nilotinib - Medications

DANZITEN (nilotinib) tablets contain nilotinib, a kinase inhibitor. Nilotinib is present as nilotinib tartrate, with the molecular formula of C 28 H 22 F 3 N 7 O . C 4 H 6 O 6 and a weight of 679.61 g/mol. Nilotinib tartrate is a white to slightly yellowish powder. The solubility of nilotinib tartrate in aqueous solutions decreases with increasing pH. The pK a 1 was determined to be 3.53; pK a 2 was estimated to be 1.55. The chemical name of nilotinib tartrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide,(2R,3R)-2,3-dihydroxybutanedionate. Its structure is shown below: DANZITEN (nilotinib) tablets contain 71 mg or 95 mg nilotinib, equivalent to 91.14 mg, and 121.95 mg nilotinib tartrate, respectively. The inactive ingredients are: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, iron oxide red (in 71 mg strength tablets), iron oxide yellow (in 95 mg strength tablets), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Danziten structure

Nilotinib capsules contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of monohydrochloride sesquihydrate, is a white or slightly yellowish or slightly greenish-yellow powder with the molecular formula and weight, respectively, of C 28 H 23 ClF 3 N 7 O. 1.5 H 2 O and 593 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C 28 H 22 F 3 N 7 O and 529 g/mol, respectively). The solubility of nilotinib practically insoluble in water and heptane, slightly soluble in anhydrous ethanol. Nilotinib is not optically active. The pKa1 was determined to be 2.6 pKa2 was estimated to be 4.2. The chemical name of nilotinib monohydrochloride sesquihydrate is 4-methyl-N-(3-(4-methyl-1H-imidazol-l-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide hydrochloride sesquihydrate. Its structure is shown below: Nilotinib capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 56 mg, 168 mg, and 224 mg nilotinib monohydrochloride sesquihydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and poloxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow) and titanium dioxide. The imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide and shellac. nilotinib-cap-structure

Nilotinib Capsules contains nilotinib d-tartrate, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib d-tartrate is a white to yellow powder with the molecular formula and weight, respectively, of C 32 H 28 F 3 N 7 O 7 and 679.61 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C 28 H 22 F 3 N 7 O and 529 g/mol, respectively). The solubility of nilotinib d-tartrate in aqueous solutions decreases with increasing pH. The pK a 1 of nilotinib d-tartrate was determined to be 4.0. The chemical name of nilotinib d-tartrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide D-Tartrate . Its structure is shown below: Nilotinib Capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib, anhydrous (equivalent to 64.172 mg, 192.517 mg, and 256.689 mg nilotinib d-tartrate, respectively). The inactive ingredients of Nilotinib Capsules are colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium aluminometasilicate, magnesium stearate, and polysorbate 80. The inactive ingredients in the empty capsules contain gelatin, iron oxide (black), iron oxide (red), iron oxide (yellow), and titanium dioxide. The black ink contains iron oxide (black), potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. structure

Nilotinib capsules contain nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, a dihydrate mono hydrochloride, is a slightly yellow to slightly greenish yellow powder with the molecular formula C 28 H 22 F 3 N 7 O. HCI. 2H 2 O and relative molecular mass of 602.02. The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pK a 1 was determined to be 2.1; pK a 2 was estimated to be 5.4. The chemical name of nilotinib is 4-Methyl-N-[3-4-methyl-1 H imidazole-1-yl)-5- (trifluoromethyl) phenyl]-3-[[4-pyridin-3-ylpyrimidin-2yl] amino] benzamide hydrochloride dihydrate. Its structure is shown below: Nilotinib capsules, for oral use, contain 150 mg or 200 mg nilotinib base, (equivalent to 170.535 mg and 227.380 mg nilotinib hydrochloride, dihydrate) with the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate anhydrous, gelatin, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. In addition, the 150 mg capsule also contains iron oxide red. The imprinting ink contains shellac, propylene glycol, strong ammonia solution. The 150 mg capsules also contain potassium hydroxide and iron oxide black. The 200 mg capsules also contain iron oxide red. nilotinibchemicalstructure

Nilotinib Capsules contains nilotinib d-tartrate, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib d-tartrate is a white to yellow powder with the molecular formula and weight, respectively, of C 32 H 28 F 3 N 7 O 7 and 679.61 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C 28 H 22 F 3 N 7 O and 529 g/mol, respectively). The solubility of nilotinib d-tartrate in aqueous solutions decreases with increasing pH. The pK a 1 of nilotinib d-tartrate was determined to be 4.0. The chemical name of nilotinib d-tartrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide D-Tartrate . Its structure is shown below: Nilotinib Capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib, anhydrous (equivalent to 64.172 mg, 192.517 mg, and 256.689 mg nilotinib d-tartrate, respectively). The inactive ingredients of Nilotinib Capsules are colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium aluminometasilicate, magnesium stearate, and polysorbate 80. The inactive ingredients in the empty capsules contain gelatin, iron oxide (black), iron oxide (red), iron oxide (yellow), and titanium dioxide. The black ink contains iron oxide (black), potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. structure

Nilotinib capsules contain nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to off-white powder with the molecular formula and weight, respectively, of C 28 H 22 F 3 N 7 O•HCl • H 2 O and 584 g/mole (corresponding molecular formula and weight of nilotinib base, anhydrous are C 28 H 22 F 3 N 7 O and 529 g/mole respectively). The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pK a 1 was determined to be 2.1; pK a 2 was estimated to be 5.4. The chemical name of nilotinib monohydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below: Nilotinib capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55 mg, 165 mg, and 221 mg nilotinib hydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate and poloxamer. The capsule shells contain gelatin, iron oxide red (50 mg and 150 mg), iron oxide yellow and titanium dioxide. The capsules are imprinted with edible black ink or maroon ink. The black ink is comprised of ammonium hydroxide, iron oxide black, propylene glycol and shellac. The maroon ink is comprised of ammonia solution, D&C Red #7 calcium lake, FD&C Blue #2 aluminum lake, FD&C Red # 40 aluminum lake, propylene glycol and shellac. chemical structure of nilotinib