Low dose entecavir formulation and use

A pharmaceutical composition for oral administration of a low dose of entecavir comprising entecavir coated by means of an adhesive substance to a carrier substrate, a lubricant, and a disintegrant wherein:

• said entecavir is present at from about 0.001 to about 10% by weight of said composition,
• said adhesive substance is present at from about 0.01 to about 10% by weight of said composition,
• said carrier substrate is present at from about 80 to about 95% by weight of said composition,
• said disintegrant is present at from about 1 to about 7% by weight of said composition, and
• said lubricant is present at from about 0.1 to about 5% by weight of said composition.

The low dose entecavir tablet composition comprising:

• about 0.01% entecavir,
• about 93.24% microcrystalline cellulose,
• about 4.0% crospovidone,
• about 2.50% povidone, and
• about 0.25% magnesium stearate, said percentages being on a weight/weight basis.

The low dose entecavir tablet composition comprising:

• about 1.0% entecavir,
• about 90.0% mannitol,
• about 4.0% croscarmellose sodium,
• about 2.50% methyl cellulose, and
• about 2.50% stearic acid, said percentages being on a weight/weight basis.

The low dose entecavir tablet composition comprising:

• about 0.5% entecavir,
• about 60.00% lactose monohydrate,
• about 32.50% microcrystalline cellulose,
• about 4.0% crospovidone,
• about 2.50% povidone, and
• about 0.50% magnesium stearate, said percentages being on a weight/weight basis.

The low dose entecavir tablet composition comprising:

• about 0.1% entecavir,
• about 60.00% lactose monohydrate,
• about 35.39% microcrystalline cellulose,
• about 4.0% crospovidone,
• about 0.01% povidone, and
• about 0.5% magnesium stearate, said percentage being on a weight/weight basis.

The low dose entecavir tablet composition comprising:

• about 0.25% entecavir,
• about 60.25% lactose monohydrate,
• about 32.50% microcrystalline cellulose,
• about 4.0% crospovidone,
• about 2.50% povidone, and
• about 0.5% magnesium stearate, said percentages being on a weight/weight basis.

The low dose entecavir capsule composition comprising:

• about 10.0% entecavir,
• about 82.03% microcrystalline cellulose,
• about 4.00% crospovidone,
• about 2.50% povidone,
• about 0.25% magnesium stearate, and
• about 1.22% hydrochloric acid, said percentages being on a weight/weight basis.

The low dose entecavir capsule composition comprising:

• about 0.05% entecavir,
• about 93.20% dicalcium phosphate,
• about 4.00% crospovidone,
• about 2.50% hydroxypropyl cellulose, and
• about 0.25% magnesium stearate, said percentages being on a weight/weight basis.

The method of preparing a pharmaceutical composition for oral administration containing a low dose of a soluble pharmaceutically active agent comprising:

• (a) dissolving said pharmaceutically active agent and an adhesive substance in a solvent,
• (b) spraying said solution from step (a) onto a carrier substrate while said carrier substrate is in motion,
• (c) drying said coated carrier substrate from step (b) to remove said solvent, and
• (d) combining said dried coated carrier substrate from step (c) with other desired ingredients to form said pharmaceutical composition.