INTEGRATED APPROACHES OF PHARMACEUTICS AND PHARMACEUTICAL ANALYSIS IN MIXING PROCESS VALIDATION

Nancy Mohapatra*, Nibedita Pradhan, Aditya Patsani and Chinmaya Sahoo

Mixing validation is a crucial step in pharmaceutical industry since it is responsible for drug formulation consistency for therapeutic efficacy. Combining the disciplines of pharmaceutical analysis and pharmaceutics can provide a better and systematic understanding of the approaches and methods for mixing validation. The following paper discusses the main methods for integrated mixing validation, and their efficiency and applicability to find and eliminate inconsistencies in the pharmaceutical process. Further, the paper highlights the major challenges that are faced during this process, such as the variability of properties and the limitations of previously used methods to find mixtures inconsistencies, and explains the potential benefits that will be obtained as the results of the collaborative aspect. Finally, the importance of integrating the scientific disciplines in pharmaceutical analysis and pharmaceutics under this issue is considered taking into account the recent studies.