BR112012023517A2 - 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) - Google Patents
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)Info
- Publication number
- BR112012023517A2 BR112012023517A2 BR112012023517A BR112012023517A BR112012023517A2 BR 112012023517 A2 BR112012023517 A2 BR 112012023517A2 BR 112012023517 A BR112012023517 A BR 112012023517A BR 112012023517 A BR112012023517 A BR 112012023517A BR 112012023517 A2 BR112012023517 A2 BR 112012023517A2
- Authority
- BR
- Brazil
- Prior art keywords
- pep
- viral infectivity
- preparation
- pancreatic
- reduced viral
- Prior art date
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
- A61K38/54—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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
-
- 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)
-
- 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)
- A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
-
- 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
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
- A61K9/5063—Compounds of unknown constitution, e.g. material from plants or animals
- A61K9/5068—Cell membranes or bacterial membranes enclosing drugs
-
- 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
-
- 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
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- 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
- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
-
- 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
- C12N9/14—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
- C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
- C12N2750/00011—Details
- C12N2750/14011—Parvoviridae
- C12N2750/14311—Parvovirus, e.g. minute virus of mice
- C12N2750/14361—Methods of inactivation or attenuation
- C12N2750/14363—Methods of inactivation or attenuation by chemical treatment
-
- 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
- C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
- C12N2770/00011—Details
- C12N2770/32011—Picornaviridae
- C12N2770/32211—Cardiovirus, e.g. encephalomyocarditis virus
- C12N2770/32261—Methods of inactivation or attenuation
- C12N2770/32263—Methods of inactivation or attenuation by chemical treatment
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Microbiology (AREA)
- Biotechnology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Virology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biophysics (AREA)
- Cell Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Botany (AREA)
- Nutrition Science (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Enzymes And Modification Thereof (AREA)
Abstract
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 UMA PREPARAÇÃO DE ENZIMA PANCREÁTICA (PEP). A presente invenção provê composições farmacêuticas que compreendem preparações de enzimas pancreáticas (PEP) com infectividade viral reduzida abaixo de níveis significativos e com atividade enzimática elevada. Os PEPs podem compreender lipases, proteases, amilases, vírus sem envelope (por exemplo, parvovírus suíno (PPV), circovírus suíno tipo 2 (PCV-2), vírus da encefalomiocardite suína (EMCV)), e vírus com envelope (por exemplo, vírus da estomatite vesicular (VSV), e gripe A) (IFA). A presente invenção também inclui métodos de tratamento de insuficiência pancreática através da administração destas composições farmacêuticas e métodos para fabricar as mesmas, tratando PEP com beta-propiolactona (BPL) para reduzir a infectividade viral.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US31581310P | 2010-03-19 | 2010-03-19 | |
PCT/IB2011/000580 WO2011114225A1 (en) | 2010-03-19 | 2011-03-18 | Beta-propiolactone for inactivation of viruses in pharmaceutical pancreatic enzyme preparations |
Publications (1)
Publication Number | Publication Date |
---|---|
BR112012023517A2 true BR112012023517A2 (pt) | 2017-10-03 |
Family
ID=44648485
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112012023517A BR112012023517A2 (pt) | 2010-03-19 | 2011-03-18 | 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) |
Country Status (10)
Country | Link |
---|---|
US (1) | US20140017223A1 (pt) |
EP (1) | EP2547765A4 (pt) |
JP (1) | JP2013522285A (pt) |
KR (1) | KR20130062905A (pt) |
CN (1) | CN102884181A (pt) |
AU (1) | AU2011228744A1 (pt) |
BR (1) | BR112012023517A2 (pt) |
CA (1) | CA2793686A1 (pt) |
RU (1) | RU2012142140A (pt) |
WO (1) | WO2011114225A1 (pt) |
Families Citing this family (22)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6632429B1 (en) | 1999-12-17 | 2003-10-14 | Joan M. Fallon | Methods for treating pervasive development disorders |
US8030002B2 (en) | 2000-11-16 | 2011-10-04 | Curemark Llc | Methods for diagnosing pervasive development disorders, dysautonomia and other neurological conditions |
US20080058282A1 (en) | 2005-08-30 | 2008-03-06 | Fallon Joan M | Use of lactulose in the treatment of autism |
US8658163B2 (en) | 2008-03-13 | 2014-02-25 | Curemark Llc | Compositions and use thereof for treating symptoms of preeclampsia |
US8084025B2 (en) | 2008-04-18 | 2011-12-27 | Curemark Llc | Method for the treatment of the symptoms of drug and alcohol addiction |
US9320780B2 (en) | 2008-06-26 | 2016-04-26 | Curemark Llc | Methods and compositions for the treatment of symptoms of Williams Syndrome |
US11016104B2 (en) | 2008-07-01 | 2021-05-25 | Curemark, Llc | Methods and compositions for the treatment of symptoms of neurological and mental health disorders |
US10776453B2 (en) | 2008-08-04 | 2020-09-15 | Galenagen, Llc | Systems and methods employing remote data gathering and monitoring for diagnosing, staging, and treatment of Parkinsons disease, movement and neurological disorders, and chronic pain |
US20100092447A1 (en) | 2008-10-03 | 2010-04-15 | Fallon Joan M | Methods and compositions for the treatment of symptoms of prion diseases |
EP2373791B1 (en) | 2009-01-06 | 2016-03-30 | Curelon LLC | Compositions comprising protease, amylase and lipase for use in the treatment of staphylococcus aureus infections |
CA2747703C (en) | 2009-01-06 | 2021-06-15 | Curemark Llc | Compositions and methods for the treatment or the prevention of infections by e. coli |
US9056050B2 (en) | 2009-04-13 | 2015-06-16 | Curemark Llc | Enzyme delivery systems and methods of preparation and use |
WO2011050135A1 (en) | 2009-10-21 | 2011-04-28 | Curemark Llc | Methods and compositions for the prevention and treatment of influenza |
US8980252B2 (en) | 2011-04-21 | 2015-03-17 | Curemark Llc | Methods of treatment of schizophrenia |
US10350278B2 (en) | 2012-05-30 | 2019-07-16 | Curemark, Llc | Methods of treating Celiac disease |
WO2015019198A2 (en) * | 2013-07-22 | 2015-02-12 | Aptalis Pharma S.R.L. | High potency pancreatin pharmaceutical compositions |
WO2016187455A1 (en) | 2015-05-19 | 2016-11-24 | Scientific Protein Laboratories, Llc | Method for reducing or inactivating viral and microbial content in the processes for the manufacture of pancreatin |
DE102015119006A1 (de) * | 2015-11-05 | 2017-05-11 | Nordmark Arzneimittel Gmbh & Co. Kg | Verfahren zur Reduzierung der Belastung von Pankreatin mit Mikroorganismen |
PT3436055T (pt) * | 2016-03-28 | 2024-01-29 | Abbott Laboratories Gmbh | Composições enzimáticas com uma reduzida contaminação viral e microbiana |
DE102016208567A1 (de) | 2016-05-19 | 2017-11-23 | Heraeus Medical Gmbh | Polymerlösung zur Viscosupplementation |
CN111630164A (zh) * | 2017-09-27 | 2020-09-04 | 雅培制药股份有限公司 | 具有减少的病毒和微生物污染的酶组合物 |
US11541009B2 (en) | 2020-09-10 | 2023-01-03 | Curemark, Llc | Methods of prophylaxis of coronavirus infection and treatment of coronaviruses |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6749851B2 (en) * | 2001-08-31 | 2004-06-15 | Clearant, Inc. | Methods for sterilizing preparations of digestive enzymes |
AU2006274835B2 (en) * | 2005-07-29 | 2012-05-24 | Abbott Laboratories Gmbh | Processes for the manufacture of sterilized pancreatin powder |
US10087493B2 (en) * | 2008-03-07 | 2018-10-02 | Aptalis Pharma Canada Ulc | Method for detecting infectious parvovirus in pharmaceutical preparations |
-
2011
- 2011-03-18 CN CN2011800226642A patent/CN102884181A/zh active Pending
- 2011-03-18 EP EP11755758.7A patent/EP2547765A4/en not_active Withdrawn
- 2011-03-18 CA CA2793686A patent/CA2793686A1/en not_active Abandoned
- 2011-03-18 KR KR1020127027016A patent/KR20130062905A/ko not_active Application Discontinuation
- 2011-03-18 AU AU2011228744A patent/AU2011228744A1/en not_active Abandoned
- 2011-03-18 JP JP2012557623A patent/JP2013522285A/ja not_active Withdrawn
- 2011-03-18 WO PCT/IB2011/000580 patent/WO2011114225A1/en active Application Filing
- 2011-03-18 BR BR112012023517A patent/BR112012023517A2/pt not_active IP Right Cessation
- 2011-03-18 RU RU2012142140/10A patent/RU2012142140A/ru not_active Application Discontinuation
-
2013
- 2013-05-01 US US13/874,813 patent/US20140017223A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
EP2547765A1 (en) | 2013-01-23 |
CN102884181A (zh) | 2013-01-16 |
AU2011228744A1 (en) | 2012-10-11 |
WO2011114225A1 (en) | 2011-09-22 |
CA2793686A1 (en) | 2011-09-22 |
RU2012142140A (ru) | 2014-04-27 |
EP2547765A4 (en) | 2013-09-04 |
JP2013522285A (ja) | 2013-06-13 |
KR20130062905A (ko) | 2013-06-13 |
US20140017223A1 (en) | 2014-01-16 |
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Legal Events
Date | Code | Title | Description |
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B08F | Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette] | ||
B08K | Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette] | ||
B350 | Update of information on the portal [chapter 15.35 patent gazette] |