2002
DOI: 10.1023/a:1016031517430
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Cited by 112 publications
(32 citation statements)
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“…Furthermore, drug substances and drug products are submitted to different temperatures and relative humidities during storage (namely, due to climatic conditions), giving rise to unexpected hydration or dehydration aging phenomena that are known to affect several drug properties, such as solubility, dissolution rate, stability, and bioavailability. 12,44 As described above, the exposure to extreme RH values (0 and 100%) results in total NCa $ NCh interconversion in substantially less than 2 weeks. However, at intermediate RH values, the same processes were found to occur in a much larger time scale.…”
Section: Critical Rh For Hydration/dehydration Processmentioning
confidence: 88%
“…Furthermore, drug substances and drug products are submitted to different temperatures and relative humidities during storage (namely, due to climatic conditions), giving rise to unexpected hydration or dehydration aging phenomena that are known to affect several drug properties, such as solubility, dissolution rate, stability, and bioavailability. 12,44 As described above, the exposure to extreme RH values (0 and 100%) results in total NCa $ NCh interconversion in substantially less than 2 weeks. However, at intermediate RH values, the same processes were found to occur in a much larger time scale.…”
Section: Critical Rh For Hydration/dehydration Processmentioning
confidence: 88%
“…It was observed that for the TG performed at 1 • C min −1 the water content was released at a lower temperature (90-125 • C; DTG peak 117.49 • C). Since the intermolecular force (hydrogen bonding) can lead to very strong water-solid interactions, a slower heating rate facilitates the dehydration process [29].…”
Section: Thermal Analysismentioning
confidence: 99%
“…During processing into tablets or capsules, APIs are subjected to different humidities, pressures, and temperatures that may alter their solid form. 1, 8 Choosing the most soluble form of a drug may allow it to change forms once processed and could lead to non-uniformity of dosage. For example, the use of moxifloxacin hydrochloride led to inconsistent active content during administration, a problem that was overcome with use of a novel hydrate.…”
mentioning
confidence: 99%