Compositions and methods of making rapidly dissolving lonically masked formulations

a technology of lonically masked formulations and compositions, applied in the direction of drug compositions, cardiovascular disorders, muscular disorders, etc., can solve the problems of patient compliance, controlled-release formulations are not amenable to large-scale production in facilities, and children and adults fail to comply with dosing instructions

Inactive Publication Date: 2007-04-26
NEOS THERAPEUTICS LP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0020] The present invention also includes those chewable formulations made by the methods disclosed and claimed herein. For example, specific chewable formulation may include one or more active agents available for immediate, modified and/or extended or controlled release for use in treating cold/cough/allergy sympt

Problems solved by technology

Many children and adults fail to comply with dosing instructions due to the size, shape, taste and/or mouth-feel of, e.g., tablets, caplets and even gelcaps.
Finally, it was recognized that despite many decades of research and development, controlled-release formulations have not been amenable to large-scale production in facilities and to amounts that are pe

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example i

[0080]

First active ingredient polistirex100.00mgSecond active ingredient polistirex15.00mgPharamaburst170.00mgSorbitol100.00mgSweetener25.00mgXylisorb30.00mgCitric acid10.00mgFlavor7.50mgDye2.50mgTalc40.00mgSteric acid10.00mg

example ii

[0081]

Pseudoephedrine polistrex99.70mgChlorpheniramine polyacrilex14.70mgPharamaburst170.00mgSorbitol100.00mgAspertame25.00mgXylisorb30.00mgCitric acid10.00mgGrape Flavor7.50mgPurple Lake Blend2.50mgTalc40.00mgSteric acid10.00mg

[0082] Below is a list of actual assay results for one example of the present invention with the composition listed as formula II above. The dissolution profile for the release of pseudoephedrine and chlorpheniramine are shown in Table 1, below.

TABLE 130 min (%)1 Hr (%)3 Hr (%)8 Hr (%)Chlorpheniramine35.142.751.660.8Pseudoephedrine27.637.859.482.0

[0083] Based on assay and dissolution profile 35.1% of the chlorpheniramine is released within 30 minutes. The release of chlorpheniramine at 1 hour is about 42.7%. The release profile after 3 hours and 8 hours demonstrate a release of 51.6% and 60.8% respectively. The dissolution profile also shows that 26.7% the pseudoephedrine is released within 30 minutes. The release of pseudoephedrine at 1 hour is about 37.8%...

example iii

[0084]

Pseudoephedrine polistrex102.92mgChlorpheniramine polyacrilex15.11mgPharamaburst170.00mgSorbitol86.97mgAspertame25.00mgXylisorb30.00mgCitric acid10.00mgGrape Flavor7.50mgPurple Lake Blend2.50mgTalc40.00mgSteric acid10.00mg

[0085] Below is a list of assay results for one example of the present invention with the composition listed as formula II above. The dissolution profile for the release of pseudoephedrine and chlorpheniramine are shown in Table 2, below.

TABLE 230 min (%)1 Hr (%)3 Hr (%)8 Hr (%)Chlorpheniramine36.442.151.060.7Pseudoephedrine27.036.353.078.4

[0086] Based on assay and dissolution profile 36.4% of the chlorpheniramine is released within 30 minutes. The release of chlorpheniramine at 1 hour is about 42.1%. The release profile after 3 hours and 8 hours demonstrate a release of 51.0% and 60.7% respectively. The dissolution profile also shows that 27.0% of the pseudoephedrine is released within 30 minutes. The release of pseudoephedrine at 1 hour is about 36.3%. Th...

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Abstract

The present invention includes compositions and methods for reduce the taste of the drug in the drug resin complex. The composition may include one or more drug-resin complexes and a highly compressible, free-flowing pharmaceutical excipient. The resin is present in an amount effective to reduce the taste of the drug in the drug resin complex relative to an otherwise identical pharmaceutical composition without the resin; and wherein the highly compressible, free-flowing pharmaceutical excipient causes release of the drug-resin complex in the mouth.

Description

FIELD OF INVENTION [0001] The invention relates to compositions and methods of making rapidly disintegrating or chewable, sustained-release formulations, and more particularly, to compositions and methods for making rapidly disintegrating ionically masked formulations. BACKGROUND OF THE INVENTION [0002] Without limiting the scope of the invention, its background is described in connection with ionically masked pharmaceutical agents that are rapidly disintegrating and delivered in an extended or sustained-release form, as an example. [0003] Methods for sustained release are known in the art. One such method of making sustained release particles is taught in U.S. Pat. No. 6,120,787, issued to Gustafsson, et al., which teach a method for preparing parenterally administrable sustained release microparticles. The method includes preparing core particles in an aqueous medium that is essentially free from organic solvent and the biologically active substance is entrapped therein during or ...

Claims

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Application Information

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IPC IPC(8): A61K31/785A61K9/68A61K9/48
CPCA61K31/785A61K47/48176A61K47/26A61K31/137A61K9/0056A61K47/48192A61K47/48184A61K31/46A61K31/4402A61K47/58A61K47/585A61K47/59A61K31/74A61P11/00A61P21/02A61P25/16A61P29/00A61P31/00A61P35/00A61P9/00A61K9/0002
Inventor TENGLER, MARKMCMAHEN, RUSSELL LEE
Owner NEOS THERAPEUTICS LP
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