The effect of spray-drying feed temperature and subsequent crystallization conditions on the physical form of lactose

Buckton, Graham; Chidavaenzi, Owen C.; Koosha, Fariba

doi:10.1208/pt0304

Cited by 24 publications

(4 citation statements)

References 5 publications

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“…All recrystallized lactose batches appear to contain ∼1 mol of water of crystallization per mol of anhydrous lactose (Table III) which was in accordance with the results of TGA and confirmed the presence of α-LM form. X-ray diffractogram of crystalline lactose has a distinct peak at 19-20°2θ as main signal, with minor peaks at different angles depending on the isomer, with α-lactose at 12.6°and β-lactose at 10.5° (37). The major peaks of all recrystallized lactose carriers were consistent with those of α-lactose and the presence of β-lactose was not detected (Fig.…”

Section: Characterization Of Polymorphic Formmentioning

confidence: 72%

Ultrasound Assisted Engineering of Lactose Crystals

et al. 2008

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Section: Characterization Of Polymorphic Formmentioning

confidence: 72%

Ultrasound Assisted Engineering of Lactose Crystals

et al. 2008

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“…Lactose, a disaccharide that consists of β- d -galactose and α/β- d -glucose fragments bonded through a β-1,4 glycosidic linkage, is isolated typically from aqueous emulsions (e.g., milk) . It is often used as a component with the active pharmaceutical ingredient in water-based pharmaceutical processing methods including, for example, wet granulation or spray-drying. ,− The two isomeric forms of lactose differ in the configuration of the hydroxyl group at the anomeric carbon C1 of the glucopyranose ring . The equilibrium between the α- and β-forms will influence the molecular species present when lactose is isolated from water (Figure and refs and).…”

Section: Introductionmentioning

confidence: 99%

Stability of Sugar Solutions: A Novel Study of the Epimerization Kinetics of Lactose in Water

et al. 2014

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This article reports on the stereochemical aspects of the chemical stability of lactose solutions stored between 25 and 60 °C. The lactose used for the preparation of the aqueous solutions was α-lactose monohydrate with an anomer purity of 96% α and 4% β based on the supplied certificate of analysis (using a GC analytical protocol), which was further confirmed here by nuclear magnetic resonance (NMR) analysis. Aliquots of lactose solutions were collected at different time points after the solutions were prepared and freeze-dried to remove water and halt epimerization for subsequent analysis by NMR. Epimerization was also monitored by polarimetry and infrared spectroscopy using a specially adapted Fourier transform infrared attenuated total reflectance (FTIR-ATR) method. Hydrolysis was analyzed by ion chromatography. The three different analytical approaches unambiguously showed that the epimerization of lactose in aqueous solution follows first order reversible kinetics between 25 to 60 °C. The overall rate constant was 4.4 × 10(-4) s(-1) ± 0.9 (± standard deviation (SD)) at 25 °C. The forward rate constant was 1.6 times greater than the reverse rate constant, leading to an equilibrium constant of 1.6 ± 0.1 (±SD) at 25 °C. The rate of epimerization for lactose increased with temperature and an Arrhenius plot yielded an activation energy of +52.3 kJ/mol supporting the hypothesis that the mechanism of lactose epimerization involves the formation of extremely short-lived intermediate structures. The main mechanism affecting lactose stability is epimerization, as no permanent hydrolysis or chemical degradation was observed. When preparing aqueous solutions of lactose, immediate storage in an ice bath at 0 °C will allow approximately 3 min (180 s) of analysis time before the anomeric ratio alters significantly (greater than 1%) from the solid state composition of the starting material. In contrast a controlled anomeric composition (~38% α and ~62% β) will be achieved if an aqueous solution is left to equilibrate for over 4 h at 25 °C, while increasing the temperature up to 60 °C rapidly reduces the required equilibration time.

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“…For fast to crystallize material (e.g., mannitol which forms well-defined crystals when spray dried), one strategy is to manipulate the drying rate of the droplets so that different degrees of supersaturation can be produced during the drying process, leading to different crystalline morphology. 4,5 There has been a mix of reports in the literature proposing the manipulation of this drying behavior by using different drying temperatures, controlled either by increasing or decreasing the inlet or outlet temperature of the spray dryer. 4−7 Some workers in this area also suggest precise manipulation of the drying history, specifically controlling specific durations of the drying process.…”

Section: Introductionmentioning

confidence: 99%

“…There are various strategies proposed in the literature for the control of in situ crystallization during the spray drying process. For fast to crystallize material (e.g., mannitol which forms well-defined crystals when spray dried), one strategy is to manipulate the drying rate of the droplets so that different degrees of supersaturation can be produced during the drying process, leading to different crystalline morphology. , There has been a mix of reports in the literature proposing the manipulation of this drying behavior by using different drying temperatures, controlled either by increasing or decreasing the inlet or outlet temperature of the spray dryer. − …”

Section: Introductionmentioning

confidence: 99%

Role of Steam as a Medium for Droplet Crystallization

Lum

Cardamone

Beliavski

et al. 2019

Ind. Eng. Chem. Res.

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Mannitol and sodium chloride (NaCl) were spray dried using a counter current superheated spray dryer. Superheated steam was found to induce relatively high nucleation during the solidification of the sprayed droplets when compared to hot air. This allowed the production of spherical mannitol particles with very fine crystals at a lower temperature. In addition, superheated steam led to the formation of unique salt microspheres consisting of hollow hopperlike sodium chloride crystals. These unique particle morphologies were not observed in hot air spray drying. Further analysis revealed that higher droplet temperature during the constant rate drying period, under superheated steam conditions, led to the high nucleation phenomenon. Results from this work illustrate the potential of superheated steam as a useful medium for in situ crystallization control in spray dryers.

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The effect of spray-drying feed temperature and subsequent crystallization conditions on the physical form of lactose

Cited by 24 publications

References 5 publications

Ultrasound Assisted Engineering of Lactose Crystals

Ultrasound Assisted Engineering of Lactose Crystals

Stability of Sugar Solutions: A Novel Study of the Epimerization Kinetics of Lactose in Water

Role of Steam as a Medium for Droplet Crystallization

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