NOVEL POLYMORPHS OF DOXOFYLLINE WITH NEW MORPHOLOGYAbstract
Doxofylline [7-(1,3-Dioxolan-2-ylmethyl) – 1,3-dimethyl purine-2,6-dione] is a Xanthine derivative drug used in the treatment of Asthma. The molecular formula is C11H14N4O4. Doxofylline is presently available in tablet form with high oral dosages of 400 mg, 800 mg and 1200 mg, Syrup with oral dosage of 100 mg/5mL and Suspension with oral dosage of 100 mg/5mL. It is also marketed as a combination drug with Terbutaline and Montelukast. Extensive literature survey revealed crystals with needle shape morphology. Novel crystal form (Form P) of Doxofylline with new rod shape morphology has been identified and fully characterized by a variety of analytical techniques such as Powder X-Ray Diffraction (PXRD), Differential Scanning Calorimeter (DSC), Thermo Gravimetric Analysis (TGA) and Polarized Microscopy (PM). Since, rod shape crystals are preferable than needle shape crystals for filtrations in pharma manufacturing. The newly prepared novel crystal form (Form P) of Doxofylline with rod shape morphology is more suitable in Doxofylline manufacturing.
S. R. C. M. Patnala, M. Khagga and R. Bhavani*
Green Evolution Laboratories, Wangapally Village, Nalgonda, Telangana State, India.
21 April, 2017
07 July, 2017
17 September, 2017
01 January, 2018