CA2617351A1 - Diltiazem controlled release formulation and method of manufacture - Google Patents

Diltiazem controlled release formulation and method of manufacture Download PDF

Info

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.)
Granted
Application number
CA002617351A
Other languages
French (fr)
Other versions
CA2617351C (en
Inventor
Xui Xui Cheng
Xiaohong Qi
Guohua Zhang
Manesh Dixit
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.)
Allergan Finance LLC
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2617351A1 publication Critical patent/CA2617351A1/en
Application granted granted Critical
Publication of CA2617351C publication Critical patent/CA2617351C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/554Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5084Mixtures 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.
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.
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.
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.
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.
CA2617351A 2005-08-11 2006-08-10 Diltiazem controlled release formulation and method of manufacture Expired - Fee Related CA2617351C (en)

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)

* Cited by examiner, † Cited by third party
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

Family Cites Families (91)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US606339A (en) * 1898-06-28 Railroad-crossing
US2798053A (en) 1952-09-03 1957-07-02 Goodrich Co B F Carboxylic polymers
US2909462A (en) 1955-12-08 1959-10-20 Bristol Myers Co Acrylic acid polymer laxative compositions
US4207893A (en) 1977-08-29 1980-06-17 Alza Corporation Device using hydrophilic polymer for delivering drug to biological environment
CA1146866A (en) 1979-07-05 1983-05-24 Yamanouchi Pharmaceutical Co. Ltd. Process for the production of sustained release pharmaceutical composition of solid medical material
US4327725A (en) 1980-11-25 1982-05-04 Alza Corporation Osmotic device with hydrogel driving member
US4434153A (en) 1982-03-22 1984-02-28 Alza Corporation Drug delivery system comprising a reservoir containing a plurality of tiny pills
US5082668A (en) 1983-05-11 1992-01-21 Alza Corporation Controlled-release system with constant pushing source
US5002776A (en) 1983-12-22 1991-03-26 Elan Corporation, Plc Controlled absorption diltiazem formulations
US4894240A (en) 1983-12-22 1990-01-16 Elan Corporation Plc Controlled absorption diltiazem formulation for once-daily administration
US5364620A (en) 1983-12-22 1994-11-15 Elan Corporation, Plc Controlled absorption diltiazem formulation for once daily administration
IT1188212B (en) 1985-12-20 1988-01-07 Paolo Colombo SYSTEM FOR THE RELEASE SPEED OF ACTIVE SUBSTANCES
DE3868077D1 (en) 1987-01-14 1992-03-12 Ciba Geigy Ag THERAPEUTIC SYSTEM FOR HEAVY-SOLUBLE ACTIVE SUBSTANCES.
US4851232A (en) * 1987-02-13 1989-07-25 Alza Corporation Drug delivery system with means for obtaining desirable in vivo release rate pattern
US4892778A (en) 1987-05-27 1990-01-09 Alza Corporation Juxtaposed laminated arrangement
US4940465A (en) 1987-05-27 1990-07-10 Felix Theeuwes Dispenser comprising displaceable matrix with solid state properties
US4876093A (en) 1987-07-02 1989-10-24 Alza Corporation Dispenser with dispersing member for delivering beneficial agent
US4915949A (en) 1987-07-13 1990-04-10 Alza Corporation Dispenser with movable matrix comprising a plurality of tiny pills
US4824675A (en) 1987-07-13 1989-04-25 Alza Corporation Dispenser with movable matrix comprising a plurality of tiny pills
EP0332392B1 (en) 1988-03-09 1994-12-07 Showa Shell Sekiyu Kabushiki Kaisha Dioxane liquid crystal compounds
US5472710A (en) 1988-04-16 1995-12-05 Schwarz Pharma Ag Pharmaceutical preparation to be administered orally with controlled release of active substance and method for its manufacture
US5344657A (en) 1988-04-27 1994-09-06 Elf Sanofi Microbeads of diltiazem, a process for their manufacture and a substained-release pharmaceutical composition containing them
US5007790A (en) 1989-04-11 1991-04-16 Depomed Systems, Inc. Sustained-release oral drug dosage form
US5417985A (en) 1989-07-20 1995-05-23 Farmalyoc Solid and porous single dosage form comprising particles in the form of beads and its preparation
US5035897A (en) 1989-09-05 1991-07-30 Alza Corporation Dosage form for delivering soluble or insoluble drugs
US5120548A (en) 1989-11-07 1992-06-09 Merck & Co., Inc. Swelling modulated polymeric drug delivery device
IT1237904B (en) 1989-12-14 1993-06-18 Ubaldo Conte CONTROLLED SPEED RELEASE TABS OF ACTIVE SUBSTANCES
IE82916B1 (en) 1990-11-02 2003-06-11 Elan Corp Plc Formulations and their use in the treatment of neurological diseases
US5075114A (en) 1990-05-23 1991-12-24 Mcneil-Ppc, Inc. Taste masking and sustained release coatings for pharmaceuticals
US5156850A (en) 1990-08-31 1992-10-20 Alza Corporation Dosage form for time-varying patterns of drug delivery
US5232705A (en) 1990-08-31 1993-08-03 Alza Corporation Dosage form for time-varying patterns of drug delivery
IT1243390B (en) 1990-11-22 1994-06-10 Vectorpharma Int PHARMACEUTICAL COMPOSITIONS IN THE FORM OF PARTICLES SUITABLE FOR THE CONTROLLED RELEASE OF PHARMACOLOGICALLY ACTIVE SUBSTANCES AND PROCEDURE FOR THEIR PREPARATION.
US5273758A (en) 1991-03-18 1993-12-28 Sandoz Ltd. Directly compressible polyethylene oxide vehicle for preparing therapeutic dosage forms
US5286497A (en) 1991-05-20 1994-02-15 Carderm Capital L.P. Diltiazem formulation
US5288505A (en) 1991-06-26 1994-02-22 Galephar P.R., Inc., Ltd. Extended release form of diltiazem
US5252338A (en) 1991-06-27 1993-10-12 Alza Corporation Therapy delayed
US5190765A (en) 1991-06-27 1993-03-02 Alza Corporation Therapy delayed
US5545423A (en) 1991-11-25 1996-08-13 Vivorx, Inc. Cytoprotective, biocompatible, retrievable macrocapsule containment systems for biologically active materials
DE4140192C2 (en) 1991-12-05 1996-02-29 Alfatec Pharma Gmbh Sol-controlled gelatin-based thermocolloid matrix for peroral sustained release forms
US5254349A (en) 1991-12-06 1993-10-19 Alza Corporation Process for lessening irritation caused by drug
CA2132012C (en) 1992-03-25 2003-04-22 John W. Shell Alkyl-substituted cellulose-based sustained-release oral drug dosage forms
US5260068A (en) 1992-05-04 1993-11-09 Anda Sr Pharmaceuticals Inc. Multiparticulate pulsatile drug delivery system
US5994341A (en) 1993-07-19 1999-11-30 Angiogenesis Technologies, Inc. Anti-angiogenic Compositions and methods for the treatment of arthritis
US5500227A (en) 1993-11-23 1996-03-19 Euro-Celtique, S.A. Immediate release tablet cores of insoluble drugs having sustained-release coating
US5419917A (en) 1994-02-14 1995-05-30 Andrx Pharmaceuticals, Inc. Controlled release hydrogel formulation
US5962477A (en) 1994-04-12 1999-10-05 Adolor Corporation Screening methods for cytokine inhibitors
US5919491A (en) 1994-05-13 1999-07-06 Smithkline Beecham Corporation Method and composition for increasing calcium uptake
US5582838A (en) 1994-12-22 1996-12-10 Merck & Co., Inc. Controlled release drug suspension delivery device
US5834024A (en) * 1995-01-05 1998-11-10 Fh Faulding & Co. Limited Controlled absorption diltiazem pharmaceutical formulation
US5676972A (en) 1995-02-16 1997-10-14 The University Of Akron Time-release delivery matrix composition and corresponding controlled-release compositions
US5945125A (en) 1995-02-28 1999-08-31 Temple University Controlled release tablet
US5567441A (en) 1995-03-24 1996-10-22 Andrx Pharmaceuticals Inc. Diltiazem controlled release formulation
US6117453A (en) 1995-04-14 2000-09-12 Pharma Pass Solid compositions containing polyethylene oxide and an active ingredient
WO1997004752A1 (en) 1995-07-26 1997-02-13 Duramed Pharmaceuticals, Inc. Pharmaceutical compositions of conjugated estrogens and methods for their use
FR2742660B1 (en) 1995-12-22 1998-04-03 Ethypharm Lab Prod Ethiques NOVEL FORMS OF EXTENDED RELEASE MICROGRANULES CONTAINING DILTIAZEM AS ACTIVE INGREDIENT
US5840332A (en) 1996-01-18 1998-11-24 Perio Products Ltd. Gastrointestinal drug delivery system
US5766623A (en) 1996-03-25 1998-06-16 State Of Oregon Acting By And Through The Oregon State Board Of Higher Education On Behalf Of Oregon State University Compactable self-sealing drug delivery agents
US6096339A (en) 1997-04-04 2000-08-01 Alza Corporation Dosage form, process of making and using same
US6048547A (en) 1996-04-15 2000-04-11 Seth; Pawan Process for manufacturing solid compositions containing polyethylene oxide and an active ingredient
US5830503A (en) 1996-06-21 1998-11-03 Andrx Pharmaceuticals, Inc. Enteric coated diltiazem once-a-day formulation
US5972389A (en) 1996-09-19 1999-10-26 Depomed, Inc. Gastric-retentive, oral drug dosage forms for the controlled-release of sparingly soluble drugs and insoluble matter
US5922352A (en) 1997-01-31 1999-07-13 Andrx Pharmaceuticals, Inc. Once daily calcium channel blocker tablet having a delayed release core
US6046177A (en) 1997-05-05 2000-04-04 Cydex, Inc. Sulfoalkyl ether cyclodextrin based controlled release solid pharmaceutical formulations
US5840329A (en) 1997-05-15 1998-11-24 Bioadvances Llc Pulsatile drug delivery system
US6635280B2 (en) 1997-06-06 2003-10-21 Depomed, Inc. Extending the duration of drug release within the stomach during the fed mode
EP0998271B3 (en) 1997-06-06 2014-10-29 Depomed, Inc. Gastric-retentive oral drug dosage forms for controlled release of highly soluble drugs
WO1999007342A1 (en) 1997-08-11 1999-02-18 Alza Corporation Prolonged release active agent dosage form adapted for gastric retention
US6342250B1 (en) 1997-09-25 2002-01-29 Gel-Del Technologies, Inc. Drug delivery devices comprising biodegradable protein for the controlled release of pharmacologically active agents and method of making the drug delivery devices
US6337091B1 (en) 1997-10-27 2002-01-08 Temple University - Of The Commonwealth System Of Higher Education Matrix for controlled delivery of highly soluble pharmaceutical agents
US6524620B2 (en) 1998-07-20 2003-02-25 Andrx Pharmaceuticals, Inc. Diltiazem controlled release formulation and method of manufacture
US6531152B1 (en) 1998-09-30 2003-03-11 Dexcel Pharma Technologies Ltd. Immediate release gastrointestinal drug delivery system
EP2020229A1 (en) 1998-11-02 2009-02-04 Elan Pharma International Limited Multiparticulate modified release composition
US6270805B1 (en) 1998-11-06 2001-08-07 Andrx Pharmaceuticals, Inc. Two pellet controlled release formulation for water soluble drugs which contains an alkaline metal stearate
US6632451B2 (en) 1999-06-04 2003-10-14 Dexcel Pharma Technologies Ltd. Delayed total release two pulse gastrointestinal drug delivery system
GB9921933D0 (en) 1999-09-17 1999-11-17 Univ Gent Solid shaped articles comprising biologically active substances and a method for their production
US7108866B1 (en) 1999-12-10 2006-09-19 Biovall Laboratories International Srl Chronotherapeutic diltiazem formulations and the administration thereof
US6753011B2 (en) 2000-01-14 2004-06-22 Osmotica Corp Combined diffusion/osmotic pumping drug delivery system
US6761895B2 (en) 2000-04-17 2004-07-13 Yamanouchi Pharmaceutical Co., Ltd. Drug delivery system for averting pharmacokinetic drug interaction and method thereof
US6419954B1 (en) 2000-05-19 2002-07-16 Yamanouchi Pharmaceutical Co., Ltd. Tablets and methods for modified release of hydrophilic and other active agents
US6368628B1 (en) 2000-05-26 2002-04-09 Pharma Pass Llc Sustained release pharmaceutical composition free of food effect
US6488962B1 (en) 2000-06-20 2002-12-03 Depomed, Inc. Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms
US6620439B1 (en) 2000-10-03 2003-09-16 Atul M. Mehta Chrono delivery formulations and method of use thereof
US6984402B2 (en) 2000-10-03 2006-01-10 Elite Laboratories, Inc. Chrono delivery formulations and method of treating atrial fibrillation
US6287599B1 (en) 2000-12-20 2001-09-11 Shire Laboratories, Inc. Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles
WO2003017981A1 (en) 2001-08-29 2003-03-06 Ranbaxy Laboratories Limited Controlled release formulation of clarithromycin or tinidazol
WO2003103637A2 (en) * 2002-01-10 2003-12-18 Ranbaxy Laboratories Limited Modified release, multiple unit drug delivery systems
PT1476138E (en) 2002-02-21 2012-02-14 Valeant Internat Barbados Srl Modified release formulations of at least one form of tramadol
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

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

Similar Documents

Publication Publication Date Title
AU2006297477B2 (en) Pharmaceutical dosage forms having immediate release and/or controlled release properties
WO2007000778A3 (en) Modified release pharmaceutical compositions on the basis of two polymers and processes thereof
ATE380022T1 (en) MULTIPARTICULAR MEDICINAL FORM CONTAINING AT LEAST TWO DIFFERENTLY COATED PELLET FORMS
WO2006044202A3 (en) Enteric coated compositions that release active ingredient(s) in gastric fluid and intestinal fluid
Cantor et al. Development and optimization of taste-masked orally disintegrating tablets (ODTs) of clindamycin hydrochloride
EP2277510A3 (en) Controlled release preparation
WO2008022932A3 (en) Controlled release system and method for manufacturing the same
BR0312347A (en) Oral Pharmaceutical Composition, Uses of Coating Thickness of a Dissolving Ph Dependent Coating Material, Coating Material, and Polymethacrylate Material
AU2013344281B2 (en) Pharmaceutical compositions comprising hydromorphone and naloxone
HK1111609A1 (en) Solid dosage form comprising proton pump inhibitor and suspension made thereof
NZ728442A (en) Taste-masked pharmaceutical compositions with gastrosoluble pore-formers
WO2004112756A8 (en) Proton pump-inhibitor-containing capsules which comprise subunits differently structured for a delayed release of the active ingredient
AU2003231126A1 (en) Chewable soft capsule
NO20084065L (en) Quick-release paracetamol tablets
WO2005007139A3 (en) Multiparticle pharmaceutical dosage form containing a mucoadhesively formulated peptide or protein active substances method for producing said pharmaceutical dosage form
WO2006044048A3 (en) Method of providing customized drug delivery correlating to a patient’s metabolic profile
AU2003212306A1 (en) Pharmaceutical formulation for the active ingredient budesonide
WO2008084698A1 (en) Tacrolimus sustained release pharmaceutical composition
GEP20043285B (en) Sustained Release Beadlets Containing Stavudine, Method for Their Production, Pharmaceutical Composition Containing the Same and Use Thereof for Treatment Retroviral Infections
ATE361060T1 (en) IONIC STRENGTH INDEPENDENT DELAYED RELEASE PHARMACEUTICAL FORMULATION
WO2005009410A3 (en) Pharmaceutical compositions having a swellable coating
CA2617351A1 (en) Diltiazem controlled release formulation and method of manufacture
US20100008987A1 (en) Modified Release Pharmaceutical Composition of Bupropion Hydrochloride
JP2002316928A (en) Coated tablet and method for preventing peeling of coated tablet
WO2007015270A3 (en) Novel controlled release compositions of selective serotonin reuptake inhibitors

Legal Events

Date Code Title Description
EEER Examination request
MKLA Lapsed

Effective date: 20220301

MKLA Lapsed

Effective date: 20200831