期刊
INTERNATIONAL JOURNAL OF PHARMACEUTICS
卷 616, 期 -, 页码 -出版社
ELSEVIER
DOI: 10.1016/j.ijpharm.2022.121530
关键词
Topical administration; Preclinical development; Fixed-dose combination product; Analgesic; Anti-inflammatory
资金
- Drugs R&D Doctoral Program by FCT (Fundacao para a Ciencia e Tecnologia, Portugal)
- Laboratorios Basi-Industria Farmaceutica, S.A. (Portugal) [PD/BDE/150302/2019]
- FCT [UID/QUI/00313/2020]
- Fundação para a Ciência e a Tecnologia [PD/BDE/150302/2019] Funding Source: FCT
This article discusses the application of fixed-dose combination products in pain management and emphasizes the role of animal models in evaluating the efficacy and safety of these formulations.
The combination in a fixed dose of two or more active pharmaceutical ingredients in the same pharmaceutical dosage form is an approach that has been used successfully in the treatment of several pathologies, including pain. In the preclinical development of a topical fixed-dose combination product with analgesic and anti-inflammatory activities for pain management, the main objective is to establish the nature of the interaction between the different active pharmaceutical ingredients while obtaining data on the medicinal product safety and efficacy. Despite the improvement of in vitro assays, animal models remain a fundamental strategy to characterise the interaction, efficacy and safety of active pharmaceutical ingredients at the physiological level, which cannot be reached by in vitro assays. Thus, the main goal of this review is to systematise the available animal models to evaluate the efficacy and safety of a new fixed-dose combination product for topical administration indicated for pain management. Particular emphasis is given to animal models that are accepted for regulatory purposes.
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