Establishment and Escalation of an Amino Acid Stacked Repressible Release Embedded System Using Quality by Design.

Abstract

The traditional approach of developing a new delivery system is an exhaustive task and requires a number of resources like manpower, money, material, and time. To overcome this problem Quality by Design (QbD) can be utilized to obtain pharmaceutical products of desired (best) quality with minimum use of the above resources as well as determination of the impact of one factor over the desired associated process. The present research is focused on establishing a design for formulating optimized gelatin microspheres using QbD. Repressible released embedded microspheres of L-arginine were prepared by performing cross linking of gelatin using glutaraldehyde. Characterization of the formulated embedded microspheres was done based on infrared spectroscopy, scanning electron microscopy, percentage yield, microsphere size, drug entrapment efficiency, and drug release. The impact of concentrations of gelatin and ethyl cellulose was determined over dependent response like percentage yield, microsphere size, and drug entrapment efficiency. A response surface curve was obtained using a 32 central composite design and the optimized batch was obtained with percentage yield, microsphere size, and drug entrapment efficiency of 89.98, 333.32 mm, and 82.61%, respectively. Validation of the optimized batch was done by formulating four different batches with optimized values of independent response and a comparison of the observed responses with the predicted ones was set up and all these batches were found close to the predicted values and show the validity of the optimized data. The QbD approach is quite efficient to get optimized drug delivery systems of L-arginine without exhaustive study.