The Similarity of a Critical Quality Study Among the Ciplukan Extract Capsule from A Laboratory Setting and a Pilot Scale in a Partner Industry

Abstract

Background: Differences in pharmaceutical product processing and equipment between laboratory development and industrial scale-up can result in dramatically variable quality. Therefore, the quality similarities across pharmaceutical dosage forms must be tested at several facilities. Similarities in the quality of dosage forms for pharmacological treatment derived from herbal ingredients from development and production scale are often overlooked, and no one has published them yet. Methods: A two-level factorial experimental design was used in the laboratory for formulation optimization, with variations in the composition of colloidal silicon dioxide and starch glycolate salts. Quality responses included loss on drying (LOD), flowability, angle of repose, uniformity of capsule weight, and disintegration time. The same responses as the performance of similarity attributes were also evaluated on pilot-scale items from partner businesses. Results: The overall quality response of the tested product met the standards for fine granules and capsules. The composition with the highest attractiveness, according to the program, was F4 at 0.686, based on a pilot-scale formulation at partner industrial facilities. According to a Jaccard similarity of 0.88, the quality test results were quite comparable. A total plate number test was performed to assess the safety of microbiological contamination throughout the processing of all goods, yielding a result of 7.07 × 104, which is still in conformity with the standards of the Indonesian Food and Drug Administration (FDA), namely 107. Conclusions: The Jaccard similarity index for capsule manufacture at two different manufacturing sites is 0.88, indicating an excellent resemblance. This suggests that the process may be repeated in larger quantities.