ABSTRACT

The main objective of the present study is to prepare robust and stable formulation and evaluvation of dimethyl fumarate delayed release enteric coated tablets in tablets in capsules. Since Dimethylfumarate degrades in the acidic environment, it is important to bypass the acidic pH of the stomach. protection of drug from acidic environment is done by coating the drug with enteric polymers by using suspension layering technique in fluidized bed process (FBP) with different enteric polymers like Methacrylic acid copolymer type A, Tri ethyl citrate, sodium lauryl sulphate. The Dimethl fumarate delayed release capsules used for treatment of multiple sclerosis patients with relapsing forms were prepared. The chemical structure of Dimethylfumarate was characterized by 1H1 NMR and FTIR spectroscopy. Then Dimethyl fumarate (DMF), an anti-inflammatory drug choosen as a model drug &prepared as capsules in three steps: Formulation of Dimethylfumarate core tablets by direct compression method, Enteric coating of Dimethylfumarate core tablets, Filling of enteric coated tablets in to capsule shells. The delayed release Dimethyl fumarate delayed release capsules were characterized for particle size, solubility, in-vitro, in-vivo targeting studies The delayed release capsule formulation F3, F4, F5, was in size range of 524,534,535 ?m respectively. The delayed release capsules were targeted for drug release was delayed from stomach to intestine so that the capsules when placed in the 0.1N HCl no drug release was observed, finally the release of drugobserved in phosphate buffer pH-6.8 in the 5 formulations F3, F4, F5 were showed good delayed release of drug. Because of that delaying of drug Dimethyl fumarate the capsules were used to treat sclerosis. Keywords: Dimethyl fumarate, Delayed release, Multiple sclerosis
Publication date: 01/10/2024

https://ijbpas.com/pdf/2024/October/MS_IJBPAS_2024_8371.pdf

Download PDF
https://doi.org/10.31032/IJBPAS/2024/13.10.8371