Stabilization of the pharmaceutical finished dosages form by using various techniques

Vikas Chandel, Hemendra Pratap Singh, Nilesh Rarokar, K. Wadher
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Abstract

The stabilization of pharmaceuticals means that the drug product is physically, chemically and microbiologically stable at the recommended storage condition throughout the predefined shelf life of the product. Pharmaceutical formulations irrespective of its physical states have been used for their efficacy and safety so for as its therapeutic activity is concern. Stability of dosage forms is the ability of drugs to remains unaffected by environmental condition viz. temperature, humidity and microbiological contamination. This research work is an attempt to stabilize the drug product at controlled room temperature for the drug product which is stable at refrigerated storage condition. Hence the aim of present study was development and stabilization of the drug product at room temperature. Investigation of alternate manufacturing processes for stabilization of the drug product at controlled room temperature was one of the objectives of the work. Keywords: Stability, shelf life, lyophilization, freeze drying
利用各种技术稳定药品成品剂型
药品的稳定化是指药品在预定的保质期内,在推荐的储存条件下保持物理、化学和微生物的稳定。药物制剂无论其物理状态如何,其疗效和安全性都是人们关注的焦点。剂型的稳定性是指药物不受环境条件(即温度、湿度和微生物污染)影响的能力。本研究试图在可控室温下稳定药物产品,使其在冷藏储存条件下保持稳定。因此,本研究的目的是开发和稳定室温下的药物产品。研究在受控室温下稳定药物产品的替代生产工艺也是研究工作的目标之一。关键词稳定性、保质期、冻干、冷冻干燥
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