FORMULATION AND EVALUATION OF TASTE-MASKED PREGABALIN ORODISPERSIBLE TABLETS USING EUDRAGIT E100 BY WET GRANULATION TECHNIQUE

Pregabalin is one of the most prescribed anti-seizure and first-line therapeutic agents used in the management of neuropathic pain, fibromyalgia, and partial seizures. Despite its clinical efficacy, the intensely bitter taste of pregabalin poses a significant challenge to patient compliance; this problem is particularly pertinent to pediatric, geriatric, and dysphagic populations who have difficulty swallowing conventional solid oral dosage forms. Orodispersible tablets offer a very promising patient-centric solution owing to their rapid disintegration in the oral cavity without the need for water; however, successful development of pregabalin ODTs requires effective taste masking without compromising rapid drug release. This study was aimed to formulate and evaluate taste-masked pregabalin orodis persible tablets using Eudragit E100 as a pH-dependent taste-masking polymer through a wet granulation method. A total of eight formulations (F1-F8) were formulated by incorporating different levels of Eudragit E100 (6.25-25% w/w) and Mannitol-based excipients such as Pearlitol SD 200 and Pearlitol 160C. Croscarmellose sodium was added both intra- and extragranularly for rapid tablet disintegration properties. The proposed formulations were assessed for pre-compression tests, post-compression properties, in vitro disintegration tests, dissolution properties, content uniformity, and taste masking efficiency by using a trained panel test with a human volunteer. Among all formulations, F8 containing 25% w/w Eudragit E100 and Pearlitol 160C showed optimum performance.