2010
DOI: 10.1002/jps.21809
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Effect of temperature and moisture on the miscibility of amorphous dispersions of felodipine and poly(vinyl pyrrolidone)

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Cited by 179 publications
(201 citation statements)
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“…9). However, similar to other model APIs with NH-type hydrogen-bond donors (5,7), this system exhibits moisture-induced amorphous-amorphous phase separation with PVP at all drug-polymer ratios investigated. These observations highlight the complexity of this phenomenon and the need to consider not only drug and polymer properties, but also the relative proportions of each component.…”
Section: Discussionsupporting
confidence: 66%
See 1 more Smart Citation
“…9). However, similar to other model APIs with NH-type hydrogen-bond donors (5,7), this system exhibits moisture-induced amorphous-amorphous phase separation with PVP at all drug-polymer ratios investigated. These observations highlight the complexity of this phenomenon and the need to consider not only drug and polymer properties, but also the relative proportions of each component.…”
Section: Discussionsupporting
confidence: 66%
“…One factor in particular, the absorption of moisture, has been shown to accelerate crystallization of amorphous APIs in pure form as well as when mixed with other ingredients (2)(3)(4). For binary systems, it has been demonstrated that the absorption of moisture can lead to the formation of regions with different API-polymer concentrations from the corresponding one-phase amorphous system (where the API and the polymer were originally mixed at the molecular level) (5). Here, the absorption of moisture induces amorphous-amorphous phase separation.…”
Section: Introductionmentioning
confidence: 99%
“…The crystallization process appeared to occur during vapor absorption in the RH range of 55-60% RH, as evident by the sharp decrease in water vapor uptake over a narrow RH range followed by the plateau in vapor uptake. It is generally recognized that temperature and RH are two important factors on the phase transition behavior and stability on amorphous phases (39,40). As expected for crystalline hydrate powders, raw trehalose dihydrate did not absorb any significant amounts of water vapor over the entire range of RH, as it is in its thermodynamically stable state.…”
Section: Discussionmentioning
confidence: 63%
“…(7) What is the effect of moisture on the stability of amorphous drugs and formulations? (15) We will focus this review on crystal growth in organic glasses. We do so because of recent progress in this area and because crystal growth in organic glasses has properties unknown for (and thus unpredictable from the behaviors of) other materials.…”
Section: Introductionmentioning
confidence: 99%