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Asst. Prof. Dr. Sadat Abdulla Aziz, Vice President for Scientific Affairs and Postgraduation Studies at Cihan University–Sulaimaniya, and Asst. Lecturer Mohammad Tofiq Salih, Head of the Medical Laboratory Analysis Department, College of Health Sciences at the same University, have published a research article in the esteemed Journal of Pharmaceutical Innovation. The study, entitled “Toxicity Assessment of Oral Liquid Formulations of Novel Ciprofloxacin-Dicarboxylic Acid Salts in Female Albino Rats: Haematological, Biochemical, and Histopathological Parameters”.
The study aimed to evaluate and compare the systemic toxicity profiles of novel ciprofloxacin salts synthesised using dicarboxylic acid counterions. To our knowledge, this represents the first in vivo comparative toxicity assessment of these specific crystalline ciprofloxacin–dicarboxylic acid salts. These salts represent previously unreported solid forms of ciprofloxacin with enhanced solubility and potential for improved oral bioavailability. Albino rats were administered oral liquid formulations, and systemic effects were assessed through haematological, biochemical, and histopathological evaluations. Aqueous Liquid dispersions of ciprofloxacin salts with succinic, glutaric, adipic, and pimelic acids were prepared and orally administered to female albino rats at doses equivalent to 20 mg/kg (low dose) and 60 mg/kg (high dose) of ciprofloxacin for 14 consecutive days. Haematological analysis revealed no significant changes in RBC and WBC counts or platelet levels. Biochemical evaluations showed only mild alterations in liver and kidney function markers, lipid profiles, and hormonal levels, largely comparable to the control group. Notably, the GAH and AAH groups exhibited significantly elevated AST and ALT levels compared to the control group (P < 0.05). AST levels in the GAH, AAH, and control groups were 459.00 ± 52.37, 467.33 ± 159.75, and 113.33 ± 32.25 U/L, and ALT levels were 62.33 ± 13.65, 65.00 ± 11.36, and 33.67 ± 11.93 U/L, respectively. The composite toxicity score identified the glutaric acid (GAH) and adipic acid (AAH) salts at high doses as having the most systemic impact (72.4% and 71.95%, respectively), while the pimelic acid salt at high dose (PAH, 21.27%) and adipic acid salt at low dose (AAL, 15.78%) were among the safest. Z-score heatmap analysis supported these findings. Histopathological examination revealed no significant pathological changes in the spleen, kidney, or heart, though minor liver changes were observed. The novel ciprofloxacin dicarboxylic acid salts demonstrated a favorable safety profile in rats, with minimal systemic toxicity and only mild histological liver alterations at higher doses. These findings provide important foundational preclinical safety data, supporting further development of these novel salt forms as potentially safer and more bioavailable ciprofloxacin formulations.
The Journal of Pharmaceutical Innovation is indexed in Scopus (Q2) with a Cite Score of 4.3 and an Impact Factor of 2.7.
The article can be accessed at the following link:
https://link.springer.com/article/10.1007/s12247-025-10079-4
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