BGT-INAD

Importance of cleaning validation in the pharmaceutical industry cannot be overstated. It is essential for preventing cross-contamination, ensuring product quality & safety, and upholding regulatory standards. The present study involved development of an effective cleaning method for five selected kinase inhibitors binimetinib (BMT), selumetinib (SMT), brigatinib (BGT), capmatinib (CPT), and baricitinib (BRT). For checking the effectiveness of the developed cleaning technique, a sensitive and specific RP-HPLC based analytical method employing a diode array detector has been established to quantitate drug residue on glass and stainless steel surfaces. A reproducible swab sampling protocol utilizing TX714A Alpha swabs wetted with an extracting solvent has been developed to collect representative samples from both surfaces. Chromatographic separation of selected kinase inhibitors was achieved in gradient mode using an Agilent Zorbax eclipsed C18 column with acetonitrile and 10 mM ammonium formate as the mobile phase. The analytes were chromatographically separated in a 12 min run time. The mean swab recovery for each drug from glass and stainless steel surfaces exceeded 90%. Cleaning with IPA (70%) and acetone (70%) effectively removed residues for all five drugs. A solution comprising 10 mM SDS with 20% IPA demonstrated good efficacy in cleaning residues of BGT, BRT, and CPT, but exhibited lower efficacy for SMT and BMT.

Walking is a fundamental physical activity with significant health implications. Backward gait training (BGT) has emerged as a novel approach with potential benefits, yet its effects in comparison to traditional forward gait training (FGT) remain uncertain. This systematic review and meta-analysis aimed to evaluate the effects of BGT on body composition, cardiopulmonary fitness, and inflammatory and metabolic markers in adults. A comprehensive search across electronic databases was conducted following the Preferred Publishing Items for Systematic Reviews and Meta-Analyses guidelines. Randomized clinical trials (RCTs) comparing BGT with FGT in adults were included. Methodological quality was assessed using the Cochrane risk-of-bias tool. The certainty of evidence was evaluated using the Grading of Recommendation, Assessment, Development, and Evaluation approach. The analysis included a total of 379 male participants across the studies. The meta-analysis demonstrated significant changes in body composition and inflammatory marker outcomes, which included waist-to-height ratio (standardized mean difference [SMD]-1.18, 95% confidence interval [CI]-1.89–0.48, I2 = 83%, P < 0.01), body mass index (SMD-0.55, 95% CI-0.77–0.32, I2= 0%, P < 0.01), and C-reactive protein (SMD-0.98, 95% CI–1.28-0.70, I2= 0%, P < 0.01). In addition, the qualitative review revealed potential enhancements in cardiopulmonary fitness and metabolic markers following BGT. While the results suggest potential benefits of BGT on body composition and inflammatory markers, the evidence remains limited and heterogeneous. Further robust research with diverse populations, longer intervention periods, and comprehensive outcome assessments is essential to elucidate the true impact of BGT and its utility for promoting overall health and well-being in adults.