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Sugar-free oral transmucosal solid dosage forms and uses thereof

A technology of oral mucosa and dosage forms, applied in the field of oral drug delivery preparations

Inactive Publication Date: 2006-03-15
CEPHALON INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, such dosage forms must exhibit a satisfactory patient-controllable rate of dissolution, drug stability, and be otherwise suitable for transmucosal delivery, as discussed above

Method used

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  • Sugar-free oral transmucosal solid dosage forms and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0136] Element

[0137] This example formulation was flavor-free and buffer-free; the pH in solution was determined by pH 7.0 phosphate-buffered saline (SS) used in the pH test. In Example 1, due to rounding, the sum of the percentages of each content (%w / w) may not exactly reach 100, and the sum of each component may not exactly reach 2000 mg. Purity Gum BE, Sugar and Purified Water Components for Confectioners Prepares a food-grade (edible) gum that enables holder assembly into a sugar-free compressed fentanyl citrate base.

Embodiment 2

[0139] Element

[0140] In Example 2, due to rounding, the percentage sum of each content (%w / w) may not be exactly 100, and the sum of each component may not be exactly 2000 mg. Purity GumBE, confectionary sugar and purified water components were used to make a food grade (edible) gum capable of assembling a holder into a sugar-free compressed fentanyl citrate base.

Embodiment 3

[0142] Element

[0143] In Example 3, due to rounding, the sum of the percentages of each content (%w / w) may not be exactly 100, and the sum of each component may not be exactly 2000 mg. Purity GumBE, confectionary sugar and purified water components were used to make a food grade (edible) gum that was used to assemble the holder into a sugar-free compressed fentanyl citrate base.

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PUM

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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.

Description

field of invention [0001] The present invention relates to oral drug delivery formulations. In particular, the present invention relates to sugar-free solid pharmaceutical dosage forms for the oromucosal delivery of pharmaceutically active substances. Background of the invention [0002] Solid pharmaceutical dosage forms are well known in the art. Oral solid dosage forms are the most preferred dosage form compared to other dosage forms, accounting for 80% of all drug products on the market. Solid dosage forms are easier for patients or caregivers to identify, handle and administer. Solid dosage forms are also non-invasive and highly patient adaptable. [0003] Solid dosage forms can be further divided into several subgroups based on the route of drug delivery, including, for example, gastrointestinal (GI) tract delivery, suppository (rectal, vaginal, and urethral) delivery, and transmucosal delivery. Most solid dosage forms on the market are designed for gastrointestinal...

Claims

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Application Information

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IPC IPC(8): A61K9/20
Inventor 布赖恩·黑格林恩·J·马兰德
Owner CEPHALON INC
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