WO2015150942A3 - Improved process for preparing microparticles - Google Patents

Improved process for preparing microparticles Download PDF

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Publication number
WO2015150942A3
WO2015150942A3 PCT/IB2015/051835 IB2015051835W WO2015150942A3 WO 2015150942 A3 WO2015150942 A3 WO 2015150942A3 IB 2015051835 W IB2015051835 W IB 2015051835W WO 2015150942 A3 WO2015150942 A3 WO 2015150942A3
Authority
WO
WIPO (PCT)
Prior art keywords
microparticles
preparing
improved process
preparing microparticles
release
Prior art date
Application number
PCT/IB2015/051835
Other languages
French (fr)
Other versions
WO2015150942A2 (en
Inventor
Mukesh Kumar
Suhas KAKADE
Peter Markland
Girish Kumar Jain
Original Assignee
The WOCKHARDT 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 The WOCKHARDT LIMITED filed Critical The WOCKHARDT LIMITED
Priority claimed from IN1188MU2014 external-priority patent/IN2014MU01188A/en
Priority claimed from IN1189MU2014 external-priority patent/IN2014MU01189A/en
Publication of WO2015150942A2 publication Critical patent/WO2015150942A2/en
Publication of WO2015150942A3 publication Critical patent/WO2015150942A3/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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K9/1682—Processes
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient

Abstract

There is provided an improved process for preparing microparticles. More particularly, a process is provided for preparing microparticles having a selected release profile for release of drug contained in the microparticles. By subjecting the emulsion to multiple steps including quenching, fine removal by decantation, washing and de-watering in a single vessel followed by lyophilization as a intermediate step that is performed during the preparation of the microparticles, good quality microparticles can be prepared. The process of manufacturing the microparticles according to the invention is simple, robust and requires relativey less control of processing parameters. Further, the resulting microparticles possess excellent shape uniformity, exhibiting lesser agglomerating tendency after intermediate stage drying and good flowability in case of dry powder vial filling.
PCT/IB2015/051835 2014-03-29 2015-03-13 Improved process for preparing microparticles WO2015150942A2 (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
IN1188/MUM/2014 2014-03-29
IN1190MU2014 2014-03-29
IN1190/MUM/2014 2014-03-29
IN1189/MUM/2014 2014-03-29
IN1188MU2014 IN2014MU01188A (en) 2014-03-29 2015-03-13
IN1189MU2014 IN2014MU01189A (en) 2014-03-29 2015-03-13

Publications (2)

Publication Number Publication Date
WO2015150942A2 WO2015150942A2 (en) 2015-10-08
WO2015150942A3 true WO2015150942A3 (en) 2015-11-26

Family

ID=54241388

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2015/051835 WO2015150942A2 (en) 2014-03-29 2015-03-13 Improved process for preparing microparticles

Country Status (1)

Country Link
WO (1) WO2015150942A2 (en)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5650173A (en) * 1993-11-19 1997-07-22 Alkermes Controlled Therapeutics Inc. Ii Preparation of biodegradable microparticles containing a biologically active agent
US5654008A (en) * 1993-11-19 1997-08-05 Alkermes Controlled Therapeutics Inc. Ii Preparation of biodegradable microparticles containing a biologically active agent
US20050260272A1 (en) * 2004-05-05 2005-11-24 Alkermes Controlled Therapeutics, Inc. Method of forming microparticles that include a bisphosphonate and a polymer
US20080317865A1 (en) * 2007-06-20 2008-12-25 Alkermes, Inc. Quench liquids and washing systems for production of microparticles
WO2014027253A1 (en) * 2012-08-14 2014-02-20 Wockhardt Limited Pharmaceutical microparticulate compositions of polypeptides
WO2014027254A1 (en) * 2012-08-14 2014-02-20 Wockhardt Limited Pharmaceutical microparticulate compositions of polypeptides

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2010115A1 (en) 1970-03-04 1971-09-16 Farbenfabriken Bayer Ag, 5090 Leverkusen Process for the production of micro-granules
DE69024953T3 (en) 1989-05-04 2005-01-27 Southern Research Institute, Birmingham encapsulation
US5945126A (en) 1997-02-13 1999-08-31 Oakwood Laboratories L.L.C. Continuous microsphere process
US6194006B1 (en) 1998-12-30 2001-02-27 Alkermes Controlled Therapeutics Inc. Ii Preparation of microparticles having a selected release profile
US20020114843A1 (en) 2000-12-27 2002-08-22 Ramstack J. Michael Preparation of microparticles having improved flowability

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5650173A (en) * 1993-11-19 1997-07-22 Alkermes Controlled Therapeutics Inc. Ii Preparation of biodegradable microparticles containing a biologically active agent
US5654008A (en) * 1993-11-19 1997-08-05 Alkermes Controlled Therapeutics Inc. Ii Preparation of biodegradable microparticles containing a biologically active agent
US20050260272A1 (en) * 2004-05-05 2005-11-24 Alkermes Controlled Therapeutics, Inc. Method of forming microparticles that include a bisphosphonate and a polymer
US20080317865A1 (en) * 2007-06-20 2008-12-25 Alkermes, Inc. Quench liquids and washing systems for production of microparticles
WO2014027253A1 (en) * 2012-08-14 2014-02-20 Wockhardt Limited Pharmaceutical microparticulate compositions of polypeptides
WO2014027254A1 (en) * 2012-08-14 2014-02-20 Wockhardt Limited Pharmaceutical microparticulate compositions of polypeptides

Also Published As

Publication number Publication date
WO2015150942A2 (en) 2015-10-08

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