Design and Invitro Evaluation of Delayed Release Tablets of Thiamine

Gopala Krishna Tadakamalla*¹, K. Someshwar², P. Nithin kumar¹, Vagdevi. Y^1
1Research Assistant, KP Labs, Kothapet (A Division of KDPL), Hyderabad.
²Manager, Formulation R&D, KP Labs (A Division of KDPL), Kothapet, Hyderabad

Abstract
Eight formulations of  enteric coated tablets of Thiamine  were developed by preparing core tablets using mannitol as diluent and Crospovidone as super disintegrant and povidone (PVP K-30) as binder in different proportions and varying the compositions of sub coating and enteric coating using  sicovit yellow ,titanium dioxide and Eudragit (L30D55) .The core tablets were prepared by dry granulation method. F7 was found to be best of all the trials showing drug release matching the innovator product. The best formulation F7 was repeated again for reproducibility, and all the quality control tests were done for conformation. Stability study is carried out for 2 months at 25°C; 60% RH: and 40°C; 75%RH, according to ICH guidelines. The tablets were tested for acid release during the stability period and confirmed that results were found within the limits.
Keywords: Thiamine, Delayed release drug delivery system, Eudragit polymer