WO2009135646A3 - Stable pharmaceutical compositions and their processes for preparation suitable for industrial scale - Google Patents

Stable pharmaceutical compositions and their processes for preparation suitable for industrial scale Download PDF

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Publication number
WO2009135646A3
WO2009135646A3 PCT/EP2009/003211 EP2009003211W WO2009135646A3 WO 2009135646 A3 WO2009135646 A3 WO 2009135646A3 EP 2009003211 W EP2009003211 W EP 2009003211W WO 2009135646 A3 WO2009135646 A3 WO 2009135646A3
Authority
WO
WIPO (PCT)
Prior art keywords
processes
industrial scale
pharmaceutical compositions
stable pharmaceutical
preparation suitable
Prior art date
Application number
PCT/EP2009/003211
Other languages
French (fr)
Other versions
WO2009135646A2 (en
Inventor
Joaquìn AMELA-NAVARRO
Francisco Gual-Pujol
Chitra Shah
Abhijit Dhamne
Smita Dhuri
Original Assignee
Farmaprojects, Sa
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 Farmaprojects, Sa filed Critical Farmaprojects, Sa
Priority to EP09741865A priority Critical patent/EP2291177A2/en
Publication of WO2009135646A2 publication Critical patent/WO2009135646A2/en
Publication of WO2009135646A3 publication Critical patent/WO2009135646A3/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
    • A61K9/14—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
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4365—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system having sulfur as a ring hetero atom, e.g. ticlopidine
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • 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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/549—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
    • 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

Abstract

The present invention relates to the pharmaceutical filed, and particularly to stable pharmaceutical compositions and processes for preparing such compositions, which are suitable for industrial scale.
PCT/EP2009/003211 2008-05-05 2009-05-05 Stable pharmaceutical compositions and their processes for preparation suitable for industrial scale WO2009135646A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP09741865A EP2291177A2 (en) 2008-05-05 2009-05-05 Stable pharmaceutical compositions and their processes for preparation suitable for industrial scale

Applications Claiming Priority (12)

Application Number Priority Date Filing Date Title
EP08103813.5 2008-05-05
EP08103813 2008-05-05
EP08104074.3 2008-05-23
EP08104074 2008-05-23
IN1863MU2008 2008-09-02
IN1863/MUM/2008 2008-09-02
EP08105415 2008-09-23
EP08105415.7 2008-09-23
EP08168337 2008-11-05
EP08168337.7 2008-11-05
EP08172848 2008-12-23
EP08172848.7 2008-12-23

Publications (2)

Publication Number Publication Date
WO2009135646A2 WO2009135646A2 (en) 2009-11-12
WO2009135646A3 true WO2009135646A3 (en) 2011-03-17

Family

ID=40851992

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2009/003211 WO2009135646A2 (en) 2008-05-05 2009-05-05 Stable pharmaceutical compositions and their processes for preparation suitable for industrial scale

Country Status (2)

Country Link
EP (1) EP2291177A2 (en)
WO (1) WO2009135646A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7051638B2 (en) 2017-04-10 2022-04-11 東和薬品株式会社 Escitalopram pharmaceutical composition

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0822171D0 (en) * 2008-12-04 2009-01-14 Arrow Int Ltd Temisartan formulations
PL2364141T5 (en) * 2008-12-08 2018-02-28 Ratiopharm Gmbh Compacted moxifloxacin
TR200907227A2 (en) * 2009-09-18 2011-04-21 Bi̇lgi̇ç Mahmut Stable micronized granules with high solubility.
WO2011136751A2 (en) * 2010-04-26 2011-11-03 Mahmut Bilgic Water soluble pharmaceutical composition
EP2608773A4 (en) 2010-08-24 2014-03-05 Univ Rutgers Formulation and manufacture of pharmaceuticals by impregnation onto porous carriers
TR201011148A1 (en) * 2010-12-30 2012-07-23 Sanovel İlaç Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ Levetiracetam pharmaceutical compositions.
EP2491921A1 (en) * 2011-02-25 2012-08-29 Deva Holding Anonim Sirketi Conservation of anhydrous form of gemifloxacin
JP6363993B2 (en) * 2012-04-27 2018-07-25 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツングＭｅｒｃｋ Ｐａｔｅｎｔ Ｇｅｓｅｌｌｓｃｈａｆｔ ｍｉｔ ｂｅｓｃｈｒａｅｎｋｔｅｒ Ｈａｆｔｕｎｇ Tablet with coating and manufacture of the tablet
FR2992218B1 (en) * 2012-06-22 2015-01-23 Rivopharm Sa PHARMACEUTICAL COMPOSITION OF MOXIFLOXACIN HYDROCHLORIDE AND PROCESS FOR PREPARING THE SAME
WO2014068507A1 (en) 2012-11-02 2014-05-08 Abbott Healthcare Pvt. Ltd. Solid oral pharmaceutical compositions of telmisartan, essentially free of surfactants
WO2014091263A1 (en) * 2012-12-11 2014-06-19 Egis Pharmaceuticals Public Limited Company Telmisartan containing pharmaceutical composition
EP3380079A4 (en) * 2015-11-25 2019-08-21 Patheon Development Services Inc. Amorphous dispersion granules and oral dosage forms
US9687475B1 (en) 2016-03-24 2017-06-27 Ezra Pharma Llc Extended release pharmaceutical formulations with controlled impurity levels
US9675585B1 (en) 2016-03-24 2017-06-13 Ezra Pharma Extended release pharmaceutical formulations
JP2016145258A (en) * 2016-05-16 2016-08-12 テバ製薬株式会社 Stabilized pharmaceutical composition
JP6422464B2 (en) * 2016-05-19 2018-11-14 エルメッド エーザイ株式会社 Levetiracetam-containing pharmaceutical composition and method for producing the same, method for preventing delay of dissolution and / or dissolution of levetiracetam-containing pharmaceutical composition, and agent for preventing delay and / or dissolution of levetiracetam-containing pharmaceutical composition
WO2020021111A1 (en) 2018-07-27 2020-01-30 Sisteks D.O.O. Straw for oral administration of pharmaceutical formulation
CN113116827B (en) * 2019-12-30 2022-09-23 上海复星星泰医药科技有限公司 Oseltamivir phosphate granules and preparation method thereof
GB202001237D0 (en) 2020-01-29 2020-03-11 Sisteks D O O Granular pharmaceutical product for oral administration from a pre-filled straw and method of manufacturing such pharmaceutical product
KR102441089B1 (en) * 2020-06-15 2022-09-07 환인제약 주식회사 A Pharmaceutical Composition

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005020998A1 (en) * 2003-09-03 2005-03-10 Ranbaxy Laboratories Limited Pharmaceutical compositions of moxifloxacin and processes for their preparation
US20050147674A1 (en) * 2001-07-31 2005-07-07 Christensen Troels V. Crystalline composition containing escitalopram
WO2005068453A2 (en) * 2004-01-09 2005-07-28 Ratiopharm Gmbh Crystalline forms of rizatriptan benzoate
EP1810676A1 (en) * 2006-01-24 2007-07-25 Teva Pharmaceutical Industries Limited Levetiracetam formulations and methods for their manufacture
EP1854454A2 (en) * 2002-01-16 2007-11-14 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG Bilayer pharmaceutical tablet comprising telmisartan and a diuretic and preparation thereof
WO2007144175A2 (en) * 2006-06-16 2007-12-21 Lek Pharmaceuticals D.D. Pharmaceutical composition comprising hydrochlorothiazide and telmisartan
WO2009058950A2 (en) * 2007-10-30 2009-05-07 Dr. Reddy's Laboratories Ltd. Pharmaceutical formulations comprising telmisartan and hydrochlorothiazide

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SI9210098B (en) 1991-02-06 2000-06-30 Dr. Karl Thomae Benzimidazoles, drugs with this compounds, and process for their preparation
DE10244681A1 (en) 2002-09-24 2004-04-08 Boehringer Ingelheim International Gmbh New solid telmisartan-containing pharmaceutical formulations and their preparation
US20070116759A1 (en) 2005-11-22 2007-05-24 Gershon Kolatkar Pharmaceutical compositions of telmisartan
US8637078B2 (en) 2005-11-24 2014-01-28 Boehringer Ingelheim International Gmbh Bilayer tablet comprising telmisartan and diuretic
EP1970053A1 (en) 2007-03-14 2008-09-17 Boehringer Ingelheim Pharma GmbH & Co. KG Pharmaceutical composition

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050147674A1 (en) * 2001-07-31 2005-07-07 Christensen Troels V. Crystalline composition containing escitalopram
EP1854454A2 (en) * 2002-01-16 2007-11-14 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG Bilayer pharmaceutical tablet comprising telmisartan and a diuretic and preparation thereof
WO2005020998A1 (en) * 2003-09-03 2005-03-10 Ranbaxy Laboratories Limited Pharmaceutical compositions of moxifloxacin and processes for their preparation
WO2005068453A2 (en) * 2004-01-09 2005-07-28 Ratiopharm Gmbh Crystalline forms of rizatriptan benzoate
EP1810676A1 (en) * 2006-01-24 2007-07-25 Teva Pharmaceutical Industries Limited Levetiracetam formulations and methods for their manufacture
WO2007144175A2 (en) * 2006-06-16 2007-12-21 Lek Pharmaceuticals D.D. Pharmaceutical composition comprising hydrochlorothiazide and telmisartan
WO2009058950A2 (en) * 2007-10-30 2009-05-07 Dr. Reddy's Laboratories Ltd. Pharmaceutical formulations comprising telmisartan and hydrochlorothiazide

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7051638B2 (en) 2017-04-10 2022-04-11 東和薬品株式会社 Escitalopram pharmaceutical composition

Also Published As

Publication number Publication date
EP2291177A2 (en) 2011-03-09
WO2009135646A2 (en) 2009-11-12

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