Effect on dissolution of tablet storage in counting machines.

Area of Science:

• Pharmaceutical Sciences
• Drug Product Stability
• Bioequivalence Studies

Background:

• Automatic counting and dispensing machines are common in pharmacies.
• Concerns exist regarding the potential impact of these machines on drug product quality.
• Five drug products with known or suspected bioequivalence issues were selected for study.

Purpose of the Study:

• To investigate the effect of storage in automatic counting machines on the dissolution rates and content uniformity of specific drug products.
• To determine if environmental conditions within dispensing machines alter drug product performance.

Main Methods:

• Collected paired samples (exposed vs. unexposed) of amitriptyline hydrochloride, digoxin, prednisone, hydrochlorothiazide, and tolbutamide tablets from 10 pharmacies.
• Tested dissolution rate and content uniformity for all collected samples.
• Recorded storage times and average pharmacy temperatures during the sampling period.

Main Results:

• No substantial differences in dissolution rate or content uniformity were observed between tablets exposed and unexposed to automatic counting machines.
• Average pharmacy temperatures ranged from 72 to 79 degrees F.
• Storage durations in machines varied from 9 to 46 days.

Conclusions:

• Storage in automatic counting and dispensing machines does not appear to significantly affect the dissolution rate or content uniformity of the studied drug products.
• Environmental conditions encountered during typical storage in these machines did not noticeably impact tablet dissolution.
• The findings suggest that current automatic dispensing technologies maintain drug product integrity.