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Stable liquid oily ready-to-use formulations, preparation thereof and use thereof
专利权人:
CTS CHEMICAL INDUSTRIES LTD.
发明人:
FIRST, SIGAL,佛斯特 西格尔,佛斯特 西格爾
申请号:
TW100113206
公开号:
TW201210634A
申请日:
2011.04.15
申请国别(地区):
TW
年份:
2012
代理人:
摘要:
The invention relates to a stable liquid oily ready-to-use formulation, comprising: (i) an active pharmaceutical ingredient, which has hydrophobic and/or lipophilic properties and/or which exhibits stability problems in aqueous environments, (ii) an oily vehicle, in which the active pharmaceutical ingredient is dissolved or dispersed, and which is selected from vegetable oils, synthetic oils, fatty acids or combinations thereof and optionally one or more of a thickening/suspending agent, an antioxidant, a preservative, a flocculating agent, a surface stabilising agent, a sweetener, a flavouring agent, an emulsifier and a colouring agent, or combinations thereof, as well as to said formulation for use in the medical treatment of a patient group selected from (i) paediatric patients, (ii) elderly pa-tients, (iii) patients suffering from dysphagia, or (iv) patients requiring medica-tion via nasogastric or gastrostomy tubes and to a method for preparing a stable liquid oily ready-to-use formulation comprising the following steps: (a) heating the oily vehicle under mild stirring, (b) dissolving the antioxidant, (c) dissolving or melting the thickening/suspending agent and optionally emulsifying agent(s), until a clear solution is obtained, and cooling the solution to room temperature, (d) optionally adding further thickening/suspending agent, (e) adding and op-tionally disperging the active pharmaceutical ingredient, (f) optionally adding the sweetener, flavouring and/or colouring agents, (g) completing the volume with the oily vehicle to the desired amount, and (h) optionally performing homogeni-sation.本發明有關一種安定之液態油性即用調和物,其包含:(i)活性藥學成份,此成份具有疏水性及/或親脂性且/或於水性環境中出現安定性問題,(ii)油性載劑,將活性藥學成份溶解或分散於其中,且其係選自植物油、合成油、脂肪酸或其組合;及視情況存在之一或多種增稠劑/懸浮劑、抗氧化劑、防腐劑、凝聚劑、表面安定劑、甜味劑、調味劑、乳化劑及著色劑或其組合,且有關用以對選自以下之患者群組進行醫療處置的調和物:(i)兒科患者,(ii)老年患者,(iii)患有吞嚥困難之患者,或(iv)需要經由鼻胃管或胃造口管投藥之患者,且有關一種製備安定之液態油性即用調和物的方法,其包含以下步驟:(a)在溫和攪拌下加熱該油性載劑,(b)將抗氧化劑溶解,(c)溶解或熔融該增稠劑/懸浮劑及視情況使用之乳化劑,直至得到澄清溶液,將溶液冷卻至室溫,(d)視情況添加其他增稠劑/懸浮劑,(e
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