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Abstract. Liquid mixing scale-up in pharmaceutical industry has often been based on empirical approach in spite of tremendous understanding of liquid mixing scale-up in engineering fields. In this work, we attempt to provide a model-based approach to scale-up dissolution process from a 2 l lab-scale vessel to a 4,000 l scale vessel used in manufacturing. Propylparaben was used as a model compound to verify the model predictions for operating conditions at commercial scale that would result in similar dissolution profile as observed in lab scale. Geometric similarity was maintained between both of the scales to ensure similar mixing characteristics. We utilized computational fluid dynamics (CFD) to ensure that the operating conditions at laboratory and commercial scale will result in similar power per unit volume (P/V). Utilizing this simple scale-up criterion of similar P/V across different scales, results obtained indicate fairly good reproducibility of the dissolution profiles between the two scales. Utilization of concepts of design of experiments enabled summarizing scale-up results in statistically meaningful parameters, for example −90% dissolution in lab scale at a given time under certain operating conditions will result in 75-88% at commercial scale with 95% confidence interval when P/V is maintained constant across the two scales. In this work, we have successfully demonstrated that scale-up of solid dissolution can be done using a systematic process of lab-scale experiments followed by simple CFD modeling to predict commercial-scale experimental conditions.

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The Technology Transfer is both integral and critical to drug discovery and development process for new medicinal products this process gives necessary information for technology transfer from R&D to PDL department and development of existing product to the production for commercialization. The finishing product during manufacturing as well as assure constant quality transferred the situation for developing countries is controversial because it denied people with technical skills from developed countries to developing countries do not migrate the process of movement of technology from one unit to another. The transfer may be said to be successful if the receiving unit and the transferee can effectively utilize the technology for business gain.Technology transfer plays a vital role in the process of drug discovery to the product development and the full scale commercialization the article attempts to discus about the pharmaceutical technology transfer process steps, reasons and importance of technology transfer and the issues involved in the technology transfer in the pharmaceutical industry. Given technology centrality to development and technology acquisition necessity by developing countries for further development and benefit it is desirable to generate transfer and diffuse the best available pharmaceutical technology in these countries through product development and scale-up technique a commercialised drug product and to highlight how technology is transferred, importance of technology transfer, rezones for technology transfer, factors influencing technology transfer, drivers and barriers. The ultimate goal for successful technology transfer is to have documented evidence that the manufacturing processes for drug substances and drug product.