International Journal of Drug Delivery Technology
Volume 14, Issue 3

Global Progress in HIV Therapeutics: An In-Depth Analysis of Dispersible Fixed-Dose Antiretroviral Combination and Their Regulatory Pathways: A Review

Nitin Mehetre*, Inderbir Singh

Chitkara College of Pharmacy, Chitkara University, Rajpura 140401, Punjab, India. 

Received: 15th March, 2024; Revised: 23rd May, 2024; Accepted: 13th August, 2024; Available Online: 25th September, 2024 

ABSTRACT

This review offers a detailed examination of recent advancements in human immunodeficiency virus (HIV) therapeutics, with a particular focus on dispersible fixed-dose combinations (FDCs) of antiretroviral drugs and their associated regulatory pathways. The paper highlights the global progress made in the development and implementation of these formulations, emphasizing their benefits in facilitating administration and enhanced patient adherence. Dispersible FDCs are especially beneficial for pediatric, geriatric, and bedridden patients, as they simplify dosing and improve medication compliance. The review explores the evolution of FDCs, assessing their clinical efficacy and safety profiles while also discussing the regulatory frameworks and approval processes employed by major health authorities across the globe, including the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and other key regulatory bodies. By analyzing these aspects, the review aims to illuminate the critical role that FDCs play in optimizing HIV treatment and their broader implications for public health.

Antiretroviral therapy has significantly transformed HIV/AIDS management, leading to extended lifespan and a better enhanced well-being for patients. Fixed-dose combinations have simplified treatment regimens and improved adherence. However, the path to developing and approving antiretroviral FDC dispersible tablets is fraught with regulatory challenges. This review not only identifies these challenges but also proposes strategies to overcome them, with the goal of ensuring timely access to safe and effective medications for HIV/AIDS treatment. Through this analysis, the review contributes to understanding how regulatory practices can support the advancement of HIV therapies and enhance global health outcomes.

Keywords: HIV therapeutics, Dispersible fixed-dose combinations, Antiretroviral drugs, Regulatory challenges, Regulatorypathways.International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.3.74

How to cite this article: Mehetre N, Singh I. Global Progress in HIV Therapeutics: An In-Depth Analysis of Dispersible Fixed-Dose Antiretroviral Combination and Their Regulatory Pathways: A Review. International Journal of Drug Delivery Technology. 2024;14(3):1773-1784.

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