Manufacturing Process Optimization of Anti-fungal Drug Product Itraconazole Capsules by Wet Granulation Approach

Abstract

The manufacturing process optimization study untaken here assures that the optimized manufacturing process is suitable for the intended purpose and the product consistently meets predetermined specifications and quality attributes. It gives detailed information on various steps involved in the manufacturing process like Sifting, Dry Mixing, Wet granulation, Drying, Sizing, Mixing, Blending, Capsule filling, Packing, and analysis of process challenges samples at various critical stage of manufacturing, in-process tests and finished product testing.

During this study, Critical Process Parameters (CPPs) involved in Sifting, Dry Mixing, Wet granulation, Drying, Sizing, Mixing, Blending, Capsule filling and packing were identified with the help of developmental study and evaluated during 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 blend, physical parameters of Capsules, Description, Water content (Finished product) Dissolution, Uniformity of Dosage Unit, Assay, Degradation products and Microbial examination.

After the evaluation of analytical results and discussion, it can be concluded that this optimized manufacturing process is capable of producing the product consistently meeting with quality attributes and its predetermined specification. Hence the manufacturing process of drug product is optimized and can be used for process validation batches of Itraconazole Capsules 100 mg.