SPL Set ID: 4cff04f5-3693-4d87-a9f8-a2b195e3d26e
1 drug(s) with this SPL Set ID
Erlotinib, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine hydrochloride. Erlotinib tablets contains erlotinib as the hydrochloride salt that has the following structural formula: Erlotinib hydrochloride has the molecular formula C 22 H 24 ClN 3 O 4 and a molecular weight of 429.90. The molecule has pK a of 4.44 at 25°C. Erlotinib hydrochloride is slightly soluble in methanol, practically insoluble in acetonitrile and in acetone. Aqueous solubility of erlotinib hydrochloride is dependent on pH with increased solubility at a pH of less than 5 due to protonation of the secondary amine. Over the pH range of 1.4 to 9.6, maximal solubility of approximately 0.4 mg/mL occurs at a pH of approximately 2. Erlotinib tablets for oral administration are available in three dosage strengths containing erlotinib hydrochloride (27.3 mg, 109.3 mg and 163.9 mg) equivalent to 25 mg, 100 mg and 150 mg erlotinib and the following inactive ingredients: hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide. srt