CA2440588A1 - Chronotherapeutic dosage forms - Google Patents

Chronotherapeutic dosage forms Download PDF

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Publication number
CA2440588A1
CA2440588A1 CA002440588A CA2440588A CA2440588A1 CA 2440588 A1 CA2440588 A1 CA 2440588A1 CA 002440588 A CA002440588 A CA 002440588A CA 2440588 A CA2440588 A CA 2440588A CA 2440588 A1 CA2440588 A1 CA 2440588A1
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CA
Canada
Prior art keywords
dosage form
delayed release
oral solid
solid dosage
core
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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
CA002440588A
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French (fr)
Other versions
CA2440588C (en
Inventor
Anand R. Baichwal
Paul Woodcock
Raymond Higgins
Jaclyn Cobb
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Penwest Pharmaceuticals Co
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Individual
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Publication of CA2440588A1 publication Critical patent/CA2440588A1/en
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Publication of CA2440588C publication Critical patent/CA2440588C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • 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
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic compounds
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • 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
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

A chronotherpautic pharmaceutical formulation comprising a core containing a n active agent (e.g. drug) and a delayed release compression coating comprisin g a natural or synthetic gum applied onto the surface of the core.

Claims (57)

1. A delayed release oral solid dosage form, comprising a core comprising a therapeutically effective amount of a drug, and a delayed release material compression coated onto said core, said delayed release material comprising one or more natural or synthetic gums, said compression coating delaying the release of said drug from said dosage form until after a period of time from about 2 to about 18 hours after exposure of the dosage form to an aqueous solution.
2. The delayed release oral solid dosage form of claim 1, wherein said one or more natural or synthetic gums are agglomerated with a saccharide material prior to being compression coated onto said core.
3. The delayed release oral solid dosage form of claim 1, which delays release of said drug until at least about 4 hours after exposure of the dosage form to an aqueous solution.
4. The delayed release oral solid dosage form of claim 1, wherein said gums comprise a mixture of xanthan gum and locust bean gum.
5. The delayed release oral solid dosage form of claim 4, wherein said delayed release material further comprises an ionizable gel strength enhancing agent selected from the group consisting of 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, sodium fluoride, and mixtures thereof.
6. The delayed release oral solid dosage form of claim 5, wherein said ionizable gel strength enhancing agent is calcium sulfate.
7. The delayed release oral solid dosage form of claim 1, wherein said delayed release material further comprises a surfactant selected from the group consisting of anionic surfactants, cationic surfactants, amphoteric (amphipathic/ amphophilic) surfactants, and non-ionic surfactants.
8. The delayed release oral solid dosage form of claim 1, wherein said delayed release material further comprises a hydrophobic material.
9. The delayed release oral solid dosage form of claim 8, wherein said hydrophobic material is selected from the group consisting of an alkylcellulose, a copolymer of acrylic and methacrylic acid esters, waxes, shellac, zero, hydrogenated vegetable oil, and mixtures thereof, in an amount effective to slow the hydration of said gelling agent when exposed to an environmental fluid.
10. The delayed release oral solid dosage form of claim 10, wherein said hydrophobic material comprises ethylcellulose.
11. The delayed release oral solid dosage form of claim 2, wherein said saccharide is selected from the group consisting of sucrose, dextrose, lactose, fructose, mannitol, and mixtures thereof.
12. The delayed release oral solid dosage form of claim 1, wherein said core further comprises from about 5 to about 20 percent disintegrant, by weight.
13. The delayed release oral solid dosage form of claim 12, wherein said disintegrant is a superdisintegrant.
14. The delayed release oral solid dosage form of claim 12, wherein said disintegrant is selected from the group consisting of starch, veegum, crospovidone, cellulose, kaolin, microcrystalline cellulose, crosslinked polyvinyl pyrrolidone, and mixtures thereof.
15. The delayed release oral solid dosage form of claim 13, wherein said superdisintegrant is selected from the group consisting of croscarmellose sodium, crospovidone, crosslinked carboxy methyl cellulose, sodium starch glycolate, and mixtures thereof.
16. The delayed release oral solid dosage form of claim 1, wherein said inner core further comprises an inert diluent selected from the group consisting of sucrose, dextrose, lactose, microcrystalline cellulose, fructose, xylitol, sorbitol, mannitol, starches, mixtures thereof.
17. The delayed release oral solid dosage form of claim 1, wherein said core is an immediate release core.
18. The delayed release oral solid dosage form of claim 1, wherein said core is further comprises a sustained release carrier.
19. A delayed release oral solid dosage form comprising:
a core comprising a therapeutically effective amount of a drug, and an agglomerated delayed release material compression coated onto said core, said agglomerated delayed release material comprising a gum selected from the group consisting of a homopolysaccharide, a heteropolysaccharide, and a mixture of a homopolysaccharide and a heteropolysaccharide, together with a pharmaceutically acceptable excipient, said compression coating delaying the release of said drug from said dosage form for a predetermined period of time after exposure of the dosage form to an aqueous solution.
20. The delayed release oral solid dosage form of claim 1, wherein said heteropolysaccharide gum is in an amount of from about 20 to about 80 percent of the delayed release coating and said homopolysaccharide gum is in an amount of from about 80 to about 20 percent of the delayed release coating.
21. The delayed release oral solid dosage form of claim2l, wherein said heteropolysaccharide gum is xanthan gum and said homopolysaccharide gum is locust bean gum.
22. The delayed release oral solid dosage form of claim 20, wherein said core further comprises an effective amount of disintegrant.
23. A delayed release oral solid dosage form comprising:
a core comprising a therapeutically effective amount of a drug and an effective amount of a disintegrant, and an agglomerated delayed release material compression coated onto said core, said agglomerated delayed release material consisting essentially of one or more natural or synthetic pharmaceutically acceptable gums and one or more optional pharmaceutical excipients, said compression coating delaying the release of said drug from said dosage form for a predetermined period of time after exposure of the dosage form to an aqueous solution.
24. The delayed release oral solid dosage form of claim 23, wherein said core comprises from about 5 to about 20 percent disintegrant, by weight.
25. The delayed release oral solid dosage form of claim 24, wherein said disintegrant is selected from the group consisting of starch, veegum, crospovidone, cellulose, kaolin, microcrystalline cellulose, crosslinked polyvinyl pyrrolidone, and mixtures thereof.
26. The delayed release oral solid dosage form of claim 24, wherein said disintegrant is selected from the group consisting of croscarmellose sodium, crospovidone, crosslinked carboxy methyl cellulose, sodium starch glycolate, and mixtures thereof.
27. The delayed release oral solid dosage form of claim 22 which delays the release of said drug until at least about 4 hours after exposure of the dosage form to an aqueous solution.
28. The delayed release oral solid dosage form of claim 22, wherein said gums comprise a mixture of xanthan gum and locust bean gum.
29. A delayed release oral solid dosage form comprising:
a core comprising a therapeutically effective amount of a drug and a disintegrant, and a delayed release material compression coated onto said core, said delayed release material comprising one or more natural or synthetic gums, said compression coating delaying the release of said drug from said dosage form for a predetermined period of time after exposure of the dosage form to an aqueous solution, said disintegrant being included in said core in an amount effective to cause the release of at least about 50 percent of said drug into said aqueous solution within one hour after said predetermined period of time.
30. The delayed release oral solid dosage form of claim 29, wherein said disintegrant comprises from about 5 to about 20 percent of said core, by weight.
31. The delayed release oral solid dosage form of claim 29, wherein said disintegrant comprises from about about 0.1 to about 5 percent of said oral solid dosage form, by weight.
32. The delayed release oral solid dosage form of claim 29, wherein said disintegrant is a superdisintegrant.
33. The delayed release oral solid dosage form of claim 32, wherein said superdisintegrant is selected from the group consisting of croscarmellose sodium, crospovidone, crosslinked carboxy methyl cellulose, sodium starch glycolate, and mixtures thereof.
34. The delayed release oral solid dosage form of claim 29, wherein said gums comprise a mixture of xanthan gum and locust bean gum.
35. The delayed release oral solid dosage form of claim 34, wherein said xanthan gum and said locust bean gum are agglomerated with a saccharide material prior to compression coating onto said core.
36. A delayed release oral solid tablet, comprising:

a tablet core comprising a therapeutically effective amount of a drug, and a delayed release material compression coated onto said core, said delayed release material comprising one or more natural or synthetic gums, said gums comprising from about 6.5 percent to about 83 percent of the tablet by weight, said compression coating delaying the release of said drug from said dosage form for a period of time from about 2 to about 18 hours after exposure of the dosage form to an aqueous solution.
37. The delayed release oral solid tablet of claim 36, wherein said tablet core further comprises from about 5 to about 20% superdisintegrant.
38. A chronotherapeutic, delayed release oral solid dosage form for a low dose drug, comprising a core comprising from about 0.01 mg to about 40 mg drug together with optional pharmaceutically acceptable excipients, and a delayed release material compression coated onto said core, said delayed release material comprising one or more natural or synthetic gums, said compression coating comprising from about 75 to about 94 percent by weight of the oral solid dosage form, and the ratio of the core to gum in said compression coating being from about 1:0.37 to about 1:5, by weight, said compression coating delaying the release of said drug from said dosage form for a period of time from about 2 to about 18 hours after exposure of the dosage form to an aqueous solution.
39. The oral solid dosage form of claim 38, wherein the total weight of said dosage form is from about 220 mg to about 900 mg.
40. The oral solid dosage form of claim 38, wherein the core weight is from about 50 mg to about 170 mg.
41. The oral solid dosage form of claim 38, wherein said core is from about 5 to about 23 percent by weight of the total weight of the dosage form.
42. The oral solid dosage form of claim 38, wherein said compression coating is from about 150 mg to about 850 mg.
43. The oral solid dosage form of claim 38, wherein said coating is from about 78 to 80 percent by weight of the total weight of the dosage form.
44. The oral solid dosage form of claim 38, wherein the ratio of the core to gum in the compression coating is from about 1:0.37 to about 1:1.12, most preferably from about 1:0.75.
45. The oral solid dosage form of claim 38, wherein the ratio of the core to compression coating is preferably from about 1:2 to about 1:9, by weight.
46. A chronotherapeutic, delayed release oral solid dosage form for a relatively high dose drug, comprising a core comprising from about 41 mg to about 300 mg of a drug, and a delayed release material compression coated onto said core, said delayed release material comprising one or more natural or synthetic gums, the ratio of the core to gum in said compression coating being from about 1:0.3 to about 1:3, by weight, the total weight of said oral solid dosage form being from about 500 mg to about 1500 mg, said compression coating delaying the release of said drug from said dosage form for a period of time from about 2 to about 18 hours after exposure of the dosage form to an aqueous solution.
47. The oral solid dosage form of claim 46, wherein the ratio of the core to gum in said compression coating is from about 1:0.6 to about 1:1.5, by weight.
48. The oral solid dosage form of claim 46, wherein the ratio of the core to compression coating is from about 1:1 to about 1:5, by weight.
49. The oral solid dosage form of claim 46, wherein the ratio of the core to compression coating is from about 1:2 to about 1:3.
50. The oral solid dosage form of claim 46, wherein the total weight of the dosage form is from about 750 mg to about 1000 mg.
51. A method of preparing a chronotherapeutic oral solid dosage form of a drug, comprising:
preparing a core comprising a therapeutically effective amount of a drug and from about 5 to about 20% disintegrant, by weight of the core, preparing a granulate of a delayed release material comprising one or more natural or synthetic gums, compression coating said granulate onto said core, said compression coating delaying the release of said drug from said dosage form until after a period of time from about 2 to about 18 hours after exposure of the dosage form to an aqueous solution.
52. The method of claim 51, further comprising preparing said granulate of delayed release material by wet granulating one or more natural or synthetic gums together with at least one pharmaceutically acceptable excipient, and drying the resultant granulate to obtain agglomerated particles of said delayed release material.
53. The method of claim 52, further comprising granulating said drug, said disintegrant, and a pharmaceutically acceptable inert diluent prior to said compression coating step.
54. The method of claim 53, wherein said disintegrant is a superdisintegrant incorporated into said core in an amount said disintegrant being included in said core in an amount effective to cause the release of at least about 50 percent of said drug into said aqueous solution within one hour upon completion of the time period for said delayed release.
55. The use of the oral solid dosage form of claims 1, 19, 23, 29, 36, 38 or in the preparation of a chronotherapeutic medicament, which delays release of said drug until at least about 4 hours after exposure of the dosage form to gastrointestinal fluid.
56. The oral solid dosage form claim 55, wherein after oral administration of the dosage form, the drug is not released from the dosage form for about 4 to about 12 hours.
57. The oral solid dosage form of claim 55, wherein after oral administration of the dosage form, the drug is released over a time period of at least about 4 hours after the period of delay is completed.
CA2440588A 2001-03-13 2002-03-13 Chronotherapeutic dosage forms Expired - Fee Related CA2440588C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US27538201P 2001-03-13 2001-03-13
US60/275,382 2001-03-13
PCT/US2002/007936 WO2002072034A2 (en) 2001-03-13 2002-03-13 Chronotherapeutic dosage forms

Publications (2)

Publication Number Publication Date
CA2440588A1 true CA2440588A1 (en) 2002-09-19
CA2440588C CA2440588C (en) 2010-02-09

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Family Applications (2)

Application Number Title Priority Date Filing Date
CA002440641A Abandoned CA2440641A1 (en) 2001-03-13 2002-03-13 Chronotherapeutic dosage forms containing glucocorticosteroid
CA2440588A Expired - Fee Related CA2440588C (en) 2001-03-13 2002-03-13 Chronotherapeutic dosage forms

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA002440641A Abandoned CA2440641A1 (en) 2001-03-13 2002-03-13 Chronotherapeutic dosage forms containing glucocorticosteroid

Country Status (15)

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US (4) US20030190360A1 (en)
EP (2) EP1368005B9 (en)
JP (3) JP5005157B2 (en)
KR (1) KR20040047747A (en)
CN (1) CN1499960A (en)
AP (1) AP1748A (en)
AU (2) AU2002244295B2 (en)
CA (2) CA2440641A1 (en)
EA (1) EA008224B1 (en)
ES (1) ES2436523T3 (en)
HU (1) HUP0501071A3 (en)
IL (3) IL157633A0 (en)
MX (2) MXPA03008293A (en)
NZ (1) NZ527832A (en)
WO (2) WO2002072033A2 (en)

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