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US 11,529,351 B2Granted
Fast dissolving pharmaceutical compositions
AssigneeXspray Pharma AB
InventorsMagnus Brisander, Thomas Meijer, Victor Söderberg
Life of this patent
Estimating the term…
Abstract
The present disclosure relates to the field of pharmaceutical compositions. Furthermore, the present invention relates to an immediate release pharmaceutical composition in the form of a non-effervescent tablet composition comprising dasatinib and a gas generating agent.
Claims17
An immediate release pharmaceutical composition in the form of a non-effervescent tablet, comprising:
- (a) an amorphous solid dispersion comprising dasatinib in an amount of from about 17% w/w to about 21% w/w and copovidone in an amount of from about 38% w/w to about 42% w/w;
- (b) mannitol in an amount of from about 11% w/w to 15% w/w;
- (c) at least one gas generating agent comprising sodium bicarbonate in an amount of from about 10% w/w to about 14% w/w;
- (d) crospovidone in an amount of from about 6% w/w to about 10% w/w;
- (e) at least one acidic pH modifier comprising fumaric acid in an amount of from about 2% w/w to about 6% w/w;
- (f) sodium stearyl fumarate in an amount of from about 0.1% w/w to about 4% w/w;
- and
- (g) colloidal silicon dioxide in an amount of from about 0.1% w/w to about 1% w/w;
- wherein the stated amounts are based on the total weight of the composition;
- wherein the tablet optionally comprises a coating layer;
- wherein the mole ratio of the at least one gas generating agent to the at least one acidic pH-modifier ranges from about 4:1 to about 1:4;
- and
- wherein a dasatinib dose of 100 mg provides an AUC(0-24h)fed/AUC(0-24h)fasted ratio of from about 95% to about 100%, wherein AUC(0-24h)fed corresponds to the least-squares geometric mean of the AUC(0-24h) in fed patients and wherein AUC(0-24n)fasted corresponds to the least-squares geometric mean of the AUC(0-24h) in fasted patients.
10 more elements
Dependencies are inferred from the claim text.