Biomedical Research

- Biomedical Research (2008) Volume 19, Issue 1

Establishing Therapeutic Bioequivalence of a Generic Salbutamol (ButalinĀ®) Metered Dose Inhaler to Ventolin

Inhaled beta-adrenergic receptor agonist plays an important role in the management of bronchial asthma especially in the acute setting and still salbutamol (albuterol, USAN) is the most widely prescribed drug in this class. In a randomized, open label, crossover, multicenter study, one and two actuations (100, 200μg) of Ventolin and Butalin inhaler were administered in 4 alternative different conse-quences for patients suffering from mild to moderate asthma for 4 days trial compares forced expiratory volume in the first second (FEV1) at (0, 15, 30, 45 and 60 minutes) and peak expiratory flow (PEF) at (0, 15, 30, 45, 60, 120, 240, 360 minutes) to prove equivalent pharmacodynamics, equipotency and safety. Eighty-nine patients completed the study of which 61.8% were male. There was no signifi-cant difference between Ventolin and Butalin concerning the average of Ln transformed re-cords for the FEV1 and PEF, and the AUFC0-1h for the 100 and 200 μg were (96.89-101.07) and (92.69-104.77) respectively, same for the PEF AUC0-4h that came with the ranges of (99.20-104.24) and (90.25-100.49) respectively. No significant difference was noted between the two products in regard of onset and duration of action, and the same was true when as-sessing products potency. Concluding that both products are clearly equivalent and equipotent with similar safety profile.

Author(s): Abdulrahman Al Frayh, Abdullah Abba, Aymen Iskandarani, Duraid S. Shaker, Fares Zai-toun, Layla Shahrabani, Mohammed Khan, Moussa Riachy, Ruwayda Dham

Abstract Full Text PDF