title: Investigating the effect of dehydration conditions on the compactability of glucose.
abstract: Hydrates are commonly found in pharmaceutical ingredients either in excipients or in the active pharmaceutical ingredient form. There is always the possibility that the processing involved in manufacturing can result in the dehydration of the hydrate components. It has been seen that different dehydration conditions can have an effect on the behavior of the final product; however this area has not been fully investigated. In this work, glucose monohydrate powder was dehydrated at four different conditions and then compressed to see the effect on the hardness of the compacts. Various analytical tools such as inverse gas chromatography, differential scanning calorimetry, X-ray powder diffractometry and scanning electron microscopy were used to determine any differences in the properties of the dehydrates and correlated with the obtained compact hardness. Annealing studies were performed to determine the effect of storage on the dehydrated materials both before and after compression. It was observed that while annealing of the powders did have an impact, annealing of the compacts did not influence the hardness. The results of the characterization and annealing studies showed that the difference in the behavior of glucose dehydrates were due to the presence of amorphous regions within the particulates.
authors.affiliation: Department of Industrial and Physical Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, IN 47907, USA. ntrasi@gmail.com
authors.forename: Niraj S
authors.initials: NS
authors.lastname: Trasi
authors.forename: Stephan X M
authors.initials: SX
authors.lastname: Boerrigter
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Byrn
authors.forename: Teresa M
authors.initials: TM
authors.lastname: Carvajal
mesh_terms: D000327:Adsorption; D002152:Calorimetry, Differential Scanning; D003460:Crystallization; D003890:Desiccation; D005947:Glucose / Q000737:chemistry*; D006244:Hardness; D008855:Microscopy, Electron, Scanning; D011208:Powders; D013499:Surface Properties; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*; D014867:Water / Q000737:chemistry; D014961:X-Ray Diffraction
chemical_list: D011208:Powders; D013607:Tablets; D014867:Water; D005947:Glucose