Crystalline form I of ibrutinib

A process for the preparation of ibrutinib Form I, comprising:

• dissolving ibrutinib in a solvent system selected from the group consisting of alcohol having three or more carbon atoms, ether, ketone, a mixture of alcohol with alkane, a mixture of ether and alkane, and a mixture of ketone with alkane to form a solution;
• and crystallizing said Form I by cooling the solution under ambient conditions or in a controlled manner.

A pharmaceutical composition comprising crystalline Form I of ibrutinib and a pharmaceutically acceptable carrier, wherein said crystalline Form I has an X-ray powder diffraction pattern comprising the following 2θ values measured using CuKα radiation:

• 5.2°±0.2°, 17.6°±0.2°, and 22.1°±0.2°.

A method of treating or delaying the progression or onset of a disease or disorder in connection with activity of a Bruton's tyrosine kinase (BTK), comprising administering to a subject in need thereof a pharmaceutical composition comprising crystalline Form I of ibrutinib.