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This research work focuses on the development of a formulation for a corticosteroid drug, achieved through systematic experimentation and analysis of prior data to understand the impact of process settings and material qualities on product quality. Physicochemical investigations were conducted following established protocols, referencing the United States Pharmacopoeia. The liquid dosage form of the drug was found to be unstable, necessitating its conversion to a solid dosage form via lyophilization due to its thermo-labile nature. Prior to formulation, the active pharmaceutical ingredient (API) underwent comprehensive assessment for various parameters, meeting acceptable standards. The API was processed using a magnetic stirrer to create a liquid injection, subsequently lyophilized to yield a stable lyophilized cake. Evaluation of the resulting lyophilized injection included API assay, reconstitution time, and pH analysis, passing visual inspection for the absence of foreign particles. High-performance liquid chromatography (HPLC) analysis was employed to detect related substances, ensuring compliance with regulatory specifications. This research underscores the importance of precise formulation techniques like lyophilization in pharmaceutical development to ensure product stability and efficacy.
"Formulation and Evaluation of Corticosteroid Lyophilized Injection for Arthritis Treatment", International Journal for Research Trends and Innovation (www.ijrti.org), ISSN:2456-3315, Vol.9, Issue 3, page no.414 - 422, March-2024, Available :http://www.ijrti.org/papers/IJRTI2403060.pdf
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2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator