WO2006113631A3 - Bioenhanced compositions - Google Patents

Bioenhanced compositions Download PDF

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Publication number
WO2006113631A3
WO2006113631A3 PCT/US2006/014422 US2006014422W WO2006113631A3 WO 2006113631 A3 WO2006113631 A3 WO 2006113631A3 US 2006014422 W US2006014422 W US 2006014422W WO 2006113631 A3 WO2006113631 A3 WO 2006113631A3
Authority
WO
WIPO (PCT)
Prior art keywords
arb
composition
solubility
solubility enhancing
present
Prior art date
Application number
PCT/US2006/014422
Other languages
French (fr)
Other versions
WO2006113631A2 (en
Inventor
Nagesh R Palepu
Pratibha S Pilgaonkar
Maharukh T Rustomjee
Anilkumar S Gandhi
Paras R Jain
Original Assignee
Rubicon Res Pvt Ltd
Nagesh R Palepu
Pratibha S Pilgaonkar
Maharukh T Rustomjee
Anilkumar S Gandhi
Paras R Jain
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 Rubicon Res Pvt Ltd, Nagesh R Palepu, Pratibha S Pilgaonkar, Maharukh T Rustomjee, Anilkumar S Gandhi, Paras R Jain filed Critical Rubicon Res Pvt Ltd
Priority to MX2007012947A priority Critical patent/MX2007012947A/en
Priority to EP06750455A priority patent/EP1877042A4/en
Priority to AU2006236497A priority patent/AU2006236497A1/en
Priority to CA002605183A priority patent/CA2605183A1/en
Priority to JP2008507777A priority patent/JP2008536929A/en
Publication of WO2006113631A2 publication Critical patent/WO2006113631A2/en
Publication of WO2006113631A3 publication Critical patent/WO2006113631A3/en
Priority to IL186721A priority patent/IL186721A0/en
Priority to US12/557,181 priority patent/US20100119607A1/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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • 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
    • A61K9/145—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 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
    • A61K9/141—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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • 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
    • 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
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/22—Anxiolytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • 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
    • 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

The present invention relates to the method of increasing the bioavailability of Angiotensin II Receptor Blockers (ARBs) by preparing a composition of an ARB with at least one solubility enhancing agent. In particular, the present invention relates to solubility enhancing agents that not only act as solubility enhancers but also improve the dissolution rate particularly in acidic or mildly acidic media, where solubility of the ARB is minimal. In the composition, the ARB may be present in the form of physical blend, solid dispersion, solid solution or complex with the solubility enhancing agent. The composition of an ARB with solubility enhancing agent can be incorporated in an immediate release or a controlled release or any other suitable modified release formulation. Immediate release dosage forms containing the composition of an ARB give an in vitro release of at least 40% in acidic media (pH < 3). As a result, the bioavailability of the ARB can be increased by at least 20% as measured by Cmax, AUC0-t and AUCo-∞.
PCT/US2006/014422 2005-04-18 2006-04-18 Bioenhanced compositions WO2006113631A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
MX2007012947A MX2007012947A (en) 2005-04-18 2006-04-18 Bioenhanced compositions.
EP06750455A EP1877042A4 (en) 2005-04-18 2006-04-18 Bioenhanced compositions
AU2006236497A AU2006236497A1 (en) 2005-04-18 2006-04-18 Bioenhanced compositions
CA002605183A CA2605183A1 (en) 2005-04-18 2006-04-18 Bioenhanced compositions
JP2008507777A JP2008536929A (en) 2005-04-18 2006-04-18 Bio-enhancing composition
IL186721A IL186721A0 (en) 2005-04-18 2007-10-17 Bioenhanced compositions
US12/557,181 US20100119607A1 (en) 2005-04-18 2009-09-10 Bioenhanced compositions

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN477MU2005 2005-04-18
IN477/MUM/2005 2005-04-18
IN0315/MUM/2006 2006-03-06
IN315MU2006 2006-03-06

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US11918728 A-371-Of-International 2006-04-18
US12/557,181 Continuation US20100119607A1 (en) 2005-04-18 2009-09-10 Bioenhanced compositions

Publications (2)

Publication Number Publication Date
WO2006113631A2 WO2006113631A2 (en) 2006-10-26
WO2006113631A3 true WO2006113631A3 (en) 2006-12-14

Family

ID=37115820

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/014422 WO2006113631A2 (en) 2005-04-18 2006-04-18 Bioenhanced compositions

Country Status (8)

Country Link
EP (1) EP1877042A4 (en)
JP (1) JP2008536929A (en)
KR (1) KR20080042039A (en)
AU (1) AU2006236497A1 (en)
CA (1) CA2605183A1 (en)
IL (1) IL186721A0 (en)
MX (1) MX2007012947A (en)
WO (1) WO2006113631A2 (en)

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Publication number Priority date Publication date Assignee Title
US20090123543A1 (en) * 2006-01-02 2009-05-14 Rubicon Research Private Limited Pharmaceutical compositions
EP2063888A4 (en) * 2006-09-05 2009-11-04 Astrazeneca Ab Pharmaceutical composition comprising candesartan cilexetil
KR101434334B1 (en) * 2006-10-20 2014-08-28 아비에 비.브이. Micellar nanoparticles of chemical substances
US7923026B2 (en) 2006-10-20 2011-04-12 Solvay Pharmaceuticals B.V. Embedded micellar nanoparticles
WO2008064338A2 (en) * 2006-11-22 2008-05-29 Rubicon Research Pvt. Ltd. Valsartan formulation for pulsatile delivery
US20100041644A1 (en) * 2006-11-28 2010-02-18 Laboratorios Liconsa, S. A. Stabilized solid pharmaceutical composition of candesartan cilexetil
AR064104A1 (en) * 2006-12-05 2009-03-11 Novartis Ag DOSAGE FORMS IN VALSARTAN MICROEMULSION, AND METHODS TO PREPARE THEM
US20080152717A1 (en) * 2006-12-14 2008-06-26 Isp Investments, Inc. Amorphous valsartan and the production thereof
WO2008084504A2 (en) * 2007-01-12 2008-07-17 Rubicon Research Private Limited Pharmaceutical compositions of angiotensin ii receptor blockers
MX2009011493A (en) * 2007-04-25 2009-11-09 Teva Pharma Pharmaceutical excipient complex.
US20100278909A1 (en) * 2007-06-06 2010-11-04 Dexcel Ltd. Process for forming solid oral dosage forms of angiotensin ii receptor antagonists
RU2010104960A (en) * 2007-08-01 2011-09-10 Тева Фармасьютикал Индастриес Лтд. (Il) PHARMACEUTICAL COMPOSITION OF CANDESARTAN
EP2197416A1 (en) * 2007-10-09 2010-06-23 Novartis Ag Pharmaceutical formulation of valsartan
MX2010004292A (en) * 2007-10-19 2010-08-02 Abbott Gmbh & Co Kg Solid dispersion product containing n-aryl urea-based compound.
JP5222550B2 (en) * 2007-12-27 2013-06-26 財團法人工業技術研究院 Sustained release composition and method for producing the same
WO2009084040A1 (en) * 2007-12-28 2009-07-09 Rubicon Research Private Limited Once a day formulation of angiotensin receptor blockers
EP2257288A1 (en) * 2008-02-28 2010-12-08 Novartis AG Valsartan solid oral dosage forms and methods of making such formulations
KR20110015650A (en) * 2008-06-03 2011-02-16 노파르티스 아게 Pulsatile release of valsartan
PT2165702E (en) 2008-09-17 2012-02-07 Helm Ag Stable and readily dissolved compositions of candesartan cilexetil prepared with wet granulation
DE102008047910A1 (en) 2008-09-19 2010-03-25 Molkerei Meggle Wasserburg Gmbh & Co. Kg Tabletting excipient based on lactose and cellulose
KR101817986B1 (en) * 2009-06-25 2018-01-16 진양제약주식회사 Pharmaceutical composition containing carboxylosartan and a production method therefor
WO2011028016A2 (en) * 2009-09-04 2011-03-10 한올바이오파마주식회사 Pharmaceutical preparation comprising beta-adrenergic blockers and angiotensin ii receptor blockers
WO2013119794A1 (en) * 2012-02-08 2013-08-15 Supernus Pharmaceuticals, Inc. Modified release formulations of viloxazine
JP6272328B2 (en) 2012-12-05 2018-01-31 沢井製薬株式会社 Candesartan cilexetil-containing preparation
EP2952187A4 (en) 2013-01-30 2016-08-17 Sawai Seiyaku Kk Pharmaceutical composition containing candesartan cilexetil
WO2016005994A2 (en) * 2014-07-06 2016-01-14 Gattefosse India Pvt. Ltd. Pharmaceutical composition comprising solid dispersion of bcs class ii drugs with gelucires
US9675585B1 (en) 2016-03-24 2017-06-13 Ezra Pharma Extended release pharmaceutical formulations
US9687475B1 (en) 2016-03-24 2017-06-27 Ezra Pharma Llc Extended release pharmaceutical formulations with controlled impurity levels
CA3078368A1 (en) 2017-10-04 2019-04-11 Celgene Corporation Compositions and methods of use of cis-4-[2-{[(3s,4r)-3-fluorooxan-4-yl]amino}-8-(2,4,6-trichloroanilino)-9h-purin-9-yl]-1-methylcyclohexane-1-carboxamide
CN109350609A (en) * 2018-11-14 2019-02-19 常州大学 A kind of preparation of chitosan package zeins nanoparticle and the application for loading acacetin sodium salt
CN113933472A (en) * 2020-06-29 2022-01-14 武汉武药科技有限公司 Dissolution medium for determining dissolution rate of telmisartan solid preparation and application thereof
CN112516105A (en) * 2020-12-10 2021-03-19 成都恒瑞制药有限公司 Losartan potassium oral preparation and preparation method thereof

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Also Published As

Publication number Publication date
MX2007012947A (en) 2008-04-09
CA2605183A1 (en) 2006-10-26
WO2006113631A2 (en) 2006-10-26
EP1877042A4 (en) 2011-03-02
EP1877042A2 (en) 2008-01-16
IL186721A0 (en) 2008-02-09
JP2008536929A (en) 2008-09-11
AU2006236497A1 (en) 2006-10-26
KR20080042039A (en) 2008-05-14

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