Frontiers Journal of Pharmaceutical Sciences & Clinical Trials (FJPSCT)

Formulation, Development And Evaluation Of Medroxyprogesteron Acetate Injectable Depot Suspension

Keywords : Medroxyprogesteron Acetate; Depot Parenteral Suspension (DSP); Hormonal Contraceptive; Dissolution Apparatus IV

Doi Number : 10.4172/2155-6700.2000002

Abstract

Introduction: The aim of the present investigation was to develop parenteral depot suspension of contraceptive drug (Medroxyprogesteron acetate) to achieve controlled drug delivery. Parenteral depots formulations (suspension) are widely used to improve therapeutic value of water insoluble drug’s and provide sustained drug release over a longer duration of time and solve the problem of daily intake of medicine. Long acting hormonal contraceptive depot formulation advanced the practice of contraception, where injectable and subdermal route of administration used. Objective: The Objective of present study was to develop medroxyprogesteron acetate injectable depot suspension for contraceptive use. 

Material and Methods: Medroxyprogesteron acetate injectable depot suspensions were prepared by sterile combining of API and excipient powders by rapid stirring method. Mixing speed and temperature dependent solubility of parabens were affect the particle size, specific surface area and dissolution rate of given suspension. Different excipients used in the formulation are Methylparaben and Propyllparaben used as preservative and resuspending agent, sodium chloride were used Isotonisity modifier, PEG 3350 were used as suspending agent, Tween 80 used as surfactant.

Results and Discussion: The resultant MPA suspension were evaluated for Physical properties, MPA content were 101.00 ± 2 %, viscosity were 8.58 ± 1cps, pH 5.826 ± 1 and osmolality were found to be 378 ± 5 Mosmol /kg.H2O respectively and further characterized for surface morphology, particle size, zeta potential sedimentation volume, syrengeability, hold time study, In-vitro drug dissolution. The suspensions were found to be spherical with smooth surface. Particle size, specific surface area and zeta potential were found to be (Particle size 13.4 µm with specific surface area 1530 cm2/km, -22.66 mV). Interaction between the drug and polymer were investigated by Fourier Transform Infrared (FT-IR) Spectroscopy. The MPA injectable suspension could go through 24 gauge hypodermic needle smoothly with withdrawal volume 1.70, mL, MPA suspension re-dispersed within 1 minute without forming clogs. The FT-IR analysis confirmed the compatibility of MPA with the excipients without interaction. Drug release from these MPA injectable suspension showed sustained release over a period of 48 hours (Dissolution type-II apparatus), and 90 minute (Dissolution type- IV apparatus). 

 

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