Assessment of cytotoxicity, genotoxicity, and mutagenicity of the dexchlorpheniramine reference standard and pharmaceutical formula in human peripheral blood mononuclear cells

Chaves, Pamella Eduardha Espindola; Zuravski, Luísa; Soares, Anelise Santos; Pereira, Lavínia da Veiga; Serpa, Élvio Adilio; Oliveira, Luís Flávio Souza de; Machado, Michel Mansur

doi:10.1590/s2175-97902022e20096

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Brazilian Journal of Pharmaceutical Sciences

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Article • Braz. J. Pharm. Sci. 58 • 2022 • https://doi.org/10.1590/s2175-97902022e20096 copy

Assessment of cytotoxicity, genotoxicity, and mutagenicity of the dexchlorpheniramine reference standard and pharmaceutical formula in human peripheral blood mononuclear cells

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Dexchlorpheniramine is a first-generation classical antihistamine, clinically used to treat allergies. The main objective of our study was to evaluate the effects of the dexchlorpheniramine reference standard (DCPA Ref. St) and a pharmaceutical formula on DNA in human peripheral blood mononuclear cells (PBMCs). We exposed PBMCs to five different concentrations (0.5, 2.5, 5, 10, and 50 ng/mL) of DCPA Ref. St DCPA Ref. St and pharmaceutical formula in order to evaluate their cytotoxic, genotoxic, and mutagenic potential. The results showed that both dexchlorpheniramine formulations did not affect PBMC viability and CD3+, CD4+, or CD8+ lymphocyte subpopulations. The DCPA Ref. St and pharmaceutical formula neither induced genotoxic or mutagenic effects nor numerical or structural chromosomal alterations in PBMCs after 24 hours of exposure.

Keywords:
Dexchlorpheniramine; PBMC; In vitro; DNA

Group	Mitotic Index (Medium ± SD)	Total metaphases	Normal metaphases	Numerical alteration	Structural alteration	Type of alteration
Negative Control	1.5 ± 0.57^a	300	300 (Figure 4A)	0	0	---------------
DEXCHLORPHENIRAMINE MALEATE REFERENCE STANDARD
DCPA Ref. St. 50 ng/mL	1.25 ± 0.50 ^a	300	300 (Figure 4B)	0	0	---------------
DCPA Ref. St. 10 ng/mL	1.75 ± 0.50 ^a	300	300	0	0	---------------
DCPA Ref. St. 5 ng/mL	1.5 ± 0.57 ^a	300	300	0	0	---------------
DCPA Ref. St. 2.5 ng/mL	1.5 ± 0.57 ^a	300	300	0	0	---------------
DCPA Ref. St. 0.5 ng/mL	1.25 ± 0.50 ^a	300	300	0	0	---------------
DEXCHLORPHENIRAMINE MALEATE
DCPA 50 ng/mL	1.75 ± 0.50 ^a	300	300 (Figure 4C)	0	0	---------------
DCPA 10 ng/mL	2.00 ± 0.82 ^a	300	300	0	0	---------------
DCPA 5 ng/mL	1.5 ± 0.57 ^a	300	300	0	0	---------------
DCPA 2.5 ng/mL	1.75 ± 0.50 ^a	300	300	0	0	---------------
DCPA 0.5 ng/mL	1.5 ± 0.57 ^a	300	300	0	0	---------------

Universidade de São Paulo, Faculdade de Ciências Farmacêuticas Av. Prof. Lineu Prestes, n. 580, 05508-000 S. Paulo/SP Brasil, Tel.: (55 11) 3091-3824 - São Paulo - SP - Brazil
E-mail: bjps@usp.br

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[1] *Correspondence: M. M. Machado. Universidade Federal do Pampa, Campus Uruguaiana. BR 472, Km 585. CEP: 97500-970, Uruguaiana, RS, Brasil. Phone/Fax: 55 - 55 39110200. E-mail address: michelmachado@unipampa.edu.br.