Low dose liquid entecavir formulations and use
OwnerDivyakant Desai, Danping Liinventors
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Abstract
Liquid pharmaceutical compositions are provided having a low dose of entecavir. In one embodiment of the present invention, the liquid entecavir composition is a ready-to-use composition that is formulated to be both stable and palatable. In a second embodiment of the present invention, the liquid entecavir composition is formulated from a powder composition at the time of use. The low dose entecavir compositions may also include at least one component selected from sweetener, preservative, flavoring agent, buffering agent, or combinations thereof. The liquid entecavir compositions may also be formulated in combination with other pharmaceutically active agents.
Claims40
A liquid pharmaceutical composition to treat hepatitis B virus infection comprising a pharmaceutically acceptable solvent and about 0.001% to about 20% w/v of entecavir.
A powder for constitution at the time of use as a liquid pharmaceutical composition to treat hepatitis B virus infection comprising about 0.001 wt. % to about 20 wt. % of entecavir, based on the total weight of the powder composition.
A method of preparing a liquid pharmaceutical composition for oral administration containing a low dose of entecavir comprising the step of dissolving said entecavir and preservative in a solution comprising a pharmaceutically acceptable solvent, wherein said entecavir is present in said solution in an amount about 0.001% to about 20% on a weight/volume basis of the solution.
A method of preparing a powder for reconstitution at the time of use as a liquid pharmaceutical composition for oral administration containing a low dose of entecavir comprising the step of mixing entecavir with at least one additional component selected from the group consisting of sweetener, preservative, flavoring agent, buffering agent, and any combinations thereof, wherein the powder for constitution is formed and wherein said entecavir is present in said powder for constitution composition in an amount about 0.001 wt. % to about 20 wt. %.
A liquid pharmaceutical composition comprising:
- about 0.001% to about 20% entecavir;
- about 10% to about 85% sweetener;
- about 0.001% to about 0.1% flavoring agent;
- about 0.01% to about 1% preservative;
- about 0.01% to about 5% buffering agent;
- and
- q.s. of pharmaceutically acceptable solvent,
- wherein the percentages are on a weight/volume basis.
A powder for constitution at the time of use as a liquid pharmaceutical composition comprising:
- about 0.001 wt. % to about 20 wt. % entecavir;
- about 70 wt. % to about 90 wt. % sweetener;
- about 0.001 wt. % to about 1 wt. % flavoring agent;
- about 0.01 wt. % to about 5 wt. % preservative;
- and
- about 1 wt. % to about 20 wt. % buffering agent,
- wherein the percentages are based on the total weight of said powder composition.
Dependencies are inferred from the claim text.