EA201590835A1 - Составы с низкой дозой панкрелипазы и кишечнорастворимым покрытием - Google Patents

Составы с низкой дозой панкрелипазы и кишечнорастворимым покрытием

Info

Publication number
EA201590835A1
EA201590835A1 EA201590835A EA201590835A EA201590835A1 EA 201590835 A1 EA201590835 A1 EA 201590835A1 EA 201590835 A EA201590835 A EA 201590835A EA 201590835 A EA201590835 A EA 201590835A EA 201590835 A1 EA201590835 A1 EA 201590835A1
Authority
EA
Eurasian Patent Office
Prior art keywords
digestive enzyme
dosage form
pancrelipase
compositions
low dose
Prior art date
Application number
EA201590835A
Other languages
English (en)
Other versions
EA030449B1 (ru
Inventor
Джованни Ортенци
Джузеппе Де Франца
Данило Клементи
Кристиан Столльберг
Луиджи Больтри
Original Assignee
Апталис Фарма Лимитид
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=45044628&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EA201590835(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Апталис Фарма Лимитид filed Critical Апталис Фарма Лимитид
Publication of EA201590835A1 publication Critical patent/EA201590835A1/ru
Publication of EA030449B1 publication Critical patent/EA030449B1/ru

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/465Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

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

Abstract

Настоящее изобретение направлено на фармацевтическую композицию или лекарственную форму со стабильным низким содержанием пищеварительного фермента (разбавленным пищеварительным ферментом), содержащую по меньшей мере один пищеварительный фермент и по меньшей мере один носитель, или ее лекарственную форму. Настоящее изобретение также направлено на способ получения композиции или лекарственной формы. Кроме того, настоящее изобретение направлено на лечение и предупреждение расстройств или состояний, связанных с недостаточностью пищеварительного фермента, у пациента, нуждающегося в этом, включающие введение указанному пациенту фармацевтически приемлемого количества композиции со стабильным низким содержанием пищеварительного фермента или ее лекарственной формы.
EA201590835A 2010-10-01 2011-09-30 Составы с низкой дозой панкрелипазы и кишечнорастворимым покрытием EA030449B1 (ru)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US38903710P 2010-10-01 2010-10-01

Publications (2)

Publication Number Publication Date
EA201590835A1 true EA201590835A1 (ru) 2015-11-30
EA030449B1 EA030449B1 (ru) 2018-08-31

Family

ID=45044628

Family Applications (3)

Application Number Title Priority Date Filing Date
EA201390409A EA029101B1 (ru) 2010-10-01 2011-09-30 Составы с низкой дозой панкрелипазы и кишечнорастворимым покрытием
EA201590836A EA030450B1 (ru) 2010-10-01 2011-09-30 Составы с низкой дозой панкрелипазы и кишечнорастворимым покрытием
EA201590835A EA030449B1 (ru) 2010-10-01 2011-09-30 Составы с низкой дозой панкрелипазы и кишечнорастворимым покрытием

Family Applications Before (2)

Application Number Title Priority Date Filing Date
EA201390409A EA029101B1 (ru) 2010-10-01 2011-09-30 Составы с низкой дозой панкрелипазы и кишечнорастворимым покрытием
EA201590836A EA030450B1 (ru) 2010-10-01 2011-09-30 Составы с низкой дозой панкрелипазы и кишечнорастворимым покрытием

Country Status (26)

Country Link
US (2) US11364205B2 (ru)
EP (2) EP2818160B1 (ru)
JP (2) JP6043929B2 (ru)
KR (2) KR101968457B1 (ru)
CN (2) CN108187033A (ru)
AR (1) AR093181A1 (ru)
AU (2) AU2011309763B2 (ru)
BR (1) BR112013007640A2 (ru)
CA (1) CA2812862C (ru)
CL (1) CL2011002432A1 (ru)
CO (1) CO6700848A2 (ru)
DK (1) DK2621476T4 (ru)
EA (3) EA029101B1 (ru)
ES (2) ES2657673T3 (ru)
HR (1) HRP20140995T1 (ru)
IL (1) IL225504A (ru)
MX (1) MX348118B (ru)
PL (1) PL2621476T5 (ru)
PT (1) PT2621476E (ru)
RS (1) RS53587B1 (ru)
SA (1) SA111320804B1 (ru)
SI (1) SI2621476T1 (ru)
SM (1) SMT201400149B (ru)
UA (1) UA111726C2 (ru)
WO (1) WO2012042372A1 (ru)
ZA (1) ZA201303087B (ru)

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