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US 2019/0290650 A1Published application
Formulations/compositions comprising a btk inhibitor
AssigneeJanssen Pharmaceutic N.V.
InventorsManish Kumar Gupta, Parikshit Rameshrao Kulkami, Binuraj Krishnan Nair
Life of this patent
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Abstract
Disclosed are formulations/compositions comprising a BTK inhibitor, particularly ibrutinib: as well as processes for preparing such formulations/compositions and methods of treatment of a disease or condition that comprises the use of such formulations/compositions.
Claims65
A pharmaceutical composition comprising ibrutinib, wherein ibrutinib is a compound with the structure of Compound 1,
- and wherein the pharmaceutical composition comprises i) at least 60% w/w of ibrutinib, and ii) excipients comprising about 4-7% w/w of mannitol, and about 13-16% w/w of crospovidone of the total weight of the pharmaceutical composition.
A high-load solid tablet formulation comprising at least 60% w/w of ibrutinib, and intragranular and extragranular excipients;
- wherein the intragranular excipients comprise mannitol, sodium lauryl sulfate, and crospovidone;
- and
- the extragranular excipients comprise polyvinylpyrrolidone, sodium lauryl sulfate, crospovidone, colloidal silicon dioxide, and magnesium stearate.
A high-load solid tablet formulation comprising:
- a) about 60% w/w to about 80% w/w of ibrutinib,
- b) about 4% w/w to about 7% w/w of mannitol,
- c) about 13% w/w to about 16% w/w of crospovidone,
- d) about 1% w/w to about 3% w/w of polyvinylpyrrolidone,
- e) about 5% w/w to about 10% w/w of sodium lauryl sulfate,
- f) about 0.1% w/w to about 1.0% w/w of colloidal silicon dioxide, and
- g) about 0.1% w/w to about 1.0% w/w of magnesium stearate.
4 more elements
Dependencies are inferred from the claim text.