“Implementation of Quality by Design of Sublingual Antihypertensive Drugs"

Abstract

Background

Hypertension poses a global health challenge, contributing significantly to mortality and cardiovascular diseases in both developed and low- to middle-income nations. Conventional oral tablets often fail to provide the rapid onset required for acute conditions, prompting exploration of alternative non-parenteral routes.

Main Body

This review focuses on sublingual administration as a viable option, given its potential for rapid drug absorption due to the sublingual cavity's higher permeability. Sublingual tablets offer advantages such as improved bioavailability, minimal adverse effects, and ease of use. However, formulating effective sublingual tablets presents challenges distinct from conventional tablets QbD, or quality by design, is a methodical approach to formulation development., offering benefits like high-quality pharmaceuticals, regulatory flexibility, and post-approval modification management. The QbD process involves defining quality target product profiles, understanding manufacturing processes, identifying critical material attributes, and optimizing key process parameters. This systematic approach ensures a design space that allows for constant improvement throughout the pharmaceutical product lifecycle.

Conclusion

This review aims to consolidate studies on sublingual administration of antihypertensive drugs, incorporating a systematic risk assessment approach within the QbD framework. By applying QbD principles to optimize sublingual tablet formulations, this approach promises efficient drug product development, reducing the need for extensive testing while ensuring affordability and effectiveness. Despite numerous literature reviews on sublingual tablets, this review uniquely addresses the systematic implementation of QbD for sublingual tablet development, filling a gap in the current pharmaceutical research landscape. The exploration of risk identification, analysis, and evaluation of critical quality attributes enhances our understanding of antihypertensive sublingual tablets' development, providing a valuable resource for pharmaceutical scientists and researchers.

Graphical Abstract