Process Optimization and Scale-Up of Anti-Hypertensive Bi-Layer Tablet Formulation-A Quick Review
Umesh Khatri, Ramesh Pareek · 2014
In a pharmaceutical industry, preparation of a dosage form need process scale- up in several stages. Pharmaceutical scale-up involves manufacturing drug product with increasing batch sizes on larger equipment. Production scale is typically differ-ent from R&D scale in terms of batch size. The processing conditions during R&D scale and commercialize scale are quite different from each other. The successful established conditions for a product at R&D scale would not be same at production scale. Therefore, each and every unit operation in the production of tablet formulation at production scale is optimized for successful scale-up. Therefore, scientific optimization techniques are used to provide effective, accurate, and less time consuming way to scaling up the production profile from laboratory to commercialize plant so as to have higher output without any objection on quality matters. In the present work, an attempt has been made to implement the quality by design (QbD) principles for successful process scale-up. The design of experiment (DoE) strategy was applied during the process scale-up of any product to reduce the risk of batch failure on quality attributes. Quality by design approach using design of experimentation can be implemented successfully to provide fully robust and reproducible process that will develop an assured quality product.