Crystalline Form of y-Aminobutyric Acid Analog

Abstract

A crystalline form of a γ-aminobutyric acid analog, and methods of preparing same, are provided.

1 .- 8 . (canceled) 
     
     
         9 . A pharmaceutical composition comprising crystalline 1-{[(α-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexane acetic acid having a melting point range of between about 63° C. and about 64° C. as determined by differential scanning calorimetry at a scan rate of 5° C./minute and a pharmaceutically acceptable vehicle. 
     
     
         10 . The pharmaceutical composition of  claim 9 , wherein the pharmaceutically acceptable vehicle is selected from the group consisting of water, glucose, lactose, sucrose, gelatin, malt, rice, flour, chalk, silica gel, sodium stearate, glycerol monostearate, talc, sodium chloride, dried skim milk, glycerol, propylene, glycol, water, ethanol, and combinations thereof. 
     
     
         11 . The pharmaceutical composition of  claim 9 , further comprising wetting/emulsifying agents, pH buffering agents, auxiliary agents, stabilizing agents, lubricating agents, coloring agents, and combinations thereof. 
     
     
         12 . The pharmaceutical composition of  claim 9 , wherein the composition is free of lactam side products formed by intramolecular cyclization. 
     
     
         13 . The pharmaceutical composition of  claim 12 , wherein less than 0.5% lactam by weight is formed within one year of storage. 
     
     
         14 . The pharmaceutical composition of  claim 9 , wherein the composition is in the form of a solution, suspension, emulsion, tablet, pill, pellet, capsule, powder, sustained-release formulation, suppository, aerosol, spray, lozenge, granule, syrup. 
     
     
         15 . The pharmaceutical composition of  claim 9 , wherein the composition is an oral composition in the form of a tablet, lozenge, aqueous or oily suspension, granule, powder, emulsion, capsule, syrup or elixir. 
     
     
         16 . The pharmaceutical composition of  claim 15 , further comprising one or more sweetening agent, flavoring agent, or preserving agent. 
     
     
         17 . The pharmaceutical composition of  claim 15 , wherein the tablet or pill is coated to delay disintegration and absorption in the gastrointestinal tract. 
     
     
         18 . The pharmaceutical composition of  claim 15 , wherein the suspension, elixir, or syrup comprises a diluent selected from the group consisting of water, saline, alkyelene glycol, polyalkylene glycol, oil, alcohol, buffers with a pH between 4 and 6, and combinations thereof.