Development and Characterization of Leuprolide Acetate Encapsulated PLGA Microspheres for Parenteral Controlled Release Depot Injection

Indian Journal of Pharmaceutical Education and Research

  • Soumya Ranjan Satapathy1School of Pharmaceutical Sciences, Siksha ‘O’ Anusandhan (Deemed to be University), Bhubaneswar, Odisha, INDIA.
  • Rudra Narayan Sahoo1School of Pharmaceutical Sciences, Siksha ‘O’ Anusandhan (Deemed to be University), Bhubaneswar, Odisha, INDIA., 2School of Pharmacy and Life Sciences, Centurion University of Technology and Management, Odisha, INDIA.
  • Biswaranjan Satapathy3Orbicular Technologies Pvt Ltd, Mumbai, Maharashtra, INDIA.
  • Ramachandrarao Immani4Department of Chemistry, Annamalai University, Chidambaram, Tamil Nadu, INDIA.
  • Lalatendu Panigrahi5Encube Ethicals Pvt Ltd, Mumbai, Maharashtra, INDIA.
  • Subrata Mallick1School of Pharmaceutical Sciences, Siksha ‘O’ Anusandhan (Deemed to be University), Bhubaneswar, Odisha, INDIA.

Volume 55 Issue 1 Pages 107-116

DOI: 10.5530/ijper.55.1.14

Abstract

Objectives: Polylactic acid (PLA) and copolymer polylactic-co-glycolic acid (PLGA) are the most versatile drug carriers for long acting release injectable (LAI) formulations for small molecules, peptides and macromolecules such as proteins and nucleic acids. The present research work consists of a PLGA based one-month release microsphere formulation of GnRH agonist leuprolide acetate, using double emulsion (W1/O/W2) technique. Materials and Methods: Microparticles were prepared by double emulsion solvent evaporation technique and critical quality attributes of finished products such as drug loading, entrapment efficiency, particle size distribution (PSD), surface porosity, drug distribution within microparticles were analysed. Results and Conclusion: The microspheres have shown the mean particle size of 15.2 μm and suitable particle size distribution pattern ideal for syringe ability. The microparticles were spherical in shape with uniform pore distribution and uniform distribution of API in the polymer matrix. The drug release has been sustained over a month for the microsphere formulation and could be correlated with the testosterone suppression.

Keywords

  • Leuprolide
  • PLGA Microspheres
  • Double-emulsion technique
  • Prostate cancer
  • Controlled release depot Injection
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