BR112016001289A2 - high activity pancreatin (ha-pancreatin), high potency pharmaceutical composition, process for preparation of ha-pancreatin with specific lipase activity of at least about 120 ui usp / mg and method of treating a patient having a physiological condition associated with pancreatic enzymatic insufficiency - Google Patents

high activity pancreatin (ha-pancreatin), high potency pharmaceutical composition, process for preparation of ha-pancreatin with specific lipase activity of at least about 120 ui usp / mg and method of treating a patient having a physiological condition associated with pancreatic enzymatic insufficiency

Info

Publication number
BR112016001289A2
BR112016001289A2 BR112016001289-5A BR112016001289A BR112016001289A2 BR 112016001289 A2 BR112016001289 A2 BR 112016001289A2 BR 112016001289 A BR112016001289 A BR 112016001289A BR 112016001289 A2 BR112016001289 A2 BR 112016001289A2
Authority
BR
Brazil
Prior art keywords
pancreatin
solvent
mixture
usp
mpa
Prior art date
Application number
BR112016001289-5A
Other languages
English (en)
Portuguese (pt)
Inventor
Pironti Vincenza
Becker Robert
Boltri Luigi
Ghidorsi Luigi
Arzuffi Paola
Original Assignee
Allergan Pharmaceuticals International Limited
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=52117920&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112016001289(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Allergan Pharmaceuticals International Limited filed Critical Allergan Pharmaceuticals International Limited
Publication of BR112016001289A2 publication Critical patent/BR112016001289A2/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
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/94—Pancreatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/54—Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Cephalosporin Compounds (AREA)
  • Compounds Of Unknown Constitution (AREA)
BR112016001289-5A 2013-07-22 2014-07-15 high activity pancreatin (ha-pancreatin), high potency pharmaceutical composition, process for preparation of ha-pancreatin with specific lipase activity of at least about 120 ui usp / mg and method of treating a patient having a physiological condition associated with pancreatic enzymatic insufficiency BR112016001289A2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361856952P 2013-07-22 2013-07-22
US61/856,952 2013-07-22
PCT/IB2014/002583 WO2015019198A2 (en) 2013-07-22 2014-07-15 High potency pancreatin pharmaceutical compositions

Publications (1)

Publication Number Publication Date
BR112016001289A2 true BR112016001289A2 (en) 2018-03-20

Family

ID=52117920

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112016001289-5A BR112016001289A2 (en) 2013-07-22 2014-07-15 high activity pancreatin (ha-pancreatin), high potency pharmaceutical composition, process for preparation of ha-pancreatin with specific lipase activity of at least about 120 ui usp / mg and method of treating a patient having a physiological condition associated with pancreatic enzymatic insufficiency

Country Status (13)

Country Link
US (2) US20160152968A1 (https=)
EP (1) EP3024479B2 (https=)
JP (1) JP2016527247A (https=)
KR (1) KR20160055123A (https=)
CN (1) CN105392496A (https=)
AU (1) AU2014304176A1 (https=)
BR (1) BR112016001289A2 (https=)
CA (1) CA2919114A1 (https=)
ES (1) ES2743212T5 (https=)
IL (1) IL243627A (https=)
MX (1) MX2016000794A (https=)
RU (1) RU2686460C2 (https=)
WO (1) WO2015019198A2 (https=)

Families Citing this family (14)

* 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.
JP5966202B2 (ja) 2007-02-20 2016-08-10 アラガン ファーマシューティカルズ インターナショナル リミテッド 安定な消化酵素組成物
US10087493B2 (en) 2008-03-07 2018-10-02 Aptalis Pharma Canada Ulc Method for detecting infectious parvovirus in pharmaceutical preparations
ES2657673T3 (es) 2010-10-01 2018-03-06 Aptalis Pharma Limited Formulaciones recubiertas entéricas de pancrelipasa, de baja intensidad
CA2843556A1 (en) 2011-08-08 2013-02-14 Aptalis Pharma Ltd. Method for dissolution testing of solid compositions containing digestive enzymes
US10184121B2 (en) 2013-06-28 2019-01-22 Allergan Pharmaceuticals International Limited Methods for removing viral contaminants from pancreatic extracts
CA2920844A1 (en) 2013-08-09 2015-02-12 Allergan Pharmaceuticals International Limited Digestive enzyme composition suitable for enteral administration
EP3003360B1 (en) * 2013-11-05 2020-10-07 Allergan Pharmaceuticals International Limited High potency pancreatin pharmaceutical compositions
ES2970869T3 (es) * 2016-03-28 2024-05-31 Abbott Laboratories Gmbh Composiciones enzimáticas con contaminación vírica y microbiana reducida
US11278603B2 (en) 2016-03-28 2022-03-22 Abbvie Inc. Enzyme compositions with reduced viral and microbial contamination
US11291236B2 (en) * 2017-09-11 2022-04-05 Alcresta Therapeutics, Inc. Devices and methods for the preparation of a nutritional formula
BR112020006211A2 (pt) * 2017-09-27 2020-10-13 Abbott Laboratories Gmbh preparação de enzima produzida por um método, preparação de enzima, método para produzir um produto de pancreatina, composição farmacêutica e método para tratar insuficiência pancreática exócrina
CN111394275B (zh) * 2020-02-22 2022-05-27 华东师范大学 一株解淀粉芽孢杆菌及其应用、水产饲料和水产养殖方法
FR3111559A1 (fr) * 2020-06-18 2021-12-24 Azurrx Biopharma, Inc. Formulations non porcines et leurs procédés

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB928654A (en) 1960-10-25 1963-06-12 Philips Nv Improvements in or relating to the production of pancreatin
US3168448A (en) * 1963-01-07 1965-02-02 Wilson & Co Inc Process of preparing a lipolytic enzyme composition
DE3377506D1 (en) * 1982-12-30 1988-09-01 Nordmark Arzneimittel Gmbh Process for obtaining pancreatin
DK173590D0 (da) * 1990-06-06 1990-07-19 Novo Nordisk As Rekombinante terapeutiske lipaser
DE69634248T2 (de) 1995-05-31 2006-01-12 Medzyme N.V. Zusammensetzungen zur verbesserung der verdaulichkeit und ausnutzung von nähestoffen
KR19990072826A (ko) * 1998-02-26 1999-09-27 우재영 판크레아틴장용코팅과립의제조방법
US20010046493A1 (en) 2000-02-24 2001-11-29 Alex Margolin Lipase-containing composition and methods of use thereof
AR032392A1 (es) * 2001-01-19 2003-11-05 Solvay Pharm Gmbh Mezcla de enzimas, preparado farmaceutico y utilizacion de dicho preparado.
CA2419572A1 (en) * 2003-02-18 2004-08-18 Axcan Pharma Inc. High dosage protease formulation
US20060198838A1 (en) * 2004-09-28 2006-09-07 Fallon Joan M Combination enzyme for cystic fibrosis
WO2006044529A1 (en) 2004-10-14 2006-04-27 Altus Pharmaceuticals Inc. Compositions containing lipase; protease and amylase for treating pancreatic insufficiency
RU2445952C2 (ru) * 2007-02-20 2012-03-27 Юранд Фармасьютикалз Лимитед Стабильные композиции пищеварительных ферментов
BR112012023517A2 (pt) * 2010-03-19 2017-10-03 Aptalis Pharma Canada Inc Preparação de enzima pancreática (pep) tendo infectividade viral reduzida, composição farmacêutica tendo infectividade viral reduzida, forma de dosagem oral sólida, método para tratar insuficiência pancreática em um paciente que necessita disso e método para preparar um apreparação de enzima pancreática (pep)
CA2843556A1 (en) * 2011-08-08 2013-02-14 Aptalis Pharma Ltd. Method for dissolution testing of solid compositions containing digestive enzymes
JP2013071929A (ja) * 2011-09-29 2013-04-22 Kobayashi Pharmaceutical Co Ltd 胃腸薬
CA2920844A1 (en) * 2013-08-09 2015-02-12 Allergan Pharmaceuticals International Limited Digestive enzyme composition suitable for enteral administration
EP3003360B1 (en) 2013-11-05 2020-10-07 Allergan Pharmaceuticals International Limited High potency pancreatin pharmaceutical compositions

Also Published As

Publication number Publication date
KR20160055123A (ko) 2016-05-17
US20250327059A1 (en) 2025-10-23
RU2016101760A (ru) 2017-08-28
JP2016527247A (ja) 2016-09-08
EP3024479B2 (en) 2023-02-08
MX2016000794A (es) 2016-12-02
WO2015019198A2 (en) 2015-02-12
EP3024479A2 (en) 2016-06-01
AU2014304176A1 (en) 2016-02-11
CN105392496A (zh) 2016-03-09
EP3024479B1 (en) 2019-06-05
ES2743212T3 (es) 2020-02-18
RU2016101760A3 (https=) 2018-05-14
US20160152968A1 (en) 2016-06-02
CA2919114A1 (en) 2015-02-12
WO2015019198A3 (en) 2015-05-28
IL243627A (en) 2017-12-31
RU2686460C2 (ru) 2019-04-26
ES2743212T5 (es) 2023-04-25
IL243627A0 (en) 2016-03-31

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NAO 10196/2001, QUE MODIFICOU A LEI NAO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUAANCIA PRA VIA DA ANVISA. CONSIDERANDO A APROVAA AO DOS TERMOS DO PARECER NAO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NAO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDAANCIAS CABA-VEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements