CA2617351A1 - Diltiazem controlled release formulation and method of manufacture - Google Patents
Diltiazem controlled release formulation and method of manufacture Download PDFInfo
- Publication number
- CA2617351A1 CA2617351A1 CA002617351A CA2617351A CA2617351A1 CA 2617351 A1 CA2617351 A1 CA 2617351A1 CA 002617351 A CA002617351 A CA 002617351A CA 2617351 A CA2617351 A CA 2617351A CA 2617351 A1 CA2617351 A1 CA 2617351A1
- Authority
- CA
- Canada
- Prior art keywords
- dosage formulation
- diltiazem
- extended release
- hours
- pellets
- 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.)
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Classifications
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- 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
- A61K9/5078—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 with drug-free core
-
- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/554—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem
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- 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
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
-
- 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
- A61K9/2072—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
- A61K9/48—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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
Abstract
A controlled release diltiazem dosage formulation comprising a plurality of diltiazem pellets and a gel-forming material where the time of maximum diltiazem blood plasma levels occurs more than 8 hours after administration and preferably more than 10 hours after administration.
Claims (34)
1. A controlled release oral pharmaceutical dosage formulation comprising a plurality of extended release diltiazem pellets and a gel-forming material wherein the time of maximum blood plasma diltiazem concentration occurs more than 8 hours after administration of the dosage formulation.
2. The dosage formulation as defined in claim 1 wherein the time of maximum blood plasma diltiazem concentration occurs more than 9 hours after administration of the dosage formulation.
3. The dosage formulation as defined in claim 1 wherein the time of maximum blood plasma diltiazem concentration occurs between 10 and 15 hours after administration of the dosage formulation.
4. The dosage formulation as defined in claim 1 wherein the time of maximum blood plasma diltiazem concentration occurs between 10 and 13 hours after administration of the dosage formulation.
5. The dosage formulation as defined in claim 1 wherein the plurality of diltiazem pellets are a homogeneous population of extended release coated diltiazem pellets.
6. The dosage formulation as defined in claim 1 wherein the plurality of diltiazem pellets is a heterogeneous population of pellets.
7. The dosage formulation as defined in claim 6 wherein the heterogeneous population comprises a combination of active diltiazem pellets and extended release coated pellets.
8. The dosage formulation as defined in claim 6 wherein the heterogeneous population comprises a combination of at least two types of extended release coated pellets.
9. The dosage formulation as defined in claim 6 wherein the heterogeneous population comprises a combination of at least three types of extended release coated pellets.
10. The dosage formulation as defined in claim 8 wherein each type of extended release coated pellet comprises the same extended release coating but with different coating thickness.
11. The dosage formulation as defined in claim 8 wherein each type of extended release coated pellet comprises a different extended release coating material.
12. The dosage formulation as defined in claim 11 wherein one type of the extended release coated pellets employs an enteric coating material.
13. The dosage formulation as defined in claim 9 wherein each type of extended release coated pellet comprises the same extended release coating, and wherein each extended release coated pellet has a different coating thickness.
14. The dosage formulation as defined in claim 9 wherein each type of extended release coated pellet comprises a different extended release coating material.
15. The dosage formulation as defined in claim 1 that exhibits the following dissolution profile when tested in a USP type 1 apparatus at 75 rpm in 900 ml of simulated intestinal fluid and at 37°C:
after 1 hour 0-30% of the diltiazem is released;
after 4 hours 0-40% of the diltiazem is released;
after 12 hours not less than 30% of the diltiazem is released;
and not less than 60% of the diltiazem is released after 24 hours.
after 1 hour 0-30% of the diltiazem is released;
after 4 hours 0-40% of the diltiazem is released;
after 12 hours not less than 30% of the diltiazem is released;
and not less than 60% of the diltiazem is released after 24 hours.
16. The dosage formulation as defined in Claim 15 that exhibits the following dissolution profile when tested in a USP type 1 apparatus at 75 rpm in 900 ml of simulated intestinal fluid and at 37°C:
after 1 hour 0-20% of the diltiazem is released;
after 4 hours 0-30% of the diltiazem is released;
after 12 hours not less than 40% of the diltiazem is released;
and not less than 70% of the diltiazem is released after 24 hours.
after 1 hour 0-20% of the diltiazem is released;
after 4 hours 0-30% of the diltiazem is released;
after 12 hours not less than 40% of the diltiazem is released;
and not less than 70% of the diltiazem is released after 24 hours.
17. The dosage formulation as defined in claim 1 further comprising a flux enhancer.
18. The dosage formulation as defined in claim 17 further comprising a filler, a flow aid, a glidant, a lubricant, a disintegrant or a combination of the foregoing.
19. A controlled release oral pharmaceutical dosage formulation comprising a plurality of extended release diltiazem pellets; a gel-forming material; a flux enhancer, a lubricant and a filler wherein the time of maximum blood plasma diltiazem concentration occurs between 10 and 15 hours after administration of the dosage formulation.
20. The dosage formulation as defined in claim 19 wherein the time of maximum blood plasma diltiazem concentration occurs between 10 and 13 hours after administration of the dosage formulation.
21. The dosage formulation as defined in claim 19 wherein the plurality of diltiazem pellets is a homogeneous population of extended release coated diltiazem pellets.
22. The dosage formulation as defined in claim 19 wherein the plurality of diltiazem pellets is a heterogeneous population of pellets.
23. The dosage formulation as defined in claim 22 wherein the heterogeneous population comprises a combination of active diltiazem pellets and extended release coated pellets.
24. The dosage formulation as defined in claim 22 wherein the heterogeneous population comprises a combination of at least two types of extended release coated pellets.
25. The dosage formulation as defined in claim 22 wherein the heterogeneous population comprises a combination of at least three types of extended release coated pellets.
26. The dosage formulation as defined in claim 24 wherein each type of extended release coated pellet comprises the same extended release coating but with different coating thickness.
27. The dosage formulation as defined in claim 24 wherein each type of extended release coated pellet comprises a different extended release coating material.
28. The dosage formulation as defined in claim 27 wherein one type of the extended release coated pellets employs an enteric coating material.
29. The dosage formulation as defined in claim 25 wherein each type of extended release coated pellet comprises the same extended release coating but with different coating thickness.
30. The dosage formulation as defined in claim 25 wherein each type of extended release coated pellet comprises a different extended release coating material.
31. The dosage formulation as defined in claim 19 that exhibits the following dissolution profile when tested in a USP type 1 apparatus at 75 rpm in 900 ml of simulated intestinal fluid (pH 7.5 phosphate buffer) and at 37°C:
after 1 hour 0-30% of the diltiazem is released;
after 4 hours 0-40% of the diltiazem is released;
after 12 hours not less than 40% of the diltiazem is released;
and not less than 60% of the diltiazem is released after 24 hours.
after 1 hour 0-30% of the diltiazem is released;
after 4 hours 0-40% of the diltiazem is released;
after 12 hours not less than 40% of the diltiazem is released;
and not less than 60% of the diltiazem is released after 24 hours.
32. The dosage formulation as defined in claim 31 that exhibits the following dissolution profile when tested in a USP type 1 apparatus at 75 rpm in 900 ml of simulated intestinal fluid (pH 7.5 phosphate buffer) and at 37°C:
after 1 hour 0-20% of the diltiazem is released;
after 4 hours 0-30% of the diltiazem is released;
after 12 hours not less than 50% of the diltiazem is released;
and not less than 70% of the diltiazem is released after 24 hours.
after 1 hour 0-20% of the diltiazem is released;
after 4 hours 0-30% of the diltiazem is released;
after 12 hours not less than 50% of the diltiazem is released;
and not less than 70% of the diltiazem is released after 24 hours.
33. A controlled release oral pharmaceutical dosage formulation consisting essentially of a heterogeneous population of at least three types of extended release coated diltiazem pellets; a gel-forming material; a flux enhancer, a lubricant and a filler wherein the time of maximum blood plasma diltiazem concentration occurs between 10 and 15 hours after administration of the dosage formulation.
34. The dosage formulation as defined in claim 33 wherein the extended release coating of the heterogeneous population comprises the same coating material but with different coating thickness.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/201,747 | 2005-08-11 | ||
US11/201,747 US8778395B2 (en) | 2005-08-11 | 2005-08-11 | Diltiazem controlled release formulation and method of manufacture |
PCT/US2006/031052 WO2007021754A2 (en) | 2005-08-11 | 2006-08-10 | Diltiazem controlled release formulation and method of manufacture |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2617351A1 true CA2617351A1 (en) | 2007-02-22 |
CA2617351C CA2617351C (en) | 2011-05-03 |
Family
ID=37742806
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2617351A Expired - Fee Related CA2617351C (en) | 2005-08-11 | 2006-08-10 | Diltiazem controlled release formulation and method of manufacture |
Country Status (4)
Country | Link |
---|---|
US (1) | US8778395B2 (en) |
EP (1) | EP1912631A4 (en) |
CA (1) | CA2617351C (en) |
WO (1) | WO2007021754A2 (en) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2012515765A (en) * | 2009-01-22 | 2012-07-12 | アボット ヘルスケア プライベート リミテッド | Pharmaceutical composition for time treatment |
CN114129541B (en) * | 2022-01-05 | 2023-05-30 | 南通联亚药业股份有限公司 | Diltiazem hydrochloride sustained-release capsule and preparation method and application thereof |
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MXPA05002623A (en) | 2002-09-09 | 2005-05-05 | Biovail Lab Inc | Chronotherapeutic diltiazem formulations and the administration thereof. |
US20040132826A1 (en) * | 2002-10-25 | 2004-07-08 | Collegium Pharmaceutical, Inc. | Modified release compositions of milnacipran |
EP1595535A2 (en) * | 2002-12-23 | 2005-11-16 | Osmotica Costa Rica Sociedad Anonima | Delivery device containing venlafaxine and memantine and use method thereof |
WO2005016317A1 (en) | 2003-08-19 | 2005-02-24 | Themis Laboratories Private Limited | Process for manufacture of extended release pellets containing diltiazem hci |
-
2005
- 2005-08-11 US US11/201,747 patent/US8778395B2/en not_active Expired - Fee Related
-
2006
- 2006-08-10 WO PCT/US2006/031052 patent/WO2007021754A2/en active Application Filing
- 2006-08-10 CA CA2617351A patent/CA2617351C/en not_active Expired - Fee Related
- 2006-08-10 EP EP06801043A patent/EP1912631A4/en not_active Withdrawn
Also Published As
Publication number | Publication date |
---|---|
WO2007021754A2 (en) | 2007-02-22 |
CA2617351C (en) | 2011-05-03 |
WO2007021754A3 (en) | 2007-08-09 |
US8778395B2 (en) | 2014-07-15 |
US20070036856A1 (en) | 2007-02-15 |
EP1912631A2 (en) | 2008-04-23 |
EP1912631A4 (en) | 2010-11-10 |
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