Adaptation of USP types II and IV controlled release assays for sparingly soluble compounds by direct eluent HPLC analysis.
Measurement of drug release of a sparingly soluble drug by conventional methods proceeds very slowly without the aid of surfactants. Two preliminary automated methods were developed that increase sensitivity and accelerate such studies by working at very small reservoir volumes. All high pressure liquid chromatography (HPLC) equipment components were commercially available. Results are presented for the drug release of a single pellet of the sparingly soluble drug Eliprodil in two types of drug release experiments using (1) a stirred cell and (2) a flow-through method. Release rates measured from each method were comparable.
Drug Delivery, Alcon Research Ltd., Fort Worth, Texas, USA. paul.missel@alconlabs.com
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Missel
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Stevens
D000465:Algorithms; D002021:Buffers; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003692:Delayed-Action Preparations / Q000737:chemistry*; D018691:Excitatory Amino Acid Antagonists / Q000008:administration & dosage / Q000737:chemistry; D010880:Piperidines / Q000008:administration & dosage / Q000737:chemistry; D011138:Polytetrafluoroethylene; D012995:Solubility
D002021:Buffers; D003692:Delayed-Action Preparations; D018691:Excitatory Amino Acid Antagonists; D010880:Piperidines; D011138:Polytetrafluoroethylene; C058083:eliprodil