KR960041363A - A stable liquid composition containing a wate oxidase and a freeze-dried composition for the preparation thereof - Google Patents

A stable liquid composition containing a wate oxidase and a freeze-dried composition for the preparation thereof Download PDF

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KR960041363A
KR960041363A KR1019960016029A KR19960016029A KR960041363A KR 960041363 A KR960041363 A KR 960041363A KR 1019960016029 A KR1019960016029 A KR 1019960016029A KR 19960016029 A KR19960016029 A KR 19960016029A KR 960041363 A KR960041363 A KR 960041363A
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South Korea
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composition
alanine
mannitol
composition according
poloxamer
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KR1019960016029A
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Korean (ko)
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KR100331381B1 (en
Inventor
알망 끌로드
바욜 알랭
브뢸 띠에리
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쟝 삐에르 께르쥬앙
사노피
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Priority claimed from FR9505606A external-priority patent/FR2733914B1/en
Application filed by 쟝 삐에르 께르쥬앙, 사노피 filed Critical 쟝 삐에르 께르쥬앙
Publication of KR960041363A publication Critical patent/KR960041363A/en
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Publication of KR100331381B1 publication Critical patent/KR100331381B1/en

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    • 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
    • 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
    • A61K38/44—Oxidoreductases (1)
    • A61K38/443—Oxidoreductases (1) acting on CH-OH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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

Abstract

본 발명은 우레이트 옥시다아제를 함유하는 안정한 액체 조성물 및 그의 제조를 위한 동결건조 조성물에 관한 것으로서, 상기 액체 조성물은 우레이트 옥시다아제, 0.1 내지 10㎎/㎖의 폴록사머 188을 완충 수성 매질내에 함유하는, 물리적으로 안정하고, 약학적으로 수용가능한 액체 조성물이며, 상기 조성물은 수성 용매내에서 동결건조물을 용해시킴으로써 수득될 수 있는 것을 특징으로 한다.The present invention relates to a stable liquid composition containing a urea oxidase and a freeze-dried composition for preparing the same, wherein the liquid composition comprises a urea oxidase, 0.1 to 10 mg / ml of Poloxamer 188 in a buffered aqueous medium, A physically stable, pharmaceutically acceptable liquid composition, characterized in that it can be obtained by dissolving the lyophilizate in an aqueous solvent.

Description

우레이트 옥시다아제를 함유하는 안정한 액체 조성물 및 그의 제조를 위한 동결건조 조성물A stable liquid composition containing a urease oxidase and a freeze-dried composition

본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음Since this is a trivial issue, I did not include the contents of the text.

제1도는 비이온성 계면활성제 함량의 함수로서, 소용돌이로 1분동안 교반한 후, 본 발명에 해당되거나 해당하지 않는 5개 우레이트 옥시다아제 용액의 혼탁도의 24시간 동안의 변화를 NTU 단위로 나타낸 것이고, 제2도는 폴록사머 188 함량의 함수로서, 소용돌이로 1분동안 교반한 후, 본 발명에 따른 폴록사머 188을 함유하는 6개의 우레이트 옥시다아제 용액의 혼탁도의 24시간 동안의 변화를 NTU 단위로 나타낸 것이다.1 shows the change in turbidity of the five urea oxidase solutions corresponding to the present invention or not, after stirring for one minute in a vortex as a function of nonionic surfactant content, in NTU units for 24 hours , 2, as a function of the content of poloxamer 188, after stirring for 1 minute in a vortex, the change in turbidity of the 6 urea oxidase solution containing poloxamer 188 according to the invention over 24 hours in NTU .

Claims (20)

우레이트 옥시다아제, 0.1 내지 10㎎/㎖의 폴록사며 188을 완충수용 매질내에 함유하는 것을 특징으로 하는 물리적으로 안정하고 약학적으로 수용가능한 액체 조성물.0.0 > mg / ml < / RTI > Poloxac, 188 in a buffered aqueous medium. 제1항에 있어서, 폴록사머 188을 0.5 내지 5㎎/㎖로 함유하는 것을 특징으로 하는 조성물.The composition of claim 1, wherein the composition contains 0.5-5 mg / ml of poloxamer 188. 제1항에 있어서, 추가로 알라닌을 함유하는 것을 특징으로 하는 조성물.The composition of claim 1, further comprising alanine. 제3항에 있어서, 알라닌의 양이 1 내지 50㎎/㎖인 것을 특징으로 하는 조성물.4. The composition according to claim 3, wherein the amount of alanine is 1 to 50 mg / ml. 제1항에 있어서, 추가로 만니톨을 함유하는 것을 특징으로 하는 조성물.The composition according to claim 1, further comprising mannitol. 제5항에 있어서, 만니톨의 양이 1 내지 50㎎/㎖인 것을 특징으로 하는 조성물.The composition according to claim 5, wherein the amount of mannitol is 1 to 50 mg / ml. 제1항에 있어서, 추가로 알라닌과 만니톨을 함유하는 것을 특징으로 하는 조성물.The composition of claim 1, further comprising alanine and mannitol. 제7항에 있어서, 1 내지 50㎎/㎖의 알라닌과 1 내지 50㎎/㎖의 만니톨을 함유하는 것을 특징으로 하는 조성물.8. The composition of claim 7, comprising 1 to 50 mg / ml of alanine and 1 to 50 mg / ml of mannitol. 제8항에 있어서, 15.9㎎/㎖의 알라닌과 10.6㎎/㎖의 만니톨을 함유하는 것을 특징으로 하는 조성물.9. The composition of claim 8, comprising 15.9 mg / ml alanine and 10.6 mg / ml mannitol. 제1항에 있어서, 등장액인 것을 특징으로 하는 조성물.The composition of claim 1, wherein the composition is an isotonic solution. 제1항에 있어서, 인산 나트륨 완충액을 함유하는 것을 특징으로 하는 조성물.2. The composition of claim 1, comprising a sodium phosphate buffer. 제1항에 있어서, 완충액의 농도가 5 내지 100mM인 것을 특징으로 하는 조성물.The composition of claim 1, wherein the concentration of the buffer is between 5 and 100 mM. 제1항에 있어서, pH가 7.5 내지 8.5인 것을 특징으로 하는 조성물.The composition of claim 1, wherein the pH is from 7.5 to 8.5. 제1항에 있어서, 페놀, 벤질알콜, 메타-크레졸, 메틸파라벤, 프로필파라벤, 벤즈알코늄 클로라이드 또는 벤즈에토늄 클로라이드로부터 선택된 하나 이상의 방부제를 함유하는 것을 특징으로 하는 조성물.The composition according to claim 1, comprising at least one preservative selected from phenol, benzyl alcohol, meta-cresol, methyl paraben, propyl paraben, benzalkonium chloride or benzethonium chloride. 제1항에 있어서, 수성 용매내에서 동결건조물을 용해시킴으로써 수득되는 것을 특징으로 하는 조성물.The composition according to claim 1, which is obtained by dissolving the lyophilizate in an aqueous solvent. 제1항에 있어서, 무균이며, 피하, 정맥내 또는 근육내 경로를 통해 사람 또는 동물로 주사가능한 것을 특징으로 하는 조성물.The composition of claim 1, which is sterile, injectable into a human or animal via subcutaneous, intravenous, or intramuscular routes. 제15항 및 제16항에 있어서, 동결건조물이 조성이 하기와 같은 것을 특징으로 하는 주사사능한 조성물.17. The composition according to any one of claims 15 to 16, wherein the lyophilizate has the following composition. 우레이트 옥시다아제 1.5㎎1.5 mg of urea oxidase 만니톨 10.6㎎Mannitol 10.6 mg L-알라닌 15.9㎎15.9 mg of L-alanine 이염기 인산 나트륨 도데카하이드레이트 14.32㎎Dibasic sodium phosphate dodecahydrate 14.32 mg 수성의 재생 용매의 조성은The composition of the aqueous regenerating solvent is 폴록사머 188 1㎎Poloxamer 188 1 mg 주사용 물 1㎎당 충분량Sufficient amount per 1 mg of water for injection 우레이트 옥시다아제 및 풀록사머 188을 우레이트 옥시다아제에 대한 폴록사머 188의 중량비가 0.01 내지 50으로 함유하고 있는 것을 특징으로 하는 수성 용매내에서 용해될 수 있는 동결건조 조성물.Wherein the weight ratio of the poloxamer 188 to the urease oxidase is 0.01 to 50, and wherein the weight ratio of the poloxamer 188 to the poloxamer 188 is about 0.01 to about 50. The freeze- 제18항에 있어서, 추가로 완충액을 함유하고 있는 것을 특징으로 하는 동결건조 조성물.The freeze-dried composition according to claim 18, further comprising a buffer solution. 제18항에 있어서, 수성 용매내 동결건조물을 용해시킴으로써 수득되는 수용액에 등장성을 제공하는 부형제를 추가로 함유하는 것을 특징으로 하는 동결 건조 조성물.The freeze-dried composition according to claim 18, further comprising an excipient which provides isotonicity to the aqueous solution obtained by dissolving the lyophilized product in an aqueous solvent. ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.※ Note: It is disclosed by the contents of the first application.
KR1019960016029A 1995-05-11 1996-05-11 A stable liquid composition containing a wate oxidase and a freeze-dried composition for the preparation thereof KR100331381B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR9505606A FR2733914B1 (en) 1995-05-11 1995-05-11 STABLE LIQUID COMPOSITION CONTAINING URATE OXYDASE AND LYOPHILIZED COMPOSITION FOR ITS PREPARATION
FR9505606 1995-05-11

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KR960041363A true KR960041363A (en) 1996-12-19
KR100331381B1 KR100331381B1 (en) 2002-10-09

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