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Amorphous Lactose (amorphous + lactose)
Selected AbstractsCrystallization Kinetics and X-ray Diffraction of Crystals Formed in Amorphous Lactose, Trehalose, and Lactose/Trehalose MixturesJOURNAL OF FOOD SCIENCE, Issue 5 2005Song Miao ABSTRACT: Effects of storage time and relative humidity on crystallization kinetics and crystal forms produced from freeze-dried amorphous lactose, trehalose, and a lactose/trehalose mixture were compared. Samples were exposed to 4 different relative water vapor pressure (RVP) (44.1%, 54.5%, 65.6%, 76.1%) environments at room temperature. Crystallization was observed from time-dependent loss of sorbed water and increasing intensities of peaks in X-ray diffraction patterns. The rate of crystallization increased with increasing storage humidity. Lactose crystallized as ,-lactose monohydrate, ,-anhydrous, and anhydrous forms of ,- and ,-lactose in molar ratios of 5:3 and 4:1 in lactose and lactose/trehalose systems. Trehalose seemed to crystallize as a mixture of trehalose dihydrate and anhydrate in trehalose and lactose/trehalose systems. The crystal forms in a mixture of lactose and trehalose did not seem to be affected by the component sugars, but crystallization of the component sugars was delayed. Time-dependent crystallization of lactose and trehalose in the lactose-trehalose mixture could be modeled using the Avrami equation. The results indicated that crystallization data are important in modeling of crystallization phenomena and predicting stability of lactose and trehalose-containing food and pharmaceutical materials. Keywords: crystallization, lactose, trehalose, crystal form, X-ray diffraction [source] Crystallization Kinetics of Amorphous Lactose as a Function of Moisture Content Using Isothermal Differential Scanning CalorimetryJOURNAL OF FOOD SCIENCE, Issue 2 2000C. J. Kedward ABSTRACT: Isothermal differential scanning calorimetry (DSC) was used to study the crystallization kinetics of amorphous lactose at 3 moisture contents. Each sample was heated to several temperatures between Tg and Tm. After subtraction of an induction time, the Avrami equation was used to model the data and a Lauritzen-Hoffman like expression used to fit the crystallization rates between Tg and Tm. The highest Tm/Tg ratio and crystallization rate were observed for the sample containing the most moisture. Conversely the lowest Tm/Tg ratio and crystallization rate were observed for the sample containing the least moisture. Evidence for multiple transitions was seen. The Avrami equation may not be the best way to model such data. [source] Crystallization Kinetics and X-ray Diffraction of Crystals Formed in Amorphous Lactose, Trehalose, and Lactose/Trehalose MixturesJOURNAL OF FOOD SCIENCE, Issue 5 2005Song Miao ABSTRACT: Effects of storage time and relative humidity on crystallization kinetics and crystal forms produced from freeze-dried amorphous lactose, trehalose, and a lactose/trehalose mixture were compared. Samples were exposed to 4 different relative water vapor pressure (RVP) (44.1%, 54.5%, 65.6%, 76.1%) environments at room temperature. Crystallization was observed from time-dependent loss of sorbed water and increasing intensities of peaks in X-ray diffraction patterns. The rate of crystallization increased with increasing storage humidity. Lactose crystallized as ,-lactose monohydrate, ,-anhydrous, and anhydrous forms of ,- and ,-lactose in molar ratios of 5:3 and 4:1 in lactose and lactose/trehalose systems. Trehalose seemed to crystallize as a mixture of trehalose dihydrate and anhydrate in trehalose and lactose/trehalose systems. The crystal forms in a mixture of lactose and trehalose did not seem to be affected by the component sugars, but crystallization of the component sugars was delayed. Time-dependent crystallization of lactose and trehalose in the lactose-trehalose mixture could be modeled using the Avrami equation. The results indicated that crystallization data are important in modeling of crystallization phenomena and predicting stability of lactose and trehalose-containing food and pharmaceutical materials. Keywords: crystallization, lactose, trehalose, crystal form, X-ray diffraction [source] Crystallization Kinetics of Amorphous Lactose as a Function of Moisture Content Using Isothermal Differential Scanning CalorimetryJOURNAL OF FOOD SCIENCE, Issue 2 2000C. J. Kedward ABSTRACT: Isothermal differential scanning calorimetry (DSC) was used to study the crystallization kinetics of amorphous lactose at 3 moisture contents. Each sample was heated to several temperatures between Tg and Tm. After subtraction of an induction time, the Avrami equation was used to model the data and a Lauritzen-Hoffman like expression used to fit the crystallization rates between Tg and Tm. The highest Tm/Tg ratio and crystallization rate were observed for the sample containing the most moisture. Conversely the lowest Tm/Tg ratio and crystallization rate were observed for the sample containing the least moisture. Evidence for multiple transitions was seen. The Avrami equation may not be the best way to model such data. [source] Limitations of amorphous content quantification by isothermal calorimetry using saturated salt solutions to control relative humidity: Alternative methodsJOURNAL OF PHARMACEUTICAL SCIENCES, Issue 4 2010Nawel Khalef Abstract Despite the high sensitivity of isothermal calorimetry (IC), reported measurements of amorphous content by this technique show significant variability even for the same compound. An investigation into the reasons behind such variability is presented using amorphous lactose and salbutamol sulfate as model compounds. An analysis was carried out on the heat evolved as a result of the exchange of water vapor between the solid sample during crystallization and the saline solution reservoir. The use of saturated salt solutions as means of control of the vapor pressure of water within sealed ampoules bears inherent limitations that lead in turn to the variability associated with the IC technique. We present an alternative IC method, based on an open cell configuration that effectively addresses the limitations encountered with the sealed ampoule system. The proposed approach yields an integral whose value is proportional to the amorphous content in the sample, thus enabling reliable and consistent quantifications. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99: 2080,2089, 2010 [source] Determination of amorphous content in the pharmaceutical process environmentJOURNAL OF PHARMACY AND PHARMACOLOGY: AN INTERNATI ONAL JOURNAL OF PHARMACEUTICAL SCIENCE, Issue 2 2007Marja Savolainen The amorphous state has different chemical and physical properties compared with a crystalline one. Amorphous regions in an otherwise crystalline material can affect the bioavailability and the processability. On the other hand, crystalline material can function as nuclei and decrease the stability of an amorphous system. The aim of this study was to determine amorphous content in a pharmaceutical process environment using near infrared (NIR) and Raman spectroscopic techniques together with multivariate modelling tools. Milling was used as a model system for process-induced amorphization of a crystalline starting material, ,-lactose monohydrate. In addition, the crystallization of amorphous material was studied by storing amorphous material, either amorphous lactose or trehalose, at high relative humidity conditions. The results show that both of the spectroscopic techniques combined with multivariate methods could be applied for quantitation. Preprocessing, as well as the sampling area, was found to affect the performance of the models. Standard normal variate (SNV) transformation was the best preprocessing approach and increasing the sampling area was found to improve the models. The root mean square error of prediction (RMSEP) for quantitation of amorphous lactose using NIR spectroscopy was 2.7%, when a measuring setup with a larger sampling area was used. When the sampling area was smaller, the RMSEPs for lactose and trehalose were 4.3% and 4.2%, respectively. For Raman spectroscopy, the RMSEPs were 2.3% and 2.5% for lactose and trehalose, respectively. However, for the optimal performance of a multivariate model, all the physical forms present, as well as the process environment itself, have to be taken into consideration. [source] | ||||||||||