Oral baclofen solutions
AssigneeMetacel Pharmaceuticals, LLC
InventorsThomas Jeffrey Bryant, H. G. Thomas
Life of this patent
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Abstract
The present disclosure relates to aqueous oral solutions comprising baclofen. In one embodiment, the aqueous oral solutions comprise a buffer comprising citric acid, a salt of citric acid, or any combination thereof, and are stored at from about 2° C. to about 8° C. The present disclosure also relates to buffer free aqueous oral solutions comprising baclofen. Additionally, the present disclosure relates to an assay for determining the amount of an impurity, 4-(3-carboxymethyl)-3-hydroxy-2,5-dioxopyrrolidin-1-yl)-3-(4-chlorophenyl)butanoic acid, in a baclofen containing solution, and to methods of treatment using such aqueous oral solutions.
Claims14
1-26. (canceled)
The buffer-free aqueous oral solution of claim 29, wherein the solution contains less than about 0.2% of 4-(3-carboxymethyl)-3-hydroxy-2,5-dioxopyrrolidin-1-yl)-3-(4-chlorophenyl)butanoic acid after storage at 25° C. and 60% relative humidity for 6 months.
The buffer-free aqueous oral solution of claim 29, wherein the solution contains less than about 0.05% of 4-(3-carboxymethyl)-3-hydroxy-2,5-dioxopyrrolidin-1-yl)-3-(4-chlorophenyl)butanoic acid after storage at 25° C. and 60% relative humidity for 6 months.
A buffer-free aqueous oral solution comprising:
- (i) baclofen;
- (ii) methylparaben, propylparaben, or a combination thereof;
- (iii) sucralose;
- (iv) a flavoring agent;
- and
- (v) about 2 to about 20% w/v glycerin.
A buffer-free aqueous oral solution comprising:
- (i) about 0.2% w/v baclofen;
- (ii) about 0.15% w/v methylparaben;
- (iii) about 0.02% w/v propylparaben;
- (iv) about 0.025% w/v sucralose;
- (v) about 1.0% w/v flavoring agent;
- and
- (vi) about 10% glycerin.
Dependencies are inferred from the claim text.