Comparative toxicity assessment between generic salbutamol sulphate inhaler containing hydrofluoroalkane and Ventolin Evohaler

Suvas C. Singho Roy, M. A. Jalil, Nigar Sultana Tithi, Sajal K. Saha, Sheikh Zahir Raihan, Utpal K. Chanda, Chanchal K. Ghosh, Sitesh C. Bachar

Department of Clinical Pharmacy and Pharmacology, Faculty of Pharmacy, University of Dhaka, Dhaka, Bangladesh.
Department of Gastroenterology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
Department of Pediatrics, Khulna Medical College and Hospital, Khulna, Bangladesh.
Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Dhaka, Dhaka, Bangladesh.
Department of Statistics, Biostatistics and Informatics, Faculty of Science, University of Dhaka, Dhaka, Bangladesh.

DOI: 10.4236/ojpm.2013.33037                

Abstract

Salbutamol is a short-acting β₂-adrenergic receptor agonist used for the relief of bronchospasm such as asthma and chronic obstructive pulmonary disease (COPD). It is mostly taken through an inhaler device. The comparative toxicity assessment between two salbutamol sulfate preparations containing hydrofluoroalkane (HFA) metered dose inhalers with 100 μg per puff was evaluated in selected patients with asthma and COPD after prescribing. An open label, non-randomized, non-interventional observational study was designed. A large cohort of patients with asthma or related respiratory disorder of the general population from Dhaka and Chittagong of Bangladesh were recruited and treated with prescribed generic preparation Azmasol inhaler and brand preparation Ventolin Evohaler. Total 508 patients with asthma and minor obstructive airway disease were selected by the general medical practitioners in Bangladesh those who visited out patient consultation center in hospitals and physicians’ chambers and reported any adverse side effects of inhaled medications. There were no significant differences between the metered dose generic preparation Azmasol inhaler and Ventolon Evohaler among the patients treated with the medicines in asthma and related respiratory diseases in terms of adverse effects like immune system problem,dizziness,tremor,headache,nervousness,diarrhea,nausea,vomiting,heartburn,palpitation,skin rash,hypertension and taste feeling. It is concluded that Azmasol Inhaler, the generic salbutamol sulphate metered dose preparation containing HFA was as safe as the Ventolin Evohaler,a salbutamol sulfate brand preparation containing HFA when given to the patients in primary care after their physicians’ visits. Both the preparations have shown the similar safety profiles after regular use.

Keywords

Salbutamol Sulphate; Hydrofluoroalkane; Toxicity Assessment; Adverse Drug Reaction; Asthma; Ventolin Evohaler

Conflicts of Interest

The authors declare no conflicts of interest.

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