Studies on Optimization of Process Parameters Influencing The Content Uniformity of Low Dose Active Pharmaceutical Ingredient

Abstract

Mixing of ingredients or dispersion of one phase into another is widely used operation in industry. The aim of these operations is to make homogeneous product using the minimum amount of energy and time. It is a prerequisite for manufacturing of all solid dosage forms which involves powder mixing and it has a critical contribution in achieving the Content Uniformity and Segregation of the blend is the main problem while preparing the tablets using direct compression method. Optimum mixing can be done by using different process parameters like effect of mixing pattern, strength of Active Pharmaceutical Ingredients, shape and size of diluents, and shear force. After studying on the process parameter it can be concluded that mixing pattern has much influence on the Content uniformity and Blend Uniformity. Compared to spherical excipients, fibrous and irregular shape containing excipients increased Content Uniformity, Blend Uniformity and decrease the segregation tendency of the Blend. After applying shear force to the mixture component, Uniformity of blend and Uniformity of dosage form would automatically achieve while segregation potential was decreased. In the present investigation, an attempt has been made to evaluate various process parameters on Content Uniformity of low dose Active Pharmaceutical Ingredients. Metformin Hydrochloride was selected as a model drug. From the preliminary trials and performance qualification of the equipments, 23 full factorial design was applied and the effect of Blender Volume, Mixing time and Co-mill mesh size on dependant responses like Uniformity of Content, Uniformity of Blend and Segregation tendency were measured. From the optimization study, it can be concluded that Blender Volume and Blending time were exhibited