Post-Market Quality Surveillance: Assessing Physicochemical Parameters and Inter-Brand Variations of Cinnarizine Tablets in Thi-Qar_Iraq

Abstract

As a first-line medication for vertigo management, cinnarizine has been authorized for the treatment of nausea, vomiting, motion sickness, and illnesses affecting the inner ear. Blood viscosity and nystagmus in labyrinth are both reduced by its anti-vasoconstrictor action. The primary objective of the study was to evaluate the worth of both brand-name and generic Cinnarizine available in Iraq. The following tests were performed on 25 mg cinnarizine tablets available in Iraq: in vitro dissolving test, disintegration, friability, drug content, and hardness. The innovator product, Janassen, was coded as CA1. The generic brands, Ibn Hayyan (Syria) and Sama alfayhaa (Iraq), were coded as CA2 and CA3, respectively. A spectrophotometric method was employed for the purpose of drug analysis. Results: Using spectrophotometers, we could detect active drug levels between 95% and 98% in CA1, CA3 having the maximum potency at 99.99%. In terms of mechanical qualities, all the formulations presented similar and excellent resistance to abrasion. The mean friability values were very low, ranging between 0.11% and 0.12%. The tablet hardness and the disintegration behaviors were somewhat different. The innovator product (CA1) had the maximum mechanical strength (9.5 ± 0.21 Kg) and the disintegration time was 4.15 min. The Iraqi generic (CA3) had the lowest hardness (6.5 ± 0.54 Kg) and the disintegration time was almost equal to 4.12 min. The Syrian generic (CA2) was characterized by a quick breakdown (1.47 min) in spite of its intermediate hardness (8.2 ± 0.28).