In an embodiment, therapeutic methods and uses of Bruton's Tyrosine Kinase (BTK) inhibitors for treatment of cancer, inflammation, immune disorders, and autoimmune disorders, including dermatoses, and for transplantation prophylaxis, based on BTK occupancies and/or BTK resynthesis rates for B cells in various diseases, tissue compartments, including bone marrow and lymph nodes, are described. In an embodiment, dosing regimens for a BTK inhibitor for treatment of cancer, inflammation, immune disorders, and autoimmune disorders, including dermatoses, and for transplantation prophylaxis, based on BTK occupancies and/or BTK resynthesis rates for B cells in various diseases, tissue compartments, including bone marrow and lymph nodes, are described.

Formulations of molindone having superior stability and methods of administering same are provided. The formulations may be immediate, modified, or otherwise delayed release formulations of molindone.

Provided are formulations of ivosidenib including a number of polymorphs. Further provided are formulations of ivosidenib containing a number of known impurities. Still further provided are stable compositions of ivosidenib.

A novel binder is provided. The binder comprises a polyvinyl alcohol-based polymer which has an average saponification value of 85.0 mol % to 89.0 mol % as measured according to JIS K6726 and meets requirement (A): a fluid prepared by adding 130.0 mL of 1-propanol to 100.0 g of a 5.0% by mass aqueous solution of the polyvinyl alcohol-based polymer has a transparency of 80.0% or less at 20° C.; and/or requirement (B): a supernatant from a fluid prepared by adding 230.0 mL of 1-propanol to 100.0 g of a 5.0% by mass aqueous solution of the polyvinyl alcohol-based polymer has a concentration of 0.65% by mass or more at 20° C.

A tamper resistant drug dosage is described. The drug dosage form includes a matrix polymer, a scaffold polymer, and a therapeutic agent, and the porosity of the drug dosage form is less than 10%. Methods for making and using the tamper resistant drug dosage forms are described.

The present invention relates to a solid pharmaceutical formulation comprising misoprostol or a pharmaceutically acceptable salt thereof. In particular, the invention relates to a dispersible tablet comprising misoprostol or a pharmaceutically acceptable salt thereof.

A method for managing or decreasing a risk of adverse effects in a patient undergoing treatment of bipolar I disorder is provided. The said method includes maintaining the therapeutically effective concentration of endoxifen by administrating a dose of 2 mg to 16 mg of endoxifen citrate in an enteric coated tablet once per day for at least 21 days. Further, adverse effects of alteration in thyroid functions, and thrombocytopenia can be avoided.

The invention provides an orodispersible solid pharmaceutical dosage unit having a weight between 30 and 1,000 mg, said dosage unit consisting of: 0.1-25 wt. % of estetrol particles containing at least 80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; and 75-99.9 wt. % of one or more pharmaceutically acceptable ingredients; the solid dosage unit comprising at least 100 μg of the estetrol component; and wherein the solid dosage unit can be obtained by a process comprising wet granulation of estetrol particles having a volume weighted average particle size of 2 μm to 50 μm. The solid dosage unit is easy to manufacture and perfectly suited for sublingual, buccal or sublabial administration.

The present invention relates to solid dosage forms of palbociclib comprising a water-soluble acid. The dosage forms described herein have desirable pharmacokinetic characteristics.

New synthetic methods to provide access to previously unexplored functionality at the C8 position of imidazotetrazines. Through synthesis and evaluation of a suite of compounds with a range of aqueous stabilities (from 0.5 to 40 hours), a predictive model for imidazotetrazine hydrolytic stability based on the Hammett constant of the C8 substituent was derived. Promising compounds were identified that possess activity against a panel of GBM cell lines, appropriate hydrolytic and metabolic stability, and brain-to-serum ratios dramatically elevated relative to TMZ, leading to lower hematological toxicity profiles and superior activity to TMZ in a mouse model of GBM.