in Vivo-in Vitro Evaluation of the Impact of Accelerated Stability Conditions on a Hydrophilic Matrix Tablet
Changes occur in the tensile strength of compacts produced from powdered Hydroxypropyl methylcellulose (HPMC) after storage at different relative humidities (S.Malamataris et al., Int. J. Pharm., 1994). Studies in this laboratory have noted that subjecting a hydrophilic matrix formulation of a Class I drug (Amidon et al., 1995) to accelerated stability conditions resulted in a reduction in tablet crushing strength. An in vitro dissolution method developed in this laboratory indicated that such physical changes in this hydrophilic matrix formulation could potentially result in an altered in vivo profile.
KeywordsHigh Density Polyethylene Dissolution Profile Stressed Product Hydrophilic Matrix Hydrophilic Matrix Tablet
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