Abstract

A gel is presented which represents a new category of pharmaceutical active ingredient in addition to the conventional crystalline and amorphous forms. The crystal structure of atorvastatin calcium ethylene glycol solvate suggests atorvastatin calcium to be a low-molecular weight organogelator that forms organogels with a wide variety of alkyl alcohols. Metal ion driven ionic interactions based on the amphiphilic nature of atorvastatin calcium leads to a lamellar type packing structure. Like ethylene glycol in its solvated form, alkyl alcohols, ranging from ethanol to octanol, can interact with the metal ions, and/or occupy the void spaces within that lamellar structure, thereby forming organogels featuring highly varying solubilities and unusual phase transition behaviors. An in situ dissolution study identified changes in the amounts/ratios of solvents in the atorvastatin calcium organogels without any significant structural changes, indicating that simultaneous solvent exchange is the mechanism of phas...

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