AU2003201735B2 - Pravastatin pharmaceutical formulations and methods of their use - Google Patents

Pravastatin pharmaceutical formulations and methods of their use Download PDF

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Publication number
AU2003201735B2
AU2003201735B2 AU2003201735A AU2003201735A AU2003201735B2 AU 2003201735 B2 AU2003201735 B2 AU 2003201735B2 AU 2003201735 A AU2003201735 A AU 2003201735A AU 2003201735 A AU2003201735 A AU 2003201735A AU 2003201735 B2 AU2003201735 B2 AU 2003201735B2
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AU
Australia
Prior art keywords
pravastatin
hours
formulations
release
modified
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.)
Ceased
Application number
AU2003201735A
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English (en)
Other versions
AU2003201735A1 (en
Inventor
Jackie Butler
John Devane
Paul Stark
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.)
Circ Pharma Research and Development Ltd
Original Assignee
Circ Pharma Research and Development 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 Circ Pharma Research and Development Ltd filed Critical Circ Pharma Research and Development Ltd
Publication of AU2003201735A1 publication Critical patent/AU2003201735A1/en
Assigned to BIOVAIL LABORATORIES INTERNATIONAL S.R.L. reassignment BIOVAIL LABORATORIES INTERNATIONAL S.R.L. Request for Assignment Assignors: ATHPHARMA LIMITED
Assigned to CIRC PHARMA RESEARCH AND DEVELOPMENT LIMITED reassignment CIRC PHARMA RESEARCH AND DEVELOPMENT LIMITED Request for Assignment Assignors: BIOVAIL LABORATORIES INTERNATIONAL SRL
Application granted granted Critical
Publication of AU2003201735B2 publication Critical patent/AU2003201735B2/en
Anticipated expiration legal-status Critical
Ceased 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
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225—Polycarboxylic acids
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/28—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
    • 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
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Endocrinology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
AU2003201735A 2002-01-11 2003-01-10 Pravastatin pharmaceutical formulations and methods of their use Ceased AU2003201735B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US34777502P 2002-01-11 2002-01-11
US60/347,775 2002-01-11
US40726902P 2002-09-03 2002-09-03
US60/407,269 2002-09-03
PCT/IB2003/000336 WO2003057195A1 (en) 2002-01-11 2003-01-10 Pravastatin pharmaceutical formulations and methods of their use

Publications (2)

Publication Number Publication Date
AU2003201735A1 AU2003201735A1 (en) 2003-07-24
AU2003201735B2 true AU2003201735B2 (en) 2008-11-13

Family

ID=26995414

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2003201735A Ceased AU2003201735B2 (en) 2002-01-11 2003-01-10 Pravastatin pharmaceutical formulations and methods of their use

Country Status (9)

Country Link
US (2) US6967218B2 (enExample)
EP (1) EP1465605A1 (enExample)
JP (1) JP2005519052A (enExample)
AU (1) AU2003201735B2 (enExample)
CA (1) CA2473106A1 (enExample)
IL (1) IL162937A0 (enExample)
MX (1) MXPA04006780A (enExample)
NO (1) NO20043333L (enExample)
WO (1) WO2003057195A1 (enExample)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003057195A1 (en) * 2002-01-11 2003-07-17 Athpharma Limited Pravastatin pharmaceutical formulations and methods of their use
US20050089572A1 (en) * 2002-03-22 2005-04-28 Manoj Kumar Controlled release drug delivery system of pravastatin
SI21400A (sl) * 2003-02-12 2004-08-31 LEK farmacevtska družba d.d. Stabilna farmacevtska oblika z inhibitorjem HMG-CoA reduktaze
US8987322B2 (en) * 2003-11-04 2015-03-24 Circ Pharma Research And Development Limited Pharmaceutical formulations for carrier-mediated transport statins and uses thereof
CN101262851A (zh) * 2004-01-20 2008-09-10 诺瓦提斯公司 直接压片配方和方法
HRP20211766T1 (hr) * 2004-01-20 2022-02-18 Novartis Ag Formulacija i postupak izravne kompresije
EP1563837A1 (en) * 2004-02-03 2005-08-17 Ferrer Internacional, S.A. Hypocholesterolemic compositions comprising a statin and an antiflatulent agent
US20090196889A1 (en) * 2004-11-22 2009-08-06 Dexcel Pharma Technologies Ltd. Controlled absorption of statins in the intestine
GR1006879B (el) * 2005-09-14 2010-07-13 "Φαρματεν" Φαρμακευτικη Βιομηχανικη Εμπορικη Α.Ε., Βελτιωμενες φαρμακευτικες συνθεσεις που περιεχουν αναστολεις της αναγωγασης του 3-υδροξυ-3-μεθυλογλουταρυλοσυνενζυμου α (hmg-coa) και μεθοδος παρασκευης αυτων
EP2079448A2 (en) * 2006-10-10 2009-07-22 Dexcel Pharma Technologies Ltd. Improved release of statins in the intestine
GB0713707D0 (en) * 2007-07-13 2007-08-22 Generics Uk Ltd Stable compositions
US20090226516A1 (en) * 2008-03-04 2009-09-10 Pharma Pass Ii Llc Sartan compositions
US20090226515A1 (en) * 2008-03-04 2009-09-10 Pharma Pass Ii Llc Statin compositions
JP2013535516A (ja) * 2010-08-17 2013-09-12 ルピン・リミテッド ドロネダロンの制御放出製剤
EP2692354A1 (en) * 2012-08-03 2014-02-05 Max-Delbrück-Centrum für Molekulare Medizin (MDC) Means for treating heart disease
CN112040953A (zh) * 2018-03-09 2020-12-04 布赖汉姆妇女医院 用于心血管疾病的组合治疗
CN111803462A (zh) * 2020-07-15 2020-10-23 浙江诺得药业有限公司 一种普伐他汀钠肠溶片及其制备方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0375156A2 (en) * 1988-11-21 1990-06-27 Merck & Co. Inc. Plasma cholesterol level lowering medicaments
EP0465096A1 (en) * 1990-06-26 1992-01-08 Merck & Co. Inc. Plasma cholesterol level lowering composition
US5916595A (en) * 1997-12-12 1999-06-29 Andrx Pharmaceutials, Inc. HMG co-reductase inhibitor
WO2000033821A1 (en) * 1998-12-07 2000-06-15 Bristol-Myers Squibb Company Enteric coated pravastatin bead formulation

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4904474A (en) * 1988-01-25 1990-02-27 Alza Corporation Delivery of drug to colon by oral disage form
US5030447A (en) * 1988-03-31 1991-07-09 E. R. Squibb & Sons, Inc. Pharmaceutical compositions having good stability
US5180589A (en) * 1988-03-31 1993-01-19 E. R. Squibb & Sons, Inc. Pravastatin pharmaceuatical compositions having good stability
US5376383A (en) * 1988-11-21 1994-12-27 Merck & Co., Inc. Method for enhancing the lowering of plasma-cholesterol levels
UA69413C2 (uk) 1998-05-22 2004-09-15 Брістол-Майерс Сквібб Компані Фармацевтична композиція, яка містить серцевину та ентеросолюбільну оболонку, фармацевтична композиція у вигляді сфероїдальних гранул, спосіб одержання сфероїдальних гранул та спосіб одержання фармацевтичної композиції
UA73092C2 (uk) * 1998-07-17 2005-06-15 Брістол-Майерс Сквібб Компані Таблетка з ентеросолюбільним покриттям і спосіб її приготування
SI20109A (sl) 1998-12-16 2000-06-30 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. Stabilna farmacevtska formulacija
JP2002535353A (ja) * 1999-01-29 2002-10-22 ロザン ファルマ ゲゼルシャフトミットベシュレンクテルハフツンク 医薬品組成物
US6569461B1 (en) * 1999-03-08 2003-05-27 Merck & Co., Inc. Dihydroxy open-acid and salts of HMG-CoA reductase inhibitors
WO2001077072A2 (en) * 2000-04-11 2001-10-18 Atherogenics, Inc. Compounds and methods to increase plasma hdl cholesterol levels and improve hdl functionality
US6936731B2 (en) * 2000-10-05 2005-08-30 TEVA Gyógyszergyár Részvénytársaság Pravastatin sodium substantially free of pravastatin lactone and epi-pravastatin, and compositions containing same
US20030091630A1 (en) * 2001-10-25 2003-05-15 Jenny Louie-Helm Formulation of an erodible, gastric retentive oral dosage form using in vitro disintegration test data
WO2003057195A1 (en) * 2002-01-11 2003-07-17 Athpharma Limited Pravastatin pharmaceutical formulations and methods of their use

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0375156A2 (en) * 1988-11-21 1990-06-27 Merck & Co. Inc. Plasma cholesterol level lowering medicaments
EP0465096A1 (en) * 1990-06-26 1992-01-08 Merck & Co. Inc. Plasma cholesterol level lowering composition
US5916595A (en) * 1997-12-12 1999-06-29 Andrx Pharmaceutials, Inc. HMG co-reductase inhibitor
WO2000033821A1 (en) * 1998-12-07 2000-06-15 Bristol-Myers Squibb Company Enteric coated pravastatin bead formulation

Also Published As

Publication number Publication date
JP2005519052A (ja) 2005-06-30
IL162937A0 (en) 2005-11-20
NO20043333L (no) 2004-09-13
US20050277691A1 (en) 2005-12-15
US6967218B2 (en) 2005-11-22
EP1465605A1 (en) 2004-10-13
AU2003201735A1 (en) 2003-07-24
MXPA04006780A (es) 2005-06-08
WO2003057195A1 (en) 2003-07-17
US20030176502A1 (en) 2003-09-18
CA2473106A1 (en) 2003-07-17

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Legal Events

Date Code Title Description
PC1 Assignment before grant (sect. 113)

Owner name: BIOVAIL LABORATORIES INTERNATIONAL S.R.L.

Free format text: FORMER APPLICANT(S): ATHPHARMA LIMITED

PC1 Assignment before grant (sect. 113)

Owner name: CIRC PHARMA RESEARCH AND DEVELOPMENT LIMITED

Free format text: FORMER APPLICANT(S): BIOVAIL LABORATORIES INTERNATIONAL SRL

FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired