Development and in vitro Evaluation of Enteric Coated Multiparticulate System for Resistant Tuberculosis

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Materials Science

Background:

• Sodium para aminosalicylate (Sod PAS) is an important drug for treating intestinal conditions.
• Conventional oral formulations may face challenges with gastric degradation and targeted intestinal release.
• Developing advanced drug delivery systems is crucial for enhancing therapeutic efficacy.

Purpose of the Study:

• To develop and characterize a multiparticulate formulation of Sod PAS for oral administration.
• To optimize the enteric coating of the pellets for targeted intestinal drug release.
• To evaluate the in vitro performance and morphological characteristics of the developed formulation.

Main Methods:

• Extrusion spheronization technique was employed for pellet formulation using microcrystalline cellulose as a filler.
• Pellets were coated with Eudragit L 30 D-55 using a fluidized bed processor at various weight gains.
• In vitro dissolution studies were conducted in simulated gastric (0.1 N HCl) and intestinal (phosphate buffer pH 6.8) environments.
• Scanning electron microscopy (SEM) was used to assess pellet morphology.

Main Results:

• A 60% w/w Eudragit L 30 D-55 coating level demonstrated optimal resistance to gastric conditions.
• A 3% hydroxypropyl methylcellulose (HPMC) E5 seal coat prevented drug migration, and a film coat prevented pellet aggregation.
• SEM analysis confirmed the development of smooth, spherical pellets.
• The formulation exhibited suitable in vitro dissolution profiles for intestinal delivery.

Conclusions:

• The developed multiparticulate system effectively protects Sod PAS from gastric degradation.
• The optimized formulation ensures targeted drug release in the intestinal region.
• This advanced delivery system holds promise for improved oral therapy with Sod PAS.