Characterization of zopiclone crystal forms found among generic raw materials.
This paper deals with the occurrence of polymorphs and pseudopolymorphs and their effect on the solid-state properties of zopiclone, a poorly water soluble nondiazepine sedative and hypnotic drug. X-ray powder diffraction (XRPD), infrared spectroscopy (IR), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), particle size analysis, dissolution studies, and solubility determinations were used to characterize the zopiclone raw materials. An anhydrated form, a dihydrated form, and a mixture of these two crystal forms were found and characterized among the zopiclone powders.
Terblanche
R J
RJ
Research Institute for Industrial Pharmacy, Potchefstroom University for CHE, South Africa.
Liebenberg
W
W
de Villiers
M M
MM
Lötter
A P
AP
D053961:Azabicyclo Compounds; D003460:Crystallization; D004345:Drug Industry; D016568:Drugs, Generic / Q000737:chemistry; D006993:Hypnotics and Sedatives / Q000737:chemistry*; D010316:Particle Size; D010879:Piperazines / Q000737:chemistry*; D011208:Powders; D012995:Solubility; D014961:X-Ray Diffraction
D053961:Azabicyclo Compounds; D016568:Drugs, Generic; D006993:Hypnotics and Sedatives; D010879:Piperazines; D011208:Powders; C515050:zopiclone