In vivo methodologies to assist preclinical development of topical fixed-dose combinations for pain management

• Type: Article in International Scientific Journal
• Date: 2022

Authors

Veloso, C (Author) Other; Videira, RA (Author) Other; Paula B Andrade (Author) FFUP; Cardoso, C (Author) Other; Vitorino, C (Author) Other

Journal

Title: International Journal of Pharmaceutics

Vol. 616

ISSN: 0378-5173

Publisher: Elsevier

Indexing

ISI Web of Knowledge - 0 Citations

Scopus - 0 Citations

Other information

Authenticus ID: P-00W-3Y8

DOI: 10.1016/j.ijpharm.2022.121530

Abstract (EN): 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.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 10