Process for preparing non-hygroscopic sodium valproate composition
AssigneeTaro Pharmaceuticals U.S.A., Inc.
InventorsMohammed S. Safadi, Maya Barder, Yechiel Golander, Avraham Yacobi, Daniel A. Moros, Barrie Levitt, Michael Friedman
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Abstract
The invention is directed to non-hygroscopic oral pharmaceutical compositions of a salt of valproic acid, and processes for preparing the compositions. The non-hygroscopic pharmaceutical compositions are prepared by blending a hygroscopic salt of valproic acid, carbomer, and a non-hygroscopic additive.
Claims55
A process for preparing a pharmaceutical composition comprising as an active ingredient a hygroscopic salt of valproic acid, comprising the step of intimately mixing (i) said hygroscopic salt;
- (ii) a carbomer and (iii) a non-hygroscopic additive to form a homogeneous mixture;
- wherein the amount of said carbomer and said non-hygroscopic additive are sufficient relative to the amount of said hygroscopic salt to produce said mixture having the following property:
- when compressed into tablets, said tablets do not absorb more than 5% water by weight after being stored for 3 months at 75% relative humidity.
A non-hygroscopic oral pharmaceutical composition comprising a pharmaceutically effective amount of a hygroscopic salt of valproic acid, a carbomer, and a non-hygroscopic additive, wherein the amount of said carbomer and said non-hygroscopic additive are sufficient relative to the amount of said hygroscopic salt to produce said composition having the following property:
- not absorbing more than 5% by weight water after being stored for 3 months at 75% relative humidity.
A non-hygroscopic oral pharmaceutical composition comprising a pharmaceutically effective amount of a hygroscopic salt of valproic acid, a carbomer, and a non-hygroscopic additive, wherein the amount of said carbomer and said non-hygroscopic additive are sufficient relative to the amount of said hygroscopic salt to produce said composition having the following property:
- when compressed into tablets, said tablets do not absorb more than 5% by weight water after being stored for 3 months at 75% relative humidity.
A method of treating a medical condition in a human patient, the method comprising the step of orally administering a non-hygroscopic pharmaceutical composition for release of a salt of valproic acid into the bloodstream at a physiologically effective level, wherein said composition comprises a pharmaceutically effective amount of a hygroscopic salt of valproic acid, a carrier, and a non-hygroscopic additive, and wherein the weight ratio of the carbomer to the hygroscopic salt of valproic acid is from about 1:3 to about 1:100 and the weight ratio of the non-hygroscopic additive to the hygroscopic salt of valproic acid is from about 1:6 to about 1:2.
Dependencies are inferred from the claim text.