Formulation and characterization of acyclovir based topical microemulsions by QBD approach

Abstract

Objective: The proposed study is focussed at developing acyclovir microemulsions for topical drug delivery systems. QbD was applied for better understanding of the process and to generate design space, using quality target product profile, critical quality attributes, and risk assessment. The aim of the experiment is to prepare a safe, efficacious, stable and patient compliant microemulsion dosage form of Acyclovir. Materials and methods: Pre-formulation studies were carried out which helped in developing a suitable dosage form. UV, FTIR and DSC studies were done for pre-formulation and post-formulation evaluations. QbD was applied to generate design space, using QTPP, CQA, and risk assessment. Microemulsions of acyclovir were developed by using 32 factorial designs. Pseudo terneary phase diagrams were constructed to screen various surfactants and co-surfactants for the preparation of microemulsions. Two independent variables Oil Concentration (X1) and Smix Concentration (X2) at three levels low, medium and high were selected and response surface plots were generated. The microemulsions were prepared by plotting pseudo terneary phase diagrams. Various characterizations that were carried out include % transmittance, Viscosity and % drug release. Statistical analyses of batches and surface response studies were done to understand the effect of various independent variables on the dependent variables. Results and Discussions: The λmax was confirmed at 251 nm by UV spectroscopy. The melting point was determined experimentally to be 2460C which confirms the drug to be Acyclovir. FTIR and DSC studies confirmed that the drug is Acyclovir. Conclusion: The study indicates that microemulsions of Acyclovir by QbD approach were successfully developed.
 Keywords: Microemulsion, Acyclovir, DoE, QbD