WO2016199170A3 - Paliperidone palmitate particles and compositions thereof - Google Patents

Paliperidone palmitate particles and compositions thereof Download PDF

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Publication number
WO2016199170A3
WO2016199170A3 PCT/IN2016/050177 IN2016050177W WO2016199170A3 WO 2016199170 A3 WO2016199170 A3 WO 2016199170A3 IN 2016050177 W IN2016050177 W IN 2016050177W WO 2016199170 A3 WO2016199170 A3 WO 2016199170A3
Authority
WO
WIPO (PCT)
Prior art keywords
compositions
paliperidone palmitate
palmitate particles
particles
pharmaceutical compositions
Prior art date
Application number
PCT/IN2016/050177
Other languages
French (fr)
Other versions
WO2016199170A2 (en
Inventor
Geena Malhotra
Sarabjit Singh
Khalid Akhter ANSARI
Original Assignee
Cipla 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 Cipla Limited filed Critical Cipla Limited
Publication of WO2016199170A2 publication Critical patent/WO2016199170A2/en
Publication of WO2016199170A3 publication Critical patent/WO2016199170A3/en

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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
    • A61K9/1629—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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention disclosed relates to Paliperidone palmitate particles, a process to manufacture the same and pharmaceutical compositions thereof. It further relates to the use of such pharmaceutical compositions in the treatment of schizophrenia, schizoaffective disorder and other related disorders.
PCT/IN2016/050177 2015-06-10 2016-06-09 Paliperidone palmitate particles and compositions thereof WO2016199170A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2233/MUM/2015 2015-06-10
IN2233MU2015 2015-06-10

Publications (2)

Publication Number Publication Date
WO2016199170A2 WO2016199170A2 (en) 2016-12-15
WO2016199170A3 true WO2016199170A3 (en) 2017-01-19

Family

ID=57503163

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2016/050177 WO2016199170A2 (en) 2015-06-10 2016-06-09 Paliperidone palmitate particles and compositions thereof

Country Status (1)

Country Link
WO (1) WO2016199170A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113024546B (en) * 2019-12-25 2022-06-10 江苏晶立信医药科技有限公司 Preparation method of small-particle-size paliperidone palmitate

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106727589A (en) * 2017-01-24 2017-05-31 广州帝奇医药技术有限公司 The slow releasing composition of 9-hydroxy-risperidone and its derivative and the preparation method of the slow releasing composition
JP6960475B2 (en) * 2017-06-15 2021-11-05 サビオール ライフテック コーポレーションSavior Lifetec Corporation Manufacturing method of active ingredient particles
CA3077224A1 (en) * 2017-10-27 2019-05-02 Shandong Luye Pharmaceutical Co., Ltd. Dosage regimen of paliperidone palmitate extended-release injectable suspension
CN116528837A (en) * 2020-11-30 2023-08-01 詹森药业有限公司 Method for ensuring re-suspension of paliperidone palmitate formulations
KR20230116008A (en) 2020-11-30 2023-08-03 얀센 파마슈티카 엔.브이. How to Ensure Resuspension of Paliperidone Palmitate Formulations

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050208132A1 (en) * 2002-07-29 2005-09-22 Gayatri Sathyan Methods and dosage forms for reducing side effects of benzisozazole derivatives
US20070116729A1 (en) * 2005-11-18 2007-05-24 Palepu Nageswara R Lyophilization process and products obtained thereby
US20080214808A1 (en) * 2005-04-25 2008-09-04 Thomas Frederik Ernestine Spittaels Preparation of Aseptic 3-[2-[4-((6-Fluoro-1,2-Benzisoxazol-3-Yl)-1-Piperidinyl]-6,7,8,9-Tetrahydro-9-Hydroxy-2-Methyl-4H-Pyrido[1,2-a]Pyrimidin-4-One Palmitate Ester
US20090209757A1 (en) * 2008-01-10 2009-08-20 Santiago Ini Processes for the preparation and purification of paliperidone palmitate
US20100267954A1 (en) * 2009-04-21 2010-10-21 Dipharma Francis S.R.L. Process for the purification of paliperidone
US20130171202A1 (en) * 2010-05-31 2013-07-04 Laboratorios Farmaceuticos Rovi, S.A. Antipsychotic Injectable Depot Composition
US20130280177A1 (en) * 2012-04-18 2013-10-24 Mallinckrodt Llc Immediate Release, Abuse Deterrent Pharmaceutical Compositions
US20130303502A1 (en) * 2012-05-08 2013-11-14 Aciex Therapeutics, Inc. Preparations of Hydrophobic Therapeutic Agents, Methods of Manufacture and Use Thereof

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050208132A1 (en) * 2002-07-29 2005-09-22 Gayatri Sathyan Methods and dosage forms for reducing side effects of benzisozazole derivatives
US20080214808A1 (en) * 2005-04-25 2008-09-04 Thomas Frederik Ernestine Spittaels Preparation of Aseptic 3-[2-[4-((6-Fluoro-1,2-Benzisoxazol-3-Yl)-1-Piperidinyl]-6,7,8,9-Tetrahydro-9-Hydroxy-2-Methyl-4H-Pyrido[1,2-a]Pyrimidin-4-One Palmitate Ester
US20070116729A1 (en) * 2005-11-18 2007-05-24 Palepu Nageswara R Lyophilization process and products obtained thereby
US20090209757A1 (en) * 2008-01-10 2009-08-20 Santiago Ini Processes for the preparation and purification of paliperidone palmitate
US20100267954A1 (en) * 2009-04-21 2010-10-21 Dipharma Francis S.R.L. Process for the purification of paliperidone
US20130171202A1 (en) * 2010-05-31 2013-07-04 Laboratorios Farmaceuticos Rovi, S.A. Antipsychotic Injectable Depot Composition
US20130280177A1 (en) * 2012-04-18 2013-10-24 Mallinckrodt Llc Immediate Release, Abuse Deterrent Pharmaceutical Compositions
US20130303502A1 (en) * 2012-05-08 2013-11-14 Aciex Therapeutics, Inc. Preparations of Hydrophobic Therapeutic Agents, Methods of Manufacture and Use Thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113024546B (en) * 2019-12-25 2022-06-10 江苏晶立信医药科技有限公司 Preparation method of small-particle-size paliperidone palmitate

Also Published As

Publication number Publication date
WO2016199170A2 (en) 2016-12-15

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