Quality by Design based formulation and evaluation of acyclovir microsponges

  • Asish Dev 1 Research scholar, Pacific University, Udaipur, Rajasthan, India 2 Assistant Professor, Oriental College of Pharmacy, Sanpada, Navi Mumbai, Maharashtra, India
  • Jayesh Dwivedi Associate Professor, Pacific University, Udaipur, Rajasthan, India
  • Munira Momin Principal and Professor, Dr. Bhanuben Nanavati College of Pharmacy, Mumbai, Maharashtra, India

Abstract

Objective: The proposed study is focussed at developing acyclovir microsponges for oral 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 microsponge dosage form of Acyclovir. Materials and methods: Pre-formulation studies were carried out which helped in developing a suitable dosage form. UV, FTIR, DSC, and SEM studies were done for pre-formulation and post-formulation evaluations. QbD was applied to generate design space, using QTPP, CQA, and risk assessment. Microsponges of acyclovir were developed by 23 factorial designs. Three variables Drug: Polymer ratio (X1), Concentration of surfactant (X2) and Stirring speed (RPM) (X3) at two levels low and high were selected and response surface plots were generated. The microsponges were prepared by Quassi-emulsion solvent diffusion method. Various characterizations that were carried out include entrapment efficiency, percentage yield, particle size determination, in-vitro drug release studies and kinetic modelling of 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. Eight trials were taken as per the by 23 factorial designs.  Conclusion: The study indicates that microsponges of Acyclovir by QbD approach were successfully developed.


Keywords: Microsponge, Acyclovir, DoE, QbD

Downloads

Download data is not yet available.

Author Biographies

Asish Dev, 1 Research scholar, Pacific University, Udaipur, Rajasthan, India 2 Assistant Professor, Oriental College of Pharmacy, Sanpada, Navi Mumbai, Maharashtra, India

1 Research scholar, Pacific University, Udaipur, Rajasthan, India

2 Assistant Professor, Oriental College of Pharmacy, Sanpada, Navi Mumbai, Maharashtra, India

Jayesh Dwivedi, Associate Professor, Pacific University, Udaipur, Rajasthan, India

Associate Professor, Pacific University, Udaipur, Rajasthan, India

Munira Momin, Principal and Professor, Dr. Bhanuben Nanavati College of Pharmacy, Mumbai, Maharashtra, India

Principal and Professor, Dr. Bhanuben Nanavati College of Pharmacy, Mumbai, Maharashtra, India

References

1. Shishu, Rajan S, Kamalpreet, Development of Novel Microemulsion-Based Topical Formulations of Acyclovir for the Treatment of Cutaneous Herpetic Infections, AAPS PharmSciTech, 2009; (10)2:559-565.
2. Lembhe S, Dev A, Design Development And Evaluation Of Mesalamine Loaded Microsponge Compressed Into Tablet For Colon, World Journal Of Pharmacy And Pharmaceutical Sciences, 2016; 5(7):1235-1266.
3. Desai PM, Er PX, Liew CV, Heng PW. Functionality of disintegrants and their mixtures in enabling fast disintegration of tablets by a quality by design approach. AAPS PharmSciTech 2014; 15:1093-104.
4. Chodankar R, Dev A, Optimisaton techniques: a futuristic approach for formulating and processing of pharmaceuticals, Indian J. Pharm. Biol. Res. 2016; 4(2):32-40.
5. Kharat P, Pujari R. Design and statistical optimization of antacid and analgesic effervescent tablet by using factorial design. Int J Pharm Sci 2014; 6:211-214.
6. Bhusnure O, Nandgave A. Formulation and evaluation of fast dissolving tablet on montelukast sodium by using QbD approach. Indo Am J Pharm Sci 2015; 5:1092.
Statistics
163 Views | 153 Downloads
How to Cite
Dev, A., Dwivedi, J., & Momin, M. (2019). Quality by Design based formulation and evaluation of acyclovir microsponges. Journal of Drug Delivery and Therapeutics, 9(1), 54-60. https://doi.org/10.22270/jddt.v9i1.2159