NDA 20-358: WELLBUTRIN® SR tablets

 

The firm’s preference for quality control and toward setting of specifications has been water.

Drug release specifications for each strength WELLBUTRIN® (bupropion HCL) SR tablets as proposed by the firm are as follows:

 

Time (hours)	50 mg	100 mg	150 mg
1	Whited out
4
8

 

The Division of Biopharmaceutics recommends the following dissolution specification for all strengths of WELLBUTRIN® SR tablets (50, 100, and 150 mg):

 

Time (hours)	%Dissolveda
1	whited out
4
8

 

 

IN VITRO/IN VIVO CORRELATION:

 

Correlations of the mean percent dissolved from the 50 mg (pilot batch 1W2737), 100 mg (pilot batch 1W2733), and 150 mg (pivotal batch 1R2763; pilot batches: 0X2728 and 0X2731) SR tablets at 1, 4 and 8 hours in different media (0.1N NCL, pH 4.5 phosphate buffer, water, and pH 7.5 phosphate buffer) versus the mean percent of dose absorbed in vivo were performed.

 

An in vitro/in vivo correlation was demonstrated for WELLBUTRIN® SR tablets using 0.1N HCL, pH 4.5 phosphate buffer, water, and pH 7.5 phosphate buffer as dissolution media

 

10

 

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