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Determination of the Solubility of Crystalline Low Molar Mass Compounds in Polymers by Differential Scanning Calorimetry
Institution:1. Collegeof Pharmacy, University of Kentucky, Lexington, Kentucky;2. South College School of Pharmacy, Knoxville, Tennessee;3. Department of Chemical and Materials Engineering, University of Kentucky, Lexington, Kentucky;4. AllTranz Inc., Lexington, Kentucky;5. School of Pharmacy, University of Maryland, Baltimore, Maryland;6. Department of Chemistry, Georgia Southern University;1. Division of Pharmaceutical Sciences James L. Winkle College of PharmacyUniversity of Cincinnati, Cincinnati, Ohio 45267;2. Procter & Gamble CompanyMasonOhio45040
Abstract:A mathematical equation has been derived to calculate the liquidus for a binary system consisting of an amorphous polymer and a crystalline low molar mass compound. The experimental input to this equation is an interaction enthalpy, which is derived from the variation of the melting enthalpy with composition in differential scanning calorimetry (DSC) experiments. The predictive power of the equation has been tested with mixtures of acetylsalicylic acid, carbamazepine, or intraconazole with poly(ethylene glycol) as well as mixtures of carbamazepine with poly(acrylic acid), poly(hydroxystyrene), or poly(vinylpyrrolidone). It has been confirmed that the evaluation of the melting enthalpy in DSC is a suitable method to identify the preferred solute-polymer combinations for thermodynamically stable molecular dispersions. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 103:1673-1679, 2014
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