Composition of fentanyl citrate oral solid transmucosal dosage form, excipient and binding material therefore, and methods of making
First Claim
1. A lozenge composition, comprising:
- a predetermined amount of a micronized Fentanyl salt dispersed uniformly throughout an excipient matrix comprising as its major component dextrose monohydrate.
2 Assignments
0 Petitions
Accused Products
Abstract
A process of preparing a highly uniform oral transmucosal lozenge of fentanyl citrate (a “fentanyl lollipop”) provides uniform distribution of the drug. The content uniformity between the lozenges and uniform distribution of the drug within a lozenge is achieved by dry mixing a micronized drug of a particle size of about one to ten microns with at least one major excipient, such as a dextrose, having cavities and pores on its surface after pressing into the lozenge shape. The major component of the lozenge can be a binding material prepared with a mixture of dextrose hydrate, food grade starch and water. This binding material has better strength to bind the stick to the lozenge due to stronger cross-linked matrix formation between the lozenge and the binding material.
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Citations
26 Claims
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1. A lozenge composition, comprising:
- a predetermined amount of a micronized Fentanyl salt dispersed uniformly throughout an excipient matrix comprising as its major component dextrose monohydrate.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A lozenge produced by the process comprising:
- micronizing a Fentanyl salt;
dry blending a predetermined amount of the micronized Fentanyl salt with a predetermined amount of an excipient having dextrose monohydrate as its major component to produce a mixed blend; and
compressing the mixed blend into a lozenge. - View Dependent Claims (11, 12, 13, 14)
- micronizing a Fentanyl salt;
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15. A process for making a pharmaceutically acceptable glue for a solid oral dosage form, comprising:
- suspending a predetermined amount of dextrose monohydrate to water in hot water;
elevating the water temperature to boiling and maintaining an elevated temperature until a hot clear solution is obtained;
mixing into the hot clear solution a food grade starch; and
cooling the resultant glue mass. - View Dependent Claims (16, 17)
- suspending a predetermined amount of dextrose monohydrate to water in hot water;
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18. A pharmaceutically acceptable glue for a solid oral dosage form, produced by the process comprising:
- suspending a predetermined amount of dextrose monohydrate to water in hot water;
elevating the water temperature to boiling and maintaining an elevated temperature until a hot clear solution is obtained;
mixing into the hot clear solution a food grade starch; and
cooling the resultant glue mass.
- suspending a predetermined amount of dextrose monohydrate to water in hot water;
- 19. A sold oral dosage form lozenge, wherein the improvement comprises the combination of micronized Fentanyl citrate particles in combination with an excipient being predominantly dextrose monohydrate.
- 22. An oral transmucosal lozenge defined by first to fourth volumetric quadrants each quadrant spatially outside the previous quadrant, and each quadrant having approximately the same weight as each other quadrant, said lozenge having dispersed throughout an active ingredient, wherein the active ingredient is present in each quadrant in an amount of about 20% to 30% of the total amount of active ingredient present.
Specification