Development and Evaluation of Antifungal Drug Product by Solid Dispersion Technique using Drug Coating and Seal Coating Approach (Itraconazole Capsules 100 mg)

A very important stage in developing and preserving the quality of any pharmaceutical drug product is validation. Drug product validation creates the written proof that offers a high level of certainty that a manufacturing process will reliably provide a product with predefined standards and quality features. Studying the process performance certification of the drug product Itraconazole Capsules 100 mg Immediate Release Capsule dosage form was the primary goal of my research. The research conducted here guarantees that the production process is appropriate for the intended use and that the final product continuously satisfies predefined requirements and quality standards. Sifting, dry mixing, wet granulation, drying, sizing, blending, lubrication, capsule filling, packing, and analysis of in-process tests and final product are only a few of the processes in the production process that are covered in depth. This study used developmental research to identify Critical Process Parameters (CPPs) that were involved in sifting, dry mixing, wet granulation, drying, sizing, blending, and capsule filling. The CPPs were then assessed during the process validation study. All of the critical quality attributes (also known as critical control parameters) were monitored during this process, including blend uniformity (BU), water content, blend physical characteristics, capsule physical parameters, description, water content (final product), dissolution, dosage unit uniformity, assay, degradation products, and microbiological examination. Following discussion and analysis of the analytical data, it may be said that this manufacturing process can reliably produce a product that satisfies its predefined specifications and quality features. As a result, the medicinal product's manufacturing method has been verified and is suitable for regular production of 100 mg Itraconazole Capsules.