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STABILIZED PTH COMPOSITION
专利权人:
ЛЮПИН ЛИМИТЕД (IN)
发明人:
ДЕОКАР Ваибхав Дньянешвар (IN),АПТЕ-ДЕШПАНДЕ Анджали Деепак (IN),РАУТ Шеетал Арвинд (IN),ДАМОДАРАН Баладжи (IN),КАРКАРИА Сайрус (IN)
申请号:
RU2014133818
公开号:
RU2014133818A
申请日:
2013.01.19
申请国别(地区):
RU
年份:
2016
代理人:
摘要:
1. A stabilized aqueous pharmaceutical composition comprising human parathyroid hormone and a buffer selected from lactate or glutamate. A stable aqueous pharmaceutical composition containing human parathyroid hormone selected from the groups (1-34), (1-37), (1-38), (1-41), a buffer selected from lactate or glutamate, a stabilizer and a preservative, acceptable for parenteral administration, where the composition is sterile and ready for parenteral administration and has a pH in the range of 3-7.3. The pharmaceutical composition of claim 2, wherein the human parathyroid hormone is hPTH (1-34). The pharmaceutical composition of claim 2, wherein the stabilizer is selected from the group consisting of mannitol, glycine, glycerin, EDTA, DTPA or EGTA, proline, alanine, arginine, asparagines, aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, serine, threonine, tryptophan, tyrosine, valine and NaCl. 5. The pharmaceutical composition of claim 4, wherein the stabilizer is mannitol. 6. The pharmaceutical composition of claim 2, wherein the preservative is metacresol. A stabilized aqueous pharmaceutical composition containing human parathyroid hormone (1-34), a buffer selected from lactate or glutamate, mannitol as a stabilizer, and metacresol as a preservative acceptable for parenteral administration, where the composition is sterile and ready for parenteral administration. . The pharmaceutical composition according to claim 7, containing from about 10 μg / ml to 1000 μg / ml hPTH (1-34), from about 1 mm to 100 mm lactate buffer, from about 2 to 20 weight. % mannitol, from about 0.1 to 2 weight. % metacresol having a pH in the pH range 3.0-7.0.9. The pharmaceutical composition according to claim 7, containing from about 10 μg / ml to 1000 μg /1. Стабилизированный водный фармацевтический состав, содержащий паратиреоидный гормон человека и буфер, выбранный из лактата или глутамата.2. Стабилизированный
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