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WO2011042463A3 - Pharmaceutical composition comprising poorly soluble active ingredient and hyperbranched polymer - Google Patents

Pharmaceutical composition comprising poorly soluble active ingredient and hyperbranched polymer Download PDF

Info

Publication number
WO2011042463A3
WO2011042463A3 PCT/EP2010/064916 EP2010064916W WO2011042463A3 WO 2011042463 A3 WO2011042463 A3 WO 2011042463A3 EP 2010064916 W EP2010064916 W EP 2010064916W WO 2011042463 A3 WO2011042463 A3 WO 2011042463A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
active ingredient
hyperbranched polymer
preparation
pharmaceutically active
Prior art date
Application number
PCT/EP2010/064916
Other languages
French (fr)
Other versions
WO2011042463A2 (en
Inventor
Sebastjan Reven
Ema Zagar
Original Assignee
Lek Pharmaceuticals D.D.
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
Priority claimed from EP09172391A external-priority patent/EP2311435A1/en
Application filed by Lek Pharmaceuticals D.D. filed Critical Lek Pharmaceuticals D.D.
Priority to CN2010800550800A priority Critical patent/CN102647978A/en
Priority to EP10771053A priority patent/EP2485716A2/en
Publication of WO2011042463A2 publication Critical patent/WO2011042463A2/en
Publication of WO2011042463A3 publication Critical patent/WO2011042463A3/en

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
    • 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
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • 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
    • A61K31/495—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
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K31/50—Pyridazines; Hydrogenated pyridazines
    • A61K31/501—Pyridazines; Hydrogenated pyridazines not condensed and containing further heterocyclic rings
    • 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
    • A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61K9/2004—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
    • A61K9/204—Polyesters, e.g. poly(lactide-co-glycolide)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The present invention belongs to the field of pharmaceutical industry and relates to a pharmaceutical composition comprising at least one hyperbranched polymer and at least one pharmaceutically active ingredient, wherein the polymer and the pharmaceutically active ingredient are present in a specific weight ratio, and to a process for the preparation of said pharmaceutical composition. The present invention is also directed to a powder or granulate comprising at least one hyperbranched polymer and at least one pharmaceutically active ingredient in a specific weight ratio, to a process for the preparation of said powder or granulate, and to a pharmaceutical dosage form comprising the pharmaceutical composition, powder or granulate. Furthermore, the present invention relates to a process for preparing a solid dispersion of a hyperbranched polymer and at least one API. Moreover, it relates to the use of a crystalline carrier for the preparation of a mixture of hyperbranched polymer and a pharmaceutically active ingredient, as well as to the use of polyesteramide hyperbranched polymers for the preparation of a pharmaceutical composition, to the use of a hydrophilic or hydrophobic carrier for the preparation of said composition comprising a specific group of API, and to the use of a specific API and at least one hyperbranched polymer for the preparation of a pharmaceutical composition.
PCT/EP2010/064916 2009-10-07 2010-10-06 Pharmaceutical composition comprising poorly soluble active ingredient and hyperbranched polymer WO2011042463A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN2010800550800A CN102647978A (en) 2009-10-07 2010-10-06 Pharmaceutical composition comprising poorly soluble active ingredient and hyperbranched polymer
EP10771053A EP2485716A2 (en) 2009-10-07 2010-10-06 Pharmaceutical composition comprising poorly soluble active ingredient and hyperbranched polymer

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP09172391A EP2311435A1 (en) 2009-10-07 2009-10-07 Pharmaceutical composition comprising poorly soluble active ingredient and hyperbranched polymer
EP09172391.6 2009-10-07
EP10153918.7 2010-02-18
EP10153918 2010-02-18

Publications (2)

Publication Number Publication Date
WO2011042463A2 WO2011042463A2 (en) 2011-04-14
WO2011042463A3 true WO2011042463A3 (en) 2012-02-23

Family

ID=43127622

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/064916 WO2011042463A2 (en) 2009-10-07 2010-10-06 Pharmaceutical composition comprising poorly soluble active ingredient and hyperbranched polymer

Country Status (3)

Country Link
EP (1) EP2485716A2 (en)
CN (1) CN102647978A (en)
WO (1) WO2011042463A2 (en)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1579862A1 (en) 2004-03-25 2005-09-28 Boehringer Ingelheim Vetmedica Gmbh Use of PDE III inhibitors for the reduction of heart size in mammals suffering from heart failure
US8980894B2 (en) 2004-03-25 2015-03-17 Boehringer Ingelheim Vetmedica Gmbh Use of PDE III inhibitors for the treatment of asymptomatic (occult) heart failure
EP1920785A1 (en) 2006-11-07 2008-05-14 Boehringer Ingelheim Vetmedica Gmbh Liquid preparation comprising a complex of pimobendan and cyclodextrin
EP3167876B1 (en) 2012-03-15 2021-09-08 Boehringer Ingelheim Vetmedica GmbH Pharmaceutical tablet formulation for the veterinary medical sector, method of production and use thereof
WO2014003678A1 (en) * 2012-06-28 2014-01-03 Xspray Microparticles Ab Pharmaceutical compositions comprising ambrisentan and solid dispersion particles containing tadalafil
WO2014003677A1 (en) * 2012-06-28 2014-01-03 Xspray Microparticles Ab Pharmaceutical compositions comprising solid dispersion particles containing tadalafil
WO2014045307A2 (en) 2012-09-20 2014-03-27 Ipca Laboratories Limited Pharmaceutical composition
CN113181110A (en) 2013-07-19 2021-07-30 勃林格殷格翰动物保健有限公司 Liquid aqueous pharmaceutical composition containing preserved etherified cyclodextrin derivatives
PL3106150T3 (en) 2013-12-04 2022-01-03 Boehringer Ingelheim Vetmedica Gmbh Improved pharmaceutical compositions of pimobendan
WO2017041679A1 (en) * 2015-09-07 2017-03-16 常州方楠医药技术有限公司 Solid dispersion of tadalafil and pharmaceutical excipients, and preparation method for solid dispersion
CN105613547B (en) * 2016-03-30 2017-10-24 青岛农业大学 Glibenclamide is being prepared for preventing and treating by the purposes in the bactericide of the microbial plant disease of pathogenic
US10537570B2 (en) 2016-04-06 2020-01-21 Boehringer Ingelheim Vetmedica Gmbh Use of pimobendan for the reduction of heart size and/or the delay of onset of clinical symptoms in patients with asymptomatic heart failure due to mitral valve disease
CN112535665A (en) * 2020-12-14 2021-03-23 宁夏医科大学 Glipizide solid dispersion, preparation method thereof, glipizide solid dispersion tablet containing glipizide solid dispersion and preparation method thereof
WO2024126434A1 (en) 2022-12-15 2024-06-20 Boehringer Ingelheim Vetmedica Gmbh Solid dispersions comprising amorphous pimobendan and one or more stabilizing polymers

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030180250A1 (en) * 2002-03-22 2003-09-25 Council Of Scientific And Industrial Research Compositions and complexes containing a macromolecular compound as potential anti-inflammatory agents
US20060216265A1 (en) * 2002-07-19 2006-09-28 The Regents Of The University Of California Dendrimers as molecular translocators
US20090041813A1 (en) * 2005-02-21 2009-02-12 Basf Aktiengesellschaft Active substance composition comprising at least one nitrogen atom-containing, hyperbranched polymer

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MXPA05008579A (en) 2003-02-13 2007-11-21 Nat Ct Scient Res Demokritos Multifunctional dendrimers and hyperbranched polymers as drug and gene delivery systems.

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030180250A1 (en) * 2002-03-22 2003-09-25 Council Of Scientific And Industrial Research Compositions and complexes containing a macromolecular compound as potential anti-inflammatory agents
US20060216265A1 (en) * 2002-07-19 2006-09-28 The Regents Of The University Of California Dendrimers as molecular translocators
US20090041813A1 (en) * 2005-02-21 2009-02-12 Basf Aktiengesellschaft Active substance composition comprising at least one nitrogen atom-containing, hyperbranched polymer

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
ALEXANDER C: "SYNTHETIC POLYMER SYSTEMS IN DRUG DELIVERY", EXPERT OPINION ON EMERGING DRUGS, ASHLEY PUBLICATIONS, GB LNKD- DOI:10.1517/14728214.6.2.345, vol. 6, no. 2, 1 January 2001 (2001-01-01), pages 345 - 363, XP008011196, ISSN: 1472-8214 *
MUSCAT D ET AL: "HYPERBRANCHED POLYESTERAMIDES - NEW DENDRITIC POLYMERS", TOPICS IN CURRENT CHEMISTRY, SPRINGER, BERLIN, DE LNKD- DOI:10.1007/3-540-44924-8_2, vol. 212, 1 January 2001 (2001-01-01), pages 41 - 80, XP001068479 *

Also Published As

Publication number Publication date
EP2485716A2 (en) 2012-08-15
WO2011042463A2 (en) 2011-04-14
CN102647978A (en) 2012-08-22

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