WO2007021754A3 - Diltiazem controlled release formulation and method of manufacture - Google Patents

Diltiazem controlled release formulation and method of manufacture Download PDF

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Publication number
WO2007021754A3
WO2007021754A3 PCT/US2006/031052 US2006031052W WO2007021754A3 WO 2007021754 A3 WO2007021754 A3 WO 2007021754A3 US 2006031052 W US2006031052 W US 2006031052W WO 2007021754 A3 WO2007021754 A3 WO 2007021754A3
Authority
WO
WIPO (PCT)
Prior art keywords
diltiazem
controlled release
manufacture
release formulation
administration
Prior art date
Application number
PCT/US2006/031052
Other languages
French (fr)
Other versions
WO2007021754A2 (en
Inventor
Xui Xui Cheng
Xiaohong Qi
Guohua Zhang
Manesh Dixit
Original Assignee
Andrx Labs L L C
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 Andrx Labs L L C filed Critical Andrx Labs L L C
Priority to CA2617351A priority Critical patent/CA2617351C/en
Priority to EP06801043A priority patent/EP1912631A4/en
Publication of WO2007021754A2 publication Critical patent/WO2007021754A2/en
Publication of WO2007021754A3 publication Critical patent/WO2007021754A3/en

Links

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
    • A61K9/48—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
    • 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.
PCT/US2006/031052 2005-08-11 2006-08-10 Diltiazem controlled release formulation and method of manufacture WO2007021754A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CA2617351A CA2617351C (en) 2005-08-11 2006-08-10 Diltiazem controlled release formulation and method of manufacture
EP06801043A EP1912631A4 (en) 2005-08-11 2006-08-10 Diltiazem controlled release formulation and method of manufacture

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/201,747 US8778395B2 (en) 2005-08-11 2005-08-11 Diltiazem controlled release formulation and method of manufacture
US11/201,747 2005-08-11

Publications (2)

Publication Number Publication Date
WO2007021754A2 WO2007021754A2 (en) 2007-02-22
WO2007021754A3 true WO2007021754A3 (en) 2007-08-09

Family

ID=37742806

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/031052 WO2007021754A2 (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

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Also Published As

Publication number Publication date
EP1912631A4 (en) 2010-11-10
CA2617351C (en) 2011-05-03
CA2617351A1 (en) 2007-02-22
WO2007021754A2 (en) 2007-02-22
US20070036856A1 (en) 2007-02-15
US8778395B2 (en) 2014-07-15
EP1912631A2 (en) 2008-04-23

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