Scientific papers
As widely acknowledged, the product development phase is intricate, demanding a depth of knowledge and substantial time investment. The meticulous selection of excipients, considering their appropriate functionalities and corresponding levels, is pivotal for optimal drug product performance. This study aimed to implement quality by design (QbD) principles in the formulation development process, establishing the desired product quality profile (QTPP) and critical quality attributes (CQA) for the product. QbD, as a holistic, science-based, and risk-oriented approach, enhances pharmaceutical development. Ibuprofen DC 85W served as the model drug in this study, with Cellactose® 80 and MicroceLac® 100 as fillers, and magnesium stearate, stearic acid, and sodium stearyl fumarate as lubricants.
The application of different formulation parameters to the fillers and lubricants within the QbD framework aimed to deepen the understanding of the impact of critical formulation and process parameters on CQAs, contributing to the overall quality of the drug product. An experimental design study was conducted to assess the variations in the obtained outputs, utilizing the Modde Pro 12.1 statistical computer program for optimization through modeling complex relationships. The optimal formulation results indicated that MicroceLac® 100 was the superior filler, with 1% magnesium stearate identified as the optimum lubricant. A design space outlining safe operational limits for both process and formulation variables was established. This study enhances comprehension of excipient effects in formulation and facilitates improved formulation design using experimental and mathematical modeling methods within the QbD framework.
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