Abstract
BACKGROUND: We describe a new discriminatory system for evaluating the quality of pharmaceuticals, the Pharmaceutical Polygon Fingerprint Matrix system (PharmP-FM). PharmP-FM uses both qualitative and quantitative fingerprinting techniques to assess the quality of pharmaceutical formulations and dosage forms, the system expands on the Expert System for Drug Development, which was initially created to evaluate the suitability of powder for direct compression. PharmP-FM creates a graphical representation of the product's pharmaceutical quality using a set of input parameters. The performance index (PI), normalized parameter index (NPI), and formulation index (FI) are among the system's output parameters. The objective of this study was to evaluate the performance of PharmP-FM by examining its ability to identify variations in pharmaceutical quality across products. METHODOLOGY: We examined the application of PharmP-FM in assessing batch-to-batch variability of weight-loss supplement capsules and the quality of multisource brand products of levothyroxine tablets. RESULTS: PharmP-FM exhibits potential promise as a pharmaceutical quality assessment tool. Its user-friendly nature and adaptability to different formulations and dosage forms make it a versatile discriminatory system. Additionally, PharmP-FM is an open-ended and scalable system that can incorporate additional parameters and accommodate products of varying complexities. CONCLUSION: This study supports the potential of PharmP-FM as a tool for pharmaceutical quality assessment.