Formulation and Evaluation of Bilayer Tablets of Vonoprazan Fumarate (IR) and Ibuprofen (SR) for Gastroprotective Nsaid Therapy

In this study, a bilayer tablet which combines Ibuprofen in a sustained-release layer and Vonoprazan in an immediate-release layer is designed and tested. In separate batches, three highly effective super-disintegrants - sodium starch glycolate, polyplasdone XL, and croscarmellose sodium - were utilised to formulate the IR layer at different concentration levels of 3%, 4%, and 5%. To ensure sustained drug release in accordance with USP guidelines, a combination of Ibuprofen and three hydrophilic matrix-forming polymers, namely HPMC K4M, HPMC K15M, and Hypromellose K100M CR Premium, was used at concentration levels of 15%, 20%, and 25% respectively, for the SR layer. The appearance, thickness, hardness, friability, drug content, weight uniformity, and in-vitro dissolution characteristics of the manufactured bilayer tablets have been evaluated. Formulation T9, containing 7.5 mg of croscarmellose sodium, produced outstanding results among the IR batches, achieving a 99.25% release of Vonoprazan within a 0.1 N HCl solution after a short period of just one hour. The batch containing 325 mg of Hypromellose K100M CR Premium showed the most successful sustained release in the SR layer, outperforming other studied formulations by releasing 99.12% of Ibuprofen over 12 hours, first in 0.1 N HCl for 2 hours and then in phosphate buffer with a pH of 7.2.