Process Validation of Itraconazole Capsules 100 mg Immediate Release Solid Oral Drug Product by Drug Coating and Seal Coating method

A crucial component of pharmaceutical manufacturing is process validation, which offers written proof that a production method regularly produces goods with predetermined quality standards and specifications. This study focused on the process performance qualification (PPQ) of Itraconazole Capsules 100 mg, an immediate-release dosage form, employing the solid dispersion technique through drug coating and seal coating methods. The research provides an in- depth analysis of each stage involved in the manufacturing process, including Sifting, Drug Coating, Seal Coating, Drying, Lubrication, Capsule Filling, Packing, and the assessment of in-process as well as finished product quality. Each of these steps was meticulously evaluated to ensure adherence to stringent quality standards. As part of the validation study, Critical Process Parameters (CPPs) associated with Sifting, Drug Coating, Seal Coating, Drying, Lubrication, Capsule Filling, and Packing were identified through developmental studies and further assessed during the process validation phase. The study also monitored Critical Quality Attributes (CQAs), including Blend Uniformity (BU), moisture content, physical characteristics of the lubricated blend, capsule weight variation, dissolution profile, uniformity of dosage units, assay, degradation products, and microbial examination. Each of these attributes was analyzed to ensure compliance with regulatory standards and product specifications. Based on the evaluation of analytical data and thorough discussion of results, it was concluded that the manufacturing process is robust, reproducible, and capable of consistently producing Itraconazole Capsules 100 mg that meet all required quality attributes and specifications. Consequently, the process was deemed validated, confirming its suitability for routine commercial manufacturing of the drug product.