Wilkins Christi A, Hamman Hannlie, Hamman Josias H, Steenekamp Jan H
Centre of Excellence for Pharmaceutical Sciences (Pharmacen™), Faculty of Health Sciences, North-West University, Private Bag X6001, Potchefstroom 2520, South Africa.
Pharmaceutics. 2024 Jan 26;16(2):178. doi: 10.3390/pharmaceutics16020178.
Whilst monotherapy is traditionally the preferred treatment starting point for chronic conditions such as hypertension and diabetes, other diseases require the use of multiple drugs (polytherapy) from the onset of treatment (e.g., human immunodeficiency virus acquired immunodeficiency syndrome, tuberculosis, and malaria). Successful treatment of these chronic conditions is sometimes hampered by patient non-adherence to polytherapy. The options available for polytherapy are either the sequential addition of individual drug products to deliver an effective multi-drug regimen or the use of a single fixed-dose combination (FDC) therapy product. This article intends to critically review the use of FDC drug therapy and provide an insight into FDC products which are already commercially available. Shortcomings of FDC formulations are discussed from multiple perspectives and research gaps are identified. Moreover, an overview of fundamental formulation considerations is provided to aid formulation scientists in the design and development of new FDC products.
虽然传统上单一疗法是高血压和糖尿病等慢性病首选的治疗起点，但其他疾病从治疗开始就需要使用多种药物（联合疗法）（例如，人类免疫缺陷病毒获得性免疫缺陷综合征、结核病和疟疾）。这些慢性病的成功治疗有时会因患者不坚持联合疗法而受到阻碍。联合疗法的可用选择要么是依次添加单个药品以提供有效的多药方案，要么是使用单一的固定剂量复方（FDC）治疗产品。本文旨在批判性地综述FDC药物疗法的使用，并深入了解已上市的FDC产品。从多个角度讨论了FDC制剂的缺点，并确定了研究空白。此外，还提供了基本制剂考虑因素的概述，以帮助制剂科学家设计和开发新的FDC产品。
