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Phase separation kinetics in amorphous solid dispersions upon exposure to water.
Mol Pharm. 2015 May 04; 12(5):1623-35.MP

Abstract

The purpose of this study was to develop a novel fluorescence technique employing environment-sensitive fluorescent probes to study phase separation kinetics in hydrated matrices of amorphous solid dispersions (ASDs) following storage at high humidity and during dissolution. The initial miscibility of the ASDs was confirmed using infrared (IR) spectroscopy and differential scanning calorimetry (DSC). Fluorescence spectroscopy, as an independent primary technique, was used together with conventional confirmatory techniques including DSC, X-ray diffraction (XRD), fluorescence microscopy, and IR spectroscopy to study phase separation phenomena. By monitoring the emission characteristics of the environment-sensitive fluorescent probes, it was possible to successfully monitor amorphous-amorphous phase separation (AAPS) as a function of time in probucol-poly(vinylpyrrolidone) (PVP) and ritonavir-PVP ASDs after exposure to water. In contrast, a ritonavir-hydroxypropylmethylcellulose acetate succinate (HPMCAS) ASD, did not show AAPS and was used as a control to demonstrate the capability of the newly developed fluorescence method to differentiate systems that showed no phase separation following exposure to water versus those that did. The results from the fluorescence studies were in good agreement with results obtained using various other complementary techniques. Thus, fluorescence spectroscopy can be utilized as a fast and efficient tool to detect and monitor the kinetics of phase transformations in amorphous solid dispersions during hydration and will help provide mechanistic insight into the stability and dissolution behavior of amorphous solid dispersions.

Authors+Show Affiliations

Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, Indiana 47907, United States.Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, West Lafayette, Indiana 47907, United States.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25853391

Citation

Purohit, Hitesh S., and Lynne S. Taylor. "Phase Separation Kinetics in Amorphous Solid Dispersions Upon Exposure to Water." Molecular Pharmaceutics, vol. 12, no. 5, 2015, pp. 1623-35.
Purohit HS, Taylor LS. Phase separation kinetics in amorphous solid dispersions upon exposure to water. Mol Pharm. 2015;12(5):1623-35.
Purohit, H. S., & Taylor, L. S. (2015). Phase separation kinetics in amorphous solid dispersions upon exposure to water. Molecular Pharmaceutics, 12(5), 1623-35. https://doi.org/10.1021/acs.molpharmaceut.5b00041
Purohit HS, Taylor LS. Phase Separation Kinetics in Amorphous Solid Dispersions Upon Exposure to Water. Mol Pharm. 2015 May 4;12(5):1623-35. PubMed PMID: 25853391.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase separation kinetics in amorphous solid dispersions upon exposure to water. AU - Purohit,Hitesh S, AU - Taylor,Lynne S, Y1 - 2015/04/23/ PY - 2015/4/9/entrez PY - 2015/4/9/pubmed PY - 2016/2/5/medline KW - amorphous solid dispersions KW - fluorescence KW - phase separation KW - water SP - 1623 EP - 35 JF - Molecular pharmaceutics JO - Mol Pharm VL - 12 IS - 5 N2 - The purpose of this study was to develop a novel fluorescence technique employing environment-sensitive fluorescent probes to study phase separation kinetics in hydrated matrices of amorphous solid dispersions (ASDs) following storage at high humidity and during dissolution. The initial miscibility of the ASDs was confirmed using infrared (IR) spectroscopy and differential scanning calorimetry (DSC). Fluorescence spectroscopy, as an independent primary technique, was used together with conventional confirmatory techniques including DSC, X-ray diffraction (XRD), fluorescence microscopy, and IR spectroscopy to study phase separation phenomena. By monitoring the emission characteristics of the environment-sensitive fluorescent probes, it was possible to successfully monitor amorphous-amorphous phase separation (AAPS) as a function of time in probucol-poly(vinylpyrrolidone) (PVP) and ritonavir-PVP ASDs after exposure to water. In contrast, a ritonavir-hydroxypropylmethylcellulose acetate succinate (HPMCAS) ASD, did not show AAPS and was used as a control to demonstrate the capability of the newly developed fluorescence method to differentiate systems that showed no phase separation following exposure to water versus those that did. The results from the fluorescence studies were in good agreement with results obtained using various other complementary techniques. Thus, fluorescence spectroscopy can be utilized as a fast and efficient tool to detect and monitor the kinetics of phase transformations in amorphous solid dispersions during hydration and will help provide mechanistic insight into the stability and dissolution behavior of amorphous solid dispersions. SN - 1543-8392 UR - https://www.unboundmedicine.com/medline/citation/25853391/Phase_separation_kinetics_in_amorphous_solid_dispersions_upon_exposure_to_water_ L2 - https://doi.org/10.1021/acs.molpharmaceut.5b00041 DB - PRIME DP - Unbound Medicine ER -