Process for the preparation of substantially alcohol free pharmaceutical compositions
AssigneeWarner-Lambert Company
InventorsPankaj B. Gala, Gary D'Alonzo, Jatin J. Shah, Jay Weiss
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Abstract
A novel process for the preparation of pharmaceutical compositions involving the stabilization of the active drug(s) through the reduction of residual alcohol present in a drug/carrier blend. The presence of residual alcohol in dried pharmaceutical compositions adversely affects many drugs which must be initially dissolved therein in order to achieve uniform distributions throughout the excipient carrier materials. Wherein not previously possible, its removal is achieved utilizing precise processing parameters in which water lost during the drying process is replenished during blending in a conventional solids processor.
Claims15
A method for the preparation of a solid pharmaceutical composition that is substantially free of any residual organic solvent comprising:
- a) solubilizing an active drug in an organic solvent;
- b) mixing the drug solution with at least one inert carrier material;
- c) removing said solvent from said drug carrier blend and adding water in the range from about 0.1% to approximately 5.0% based on the total weight of the composition to said blend when said solvent is reduced to less then half of its original amount, and;
- d) removing the remaining residual solvent to yield a dry powdered active which can be then tabletted or encapsulated.
A novel method for the preparation of a solid pharmaceutical composition comprising a water-insoluble drug in an inert carrier matrix comprising solubilizing the drug in alcohol, dispersing the solution throughout the inert carrier ingredients, evaporating the alcohol with heat and reduced pressure until it is substantially removed and adding water in the range from about 0.1% to approximately 5.0% based on the total weight of the composition when the alcohol is reduced to approximately 80% of its original amount followed by further heating until dry.
Dependencies are inferred from the claim text.