Abstract

Baclofen is a food and drug administration approved medication to manage reversible spasticity, mainly targeting the relief of flexor spasms, clonus and concomitant pain, which are common issues following spinal cord lesions and multiple sclerosis. It can be administered orally or intrathecally. However, there is currently no standardised method for compounding the medication for oral administration, especially in paediatric patients or those with swallowing difficulties. It is often crushed and mixed with fruit juice or milk to aid in dosage adjustments and improve swallowability, potentially affecting the dosing accuracy. Therefore, this study aims to test the stability of oral powders of baclofen at concentrations of 1 mg/ ml and 10 mg/ml in X-Temp^® oral suspension system. The suspension was stored in amber high density polyethylene bottles and stored either under refrigeration (5°±3°) or at room temperature (30°±2°) for duration of up to 90 d. The samples underwent thorough evaluation through visual inspection, pH measurement, high-performance liquid chromatography assay and microbiological stability assay. This study indicates that the baclofen suspension at concentrations of 1 mg/ml and 10 mg/ml remained consistent in physical, chemical, and microbiological characteristics for up to 90 d at both (5°±3°) and (30°±2°). Suggesting that the X-Temp^® oral suspension system as a reliable medium for compounding of active pharmaceutical ingredients.