Sugar-free oral transmucosal solid dosage forms and uses thereof
First Claim
1. A pharmaceutical composition comprising an oral transmucosal solid dosage form comprising an ionizable pharmaceutical agent, a buffer, and a pharmaceutically acceptable excipient, wherein said composition is substantially sugar-free and is bioequivalent to a sugar-containing oral transmucosal solid dosage form, and wherein said buffer is present in an amount sufficient to maintain a portion of said pharmaceutical agent, upon dissolution of said dosage form in saliva, in an ionized state.
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Abstract
The present invention is directed to oral solid dosage forms. The solid dosage forms are sugar-free, and comprise a pharmaceutical agent and a suitable pharmaceutically acceptable excipient. Preferably, the solid dosage forms of the present invention are bioequivalent to a sugar-containing solid dosage form. Bioequivalence is preferably obtained by incorporating an ionizing agent, more preferably in the form of a buffer system, into the solid dosage forms, in an amount sufficient to maintain a portion of the pharmaceutical agent, upon dissolution of said composition in saliva, in an ionized state.
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Citations
105 Claims
- 1. A pharmaceutical composition comprising an oral transmucosal solid dosage form comprising an ionizable pharmaceutical agent, a buffer, and a pharmaceutically acceptable excipient, wherein said composition is substantially sugar-free and is bioequivalent to a sugar-containing oral transmucosal solid dosage form, and wherein said buffer is present in an amount sufficient to maintain a portion of said pharmaceutical agent, upon dissolution of said dosage form in saliva, in an ionized state.
- 44. A sugar-free pharmaceutical composition for the oral transmucosal delivery of fentanyl, said composition comprising fentanyl, or a pharmaceutically acceptable salt form thereof, and a pharmaceutically acceptable excipient, wherein said sugar-free composition is in the form of an oral transmucosal solid dosage form, and wherein said oral transmucosal solid dosage form is bioequivalent to a sugar-containing oral transmucosal solid dosage form.
Specification