NDA 20-358: WELLBUTRIN® SR tablets

 

 

DISSOLUTION:

 

In vitro release data (mean ±SD) and range) were provided for pivotal biobatches (50 mg tablet, batch No.: 1Y2781, 100 mg tablet, batch No.: 1&2780, and 150 mg tablet, batch No.: 1R2763) which participated in the bioavailability studies No. 202, 206, and 07 (Tables 2-4 APPENDIX III).

 

The Dissolution Method For Bupropion HCL SR Tablets was:

 

Apparatus	Whited out
Rotation
Medium
Temperature
Volume
Sampling Times (hr)

 

In addition to water, dissolution testing for the pivotal 150 mg biobatch (1R2763) was also performed in different media such as 0.1N HCL, pH 4.5 phosphate buffer, and pH7.5 phosphate buffer under the same conditions as described above.  Sampling of media was done at 1, 4, and 8 hours (Tables 5 and 6, APPENDIX III).

 

Dissolution of bupropion HCL for the 150 mg SR tablet was slightly faster in water and was comparable in 0.1N and pH 4.5 phosphate buffer.  Overall for these three media, there was about (whited out) release in 1 hours, around (whited out) in 4 hours and greater than (whited out) in 8 hours; (CV was 2-5%).  Release was slowest in pH 7.5 phosphate butter.

 

 

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