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) SI1931316T1 (pt)
UA (1) UA92030C2 (pt)
WO (1) WO2007020259A2 (pt)

Families Citing this family (22)

* 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.
WO2007014896A1 (en) 2005-07-29 2007-02-08 Solvay Pharmaceuticals Gmbh Processes for the manufacture of sterilized pancreatin powder
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
ES2560527T3 (es) 2007-02-20 2016-02-19 Allergan Pharmaceuticals International Limited 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
ES2781949T3 (es) 2007-11-13 2020-09-09 Meritage Pharma Inc Composiciones para el tratamiento de la inflamación gastrointestinal
WO2009109856A2 (en) 2008-03-07 2009-09-11 Axcan Pharma Inc. Method for detecting infectious parvovirus in pharmaceutical preparations
WO2010144865A2 (en) 2009-06-12 2010-12-16 Meritage Pharma, Inc. Methods for treating gastrointestinal disorders
MX2012012794A (es) * 2010-05-03 2013-03-12 Aptalis Pharma Ltd Composiciones de microgranulos que comprenden pancreatina que contienen mezclas de enzimas digestivas.
AR093181A1 (es) 2010-10-01 2015-05-27 Aptalis Pharmatech Inc Formulacion con contenido de enzimas digestivas bajo estable
DK2741766T3 (en) * 2011-08-08 2016-01-11 Aptalis Pharma Ltd Process for dissolving solid compositions containing digestive enzymes
EP3030257B1 (en) 2013-08-09 2020-02-19 Allergan Pharmaceuticals International Limited Digestive enzyme composition suitable for enteral administration
MX2016016907A (es) 2014-06-19 2018-04-26 Aptalis Pharma Ltd Metodo para eliminar contaminantes virales de extractos pancreaticos.
WO2016071434A1 (en) 2014-11-05 2016-05-12 Abbott Laboratories Gmbh Processes for producing compositions with improved safety profile comprising pancreatin and compositions suitable for pharmaceutical use
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

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2923279C2 (de) 1979-06-08 1987-07-09 Kali-Chemie Pharma Gmbh, 3000 Hannover Verfahren zur Herstellung von Pankreatin-Pellets und diese enthaltende Arzneimittel
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
JPS57171428A (en) 1981-04-13 1982-10-22 Sankyo Co Ltd Preparation of coated solid preparation
GB2189698A (en) * 1986-04-30 1987-11-04 Haessle Ab Coated omeprazole tablets
US5225202A (en) 1991-09-30 1993-07-06 E. R. Squibb & Sons, Inc. Enteric coated pharmaceutical compositions
DE4227385A1 (de) 1992-08-19 1994-02-24 Kali Chemie Pharma Gmbh Pankreatinmikropellets
JP2917799B2 (ja) 1994-03-11 1999-07-12 田辺製薬株式会社 消化管内適所放出型製剤
JP3355593B2 (ja) 1994-08-19 2002-12-09 信越化学工業株式会社 固形腸溶製剤の製造方法
JP3435464B2 (ja) * 1995-01-23 2003-08-11 信越化学工業株式会社 徐放性製剤コーティング用水分散液
SE512835C2 (sv) * 1996-01-08 2000-05-22 Astrazeneca Ab Doseringsform innehållande en mångfald enheter alla inneslutande syralabil H+K+ATPas-hämmare
JP3611456B2 (ja) * 1997-09-30 2005-01-19 日研化学株式会社 テオフィリン徐放性錠剤
KR19990072826A (ko) 1998-02-26 1999-09-27 우재영 판크레아틴장용코팅과립의제조방법
UA69413C2 (uk) 1998-05-22 2004-09-15 Брістол-Майерс Сквібб Компані Фармацевтична композиція, яка містить серцевину та ентеросолюбільну оболонку, фармацевтична композиція у вигляді сфероїдальних гранул, спосіб одержання сфероїдальних гранул та спосіб одержання фармацевтичної композиції
PL199180B1 (pl) 1999-03-17 2008-08-29 Solvay Pharm Gmbh Zastosowanie fizjologicznie dopuszczalnych mieszanin enzymów
US20020146451A1 (en) 2000-07-15 2002-10-10 Sharma Virender K. Method for the administration of acid-labile drugs
IT1319655B1 (it) * 2000-11-15 2003-10-23 Eurand Int Microsfere di enzimi pancreatici con elevata stabilita' e relativometodo di preparazione.
US20040213847A1 (en) * 2003-04-23 2004-10-28 Matharu Amol Singh Delayed release pharmaceutical compositions containing proton pump inhibitors

Also Published As

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

Similar Documents

Publication Publication Date Title
BRPI0614545B8 (pt) composição farmacêutica de liberação controlada, seu processo de produção, forma de dosagem oral com revestimento entérico de pacreatina e uso da mesma
CY1115526T1 (el) Φαρμακευτικη συνθεση η οποια περιλαμβανει πιμοβενδανη
BR112017027813A2 (pt) conjugados de agente de ligação-droga (adcs) e conjugados de agente de ligação-pró-droga (apdcs) tendo grupos enzimaticamente cliváveis
AR050717A1 (es) Composiciones farmaceuticas
PE20060003A1 (es) Formulacion farmaceutica polimerica para moldear por inyeccion
EA201892836A1 (ru) Составы 2-[3-[4-амино-3-(2-фтор-4-феноксифенил)пиразол[3,4-d]пиримидин-1-ил]пиперидин-1-карбонил]-4-метил-4-[4-(оксетан-3-ил)пиперазин-1-ил]пент-2-еннитрила с модифицированным высвобождением
WO2004062577A3 (en) Two or more enteric materials to regulate drug release
MX2023006541A (es) Formulaciones de dosis fija.
CO2018005842A2 (es) Composición farmacéutica que comprende un potente inhibidor de urat 1
WO2017191130A3 (en) Arginase inhibitors and their therapeutic applications
BRPI0507830A (pt) derivados azabicìclicos, o respectivo processo de preparo e as composições farmacêuticas que os contêm
MX2011011374A (es) Composicion farmaceutica oral auto-microemulsificante de un farmaco hidrofilico y metodo de preparacion de la misma.
ATE465719T1 (de) Oral zerfallende zusammensetzung von olanzapin oder donepezil
PE20070618A1 (es) Composicion farmaceutica que contiene rosiglitazona en el tratamiento de alzheimer
ATE536864T1 (de) Metoprololsuccinat tabletten mit verlängerter freisetzung und verfahren für deren herstellung
NO20082547L (no) Orale formuleringer omfattende tigecycline
BR112016001544A8 (pt) composições farmacêuticas para a administração intraocular que compreende um agente antibacteriano e um agente anti-inflamatório
ATE390138T1 (de) Dipyridamol enthaltende zusammensetzungen mit verlängerter freisetzung und verfahren zu deren herstellung
BR112017026904A2 (pt) formulações farmacêuticas injetáveis de lefamulina
EA201201662A1 (ru) Дизамещенные тетрагидрофуранильные соединения в качестве антагонистов брадикининового рецептора в1
WO2007064620A3 (en) Compositions comprising a combination of ccr5 and cxcr4 antagonists
WO2009120389A8 (en) Oral and injectable formulations of tetracycline compounds
NO20074371L (no) Anthelmintiske imidazol-tiazolderivater
EA202091857A1 (ru) Новые низкомолекулярные лекарственные коньюгаты производных гемцитабина
CY1114306T1 (el) Νεα συνθεση για τη θεραπευτικη αντιμετωπιση της ιδιοπαθους θρομβοκυτταραιμιας

Legal Events

Date Code Title Description
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]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

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]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 15/08/2006 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF