WO2020012243A3 - Pharmaceutical composition containing a peptide - Google Patents

Pharmaceutical composition containing a peptide Download PDF

Info

Publication number
WO2020012243A3
WO2020012243A3 PCT/IB2019/000716 IB2019000716W WO2020012243A3 WO 2020012243 A3 WO2020012243 A3 WO 2020012243A3 IB 2019000716 W IB2019000716 W IB 2019000716W WO 2020012243 A3 WO2020012243 A3 WO 2020012243A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
peptide
composition containing
composition
linaclotide
Prior art date
Application number
PCT/IB2019/000716
Other languages
French (fr)
Other versions
WO2020012243A2 (en
Inventor
Christopher RUPP
Ronny SCHULZE
Rob VAN DEN AKKER
Kuldeep Bhokare
Jörn LÜDERS
George Shlieout
Jörg HAGEDORN
Original Assignee
Abbott Laboratories Gmbh
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 Abbott Laboratories Gmbh filed Critical Abbott Laboratories Gmbh
Priority to MX2021000312A priority Critical patent/MX2021000312A/en
Priority to BR112021000201-4A priority patent/BR112021000201A2/en
Publication of WO2020012243A2 publication Critical patent/WO2020012243A2/en
Publication of WO2020012243A3 publication Critical patent/WO2020012243A3/en
Priority to CONC2021/0000158A priority patent/CO2021000158A2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10—Peptides having 12 to 20 amino acids
    • 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
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

The present invention relates to a stable pharmaceutical composition for oral administration comprising Linaclotide or its pharmaceutically acceptable salts and a carrier. Methods of preparing and using the composition are also provided. In particular, the composition may be used in the treatment of gastrointestinal disorders, such as chronic constipation and irritable bowel syndrome.
PCT/IB2019/000716 2018-07-09 2019-07-08 Pharmaceutical composition containing a peptide WO2020012243A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
MX2021000312A MX2021000312A (en) 2018-07-09 2019-07-08 Pharmaceutical composition containing a peptide.
BR112021000201-4A BR112021000201A2 (en) 2018-07-09 2019-07-08 pharmaceutical composition containing a peptide
CONC2021/0000158A CO2021000158A2 (en) 2018-07-09 2021-01-12 Pharmaceutical composition containing a peptide

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201811025533 2018-07-09
IN201811025533 2018-07-09

Publications (2)

Publication Number Publication Date
WO2020012243A2 WO2020012243A2 (en) 2020-01-16
WO2020012243A3 true WO2020012243A3 (en) 2020-03-05

Family

ID=68165587

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2019/000716 WO2020012243A2 (en) 2018-07-09 2019-07-08 Pharmaceutical composition containing a peptide

Country Status (6)

Country Link
AR (1) AR115724A1 (en)
BR (1) BR112021000201A2 (en)
CL (1) CL2021000022A1 (en)
CO (1) CO2021000158A2 (en)
MX (1) MX2021000312A (en)
WO (1) WO2020012243A2 (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120088774A1 (en) * 2009-04-06 2012-04-12 Lek Pharmaceuticals D.D. Active pharmaceutical ingredient adsorbed on solid support
US20120237593A1 (en) * 2010-09-15 2012-09-20 Synergy Pharmaceuticals Inc. Formulations of Guanylate Cyclase C Agonists and Methods of Use
WO2014088623A1 (en) * 2012-07-12 2014-06-12 Forest Laboratories Holdings Limited Linaclotide compositions
WO2016097030A1 (en) * 2014-12-19 2016-06-23 Synthon B.V. Pharmaceutical composition comprising amorphous lenalidomide

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007033427A1 (en) 2005-09-23 2007-03-29 Metabolic Pharmaceuticals Limited Stabilisation of peptides with basic amino acids
MX2020005326A (en) 2008-08-15 2022-03-03 Ironwood Pharmaceuticals Inc Linaclotide-containing formulations for oral administration.
EP3180016A4 (en) 2014-08-11 2018-01-03 Sun Pharmaceutical Industries Ltd Linaclotide stable composition

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120088774A1 (en) * 2009-04-06 2012-04-12 Lek Pharmaceuticals D.D. Active pharmaceutical ingredient adsorbed on solid support
US20120237593A1 (en) * 2010-09-15 2012-09-20 Synergy Pharmaceuticals Inc. Formulations of Guanylate Cyclase C Agonists and Methods of Use
WO2014088623A1 (en) * 2012-07-12 2014-06-12 Forest Laboratories Holdings Limited Linaclotide compositions
WO2016097030A1 (en) * 2014-12-19 2016-06-23 Synthon B.V. Pharmaceutical composition comprising amorphous lenalidomide

Also Published As

Publication number Publication date
MX2021000312A (en) 2021-06-08
AR115724A1 (en) 2021-02-17
BR112021000201A2 (en) 2021-08-10
CO2021000158A2 (en) 2021-01-18
CL2021000022A1 (en) 2021-07-19
WO2020012243A2 (en) 2020-01-16

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