Evaluation of two buflomedil tablet formulations in patients with atherosclerotic disease
| Autor: | I. Iacona, I. Buggia, G. Melzi D'Eril, G. Specchia, Mario Regazzi, S. Raffaghello, P. Graziani, Mariadelfina Molinaro |
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| Rok vydání: | 1994 |
| Předmět: |
Male
Pyrrolidines Arteriosclerosis Vasodilator Agents Biological Availability Bioequivalence Pharmacology Placebo Dosage form chemistry.chemical_compound Double-Blind Method Pharmacokinetics Oral administration Buflomedil Humans Medicine Pharmacology (medical) In patient Aged business.industry Middle Aged Bioavailability Therapeutic Equivalency chemistry Delayed-Action Preparations Female business Tablets |
| Zdroj: | Journal of Clinical Pharmacy and Therapeutics. 19:111-115 |
| ISSN: | 1365-2710 0269-4727 |
| Popis: | The bioequivalence of a 600-mg methocel tablet containing buflomedil hydrochloride in sustained-release form was determined relative to a 300-mg CAP/carbovax-coated tablet of buflomedil hydrochloride in immediate-release form. The tablets were given to 20 patients in a double-blind placebo-controlled clinical study with cross-over between the administration plans. The 300-mg tablets were given b.i.d., at 8 a.m. and 8 p.m. while the 600-mg tablets were taken once a day at 8 a.m. (+placebo at 8 p.m.). Plasma samples were collected at appropriate times up to 24 h after administration and were analyzed for buflomedil with a validated high-performance liquid chromatographic procedure. Results showed an overall significant mean difference in absorption rate between the two formulations. The mean tmax (5.5 +/- 3.5 h) for the 600-mg tablet was longer (P < 0.001) than the tmax value (1.8 +/- 0.8 h) seen after administration of the first 300-mg tablet. Analysis of AUC(O-infinity) values indicated that the sustained-release preparation (32.1 +/- 20.7 micrograms/ml h) was not significantly different from the 300-mg tablet b.i.d. (28.7 +/- 16.0 micrograms/ml h). Furthermore, it was seen that single administration of a 600-mg sustained-release tablet of buflomedil hydrochloride delivered the same amount of total drug as a 300-mg tablet given twice a day. |
| Databáze: | OpenAIRE |
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