WO2012085927A3 - Tadalafil compositions - Google Patents

Tadalafil compositions Download PDF

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Publication number
WO2012085927A3
WO2012085927A3 PCT/IN2011/000820 IN2011000820W WO2012085927A3 WO 2012085927 A3 WO2012085927 A3 WO 2012085927A3 IN 2011000820 W IN2011000820 W IN 2011000820W WO 2012085927 A3 WO2012085927 A3 WO 2012085927A3
Authority
WO
WIPO (PCT)
Prior art keywords
tadalafil
solid dispersion
compositions
pharmaceutically acceptable
tadalafil compositions
Prior art date
Application number
PCT/IN2011/000820
Other languages
French (fr)
Other versions
WO2012085927A2 (en
Inventor
Pramod PARSHURAMKAR
Sachin Gahoi
Sreenadh MEDARMETLA
Manoj Pananchukunnath
Rajesh Gupta
Indu Bhushan
Original Assignee
Mylan Laboratories, Limited
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 Mylan Laboratories, Limited filed Critical Mylan Laboratories, Limited
Publication of WO2012085927A2 publication Critical patent/WO2012085927A2/en
Publication of WO2012085927A3 publication Critical patent/WO2012085927A3/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
    • 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
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
    • 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
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

Abstract

Tadalafil compositions comprising tadalafil or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipient, wherein the composition comprises a solid dispersion of crystalline tadalafil. And process of preparing solid dispersion of crystalline tadalafil and composition of tadalafil comprising solid dispersion.
PCT/IN2011/000820 2010-12-02 2011-12-01 Tadalafil compositions WO2012085927A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN3649CH2010 2010-12-02
IN3649/CHE/2010 2010-12-02

Publications (2)

Publication Number Publication Date
WO2012085927A2 WO2012085927A2 (en) 2012-06-28
WO2012085927A3 true WO2012085927A3 (en) 2012-09-07

Family

ID=46314546

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2011/000820 WO2012085927A2 (en) 2010-12-02 2011-12-01 Tadalafil compositions

Country Status (1)

Country Link
WO (1) WO2012085927A2 (en)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014003677A1 (en) * 2012-06-28 2014-01-03 Xspray Microparticles Ab Pharmaceutical compositions comprising solid dispersion particles containing tadalafil
WO2014125343A1 (en) * 2013-02-12 2014-08-21 Alembic Pharmaceuticals Limited Tadalafil tablet composition with reduced dose strength
RU2673228C2 (en) * 2013-07-05 2018-11-23 Синтон Б.В. Pharmaceutical composition comprising a solid dispersion of tadalafil
CN104188912B (en) * 2014-07-17 2017-12-22 山东大学 Tadalafei solid dispersions and its tablet
TWI586379B (en) * 2015-06-29 2017-06-11 永信藥品工業股份有限公司 Method of preparing very slightly soluble drug with solid dosage form
US20170020880A1 (en) * 2015-07-22 2017-01-26 Hetero Research Foundation Pharmaceutical compositions of trametinib
CN105496963A (en) * 2015-11-24 2016-04-20 浙江华海药业股份有限公司 A tadalafil solid dispersoid and a preparing method of a medicine preparation of the tadalafil solid dispersoid
AU2017368232A1 (en) * 2016-11-30 2019-05-23 Druggability Technologies Ip Holdco Limited Pharmaceutical formulation containing Tadalafil
CN107334737A (en) * 2017-07-21 2017-11-10 广州中医药大学 Tadalafei solid dispersion system and preparation method thereof
US20210137919A1 (en) * 2018-02-07 2021-05-13 Smawa Gmbh Pharmaceutical formulations, method for producing a pharmaceutical formulation, and medicament comprising same
WO2021145831A1 (en) * 2020-01-16 2021-07-22 Pharmacti̇ve İlaç Sanayi̇ Ve Ti̇caret A.Ş. Pharmaceutical compositions comprising tadalafil and relevant excipients
CN114028349A (en) * 2021-10-12 2022-02-11 南京恒正药物研究院有限公司 Tadalafil orally disintegrating tablet

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996038131A1 (en) * 1995-06-02 1996-12-05 Glaxo Group Limited Method of producing a solid dispersion of a poorly water soluble drug
WO2001008688A2 (en) * 1999-08-03 2001-02-08 Lilly Icos Llc Beta-carboline drug products
WO2008000042A1 (en) * 2006-06-30 2008-01-03 Iceutica Pty Ltd Methods for the preparation of biologically active compounds in nanoparticulate form
WO2008005039A1 (en) * 2006-07-07 2008-01-10 Teva Pharmaceutical Industries Ltd. Solid compositions comprising tadalafil and at least one carrier

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996038131A1 (en) * 1995-06-02 1996-12-05 Glaxo Group Limited Method of producing a solid dispersion of a poorly water soluble drug
WO2001008688A2 (en) * 1999-08-03 2001-02-08 Lilly Icos Llc Beta-carboline drug products
WO2008000042A1 (en) * 2006-06-30 2008-01-03 Iceutica Pty Ltd Methods for the preparation of biologically active compounds in nanoparticulate form
WO2008005039A1 (en) * 2006-07-07 2008-01-10 Teva Pharmaceutical Industries Ltd. Solid compositions comprising tadalafil and at least one carrier

Also Published As

Publication number Publication date
WO2012085927A2 (en) 2012-06-28

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