BRPI0614545B8 - composição farmacêutica de liberação controlada, seu processo de produção, forma de dosagem oral com revestimento entérico de pacreatina e uso da mesma - Google Patents

composição farmacêutica de liberação controlada, seu processo de produção, forma de dosagem oral com revestimento entérico de pacreatina e uso da mesma

Info

Publication number
BRPI0614545B8
BRPI0614545B8 BRPI0614545A BRPI0614545A BRPI0614545B8 BR PI0614545 B8 BRPI0614545 B8 BR PI0614545B8 BR PI0614545 A BRPI0614545 A BR PI0614545A BR PI0614545 A BRPI0614545 A BR PI0614545A BR PI0614545 B8 BRPI0614545 B8 BR PI0614545B8
Authority
BR
Brazil
Prior art keywords
dosage form
oral dosage
enteric coating
pacreatin
pharmaceutical composition
Prior art date
Application number
BRPI0614545A
Other languages
English (en)
Inventor
Koerner Andreas
Koelln Claus-Juergen
Sczesny Frithjof
Shlieout George
Onken Jens
Original Assignee
Abbott Products Gmbh
Solvay Pharm 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=35253818&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0614545(B8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Abbott Products Gmbh, Solvay Pharm Gmbh filed Critical Abbott Products Gmbh
Publication of BRPI0614545A2 publication Critical patent/BRPI0614545A2/pt
Publication of BRPI0614545B1 publication Critical patent/BRPI0614545B1/pt
Publication of BRPI0614545B8 publication Critical patent/BRPI0614545B8/pt

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • 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
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Nutrition Science (AREA)
  • Obesity (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

composições farmacêuticas de liberação controlada para fármacos instáveis em ácido. a presente invenção refere-se a uma forma de dosagem oral com revestimento entérico compreendendo um ingrediente farmacêutico ativo instável em ácido, em que a composição está substancialmente isenta de ésteres de ácido ftálico monoméricos e óleos sintéticos como aqui descrita. também são proporcionados métodos para preparar e utilizar a forma de dosagem oral com revestimento entérico. as composições farmacêuticas descritas compreendem um revestimento entérico que inclui, pelo menos, um plastificante, pelo menos, um agente filmogênico e, opcionalmente, pelo menos, um agente antiaderente.
BRPI0614545A 2005-08-15 2006-08-15 composição farmacêutica de liberação controlada, seu processo de produção, forma de dosagem oral com revestimento entérico de pacreatina e uso da mesma BRPI0614545B8 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US70869205P 2005-08-15 2005-08-15
US60/708,692 2005-08-15
EP05107472.2 2005-08-15
EP05107472 2005-08-15
PCT/EP2006/065311 WO2007020259A2 (en) 2005-08-15 2006-08-15 Controlled release pharmaceutical compositions for acid labile drugs

Publications (3)

Publication Number Publication Date
BRPI0614545A2 BRPI0614545A2 (pt) 2011-04-05
BRPI0614545B1 BRPI0614545B1 (pt) 2020-03-31
BRPI0614545B8 true BRPI0614545B8 (pt) 2021-05-25

Family

ID=35253818

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0614545A BRPI0614545B8 (pt) 2005-08-15 2006-08-15 composição farmacêutica de liberação controlada, seu processo de produção, forma de dosagem oral com revestimento entérico de pacreatina e uso da mesma

Country Status (17)

Country Link
EP (1) EP1931316B2 (pt)
JP (1) JP5452918B2 (pt)
CN (1) CN101242811B (pt)
AT (1) ATE457719T2 (pt)
AU (1) AU2006281414B2 (pt)
BR (1) BRPI0614545B8 (pt)
CA (1) CA2619475C (pt)
DK (1) DK1931316T4 (pt)
ES (1) ES2341284T5 (pt)
MX (1) MX2008001558A (pt)
NZ (1) NZ565960A (pt)
PL (1) PL1931316T5 (pt)
PT (1) PT1931316E (pt)
RU (1) RU2440101C2 (pt)
SI (2) SI1931316T2 (pt)
UA (1) UA92030C2 (pt)
WO (1) WO2007020259A2 (pt)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1319655B1 (it) 2000-11-15 2003-10-23 Eurand Int Microsfere di enzimi pancreatici con elevata stabilita' e relativometodo di preparazione.
BRPI0614914A2 (pt) 2005-07-29 2011-04-19 Solvay Pharm Gmbh processos para a fabricação de pó de pancreatina esterilizada
US11266607B2 (en) 2005-08-15 2022-03-08 AbbVie Pharmaceuticals GmbH Process for the manufacture and use of pancreatin micropellet cores
US9198871B2 (en) 2005-08-15 2015-12-01 Abbott Products Gmbh Delayed release pancreatin compositions
US8497258B2 (en) 2005-11-12 2013-07-30 The Regents Of The University Of California Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract
US10072256B2 (en) 2006-05-22 2018-09-11 Abbott Products Gmbh Process for separating and determining the viral load in a pancreatin sample
AR065405A1 (es) 2007-02-20 2009-06-03 Eurand Pharmaceuticals Ltd Composiciones estables de enzimas digestivas
EP2044932A1 (en) * 2007-10-04 2009-04-08 Laboratorios del Dr. Esteve S.A. Mechanical protective layer for solid dosage forms
DK2211896T3 (en) 2007-11-13 2018-03-12 Meritage Pharma Inc COMPOSITIONS FOR THE TREATMENT OF GASTROINTESTINAL INFLAMMATION
WO2009109856A2 (en) 2008-03-07 2009-09-11 Axcan Pharma Inc. Method for detecting infectious parvovirus in pharmaceutical preparations
EP2440210A4 (en) 2009-06-12 2014-01-29 Meritage Pharma Inc METHOD FOR THE TREATMENT OF STOMACH DARM DISEASES
WO2011140106A1 (en) * 2010-05-03 2011-11-10 Eurand Pharmaceuticals Limited Micropellet compositions comprising pancreatin containing digestive enzyme mixtures
EP2621476B8 (en) 2010-10-01 2020-12-23 Société des Produits Nestlé S.A. Enteric coated, low-strength pancrelipase formulations
CN103732245B (zh) 2011-08-08 2016-07-06 阿普塔利斯制药有限公司 用于含有消化酶的组合物的溶出度测试的方法
MX2016001593A (es) 2013-08-09 2016-09-29 Allergan Pharmaceuticals Int Ltd Composicion de enzima digestiva adecuada para administracion enterica.
EP3157568A1 (en) 2014-06-19 2017-04-26 Aptalis Pharma Limited Methods for removing viral contaminants from pancreatic extracts
CN107073084B (zh) 2014-11-05 2022-03-25 雅培制药股份有限公司 用于生产具有改善的安全特性的具有脂肪酶活性的组合物和适用于药物用途的组合物的方法
CN104906565B (zh) * 2015-05-13 2018-06-19 西南大学 一种胰酶肠溶微丸及其制备方法
CN105902513B (zh) * 2016-05-11 2018-10-16 广州市义和化工有限公司 一种肠溶型金霉素微丸预混剂及其制备方法
CN108553439B (zh) * 2018-04-20 2020-10-16 广州白云山医药集团股份有限公司白云山制药总厂 一种含s-羧甲基-l-半胱氨酸的肠溶片剂
RU2706003C1 (ru) * 2019-09-09 2019-11-13 Акционерное общество "АВВА РУС" Микрогранулы, содержащие панкреатин
KR102432084B1 (ko) * 2021-11-16 2022-08-12 알리코제약(주) S-오메프라졸을 함유하는 안정성이 개선되고 소형화된 정제
CN119286984B (zh) * 2024-12-10 2025-07-22 浙江陆恒环境科技有限公司 用于水体总氮检测的水样前处理试剂、总氮检测试剂盒及检测方法

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JPS5855125B2 (ja) * 1980-03-10 1983-12-08 信越化学工業株式会社 固形薬剤用腸溶性コ−テイング剤組成物
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Also Published As

Publication number Publication date
DK1931316T4 (en) 2017-05-15
WO2007020259A3 (en) 2007-05-10
PT1931316E (pt) 2010-03-29
PL1931316T5 (pl) 2017-10-31
PL1931316T3 (pl) 2010-07-30
JP2009504709A (ja) 2009-02-05
DK1931316T3 (da) 2010-05-17
BRPI0614545A2 (pt) 2011-04-05
RU2440101C2 (ru) 2012-01-20
CA2619475A1 (en) 2007-02-22
ES2341284T5 (es) 2017-09-05
EP1931316B1 (en) 2010-02-17
EP1931316A2 (en) 2008-06-18
AU2006281414A1 (en) 2007-02-22
AU2006281414B2 (en) 2011-09-01
CN101242811A (zh) 2008-08-13
WO2007020259A2 (en) 2007-02-22
RU2008109652A (ru) 2009-09-27
ATE457719T2 (de) 2010-03-15
UA92030C2 (ru) 2010-09-27
NZ565960A (en) 2012-03-30
CA2619475C (en) 2015-09-29
JP5452918B2 (ja) 2014-03-26
MX2008001558A (es) 2008-02-15
ES2341284T3 (es) 2010-06-17
SI1931316T1 (sl) 2010-06-30
BRPI0614545B1 (pt) 2020-03-31
SI1931316T2 (sl) 2017-05-31
EP1931316B2 (en) 2017-02-22
CN101242811B (zh) 2015-06-17

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B25D Requested change of name of applicant approved

Owner name: ABBOTT PRODUCTS GMBH (DE)

B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
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B06T Formal requirements before examination [chapter 6.20 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 31/03/2020, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

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