2008
DOI: 10.1007/s11095-008-9775-0
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Subambient Behavior of Mannitol in Ethanol–Water Co-solvent System

Abstract: In the presence of ethanol, crystallization of mannitol was inhibited under subambient conditions. Annealing or slower cooling promoted the crystallization of mannitol during the freezing process.

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Cited by 8 publications
(3 citation statements)
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“…The shelf was cooled from ambient temperature to −50°C at a rate of 0.5°C/min and maintained at −50°C for 30 min. For cycles with an annealing step, 60 min of annealing was inserted into the freezing process at −20°C for aqueous solutions and at −30°C for ethanol-containing solutions, referring to our previous study (23). In addition, two methods of primary drying were carried out, one for the aqueous solutions and one for the ethanolcontaining solutions.…”
Section: Freeze-dryingmentioning
confidence: 99%
“…The shelf was cooled from ambient temperature to −50°C at a rate of 0.5°C/min and maintained at −50°C for 30 min. For cycles with an annealing step, 60 min of annealing was inserted into the freezing process at −20°C for aqueous solutions and at −30°C for ethanol-containing solutions, referring to our previous study (23). In addition, two methods of primary drying were carried out, one for the aqueous solutions and one for the ethanolcontaining solutions.…”
Section: Freeze-dryingmentioning
confidence: 99%
“…Ethanol is one of the typical organic solvents highly miscible with water, also it is classified in Class 3 of ICH guidelines and residual ethanol in finished product has a low safety risk [8]. The increased solubility with the addition of ethanol is most likely due to the formation of hydration shell around the MMC that acts as a compatible layer between the drug and ethanol [9].…”
Section: Introductionmentioning
confidence: 99%
“…The most commonly used methods for the dehydration of ethanol are distillation, extraction, molecular sieve adsorption, and pervaporation . In the pharmaceutical industry, ethanol–water mixtures, as cosolvent systems, have been evaluated in order to increase drug solubility, because the solubility of many drugs in pure water is very low and residual ethanol in the finished product imposes a low safety risk . Studies of the solubility of many pharmaceutical compounds such as mitomycin C , L‐glutamine , sulphapyridine , and so on, have been recently published.…”
Section: Introductionmentioning
confidence: 99%