Immediate release tablet
View Patent ↗An immediate release tablet is provided. The tablet comprises at least 60 weight % of an active ingredient and powdered wax having a melting point greater than about 90° C. The tablet may advantageously be produced by direct compression. Although the wax is hydrophobic, the tablet has excellent disintegration.
1. A swallowable immediate release tablet consisting essentially of at least 60 weight % of acetaminophen, from about 1 to about 10 weight % of a powdered wax having an melting point greater than about 90° C. and a particle size in the range of about 5 to about 100 microns, and less than about 25 weight % of a disintegrant, wherein the acetaminophen is released from the swallowable immediate release tablet by 30 minutes in pH 5.8 buffer.
2. The tablet of claim 1 , wherein the wax is selected from the group consisting of linear hydrocarbons, microcrystalline wax, and mixtures thereof.
3. The tablet of claim 1 prepared by direct compression.
4. The tablet of claim 1 which is substantially free of water-soluble, non-saccharide polymeric binders.
5. The tablet of claim 1 , which is substantially free of hydrated polymers.
6. The tablet of claim 1 further comprising an excipient selected from the group consisting of flow aids, and lubricants.
7. A swallowable immediate release tablet consisting essentially of at least 60 weight percent of acetaminophen, from about 1 to about 10 weight % of a powdered wax having a particle size in the range of about 5 to about 100 microns that is selected from the group consisting of shellac wax, paraffin-type waxes, polyethylene glycol, and mixtures thereof, and less than about 25 weight % of a disintegrant, wherein said swallowable immediate release tablet is prepared by direct compression, and the acetaminophen is released from the swallowable immediate release tablet by 30 minutes in pH 5.8 buffer.
8. A swallowable immediate release tablet consisting essentially of at least 60 weight percent of acetaminophen, from about 1 to about 10 weight % of a powdered wax having a particle size in the range of about 5 to about 100 microns that is selected from the group consisting of shellac wax, paraffin-type waxes, polyethylene glycol, and mixtures thereof, and less than about 25 weight % of a disintegrant, wherein said swallowable immediate release tablet is substantially free of water-soluble, non-saccharide polymeric binders, and the acetaminophen is released from the swallowable immediate release tablet by 30 minutes in pH 5.8 buffer.
9. A swallowable immediate release tablet consisting essentially of at least 60 weight percent of acetaminophen, from about 1 to about 10 weight % of a powdered wax having a particle size in the range of about 5 to about 100 microns that is selected from the group consisting of shellac wax, paraffin-type waxes, polyethylene glycol, and mixtures thereof, and less than about 25 weight % of a disintegrant, wherein said swallowable immediate release tablet is substantially free of hydrated polymers, and the acetaminophen is released from the swallowable immediate release tablet by 30 minutes in pH 5.8 buffer.