4.      Question-Based Review

 

4.1    General Attributes

 

4.1.1        What are the highlights of the chemistry and physical-chemical properties of Wellbutrin XL, and the formulation of the drug product?

 

The following information has been extracted from the proposed labeling.

 

Wellbutrin XL tablets contain bupropion hydrochloride.  Bupropion hydrochloride is chemically designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride and its structural formula is:

 

The empirical formula of bupropion is HCl is C13H18C1NO·HCl and its molecular weight is 276.2.  Bupropion hydrochloride is a white crystalline powder that is highly soluble in water.

 

Wellbutrin XL extended release tablets are diffusion controlled tablets that consist of a tablet core surrounded by coatings that form a membrane responsible for controlling the release of bupropion HCl.  Wellbutrin XL tablets are creamy white to pale yellow tablets.  According to the sponsor, tablets are printed with edible black ink.  The composition of the 150 mg and 300 mg tablets, including inactive ingredients, are shown in the table below.

 

 

 

8

 

 

Back a Page
Next Page
Back to Wellbutrin XL NDA Index Page
Back to Main Index Page