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Solution stability of the drug is the major challenge of the parmaceutical industries. Lyophilization is also known as freeze drying is the subjectof current research for most of the scientists to overcome these challenges.Lyophilization consists of three steps freezing, primary drying and secondary drying.Freezing is the pre requisite step for the primary drying where all the unbound water turns into freeze concentrate and water molecules removed by sublimation. Primary drying is the longest step of the lyophiization.In secondary drying the bound water which is associated with the drug molecules can be removed by the desorption by the application of heat and vaccum.The objective of study is Parecoxib different formulations used to Optimization of Lyophilization cycles and the main focus is to minimize consistently drying times, while maintaining constant Parecoxib Powder for Solution for Injection product quality. Methods: The various formulations were studied for thermal events by DSC technique and the determination of the critical events by FDM analysis. By collaborated observations from these studies the lyophilzation cycles were developed and studied. Results: The data obtained from DSC and FDM analysis of drug solution was used to determine set temperature to be used during freezing, primary drying and secondary drying set temperatures. The set vacuum for the chamber during the primary drying and secondary drying was determined from the operation manual of Lyodryer LSI Freeze dryer. The optimized cycle was about 66 hrs used for better productivity. Evaluated the lyophilized product for water content and assay and x ray diffraction. Pharmaceutical equivalence study was conducted for Parecoxib powder for solution for injection with innovator product (Dynastat®). Conclusion: Finally concluded that the present developed lyo cycle was used to execute the Parecoxib Powder for Solution for Injection product. Keywords: Parecoxib, Lyophilization cycle, Impedance, FDM analysis,DSC Analysis, Poor thermal stability, Freezing, Primary drying, Secondary drying, X-Ray diffraction. |
