HOW PRODUCTS WERE EVALUATED:
How Products were Selected:
Products tested represent a sampling of the original and generic forms of extended-release bupriopion available for sale through licensed U.S. pharmacies at the time this study began. ConsumerLab.com purchased all products from pharmacies and did not receive products from manufacturers or distributors.
Testing Methods:
Bupropion hydrochloride SR and XL products were tested for their total amount of bupropion hydrochloride by HPLC using the USP 30 (United States Pharmacopoeia) chromatographic recommendations in the Bupropion Hydrochloride Extended-Release Tablets monograph. Quantitation was done at 298 nm, utilizing a photodiode array (PDA) and the USP Bupropion Hydrochloride reference standard.
Bupropion hydrochloride SR and XL products were also tested and their ability to release bupropion hydrochloride in solution as follows:
SR Products:
- Utilized USP 30, Bupropion Hydrochloride Extended-Release Tablets monograph, test 1 with additional pull points.
- Apparatus: USP Apparatus 2 (paddle): 50 rpm
- Medium: 900 mL of water at 37°C
- Time points: 1, 2, 4, 6 and 8 hours.
- The amount of bupropion HCl dissolved was determined by UV (298 nm) with a 1.0 cm cell for each of the 6 samples per product at designated time point. Determination the concentration dissolved was calculated by comparing the absorbance from the sample taken to a standard curve utilizing the USP Bupropion Hydrochloride reference standard in water (same as dissolution medium). An average concentration from the 6 samples was utilized for each time point on the graph for the individual products.
- Utilized dissolution conditions specified in FDA drug approval letters for Wellbutrin XL and Bupropion XL.
- Apparatus: USP Apparatus 1 (basket) at 75 rpm
- Medium: 900 mL of 0.1N hydrochloric acid (HCl) at 37°C
- Time points: 2, 4, 8, 12 and 16 hours.
- The amount of bupropion HCl dissolved was determined by UV (298 nm) with a 1.0 cm cell for each of the 6 samples per product at designated time point. Determination the concentration dissolved was calculated by comparing the absorbance from the sample taken to a standard curve utilizing the USP Bupropion Hydrochloride reference standard in 0.1N HCl (same as dissolution medium). An average concentration from the 6 samples was utilized for each time point on the graph for the individual products.
