alexa Abstract | Sterilization of Glucocorticosteroids for Inhalation Delivery


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Review Article Open Access

Abstract

Sterile drug products are defined as those products that are free from all viable microorganisms. They provide a number of benefits, both medically and economically. Glucocorticoid (GC) is a class of steroid hormones that bind to the glucocorticoid receptor (GR), which is present in almost every vertebrate animal cell. The name glucocorticoid (glucose + cortex + steroid) derives from their role in the regulation of the metabolism of glucose, their synthesis in the adrenal cortex, and their steroidal structure. Steroids in powder form are not stable at temperatures above 600 C. The major problems are related to the high temperatures of the sterilization process and to the consequent thermal instability of the drug substance that frequently leads to degradation with modification of the impurities profile and of the physicochemical characteristics of the drug. For solid drug substances suitable for inhalation delivery to be suspended in aqueous formulations, the particle size distribution, as well as its preservation during the shelf life of the finished product, is particularly crucial parameters. The main focus of this review article is to provide different processes for the sterilization of a powdered form of a glucocorticosteroid and use thereof in the treatment of an allergic &/or inflammatory conditions of the nose or lungs.

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Author(s): Chandrashekhar Laxman Bhingare, Sampada Dhaval Dalvi, Suhas Vasudeo Joshi, Vibhuti Ashok Mishra

Keywords

Glucocorticosteroid, inhalation, particle size distribution, sterile, Liver Inflammation

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