Single dose and steady-state pharmacokinetics of 4 mg and 8 mg oral salbutamol controlled-release in patients with bronchial asthma
| Autor: | R A Clark, D. P. Dhillon, Denis G. McDevitt, Brian J. Lipworth, J. B. D. Palmer, M. K. Charter |
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| Rok vydání: | 1989 |
| Předmět: |
Adult
Male Time Factors medicine.drug_class Pharmacology Dosage form Double-Blind Method Pharmacokinetics Oral administration Forced Expiratory Volume Bronchodilator Humans Medicine Albuterol Pharmacology (medical) Randomized Controlled Trials as Topic Asthma business.industry Respiratory disease General Medicine Middle Aged medicine.disease Controlled release Delayed-Action Preparations Anesthesia Salbutamol Female business medicine.drug |
| Zdroj: | European Journal of Clinical Pharmacology. 37:49-52 |
| ISSN: | 1432-1041 0031-6970 |
| Popis: | Fifteen patients with asthma were given salbutamol controlled-release (SCR) 4 mg or 8 mg twice daily for seven days, in a randomised double-blind cross-over design. Plasma salbutamol levels were measured after the first and fifteenth doses for a 12 h period following drug ingestion. At steady-state the geometric mean values for Cmax were 8.2 ng/ml for 4 mg, and 16.1 ng/ml for 8 mg. Median tmax values were 300 and 240 min respectively. The geometric mean AUC (0-12) were 4507 ng.min.ml-1 and 8980 ng.min/ml. Peak to trough fluctuation ratios were 0.577 and 0.572. There were no significant differences between 4 mg or 8 mg formulations, for any of the parameters measured, after appropriate corrections for dose. The concentration-time profiles at steady-state showed little fluctuation in plasma salbutamol levels over the twelve hour dosing interval. These results show that 4 mg and 8 mg formulations of SCR provide smooth plasma profiles at steady-state with a twice daily dosing regime. |
| Databáze: | OpenAIRE |
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