CA2476496A1 - Controlled release dosage forms - Google Patents

Controlled release dosage forms Download PDF

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Publication number
CA2476496A1
CA2476496A1 CA002476496A CA2476496A CA2476496A1 CA 2476496 A1 CA2476496 A1 CA 2476496A1 CA 002476496 A CA002476496 A CA 002476496A CA 2476496 A CA2476496 A CA 2476496A CA 2476496 A1 CA2476496 A1 CA 2476496A1
Authority
CA
Canada
Prior art keywords
coating composition
controlled release
release coating
amount
stable controlled
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
Application number
CA002476496A
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French (fr)
Other versions
CA2476496C (en
Inventor
Fang Zhou
Paul J. Maes
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Valeant International Bermuda
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Individual
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Application filed by Individual filed Critical Individual
Publication of CA2476496A1 publication Critical patent/CA2476496A1/en
Application granted granted Critical
Publication of CA2476496C publication Critical patent/CA2476496C/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
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
    • 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
    • A61K9/2009—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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Abstract

The invention provides stable controlled release monolithic coating compositions for use in coating pharmaceutical oral dosage forms comprising a polyglycol having a melting point greater than 55~C and an aqueous dispersio n of a neutral ester copolymer lacking functional groups.

Claims (40)

Claims:
1. A stable controlled release monolithic coating composition for use in coating a pharmaceutical oral dosage form, said coating comprising:
a) an aqueous dispersion of a neutral ester copolymer without any functional groups;
b) a poly glycol having a melting point greater than 55°C, and c) one or more pharmaceutically acceptable excipients;
wherein said coating composition is coated onto said pharmaceutical oral dosage form and cured at a temperature at least equal to or greater than the melting point of said poly glycol.
2. The stable controlled release coating composition of claim 1 wherein said neutral ester copolymer without any functional groups is selected from the group consisting of Eudragit NE30D, Eudragit NE40D and any combination thereof.
3. The stable controlled release coating composition of claim 2 wherein said neutral ester copolymer without any functional groups is NE30D.
4. The stable controlled release coating composition of claim of claim 1 wherein said neutral ester copolymer without any functional groups is present in an amount of from about 1% to about 35% by weight of the coating composition.
5. The stable controlled release coating composition of claim 4 wherein said neutral ester copolymer without any functional groups is present in an amount of from about 1% to about 25% by weight of the coating composition.
6. The stable controlled release coating composition of claim 5 wherein said neutral ester copolymer without any functional groups is present in an amount of from about 1% to about 7%.
7. The stable controlled release coating composition of claim 1 wherein said poly glycol is selected from the group consisting of polyethylene glycol 8000, polyethylene glycol 10000, polyethylene glycol 20000, Poloxamer 188, Poloxamer 338, Poloxamer 407, Polyethylene Oxides, Polyoxyethylene Alkyl Ethers, Polyoxyethylene Sorbitan Fatty Acid Esters, and Polyoxyethylene Stearates.
8. The stable controlled release coating composition of claim 1 wherein said poly glycol is selected from the group consisting of polyethylene glycol 8000, polyethylene glycol 10000, polyethylene glycol 20000 and any combination thereof.
9. The stable controlled release coating composition of claim 8 wherein said polyethylene glycol is polyethylene glycol 8000.
10. The stable controlled release coating composition of claim 1 wherein said polyethylene glycol or derivative thereof is present in an amount of from about 0.1% to about 10% by weight of the coat composition.
11. The stable controlled release coating composition of 10 wherein said polyethylene glycol or derivative there of is present in an amount of from about 0.1% to about 5% by weight of the coat composition.
12. The controlled release coating composition of claim 11 wherein said polyethylene glycol or derivative thereof is present in an amount of from about 0.1% to about 3% by weight of the coat composition.
13. The controlled release coating composition of claim 12 wherein said polyethylene glycol or derivative thereof is present in an amount of from about 0.1% to about 0.5% by weight of the coat composition.
14. The stable controlled release coating composition of claim 1 wherein the one or more pharmaceutically acceptable excipients is selected from the group consisting of anti-tacking agents, emulsifying agents, hydrophilic agents, anti-foaming agents, flavourants, colourants, sweeteners and any combination thereof.
15. The stable controlled release coating composition of claim 14 wherein the anti-tacking agent is selected from the group consisting of adipic acid, magnesium stearate, calcium stearate, zinc stearate, hydrogenated vegetable oils, sterotex, glyceryl monostearate, talc, sodium benzoate, sodium lauryl sulfate, magnesium lauryl sulfate and any combination thereof.
16. The stable controlled release coating composition of claim 15 wherein the anti-tacking agent is talc.
17. The stable controlled release coating composition of claim 15 wherein the anti-tacking agent is present in an amount of from about 1% to about 15% by weight of the coating composition.
18. The stable controlled release coating composition of claim 16 wherein the anti-tacking agent is present in an amount of from about 1% to about 7%.
19. The stable controlled release coating composition of claim 14 wherein said hydrophilic agent is selected from the group consisting of hydroxypropyl cellulose, hydroxypropyl methylcellulose and any combination thereof.
20. The stable controlled release coating composition of claim 19 wherein said hydrophilic agent is hydroxypropyl methylcellulose.
21. The stable controlled release coating composition of claim 19 wherein said hydrophilic agent is present in an amount from about 0.1% to about 10% by weight of the coat composition.
22. The stable controlled release coating composition of claim 21 wherein said hydrophilic agent is present in an amount from about 0.1% to about 6% by weight of the coat composition.
23The stable controlled release coating composition of claim 22 wherein said hydrophilic agent is present in an amount from about 0.1% to about 3% by weight of the coating composition.
24. The stable controlled release coating composition of claim 14 wherein said anti-foaming agent is selected from the group consisting of silicon oil, simethicone and any combination thereof.
25. The stable controlled release coating composition of claim 24 wherein said anti-foaming agent is simethicone.
26. The stable controlled release coating composition of claim 24 wherein said anti-foaming agent is present in an amount up to about 0.5% by weight of the coating composition.
27. The stable controlled release coating composition of claim 26 wherein said anti-foaming agent is present in an amount from about 0.1% to about 0.4% by weight of the coating composition.
28. The stable controlled release coating composition of claim 14 wherein said emulsifying agent is selected from the group consisting of polysaccharides, glycerol esters, cellulose ethers, sorbitan esters, polysorbates and any combination thereof.
29. The stable controlled release coating composition of claim 28 wherein said polysorbate is polyoxyethylene sorbitan mono-oleate.
30. The stable controlled release coating composition of claim 29 wherein said polyoxyethylene sorbitan mono-oleate is present in an amount of up to about 0.5% by weight of the coat composition.
31. The stable controlled release coating composition of claim 30 wherein said polyoxyethylene sorbitan mono-oleate is present in an amount of from about 0.1% to about 0.3% by weight of the coat composition.
32. The stable controlled release coating composition of claim 14 wherein said colorant is selected from group consisting of iron oxide pigments, titanium dioxide, aluminum Lakes and any combination thereof.
33. The stable controlled release coating composition of claim 32 wherein said colorant is titanium dioxide.
34. The stable controlled release coating composition of claim 32 wherein said colorant is present in an amount of from about 0.1% to about 10% by weight of the coat composition.
35. The stable controlled release coating composition of claim 34 wherein said colorant is present in an amount of from about 0.1% to about 5% by weight of the coat composition.
36. The stable controlled release coating composition of claim 35 wherein said colorant is present in an amount of from about 0.1% to about 2% by weight of the coat composition.
37. The stable controlled release coating composition of claim 1 wherein said pharmaceutical oral dosage form is selected from the group consisting of tablets and capsules.
38. A stable controlled release monolithic coating composition for use in coating a pharmaceutical oral dosage form, said coating comprising an aqueous dispersion of Eudragit NE30D, polyethylene glycol 8000, hydroxypropyl methylcellulose, talc, simethicone, titanium dioxide, and polyoxyethylene sorbitan mono-oleate, said Eudragit NE30D is present in an amount of from about 1% to about 35% by weight of the coat composition, said polyethylene glycol is present in an amount of from about 0.1% to about 3% by weight of the coat composition, said hydroxypropyl methylcellulose is present in an amount of from about 0.1%
to about 6% by weight of the coat composition, said talc is present in an amount of from about 0.1% to about 7% by weight of the coat composition, said simethicone is present in an amount up to about 0.5% by weight of the coat composition, said polyoxyethylene sorbitan mono-oleate is present in an amount of up to about 0.5% by weight of the coat composition, said titanium dioxide is present in an amount of from about 0.% to about 2% by weight of the coat composition; and composition is coated onto said pharmaceutical oral dosage form and cured at a temperature at least equal to or greater than the melting point of said polyglycol.
39. The controlled release oral dosage form of claim 38, wherein said pharmaceutical dosage form is selected from the group consisting of tablets and capsules
40. A controlled release oral dosage form comprising:
a) a core, wherein said core comprises:
i) an effective amount of at least one therapeutically active agent, and ii) one or more first pharmaceutically acceptable excipients, and b) a stable controlled release monolithic coating composition for coating said core, said coating composition comprising:
i) an aqueous dispersion of a neutral ester copolymer without any functional groups;
ii) a poly glycol having a melting point greater than 55°C, and iii) one or more second pharmaceutically acceptable excipients;
wherein said coating composition is coated onto said core and cured at a temperature at least equal to or greater than the melting point of the poly glycol.
CA002476496A 2002-02-21 2003-02-21 Controlled release dosage forms Expired - Fee Related CA2476496C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US35785102P 2002-02-21 2002-02-21
US60/357,851 2002-02-21
PCT/US2003/004867 WO2003072089A1 (en) 2002-02-21 2003-02-21 Controlled release dosage forms

Publications (2)

Publication Number Publication Date
CA2476496A1 true CA2476496A1 (en) 2003-09-04
CA2476496C CA2476496C (en) 2009-12-15

Family

ID=27765948

Family Applications (2)

Application Number Title Priority Date Filing Date
CA002476201A Expired - Fee Related CA2476201C (en) 2002-02-21 2003-02-21 Modified release formulations of at least one form of tramadol
CA002476496A Expired - Fee Related CA2476496C (en) 2002-02-21 2003-02-21 Controlled release dosage forms

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA002476201A Expired - Fee Related CA2476201C (en) 2002-02-21 2003-02-21 Modified release formulations of at least one form of tramadol

Country Status (15)

Country Link
US (4) US7780987B2 (en)
EP (2) EP1476139B1 (en)
JP (3) JP5069395B2 (en)
AT (1) ATE536173T1 (en)
AU (2) AU2003211146B2 (en)
CA (2) CA2476201C (en)
CY (1) CY1112517T1 (en)
DK (1) DK1476138T3 (en)
ES (2) ES2627842T3 (en)
MX (2) MXPA04008164A (en)
NO (1) NO20043913L (en)
NZ (2) NZ535455A (en)
PT (1) PT1476138E (en)
SI (1) SI1476138T1 (en)
WO (2) WO2003072089A1 (en)

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