PT93744A - Processo para a preparacao de formulacoes liofilizadas de peptidios, nomeadamente, de timopentina - Google Patents

Processo para a preparacao de formulacoes liofilizadas de peptidios, nomeadamente, de timopentina Download PDF

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Publication number
PT93744A
PT93744A PT93744A PT9374490A PT93744A PT 93744 A PT93744 A PT 93744A PT 93744 A PT93744 A PT 93744A PT 9374490 A PT9374490 A PT 9374490A PT 93744 A PT93744 A PT 93744A
Authority
PT
Portugal
Prior art keywords
peptide
process according
composition
salt
amino acid
Prior art date
Application number
PT93744A
Other languages
English (en)
Inventor
Gideon Goldstein
Tapan Audhya
Original Assignee
Immunobiology Res Inst Inc
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 Immunobiology Res Inst Inc filed Critical Immunobiology Res Inst Inc
Publication of PT93744A publication Critical patent/PT93744A/pt

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Classifications

    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Claims (2)

  1. eí nmie i* — Processo para a preparação de formulações llofilizadas cie pêptidos, nomeadamente, de timopentina, que «antera a sua plena actividade biológica, caracterizado pelo facto de se misturar o referido péptído com um sal tampão muito solúvel em água fisiologicamente aceitável, e o veiculo apropriado que consiste em albumina de soro humano e a combinaçpo de rafino-se e um aminoácido; se congelar a composição contendo o pépti-do resultante a uma temperatura enfieiente para evitar a formação de cristais de gelo; s se liofilisar a mencionada composição contendo o pêptido em condições de temperatura inferior a 2220 o de vácuo compreendido entre 40 e 80 militar durante um intervalo de tempo suficiente para reter na citada composição um teor de humidade inferior a 6%.
  2. 2* - Processo de acordo com a reivindicação 1, caracterizado pelo facto de o referido veiculo ser uma mistura de ô»5 a 2% em peso dum aminoácido escolhido do grupo que consiste em gli-eina, arginina, Usina, ácido aspârtico ou ácido glutSnico e 1 a 6% em peso de rafinose. 3a - Processo de acordo com a reivindicação 2, caracterizado pelo facto de o referido aminoácido ser glieina. 4« _ Processo de acordo com a reivindicação 2, caracterizado pelo facto de o quociente entre as concentrações do mencionando aainoãcidoe da rafinose ser aproximadamenhe igual a 1:2. ga « Processo de acordo com á reivindicação 1» caracterizado pelo facto de © citado veiculo ser albumina de soro humano. 6* - Processo de acordo com a reivindicação 1, caracterizado peio facto de o referido sai que acttm como tampão ter uma solubilidade em água maior do que 1 grama/mililitro. 7* - Processo de acordo com a reivindicação 3« caracterizado pelo facto de o mencionado sal que autua como tampão ser um de citrato. 8* - Processo de acordo com a reivindicação 1, caracterizado pelo facto de a citada composição que contêm o péptido ter u» valor de pH compreendido entre ©,S e 7,2. ç* - Processo de acordo com ã reivindicação 1, caracterizado pelo facto de a referida temperatura da operação de liofili-zar estar compreendida entre cerca de 5S e cerca de 2220. 10* « Processo de acordo com a reivindicação 1, caracterizado pelo facto de o vácuo sob que se realiza a mencionada opera» çSo de liofilização ser aproximadamente igual a 60 milibar. 11a - Processo de acordo com a reivindicação 1, caracterizado pelo facto de a citada composição que contêm um péptido ter um teor de humidade compreendido entre 3% e 6%. 4
PT93744A 1989-04-11 1990-04-11 Processo para a preparacao de formulacoes liofilizadas de peptidios, nomeadamente, de timopentina PT93744A (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US33623689A 1989-04-11 1989-04-11

Publications (1)

Publication Number Publication Date
PT93744A true PT93744A (pt) 1990-11-20

Family

ID=23315165

Family Applications (1)

Application Number Title Priority Date Filing Date
PT93744A PT93744A (pt) 1989-04-11 1990-04-11 Processo para a preparacao de formulacoes liofilizadas de peptidios, nomeadamente, de timopentina

Country Status (5)

Country Link
EP (1) EP0420964A4 (pt)
JP (1) JPH03505334A (pt)
CA (1) CA2028848A1 (pt)
PT (1) PT93744A (pt)
WO (1) WO1990012029A1 (pt)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5541116A (en) * 1991-09-30 1996-07-30 B.R.A.H.M.S. Diagnostica Gmbh Method for the stabilization of endogenous, physiologically active peptides
US6288030B1 (en) * 1993-12-22 2001-09-11 Amgen Inc. Stem cell factor formulations and methods
DE19539574A1 (de) 1995-10-25 1997-04-30 Boehringer Mannheim Gmbh Zubereitungen und Verfahren zur Stabilisierung biologischer Materialien mittels Trocknungsverfahren ohne Einfrieren
ES2408784T3 (es) * 1999-05-31 2013-06-21 Mitsubishi Chemical Corporation Preparaciones liofilizadas de HGF
KR100400541B1 (ko) * 2000-12-28 2003-10-08 엘지전자 주식회사 광자기 기록장치
US6803046B2 (en) * 2002-08-16 2004-10-12 Bracco International B.V. Sincalide formulations
US7772188B2 (en) 2003-01-28 2010-08-10 Ironwood Pharmaceuticals, Inc. Methods and compositions for the treatment of gastrointestinal disorders
KR101198346B1 (ko) 2003-04-08 2012-11-06 노보 노르디스크 에이/에스 크로마토그래피 고정상의 재생
WO2004089985A1 (en) * 2003-04-11 2004-10-21 Novo Nordisk A/S Stable pharmaceutical compositions
CN102186490B (zh) 2008-08-15 2015-07-29 硬木药品公司 适合口服给药的鸟苷酸环化酶-c受体激动剂多肽的稳定的固体制剂
CA2770077A1 (en) 2009-08-06 2011-02-10 Ironwood Pharmaceuticals, Inc. Formulations comprising linaclotide
TR201711271T4 (tr) 2010-02-17 2019-02-21 Ironwood Pharmaceuticals Inc Gastrointestinal Bozukluklar İçin Tedaviler
PL2603232T3 (pl) 2010-08-11 2020-05-18 Ironwood Pharmaceuticals, Inc. Stabilne formulacje linaklotydu
CN104053449B (zh) 2011-08-17 2016-12-07 硬木药品公司 胃肠疾患的治疗
US11110063B2 (en) 2017-08-25 2021-09-07 MAIA Pharmaceuticals, Inc. Storage stable sincalide formulations
CN114111232B (zh) * 2021-12-27 2024-06-25 山东新华医疗器械股份有限公司 一种冻干机控温系统

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4000256A (en) * 1975-04-30 1976-12-28 Merck & Co., Inc. Varicella vaccine and process for its preparation
US4190646A (en) * 1975-11-11 1980-02-26 Sloan-Kettering Institute For Cancer Research Polypeptide compositions and methods
JPS61165322A (ja) * 1985-01-14 1986-07-26 Microbial Chem Res Found スパガリン類の注射用凍結乾燥製剤
US4764463A (en) * 1986-10-30 1988-08-16 The University Of Tennessee Research Corporation Platelet cyropreservation

Also Published As

Publication number Publication date
CA2028848A1 (en) 1990-10-12
JPH03505334A (ja) 1991-11-21
EP0420964A1 (en) 1991-04-10
WO1990012029A1 (en) 1990-10-18
EP0420964A4 (en) 1991-09-25

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Effective date: 19960124