Establishment and Escalation of Amino Acid Stacked Repressible Release Embedded System Using QbD

INTRODUCTION: Traditional approach of developing a new delivery system is an exhaustive task and requires a number of resources like man, money, material and time. To overcome this problem Quality by Design (QbD) can be utilized to get the pharmaceutical product of desired (best) quality with minimum use of above resources as well as determination of 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.

METHODS: Characterization of formulated microspheres was done by infra red spectroscopy, scanning electron microscopy, percentage yield, microsphere size, drug entrapment efficiency and drug release. Impact of concentration of gelatin and ethyl cellulose was determine over dependent response like percentage yield, microsphere size and drug entrapment efficiency.

RESULTS: Response surface curve was obtained by using 32 central composite design and optimized batch was obtained with percentage yield, microsphere size and drug entrapment efficiency as 89.98, 333.32 mm and 82.61% respectively. Validation of optimized batch was done formulatin four different batches with optimzed values of independent response and a comparison of the observed responses with the predicted ones setting up and all these batches were found close to the and show validity of optimized data.

DISCUSSION AND CONCLUSION: QbD approach is quite efficient to get optimized drug delivery systems of L-Arginine without doing exhaustive study.