potassium sulfate, sodium carbonate, lithium chloride, tripotassium phosphate, sodium borate, potassium bromide, potassium fluoride, sodium bicarbonate, calcium chloride, magnesium chloride, sodium citrate, sodium acetate, calcium lactate, magnesium sulfate, alkali metal chlorides, sodium fluoride, organic acids such s citric, succinic, fumaric, malic, maleic, glutaric, lactic and the like; alkali metal sulfates such as sodium sulfate; dihydrogen sodium phosphate, monohydrogen sodium phosphate, disodium hydrogen phosphate, and mixtures thereof, and multivalent metal cations.
18. A vehicle according to claim 17, wherein the salt is calcium sulfate or sodium chloride.
19. A vehicle according to claim 9, wherein the agent is an organic acid selected from the group consisting of benzoic acid, succinic acid, citric acid and adipic acid and other pharmaceutically approved organic acids.
20. A vehicle according to any of the preceding claims further comprising one or more additives selected from the group consisting of surfactants, coloring agents, sweetening agents, taste-masking agents, antioxidants, polysaccharides, sugars, wetting agents, UV-absorbers, suspending agents, stabilizers, solubilizers, preservatives, processing aids, pH controlling agents, plasticizers, odor masking agents, nutrients, flavouring agents, flavour masking agents, emulsifiers, thickening agents, dispersing agents, crystal grow inhibitors, crystallization promoters, chelating agents, buffers, bases, and antimicrobials, and mixtures thereof.
21. A vehicle according to any of the preceding claims further comprising glycerol.
22. A vehicle according to any of the preceding claims comprising a pH-adjusting agent selected from the group consisting of any material which is suitable to adjust the pH of an aqueous gel such as, e.g., sodium bicarbonate, sodium phosphate, sodium hydroxide, ammonium hydroxide, sodium stannate, triethanolamine, citric acid, hydrochloric acid, sodium citrate, and combinations thereof.
23. A vehicle according to claim 22, wherein the pH adjusting agent is present in an amount so as to adjust the pH of the gel formed upon addition of an aqueous medium to about 4.5 to about 11, preferably from about 5 to about 9, and more preferably from about 5 to about 8.
24. A vehicle according to claim 22, wherein the pH adjusting agent is present in an amount of from about 0.01% to about 15% w/w such as, e.g., from about 0.05% to about 5% w/w.
25. A vehicle according to any of the preceding claims comprising a wetting agent selected from the group consisting of pharmaceutically acceptable anionic surfactants, cationic surfactants, amphoteric (amphipathic/amphophilic) surfactants, and non-ionic surfactants including poloxamer, PEG, and PEO; alkane metal sulfates, wherein the alkyl group is from 1 to 14 carbon atoms, such as sodium methyl sulfate, sodium lauryl sulfate and the like as well as dioctyl sodium sulfosuccinate.
26. A vehicle according to any of the preceding claims in the form of a powder blend.
27. A vehicle according to any of claims 1-25 in the form of granules, beads, oblates or pellets.
28. A vehicle according to any of the preceding claims, wherein at least one of the additives as defined in any of claims 9-24 and/or the swelling and/or gelling agent is added to a granulate material.
29. A vehicle according to any of claims 1-25 in the form of a granulate.
30. A vehicle according to any of the preceding claims further comprising one or more active substances.
31. A vehicle according to claim 30, wherein an active substance is present in admixture with the vehicle.
32. A vehicle according to claim 28 or 29, wherein an active substance is present in the granulate.
33. A vehicle according to claim 30, wherein the active substance is present in a coated and/or microencapsulated form or embedded in a matrix.
34. A vehicle according to claim 30, wherein the active substance is present in a form that allows for controlled release of the active substance.
35. A vehicle according to any of the preceding claims, wherein the vehicle passes the drop down test described herein.
36. A pharmaceutical composition for oral administration comprising one or more active substances and a gellan gum arranged in a configuration allowing optimal water diffusion so that upon addition of a predetermined amount of an aqueous medium, without the necessity of applying shear forces or other mixing forces, within a time period of 5 minutes or less, the composition swells and/or gels and the texture of the swelled composition being similar to that of a soft pudding and having a viscosity of at least about 10,000 cps as measured by a Brookfield Viscometer with a #4 LV
spindle at 6 rpm and at 20-25 °C.
37. A pharmaceutical composition according to claim 36 comprising one or more active substances and a vehicle comprising gellan gum as defined in any of claims 1-35.
38. A pharmaceutical composition according to claim 37, wherein the active substance is in admixture with the vehicle.
39. A pharmaceutical composition according to claim 37, wherein the active substance and the vehicle is in the form of granules, beads, oblates or pellets.
40. A pharmaceutical composition according to claims 37, wherein the active substance and the vehicle is in the form of a granulate.
41. A pharmaceutical composition according to any of claims 36-40, which passes the drop down test described herein.
42. A pharmaceutical composition according to any of claims 36-41 in the form of a solid dosage form.
43. A pharmaceutical composition according to claim 42 in the form of a unit dosage form.
44. A pharmaceutical composition according to any of claims 36-43 in the form of a dosage kit comprising a dispensing unit incorporating the solid dosage form.
45. A pharmaceutical composition according to claim 44, wherein the dispensing unit is a spoon.
46. A dispensing unit comprising a pharmaceutical composition for oral administration comprising one or more active substances and a gellan gum arranged in a configuration allowing optimal water diffusion so that upon addition of a predetermined amount of an aqueous medium, without the necessity of applying shear forces or other mixing forces, within a time period of 5 minutes or less, the composition swells and/or gels and the texture of the swelled composition being similar to that of a soft pudding and having a viscosity of at least about 10,000 cps as measured by a Brookfield Viscometer with a #4 LV spindle at 6 rpm and at 20-25 °C.
47. A dispensing unit according to claim 46, wherein the pharmaceutical composition is as defined in any of claims 36-45.
48. A dispensing unit according to claim 46 or 47 in unit dosage form.
49. A dispensing unit according to any of claims 46-48, wherein the pharmaceutical composition is adhered or glued to a surface of the dispensing unit.
50. A dispensing unit according to any of claims 46-49 having a concave surface.
51. A dispensing unit according to any of claims 46-50 in the form of a spoon.
52. A dispensing unit according to claim 51 in which the pharmaceutical composition is adhered or glued to the concave part of the spoon.
53. A dispensing unit according to any of claims 49-52, wherein the glue comprises one or more components in liquid form or in solution selected from the group consisting of sugar alcohols, sugars, polyvinylpyrrolidone (PVP), gums.
54. A dispensing unit according to any of claism 49-53, wherein the glue comprises a mixture of PVP and glycerol.
55. A method for preparing a pharmaceutical composition according to any of claims 36-45, the method comprising blending the dry components to a homogeneous mixture and optionally granulating the mixture with a binder.
56. A method for preparing a pharmaceutical composition according to any of claims 36-45 comprising one or more excipients and/or active ingredients which have a solubility substantial lower than the solubility of the gellan gum.
57. A method according to claim 56 comprising i) granulating a first blend comprising gellan gum but essentially not containing the one or more excipients and/or active ingredients which have a solubility substantial lower than the solubility of the gellan gum, ii) adding the one or more excipients and/or active ingredients which have a solubility substantial lower than the solubility of the gellan gum to the granulated first blend.
58. A method according to claim 57 wherein the one or more excipients and/or active ingredients which have a solubility substantial lower than the solubility of the gellan gum is added to the granulated first blend as a blend or granulate with additional excipients.
CA2566793A 2004-05-11 2005-05-11 A novel dosage form Active CA2566793C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DKPA200400755 2004-05-11
DKPA200400755 2004-05-11
PCT/DK2005/000317 WO2005107713A2 (en) 2004-05-11 2005-05-11 Swellable dosage form comprising gellan gum

Publications (2)

Publication Number Publication Date
CA2566793A1 true CA2566793A1 (en) 2005-11-17
CA2566793C CA2566793C (en) 2013-07-16

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Family Applications (1)

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CA2566793A Active CA2566793C (en) 2004-05-11 2005-05-11 A novel dosage form

Country Status (8)

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US (2) US8383154B2 (en)
EP (2) EP1758557B1 (en)
JP (1) JP5154924B2 (en)
AT (1) ATE516019T1 (en)
CA (1) CA2566793C (en)
DK (2) DK1758557T3 (en)
ES (2) ES2517244T3 (en)
WO (1) WO2005107713A2 (en)

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