abstract |
PROBLEM TO BE SOLVED: To provide a pharmaceutical dosage unit tablet containing a drug and an excipient, and a process for forming a tablet. SOLUTION: The pharmaceutical dosage unit is a tablet core, (1) a particulate pharmaceutical active drug which is about 5% by weight or more of cobimetinib hemiphmalate polymorphic form A, and (2) the pharmaceutical dosage unit. A lubricant containing magnesium stearate, sodium stearyl fumarate, or a combination thereof having a content of about 0.5% by weight to about 5% by weight based on the weight of the tablet core, (3) the pharmaceutical dosage unit tablet core. Based on the weight of the pharmaceutical dosage unit tablet core, a disintegrant containing about 2% by weight to about 7% by weight of sodium glycolate starch, croscarmellose sodium, or a combination thereof. , A pharmaceutical containing (1) lactose having a content of about 60% by weight to about 78% by weight and having a weight ratio of lactose to crystalline cellulose of about 1: 1.5 to about 4: 1. Dosage unit Tablet core. [Selection diagram] None |