Basic Description of Colazal (balsalazide disodium)
Capsules
Each COLAZAL capsule contains 750 mg of balsalazide disodium, a prodrug
that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic
acid), an anti-inflammatory drug. Each daily dose of COLAZAL (6.75 grams) is
equivalent to 2.4 grams of mesalamine. Balsalazide disodium has the chemical name
(E)-5-[[-4-[[(2-carboxyethyl) amino]carbonyl] phenyl]azo]-2-hydroxybenzoic acid,
disodium salt, dihydrate. Its structural formula is:
Molecular Weight: 437.32
Molecular Formula: C17H13N3O6Na2 � 2H2O
Balsalazide disodium is a stable, odorless orange to yellow microcrystalline powder.
It is freely soluble in water and isotonic saline, sparingly soluble in methanol and
ethanol, and practically insoluble in all other organic solvents.
Inactive Ingredients: Each hard gelatin capsule contains colloidal silicon dioxide
and magnesium stearate. The sodium content of each capsule is approximately 86 mg.