Formulation And Evaluation of Miglustat Sustained Release Matrix Tablet in The Treatment of Gaucher's Disease

Gaucher disease is a rare lysosomal storage disorder caused by a deficiency in the enzyme glucocerebrosidase, leading to the accumulation of glucocerebroside in organs such as the spleen, liver, and bone marrow. Current treatment strategies include enzyme replacement   therapy (ERT) and substrate reduction therapy (SRT), with Miglustat being a key oral therapeutic agent. This study focuses on developing a sustained-release matrix tablet formulation of Miglustat to enhance its therapeutic efficacy and patient compliance.The formulation was prepared using the direct compression method, incorporating Hydroxypropyl Methylcellulose (HPMC) as a release-retardant polymer, along with other excipients like magnesium stearate and polyvinylpyrrolidone. The prepared tablets were evaluated for micromeritic properties, weight variation, hardness, friability, thickness, drug content uniformity, and in vitro drug release. Stability studies were conducted as per ICH guidelines under different temperature and humidity conditions.Results showed that the formulated sustained-release Miglustat tablets exhibited desirable physical and mechanical properties, ensuring controlled drug release. The optimized formulation met pharmacopoeial standards, demonstrating its potential for improved therapeutic management of Gaucher’s disease.