Temodal Capsules, For Personal, Hospital, Clinical, Grade Standard : Medicine Grade

TEMODAR contains temozolomide, an imidazotetrazine derivative. The chemical name of temozolomide is 3,4-dihydro-3methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula is:
TEMODAR® (temozolomide) Structural Formula Illustration
The material is a white to light tan/light pink powder with a molecular formula of C 6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH ( < 5) and labile at pH > 7; hence TEMODAR 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.
TEMODAR Capsules : Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide.
The inactive ingredients for TEMODAR Capsules are as follows :

• TEMODAR 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 mg).
• TEMODAR 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).
• TEMODAR 100 mg : lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg).
• TEMODAR 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).
• TEMODAR 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).
• TEMODAR 250 mg : lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg).

The body of the capsules is made of gelatin, and is opaque white. The cap is also made of gelatin, and the colors 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.

• TEMODAR 5 mg : The green cap contains gelatin, titanium dioxide, iron oxide yellow, sodium lauryl sulfate, and FD&C Blue #2.
• TEMODAR 20 mg : The yellow cap contains gelatin, sodium lauryl sulfate, and iron oxide yellow.
• TEMODAR 100 mg : The pink cap contains gelatin, titanium dioxide, sodium lauryl sulfate, and iron oxide red.
• TEMODAR 140 mg : The blue cap contains gelatin, sodium lauryl sulfate, and FD&C Blue #2.
• TEMODAR 180 mg : The orange cap contains gelatin, iron oxide red, iron oxide yellow, titanium dioxide, and sodium lauryl sulfate.
• TEMODAR 250 mg : The white cap contains gelatin, titanium dioxide, and sodium lauryl sulfate.

TEMODAR for Injection : Each vial contains 100 mg of sterile and pyrogen-free temozolomide lyophilized powder for intravenous injection.
The inactive ingredients are : Mannitol (600 mg), L-threonine (160 mg), polysorbate 80 (120 mg), sodium citrate dihydrate (235 mg) and hydrochloric acid (160 mg).