Abstract

QUALITY ASSESSMENT OF 2% LIDOCAINE INJECTABLE SOLUTIONS USED IN DENTAL CLINICS IN YAOUNDE, CAMEROON

Soppo Lobe Charlotte Vanessa*, Nokam Marie Elvire, Biwole Steven Olivier,
Benga Mekoulou Chimène Felecité, Nnanga Nga

ABSTRACT

Background: Local anesthetics, particularly 2% lidocaine, are essential in dental practice. The quality of injectable formulations directly affects patient safety and therapeutic effectiveness. Substandard medicines remain a concern in low- and middle-income countries. Objective: To evaluate the physicochemical, microbiological, and labeling quality of 2% lidocaine injectable solutions used in dental clinics in Yaoundé, Cameroon. Methods: A descriptive and analytical study was conducted between November 2018 and July 2019. Fifteen batches of 2% lidocaine were collected from 11 dental clinics using consecutive sampling. Each batch underwent labeling inspection, visual examination, microbiological testing, pH measurement, and active ingredient assay using UV-visible spectrophotometry. Results were expressed as means ± standard deviation, proportions, and 95% confidence intervals (95% CI). Results: Among the 15 batches analyzed, 80% originated from India, 13% from France, and 7% from Spain. Two batches (13.3%; 95% CI: 1.7–40.5%) showed labeling non-conformities. All samples were clear and sterile. Four batches (26.7%; 95% CI: 7.8–55.1%) had pH values below pharmacopoeial standards. The lidocaine concentration was compliant in all samples (mean: 2.01% ± 0.04%; 95% CI: 1.97–2.05%). Conclusion: Most analyzed batches complied with quality standards; however, labeling deficiencies and pH deviations were observed. Regular quality control and strengthened pharmaceutical surveillance are recommended.

Keywords: Quality control; Lidocaine 2%; Injectable drugs; Dental anesthesia; Cameroon.