Fast dissolving/disintegrating coating compositions
View Patent ↗A pharmaceutical composition for oral administration comprising a core and a film coating on the core that exhibits enhanced disintegration characteristics is disclosed. The film coating comprises a film forming polymer, an organic solvent, a super-disintegrant and, optionally, an acid labile material.
1. A pharmaceutical dosage form having enhanced disintegration characteristics comprising a core, wherein the core is selected from the group consisting of a tablet and a caplet, and a film coating, wherein the film coating consists of hydroxypropylcellulose and sodium croscarmellose, wherein the film coating weight gain is about 2.5%, and wherein the film coating disintegrates in water in less than 15 seconds.
2. The pharmaceutical dosage form of claim 1 , further comprising openings which extend through a surface of the film coating to a surface of the core.
3. The pharmaceutical dosage form of claim 1 , wherein the tablet is selected from a chewable tablet and an orally disintegrating tablet.
4. A method of preparing a pharmaceutical dosage form, comprising preparing a film coating; and applying the film coating to a core, wherein preparing the film coating comprises a step of suspending a super-disintegrant in an organic solvent and a step of dissolving the hydroxypropylcellulose in the organic solvent.
5. The method of claim 4 , wherein the organic solvent is selected from the group consisting of ethanol, acetone, methanol and isopropanol.
6. The method of claim 4 , wherein the organic solvent is a mixture of two or more organic solvents.
7. The method of claim 6 , wherein the organic solvent is a mixture of ethanol and a secondary solvent selected from acetone, methanol and isopropanol.
8. The method of claim 7 , wherein the ratio of ethanol to secondary solvent is from about 50:50 to about 99:1.
9. The method of claim 4 , wherein the film coating is applied to the core via a spraying process.
10. The pharmaceutical dosage form of claim 1 , wherein the film coating is prepared by suspending the hydroxypropylcellulose and the croscarmellose in an organic solvent.
11. The pharmaceutical dosage form of claim 1 , wherein the core comprises acetaminophen.