Manufacturing Process Optimization of Anti-fungal Drug Product by Drug Coating and Seal Coating Method Approach

Abstract

The manufacturing process optimization study untaken here assures that the optimized manufacturing process is suitable for the intended purpose and that the product consistently meets predetermined specifications and quality attributes. It gives detailed information on various steps involved in the manufacturing process like Sifting, Drug Coating, Seal Coating, Drying, Lubrication, Capsule filling, Packing and analysis of process challenges samples at various critical stages of manufacturing, in-process tests, and finished product testing.
During this study, Critical Process Parameters (CPPs) involved in Sifting, Drug Coating, Seal Coating, Drying, Lubrication, Capsule filling, and packing were identified with the help of a developmental study and evaluated during the manufacturing process optimization study batch. During this process, all the Critical Quality Attributes (CQA) were observed such as Blend Uniformity (BU), Water content, Physical characteristics of lubricated blend, physical parameters of Capsules, Description, Water content (Finished product) Dissolution, Uniformity of Dosage Unit, Assay, Degradation products and Microbial examination.
After evaluating the analytical results and discussing them, it can be concluded that this optimized manufacturing process is capable of consistently producing the product meeting quality attributes and its predetermined specifications. Hence, the drug product manufacturing process is optimized and can be used for process validation batches of Itraconazole Capsules 100 mg.