Perpustakaan Digital ITB

Background and objectives: Theophylline anhydrate is a drug belongs to xanthines family which is effectively used as bronchodilators mainly in the treatment of asthma symptoms. It consists of several polymorphs, however, only polymorph I and II will be selected to be used in this research. The objective of this research is to determine the crystal habits, polymorphic transformation and water content determination after milling treatment followed by after storage in illuminated chamber and desiccator for theophylline anhydrate polymorph I and II. Method: Polyrnorphs I, II and the mixture I and ll were prepared through heating in various temperatures. Powder X-Ray Diffractometry (PXRD) is to determine the genuine polymorph as well as the polymorph changes after being milled. Differential Thermal Analysis (DTA) instrument is to determine melting point of the polymorphs and be supporting data for PXRD. Polarizing microscope and Scanning Electron Microscope (SEM), on the other hand, can be used to identify crystal habits. Milling was performing for 60 minutes throughout polymorphs II, mixture I and II, thereafter stored in both illuminated chamber (40°C, RH 75%) and desiccator (27°C, RH 75%) for four weeks and water content is then determined in the period of storage. Result: The shape resulting for polymorph II is broad rod shape, a mixture of thin rod and needle like shape belongs to polymorph 1 and for polymorph mixture I and II consist of rod fusion with needle like shape. The entire polymorphs exhibit partially amorphous form after milled. There are polymorphic transformation can be seen in PXRD diffractogram with supporting data from DTA for all genuine polymorph, end product of milling for 60 minutes and after stored in illuminated chamber and desiccator for after three days and fourth weeks of storage. Conclusion: Storage condition in illuminated chamber (40°C, RH 75%) is better compared to desiccator for all polymorphs. Theophylline anhydrate polymorph II thus, can be concluded as the most stable form among others even in the milled form.