Development and Evaluation of Co-Processed Excipient for Orally Dissolving Tablets
In this study, attempts were made on the design, development and evaluation of co-processed excipient that would be helpful in preparing Orally Dissolving Tablet. Co-processed excipient is mainly composed of known additives that are commonly used in the manufacturing of ODTs including mannitol, Microcrystalline Cellulose (MCC) and maize starch. Among different available techniques for co-processing, a more economical conventional technique was selected for the developing co-processed excipient consisting of excipient sizing, blending and physical agglomeration by wetting, wet screening, drying and followed by dry screening.
Experiments were performed according to 32-level factorial design to observe the effect of two variables on critical quality attributes of co-processed excipient. The concentration of Microcrystalline Cellulose (X1) and maize starch (X2) were two numeric factors (independent variables). The studied responses were critical quality attributes of co-processed excipient.
All possible nine combinations were prepared and F4 formulation was selected as optimized based on its quality parameters. Later it was used with low content API (Active Pharmaceutical Ingredient) Montelukast sodium and high content API Paracetamol taste masked granules to prepare Orally Dissolving Tablet and each was evaluated for all critical quality attributes.
It is concluded co-processed excipient developed in the current study is cost effective, reproducing and meeting all quality criteria for further developing Orally Dissolving Tablet.