Temozolomidedrug info

11. DESCRIPTION Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as -tetrazine-8-carboxamide. The structural formula of temozolomide is: The material is a white to light tan/light pink powder with a molecular formula of C 6 H 6 N 6 O 2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMOZOLOMIDE can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. TEMOZOLOMIDE Capsules, USP: TEMOZOLOMIDE Capsules, USP for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: TEMOZOLOMIDE Capsules, USP 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3.0 mg). TEMOZOLOMIDE Capsules, USP 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg). TEMOZOLOMIDE Capsules, USP 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3.0 mg), and stearic acid (6.0 mg). TEMOZOLOMIDE Capsules, USP 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg). TEMOZOLOMIDE Capsules, USP 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg). TEMOZOLOMIDE Capsules, USP 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9.0 mg), and stearic acid (13.5 mg). The body of the capsules is made of gelatin and titanium dioxide and is opaque white. The cap is also made of gelatin and the colors may vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. T EMOZOLOMIDE Capsules, USP 5 mg: The opaque green cap contains gelatin, titanium dioxide, iron oxide yellow and FD&C Blue 2. TEMOZOLOMIDE Capsules, USP 20 mg: The opaque yellow cap contains gelatin, titanium dioxide and iron oxide yellow. TEMOZOLOMIDE Capsules, USP 100 mg: The opaque flesh cap contains gelatin, titanium dioxide and iron oxide red. TEMOZOLOMIDE Capsules, USP 140 mg: The transparent blue cap contains gelatin, FD&C Blue #2, and titanium dioxide. TEMOZOLOMIDE Capsules, USP 180 mg: The opaque orange cap contains gelatin, titanium dioxide and iron oxide red. TEMOZOLOMIDE Capsules, USP 250 mg: The opaque white cap contains gelatin and titanium dioxide. FDA approved dissolution test specifications differ from USP