CA2008972A1 - Nifedipine-containing pharmaceutical compositions and process for the preparation thereof - Google Patents

Nifedipine-containing pharmaceutical compositions and process for the preparation thereof

Info

Publication number
CA2008972A1
CA2008972A1 CA2008972A CA2008972A CA2008972A1 CA 2008972 A1 CA2008972 A1 CA 2008972A1 CA 2008972 A CA2008972 A CA 2008972A CA 2008972 A CA2008972 A CA 2008972A CA 2008972 A1 CA2008972 A1 CA 2008972A1
Authority
CA
Canada
Prior art keywords
nifedipine
amount
preparation
pharmaceutical compositions
polyvinylpyrrolidone
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
CA2008972A
Other languages
French (fr)
Other versions
CA2008972C (en
Inventor
Alan Rhodes
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.)
Ethical Pharmaceuticals Ltd
Original Assignee
Alan Rhodes
Ethical Pharmaceuticals Ltd.
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 Alan Rhodes, Ethical Pharmaceuticals Ltd. filed Critical Alan Rhodes
Publication of CA2008972A1 publication Critical patent/CA2008972A1/en
Application granted granted Critical
Publication of CA2008972C publication Critical patent/CA2008972C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • 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

Abstract

A pharmaceutical composition which comprises particles of a finely divided pharmaceutically acceptable water soluble diluent coated with microcrystalline particles of nifedipine, the majority of which have a particle size of 100 micrometres or less in the presence of polyvinyl-pyrrolidone, the polyvinylpyrrolidone being present in an amount of from 10 to 90% by weight based on the weight of the nifedipine.
The incorporation of polyvinylpyrrolidone in an amount of less than the amount of nifedipine significantly slows the dissolution of nifedipine from the finished solid dosage form.
CA002008972A 1989-02-14 1990-01-31 Nifedipine-containing pharmaceutical compositions and process for the preparation thereof Expired - Fee Related CA2008972C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB898903328A GB8903328D0 (en) 1989-02-14 1989-02-14 Nifedipine-containing pharmaceutical compositions and process for the preparation thereof
GB8903328.6 1989-02-14

Publications (2)

Publication Number Publication Date
CA2008972A1 true CA2008972A1 (en) 1990-08-14
CA2008972C CA2008972C (en) 1996-09-03

Family

ID=10651674

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002008972A Expired - Fee Related CA2008972C (en) 1989-02-14 1990-01-31 Nifedipine-containing pharmaceutical compositions and process for the preparation thereof

Country Status (17)

Country Link
US (1) US5145683A (en)
EP (1) EP0385582B1 (en)
JP (1) JPH07112974B2 (en)
AT (1) ATE79032T1 (en)
AU (1) AU626130B2 (en)
CA (1) CA2008972C (en)
DE (1) DE69000240T2 (en)
DK (1) DK0385582T3 (en)
ES (1) ES2052168T3 (en)
FI (1) FI95347C (en)
GB (1) GB8903328D0 (en)
GR (1) GR3005477T3 (en)
IE (1) IE64682B1 (en)
NO (1) NO175925C (en)
NZ (1) NZ232287A (en)
PH (1) PH26850A (en)
ZA (1) ZA90904B (en)

Families Citing this family (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5624683A (en) * 1986-08-06 1997-04-29 Eisai Co., Ltd. Sustained-release multi-granule tablet
GB9200607D0 (en) * 1992-01-13 1992-03-11 Ethical Pharma Ltd Pharmaceutical compositions containing nifedipine and process for the preparation thereof
US6726930B1 (en) * 1993-09-09 2004-04-27 Penwest Pharmaceuticals Co. Sustained release heterodisperse hydrogel systems for insoluble drugs
US5773025A (en) * 1993-09-09 1998-06-30 Edward Mendell Co., Inc. Sustained release heterodisperse hydrogel systems--amorphous drugs
US5662933A (en) * 1993-09-09 1997-09-02 Edward Mendell Co., Inc. Controlled release formulation (albuterol)
US5455046A (en) * 1993-09-09 1995-10-03 Edward Mendell Co., Inc. Sustained release heterodisperse hydrogel systems for insoluble drugs
PT800392E (en) * 1994-12-29 2002-06-28 Shire Deutschland Gmbh & Co Kg PHARMACEUTICAL PREPARATIONS CONTAINING NIFEDIPIN AND PROCESSES FOR THEIR PREPARATION
US5871776A (en) * 1995-01-31 1999-02-16 Mehta; Atul M. Controlled-release nifedipine
CN1049114C (en) * 1995-12-07 2000-02-09 上海华联制药公司 Method for prepn. of slowly-released medicaments preparation
CA2231195C (en) 1996-07-08 2003-01-21 Edward Mendell Co., Inc. Sustained release matrix for high-dose insoluble drugs
EP0852141A1 (en) 1996-08-16 1998-07-08 J.B. Chemicals & Pharmaceuticals Ltd. Nifedipine containing pharmaceutical extended release composition and a process for the preparation thereof
IT1284604B1 (en) * 1996-09-27 1998-05-21 Roberto Valducci CONTROLLED RELEASE PHARMACEUTICAL COMPOSITIONS FOR ORAL ADMINISTRATION CONTAINING NIFEDIPINE AS THE ACTIVE SUBSTANCE
US5922352A (en) * 1997-01-31 1999-07-13 Andrx Pharmaceuticals, Inc. Once daily calcium channel blocker tablet having a delayed release core
US5837379A (en) * 1997-01-31 1998-11-17 Andrx Pharmaceuticals, Inc. Once daily pharmaceutical tablet having a unitary core
US6056977A (en) * 1997-10-15 2000-05-02 Edward Mendell Co., Inc. Once-a-day controlled release sulfonylurea formulation
US6485748B1 (en) 1997-12-12 2002-11-26 Andrx Pharmaceuticals, Inc. Once daily pharmaceutical tablet having a unitary core
US6168806B1 (en) 1999-03-05 2001-01-02 Fang-Yu Lee Orally administrable nifedipine pellet and process for the preparation thereof
US20040115134A1 (en) * 1999-06-22 2004-06-17 Elan Pharma International Ltd. Novel nifedipine compositions
JP4627825B2 (en) * 1999-09-27 2011-02-09 三生医薬株式会社 Encapsulated granular material and method for producing the same
ES2304980T3 (en) * 1999-09-30 2008-11-01 Penwest Pharmaceuticals Co. SUSTAINED LIBERATION MATRIX SYSTEMS FOR HIGHLY SOLUBLE PHARMACOS.
DE60028754T2 (en) * 1999-11-12 2007-05-31 Abbott Laboratories, Abbott Park SOLID DISPERSION WITH RITONAVIR, FENOFIBRATE OR GRISEOFULVIN
US7364752B1 (en) 1999-11-12 2008-04-29 Abbott Laboratories Solid dispersion pharamaceutical formulations
DE10026698A1 (en) 2000-05-30 2001-12-06 Basf Ag Self-emulsifying active ingredient formulation and use of this formulation
EP1406630A1 (en) * 2001-07-06 2004-04-14 Endo Pharmaceuticals Inc. Parenteral administration of 6-hydroxy-oxymorphone for use as an analgesic
US8025899B2 (en) 2003-08-28 2011-09-27 Abbott Laboratories Solid pharmaceutical dosage form
US8377952B2 (en) 2003-08-28 2013-02-19 Abbott Laboratories Solid pharmaceutical dosage formulation
EP2112925A4 (en) * 2006-11-15 2013-01-09 Abbott Lab Solid pharmaceutical dosage formulations
GB2460915B (en) 2008-06-16 2011-05-25 Biovascular Inc Controlled release compositions of agents that reduce circulating levels of platelets and methods therefor
RU2629843C1 (en) * 2016-05-24 2017-09-04 федеральное государственное автономное образовательное учреждение высшего образования Первый Московский государственный медицинский университет имени И.М. Сеченова Министерства здравоохранения Российской Федерации (Сеченовский университет) Method for production of nifedipine ointment (versions)
CN109172534B (en) * 2018-10-23 2020-08-07 迪沙药业集团有限公司 Nifedipine sustained-release tablet composition

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1579818A (en) * 1977-06-07 1980-11-26 Yamanouchi Pharma Co Ltd Nifedipine-containing solid preparation composition
US4285665A (en) * 1978-05-08 1981-08-25 Johnson, Matthey & Co., Limited Engines
DE3033919A1 (en) * 1980-09-09 1982-04-22 Bayer Ag, 5090 Leverkusen SOLID PHARMACEUTICAL PREPARATIONS CONTAINING NIFEDIPINE AND METHOD FOR THE PRODUCTION THEREOF
JPS5846019A (en) * 1981-09-14 1983-03-17 Kanebo Ltd Nifedipine preparation with prolonged action
DE3318649A1 (en) * 1983-05-21 1984-11-22 Bayer Ag, 5090 Leverkusen TWO-PHASE FORMULATION
FR2556964A1 (en) * 1983-12-23 1985-06-28 Ile De France NEW GALENIC FORMS OF SULPIRIDE USED ORALALLY
DE3424553A1 (en) * 1984-07-04 1986-01-09 Bayer Ag, 5090 Leverkusen SOLID DRUG PREPARATIONS WITH DIHYDROPYRIDINE AND METHOD FOR THE PRODUCTION THEREOF
IT1178511B (en) * 1984-09-14 1987-09-09 Pharmatec Spa PROCEDURE FOR THE PREPARATION OF A SOLID FORM FOR ORAL USE BASED ON NIFEDIPINE WITH RELEASE
IT1187751B (en) * 1985-10-15 1987-12-23 Eurand Spa PROCEDURE FOR THE PREPARATION OF SOLID FORMULATIONS OF NIFEDIPINE WITH HIGH BIO AVAILABILITY AND WITH PROLONGED EFFECT AND FORMULATIONS SO OBTAINED
SE457326B (en) * 1986-02-14 1988-12-19 Lejus Medical Ab PROCEDURES FOR PREPARING A QUICK SUBSTANTIAL CANDLES CONTAINING BLA MICROCRISTALLIN CELLULOSA

Also Published As

Publication number Publication date
EP0385582A1 (en) 1990-09-05
US5145683A (en) 1992-09-08
DE69000240D1 (en) 1992-09-10
NO175925C (en) 1995-01-04
FI900633A0 (en) 1990-02-08
GR3005477T3 (en) 1993-05-24
PH26850A (en) 1992-11-05
NO900370L (en) 1990-08-15
IE900286L (en) 1990-08-14
CA2008972C (en) 1996-09-03
NZ232287A (en) 1992-01-29
NO900370D0 (en) 1990-01-26
DE69000240T2 (en) 1993-02-11
ATE79032T1 (en) 1992-08-15
EP0385582B1 (en) 1992-08-05
ZA90904B (en) 1991-06-26
IE64682B1 (en) 1995-08-23
FI95347C (en) 1996-01-25
GB8903328D0 (en) 1989-04-05
DK0385582T3 (en) 1992-09-14
AU626130B2 (en) 1992-07-23
AU4893790A (en) 1990-08-23
JPH02235815A (en) 1990-09-18
FI95347B (en) 1995-10-13
ES2052168T3 (en) 1994-07-01
JPH07112974B2 (en) 1995-12-06
NO175925B (en) 1994-09-26

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