ABSTRACT

The current research was to develop mucoadhesive buccal tablets of Lisinopril dihydrate to treat high blood pressure. Lisinopril is an ACE inhibitor that has extensive first-pass metabolism and low oral bioavailability (25%). The objective of this study is to enhance the drug's bioavailability through the application of various polymers, such as Carbopol 934p, HPMC K100M, and Chitosan, using the direct compression technique following a Quality by Design (QbD) approach. The tablets were assessed for solubility characteristics, drug-carrier interaction through FTIR and DSC analysis, as well as in vitro and in vivo drug release profiles. The formulated tablets were optimized by Box-Behnken design. The optimization of these formulations was carried out to study the effect of independent variables like Carbopol(A), HPMC K100M(B), and Chitosan(C). In this design, three responses were evaluated Mucoadhesive strength(R1), Swelling index(R2), and Drug release(R3). Every formulation exhibited significant enhancements in mucoadhesive strength, swelling index, and in vitro drug release. However, formulation LD BT 18 was selected as the optimized formulation due to its in vitro drug release, which extended for 10 hours, surpassing that of the commercially available tablet. Pharmacokinetic parameters exhibited a threefold enhancement of bioavailability of lisinoprilbuccal tablets than the pure drug and marketed formulation. Keywords: Lisinopril dihydrate, Mucoadhesive buccal tablets, Box-Behnken design, Carbopol 934p, invitro drug release
Publication date: 01/12/2024

https://ijbpas.com/pdf/2024/December/MS_IJBPAS_2024_8515.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.12.8515