A COMPARATIVE STUDY OF SOME BRANDS OF TOLBUTAMIDE AVAILABLE IN CANADA. II. PHARMACEUTICAL ASPECTS.

Pharmaceutical analyses were carried out on 26 lots of tolbutamide from 21 manufacturers. All lots were found to be satisfactory with respect to identity and strength. Disintegration time of 24 lots ranged from one to 35 minutes, with 72 and 83 minutes for the other two. The time to 90% dissolution in intestinal solution (pH 7.5) ranged from five to 69 minutes in all except two lots for which the times were 99 and over 120 minutes. While the clinical significance of these findings cannot be ascertained in the absence of data from controlled studies, the evidence does not suggest that most of the non-proprietary products available in Canada would not be satisfactory for the purpose intended.