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FR3102931B1 - Procédé de fabrication d’une composition pharmaceutique à administration orale et à délivrance colonique - Google Patents

Procédé de fabrication d’une composition pharmaceutique à administration orale et à délivrance colonique Download PDF

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Publication number
FR3102931B1
FR3102931B1 FR1912643A FR1912643A FR3102931B1 FR 3102931 B1 FR3102931 B1 FR 3102931B1 FR 1912643 A FR1912643 A FR 1912643A FR 1912643 A FR1912643 A FR 1912643A FR 3102931 B1 FR3102931 B1 FR 3102931B1
Authority
FR
France
Prior art keywords
meth
anionic
acrylate copolymer
pharmaceutical composition
spraying
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
FR1912643A
Other languages
English (en)
Other versions
FR3102931A1 (fr
Inventor
Catherine Herry
Yuqiu Zhu
Bruno Criere
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ethypharm SAS
Original Assignee
Ethypharm SAS
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 Ethypharm SAS filed Critical Ethypharm SAS
Priority to FR1912643A priority Critical patent/FR3102931B1/fr
Priority to PCT/FR2020/052082 priority patent/WO2021094697A1/fr
Priority to US17/776,723 priority patent/US20230301927A1/en
Priority to CN202080078817.4A priority patent/CN115461046A/zh
Priority to EP20823891.5A priority patent/EP4057998A1/fr
Publication of FR3102931A1 publication Critical patent/FR3102931A1/fr
Application granted granted Critical
Publication of FR3102931B1 publication Critical patent/FR3102931B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/606—Salicylic acid; Derivatives thereof having amino groups
    • 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
    • A61K9/50—Microcapsules 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
    • A61K9/5089—Processes
    • 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
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention porte sur un procédé de préparation d’une composition pharmaceutique à administration orale et à délivrance colonique comprenant au moins un cœur et une couche d’enrobage, permettant d’obtenir une composition pharmaceutique présentant une dissolution homogène et reproductible et donc une libération du principe actif également homogène et reproductible avec de faibles coefficients de variation, ledit procédé étant caractérisé en ce qu’il comprend les étapes suivantes : a) Pulvérisation sur un support neutre d’une suspension aqueuse comprenant au moins un copolymère (méth)acrylate anionique soluble à pH supérieur à 5,5 et au moins un principe actif destiné à être délivré dans le côlon ; ou a’) Pulvérisation sur un support neutre d’une suspension aqueuse comprenant au moins un copolymère (méth)acrylate anionique soluble à pH supérieur à 5,5 puis b’) Poudrage d’au moins un principe actif destiné à être délivré dans le côlon sur les microgranules obtenus après l’étape a’) ; c’) réalisation des étapes a’) et b’) alternativement jusqu’à obtention de la teneur en principe actif voulue et d) Enrobage des microgranules obtenus après l’étape a) ou c’) par pulvérisation d’une composition comprenant au moins un copolymère (méth)acrylate anionique soluble à pH supérieur à 6, un copolymère (méth)acrylate anionique soluble à pH supérieur à 7 et un copolymère (méth)acrylate anionique insoluble en milieu aqueux.
FR1912643A 2019-11-13 2019-11-13 Procédé de fabrication d’une composition pharmaceutique à administration orale et à délivrance colonique Active FR3102931B1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
FR1912643A FR3102931B1 (fr) 2019-11-13 2019-11-13 Procédé de fabrication d’une composition pharmaceutique à administration orale et à délivrance colonique
PCT/FR2020/052082 WO2021094697A1 (fr) 2019-11-13 2020-11-13 Procédé de fabrication d'une composition pharmaceutique à administration orale et à délivrance colonique
US17/776,723 US20230301927A1 (en) 2019-11-13 2020-11-13 Process for producing an orally administered pharmaceutical composition with colonic delivery
CN202080078817.4A CN115461046A (zh) 2019-11-13 2020-11-13 用于生产具有结肠递送的口服施用药物组合物的方法
EP20823891.5A EP4057998A1 (fr) 2019-11-13 2020-11-13 Procédé de fabrication d'une composition pharmaceutique à administration orale et à délivrance colonique

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1912643 2019-11-13
FR1912643A FR3102931B1 (fr) 2019-11-13 2019-11-13 Procédé de fabrication d’une composition pharmaceutique à administration orale et à délivrance colonique

Publications (2)

Publication Number Publication Date
FR3102931A1 FR3102931A1 (fr) 2021-05-14
FR3102931B1 true FR3102931B1 (fr) 2021-12-24

Family

ID=69468863

Family Applications (1)

Application Number Title Priority Date Filing Date
FR1912643A Active FR3102931B1 (fr) 2019-11-13 2019-11-13 Procédé de fabrication d’une composition pharmaceutique à administration orale et à délivrance colonique

Country Status (1)

Country Link
FR (1) FR3102931B1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116785238B (zh) * 2023-05-25 2025-08-26 北京诺康达医药科技股份有限公司 一种光敏药物口服溶液及其制备方法

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE8003805L (sv) 1980-05-21 1981-11-22 Haessle Ab En farmaceutisk beredning med forbettrade utlosningsegenskap
IT1230576B (it) * 1988-10-20 1991-10-28 Angeli Inst Spa Formulazioni farmaceutiche per via orale a liberazione selettiva nel colon
JOP20200144A1 (ar) * 2012-04-30 2017-06-16 Tillotts Pharma Ag تركيبة عقار ذو إطلاق متأخر

Also Published As

Publication number Publication date
FR3102931A1 (fr) 2021-05-14

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