Nghiên cứu bào chế viên nén phân tán nhanh Methylprednisolon 4mg

ABSTRACT Objective: Methylprednisolon is a powerful anti-Inflammatory drug belonging to the class IV pharmacokinetic classification system, with poor solubility and permeability. The goal of the study is to improve the water solubility of Methylprednisolone by solid dispersing technique and rapid dispersing modifier. Methylprednisolon 4 mg tablets are convenient and high effective in the treatment for patients who are difficult to swallow sush as the elderly and children. Experimental Method: Studies on solid dispersion system containing Methylprednisolon (MEP) and and polyethyl Glycol 6000 (PEG 6000), F-cyclodextrin (FCD), Hydroxypropyl-F-cyclodextrin (HP-FCD), with different ratios. Evaluate the solid dispersion system by melting and using DSC method (Differential scanning calorimetry) to find the optimal carrier and combined ratio. From the Methylprednisolon solid dispersion system with selected carriers, pelletizing excipients for quickly dispersed by direct stamping method are studied. The tablets are evaluated through parameters such as the uniformity of weight, disintegration, solubility, dispersion time. Result: The Methylprednisolon solid dispersion system with F-cyclodextrin carrier (FCD) ratio of 1: 3 which increased 3.4 times compared to the original material. The formula of dispersed tablets BH4 uses Crosscarmellose sodium excipients with the fastest decay time of 7 seconds, the solubility reaches over 96% after 30 minutes. Thus, creating a solid dispersion system is an effective method to improve both the dissolution speed of Methylprednisolon and the preparation of rapid dispersal pellets containing solid dispersion system can increase the bioavailability of drug