Solid forms of bendamustine hydrochloride
Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.
1. A pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and
a crystalline form of bendamustine hydrochloride that is Form 2 that produces an X-ray powder diffraction pattern comprising the following reflections: 18.8, 20.1, 20.4, and 20.9±0.2 degrees 2θ; and
a crystalline form of bendamustine hydrochloride that is Form 3 that produces an X-ray powder diffraction pattern comprising the following reflections: 7.9, 15.5, and 26.1±0.2 degrees 2θ.
2. The pharmaceutical composition of claim 1 , wherein the crystalline form of bendamustine hydrochloride that is Form 3 produces an X-ray powder diffraction pattern further comprising one or more of the following reflections: 21.3 and/or 23.3±0.2 degrees 2□.
3. The pharmaceutical composition of claim 1 , wherein the excipient is sodium phosphate, potassium phosphate, citric acid, tartaric acid, gelatin, glycine, mannitol, lactose, sucrose, maltose, glycerin, dextrose, dextran, trehalose, hetastarch, or a mixture thereof.
4. The pharmaceutical composition of claim 3 , wherein the excipient is mannitol.
5. The pharmaceutical composition of claim 1 , further comprising amorphous bendamustine hydrochloride.
6. A method of treating chronic lymphocytic leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or breast cancer in a patient in need thereof comprising administering to the patient a pharmaceutical composition according to claim 1 .
7. The method according to claim 6 , wherein the non-Hodgkin's lymphoma is indolent B-cell non-Hodgkin's lymphoma.
8. The method according to claim 6 , comprising administering the composition as a reconstituted injectable preparation.