Patidar Mohini*, Pillai Sujit, Deshmukh Nitin, Patel Sumit and Mahajan Aakansha
Baclofen is a centrally acting skeletal muscle relaxant used to treat muscle spasticity and multiple sclerosis. Baclofen hydrophilic characteristics make it challenging for it to cross the blood brain barrier, resulting in a bioavailability of less than 60%. The current study's objectives are to develop, optimize and validate an analytical method for the quantitative estimation of Baclofen by UV-visible spectrophotometer in accordance with ICH guidelines, as well as to improve the bioavailability and efficacy of drug release by formulating micro emulsion of Baclofen. Four different batches were formulated on the bases of S/Cos ratios 3:1, 3.5:1, 4.5:1 and 1.5:1 respectively by water titration method. Tween 80, span 80 and PEG 400 were blended together to form a homogeneous mixture, Baclofen was dissolved in oil phase. Oil phase and surfactant mixture were mixed slowly with continuous trituration. Drop wise additions of water were made to the existing mixture, which was stirred for 30 minutes at 3000 rpm on a magnetic stirrer. The result of FTIR study were indicated compatibility in between Baclofen and excipients. On the bases of solubility studies 0.1 N NaOH was selected for analytical method validation. The ?max and regression equation found to be 221 nm and Y=0.0603x+0.0207, R2=0.999. The result of all analytical validation parameters was not exceeding by 2% RSD value. Out of all batches M1 shows more transparent, no phase separation, pH of 6.7, particle size 100 nm, low viscosity and 96.73% drug content value. It exhibited good stability over the course of the six month stability tests, with no significant changes in its physicochemical characteristics. Hence, it was concluded that the micro emulsion formulation of Baclofen is a potential method for oral delivery that will increase bioavailability.
Published Date: 2024-03-12; Received Date: 2023-06-14
