A Better Dissolution Method for Ranitidine Tablets USP

Abstract

Ranitidine tablets USP showed variable intra- and inter-lab dissolution results. In order to ascertain the reason for this behavior, ranitidine tablets USP produced by (BIPI) Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, and Zantac® Tablets (brand of ranitidine USP), Glaxo Inc., Research Triangle, NC, were subjected to the compendia (USP) dissolution testing using paddle and basket apparatus. Two potencies of tablets 150 mg and 300 mg were tested. Comparison of BIPI tablets and matching Zantac® tablets indicated that both brands of ranitidine tablets USP had similar dissolution behavior. When the basket apparatus was substituted for the paddle apparatus the overall rate and extent of tablet dissolution increased, while the individual tablet variability decreased. BIPI 150 mg tablets using the basket apparatus, but at reduced rotational speed of 30 rpm, showed increase in rate and extent of drug dissolved, with less individual tablet variability compared to the paddle apparatus at 50 rpm. The 300 mg tablet (30 rpm/basket apparatus) had an initial slower rate, but then rapidly equaled the paddle apparatus dissolution results, and had less individual tablet variability. Paddle apparatus tablet sinkers were used to prevent tablets from sticking to the bottom of the dissolution vessel. Overall dissolution for all tablets with sinkers showed a trend which was more rapid and complete than tablets without sinkers. Results showed that dissolution artifacts for ranitidine tablets could be reduced by the use of baskets or tablet sinkers.

Keywords:

• Basket-dissolution
• Dissolution
• Paddle-dissolution
• Ranitidine tablets
• Rotational speed
• Tablet sinkers
• USP dissolution apparatus I
• USP dissolution apparatus II