Formulations of low dose diclofenac and beta-cyclodextrin
AssigneeJavelin Pharmaceuticals, Inc.
InventorsCurtis Wright, Daniel B. Carr, Fred H. Mermelstein
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Abstract
The present invention is directed to a pharmaceutical composition containing a unit dose of a diclofenac compound effective to induce analgesia; and a beta-cyclodextrin compound; wherein the dose of the diclofenac compound is less than 10 mg. The present invention is also directed to methods of treating a subject in need of analgesia with the pharmaceutical compositions of the invention.
Claims31
A method for treating a mammal in need of analgesia, which comprises parenterally administering a pharmaceutical composition comprising:
- (a) a dose of a diclofenac compound effective to induce analgesia;
- and
- (b) a beta-cyclodextrin compound;
- wherein the dose of the diclofenac compound:
- (i) is less than 75 mg;
- and
- (ii) has a faster onset of action in the mammal than if it were not administered with the beta-cyclodextrin compound.
A method for treating a mammal in need of analgesia, which comprises parenterally administering a pharmaceutical composition comprising:
- (a) a dose comprising no more than 37.5 mg (+/−20%) of a diclofenac compound;
- and
- (b) a beta-cyclodextrin compound;
- wherein:
- (i) the administration of the pharmaceutical composition is sufficient to provide a Total Pain Score of at least 134 (+/−20%), six hours post-administration and based on a 100 mm Visual Analog Scale;
- and
- (ii) the diclofenac compound present in the pharmaceutical composition has a faster onset of action in the mammal than if it were not administered with the beta-cyclodextrin compound.
The method of claim 14, wherein the dose diclofenac compound is 37.5 mg (+/−20%).
A method for treating a mammal in need of analgesia, which comprises parenterally administering a pharmaceutical composition comprising:
- (a) a dose comprising 37.5 mg (+/−20%) of a diclofenac compound;
- and
- (b) a beta-cyclodextrin compound;
- wherein:
- (i) the administration of the pharmaceutical composition is sufficient to provide substantially the same percentage maximum Total Pain Score, six hours post-administration and based on a 100 mm Visual Analog Scale, as that provided by a 75 mg dose of the diclofenac compound when parenterally administered with the beta-cyclodextrin compound to the mammal;
- and
- (ii) the diclofenac compound present in the pharmaceutical composition has a faster onset of action in the mammal than if it were not administered with the beta-cyclodextrin compound.
A pharmaceutical composition suitable for parenteral administration to a mammal comprising:
- (a) no more than 37.5 mg (+/−20%) of a diclofenac compound;
- and
- (b) a beta-cyclodextrin compound;
- wherein upon parenteral administration to the mammal:
- (i) the pharmaceutical composition is sufficient to provide a Total Pain Score of at least 134 (+/−20%), six hours post-administration and based on a 100 mm Visual Analog Scale;
- and
- (ii) the diclofenac compound present in the pharmaceutical composition has a faster onset of action in the mammal than if it were not administered with the beta-cyclodextrin compound.
A pharmaceutical composition suitable for parenteral administration to a mammal comprising:
- (a) a dose comprising 37.5 mg (+/−20%) of a diclofenac compound;
- and
- (b) a beta-cyclodextrin compound;
- wherein upon to the mammal:
- (i) the pharmaceutical composition is sufficient to provide substantially the same percent maximum Total Pain Score, six hours post-administration and based on a 100 mm Visual Analog Scale, as provided by a 75 mg (+/−20%) dose of the diclofenac compound when parenterally administered with the beta-cyclodextrin compound to the mammal;
- and
- (ii) the diclofenac compound present in the pharmaceutical composition has a faster onset of action in the mammal than if it were not administered with the beta-cyclodextrin compound.
Dependencies are inferred from the claim text.