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Testing of acute and sub-acute toxicity profile of novel naproxen sodium nanoformulation in male and female mice.
Qureshi, Irfan Zia; Razzaq, Ayesha; Naz, Syeda Sohaila.
Afiliação
  • Qureshi IZ; Laboratory of Animal and Human Physiology, Department of Zoology (Animal Sciences), Faculty of Biological Sciences, Quaid-a-Azam University, Islamabad, 45320, Pakistan. Electronic address: irfanzia@qau.edu.pk.
  • Razzaq A; Laboratory of Animal and Human Physiology, Department of Zoology (Animal Sciences), Faculty of Biological Sciences, Quaid-a-Azam University, Islamabad, 45320, Pakistan.
  • Naz SS; Nanosciences and Technology Department, National Centre for Physics, Quaid-a- Azam University Campus, Islamabad, 44000, Pakistan.
Regul Toxicol Pharmacol ; 150: 105650, 2024 Jun.
Article em En | MEDLINE | ID: mdl-38782233
ABSTRACT
Nanodrugs offer promising alternatives to conventionally used over the counter drugs. Compared to its free form, therapeutic benefits, and gastric tissue safety of naproxen sodium nanoformulation (NpNF) were recently demonstrated. Essential regulatory safety data for this formulation are, however, not available. To address this, male and female BALB/c mice were subjected to acute and 14-day repeated-oral dose assessments. Our data indicate that NpNF was well tolerated up to 2000 mg/kg b.w. A 14-day subacute toxicity testing revealed that the oral administration of low dose (30 mg/kg) NpNF did not produce any adverse effects on blood profile and serum biochemical parameters. Levels of oxidative stress markers and antioxidant enzymes neared normal. Histology of selected tissues also showed no evidence of toxicity. In contrast, a ten-fold increase in NpNF dosage (300 mg/kg), demonstrated, irrespective of gender, mild to moderate toxicity (p < 0.05) in the brain, stomach, and heart tissues, while ROS, LPO, CAT, SOD, POD, and GSH levels remained unaffected in the liver, kidney, spleen, testis, and seminal vesicles. No effect on serum biochemical parameters, overall indicated a no-observed-adverse-effect level (NOAEL) is 300 mg/kg. Further increase in dosage (1000 mg/kg) significantly altered all parameters demonstrating that high dose is toxic.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Naproxeno / Testes de Toxicidade Aguda / Testes de Toxicidade Subaguda / Camundongos Endogâmicos BALB C Limite: Animals Idioma: En Revista: Regul Toxicol Pharmacol Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Naproxeno / Testes de Toxicidade Aguda / Testes de Toxicidade Subaguda / Camundongos Endogâmicos BALB C Limite: Animals Idioma: En Revista: Regul Toxicol Pharmacol Ano de publicação: 2024 Tipo de documento: Article