2020
DOI: 10.1016/j.xphs.2019.11.016
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Absorptive Dissolution Testing: An Improved Approach to Study the Impact of Residual Crystallinity on the Performance of Amorphous Formulations

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Cited by 17 publications
(14 citation statements)
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“…Further, the low release indicates that the polymers are unable to substantially delay crystal growth in hydrated conditions, making residual crystallinity extremely detrimental to ASD performance. This is different from the case of indomethacin, where residual crystals were found to be effectively poisoned by the ASD polymer [39] , but similar to tacrolimus [38] , [57] , and bicalutamide [58] dispersions with residual crystallinity, where trace crystallinity substantially impacted release extent. Interestingly, HPMCAS ASDs appeared to contain a higher extent of residual crystallinity than the corresponding HPMCP ASDs at a comparable drug loading (20% DL, Fig.…”
Section: Discussioncontrasting
confidence: 70%
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“…Further, the low release indicates that the polymers are unable to substantially delay crystal growth in hydrated conditions, making residual crystallinity extremely detrimental to ASD performance. This is different from the case of indomethacin, where residual crystals were found to be effectively poisoned by the ASD polymer [39] , but similar to tacrolimus [38] , [57] , and bicalutamide [58] dispersions with residual crystallinity, where trace crystallinity substantially impacted release extent. Interestingly, HPMCAS ASDs appeared to contain a higher extent of residual crystallinity than the corresponding HPMCP ASDs at a comparable drug loading (20% DL, Fig.…”
Section: Discussioncontrasting
confidence: 70%
“…3 A ), performed poorly. Presumably, the DLM crystals present in the ASD were able to grow either in the hydrated matrix, or after release into solution, reducing the achievable supersaturation and leading to poor release, as observed in other systems [38] , [39] . For HPMCP, the drug release dropped to 50% for the 20% DL ASD, which further decreased to 20% for the 25% DL.…”
Section: Resultsmentioning
confidence: 92%
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“…5,6 Hence, there is interest in dissolution that incorporates an absorption component. [7][8][9][10][11][12][13] Caco-2 cell monolayers are a widely used model of human intestinal Papp. [14][15][16] We previously combined dissolution and a Caco-2 membrane to experimentally introduce an absorptive compartment into dissolution testing.…”
Section: Introductionmentioning
confidence: 99%
“…These experiments were carried out in combination with mass transport measurements using the recently developed absorptive dissolution testing apparatus . Absorptive dissolution testing has been observed to alter the kinetics of competing processes involving mass transfer, such as crystallization or adsorption to a surface, due to removal of the drug via membrane transport. , Herein, the impact of concurrent absorption across a membrane on drug release extent and kinetics was assessed.…”
Section: Introductionmentioning
confidence: 99%