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Buccal, polar and non-polar spray or capsule

Inactive Publication Date: 2005-12-22
DUGGER HARRY A III
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0003] A buccal aerosol spray or soft bite gelatin capsule using a polar or non-polar solvent has now been developed which provides biologically active compounds for rapid absorption through the oral mucosa, resulting in fast onset of effect.

Problems solved by technology

However, formulations suitable for such administration by these latter routes present their own problems.

Method used

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  • Buccal, polar and non-polar spray or capsule

Examples

Experimental program
Comparison scheme
Effect test

example 1

Biologically Active Peptides Including Peptide Hormones

[0037] A. Cyclosporine lingual spray

preferredmost preferredAmountsamountamountCyclosporine5-5010-3515-25water5-207.5-50 9.5-12 ethanol5-607.5-50 10-20polyethylene glycol20-60 30-4535-40flavors0.1-5  1-42-3

[0038] B. Cyclosporine Non-Polar lingual spray

preferredmost preferredAmountsamountamountCyclosporine1-503-40 5-30Migylol ®*30-40Polyoxyethylated30-40castor oilButane25-80 30-70 33-50flavors0.1-5  1-4 2-3

*Miglyol is a registered trademark of Huels AG and describes a fractionated coconut oil of boiling point 240-270° C. comprising saturated C8 and C10 triglycerides.

[0039] C. Cyclosporine non-polar bite capsule

preferredmost preferredAmountsamountamountCyclosporine 1-355-2510-20olive oil25-6035-55 30-45polyoxyethylated25-6035-55 30-45oleic glyceridesflavors0.1-5  1-4 2-3

[0040] D. Cyclosporine bite capsule

preferredmost preferredAmountsamountamountCyclosporine5-5010-3515-25polyethylene glycol20-60 30-4535-40glycerin5-307.5-...

example 2

CNS Active Amines and Their Salts: Including but not Limited to Tricyclic Amines, GABA Analogues, Thiazides, Phenothiazine Derivatives, Serotonin Antagonists and Serotonin Reuptake Inhibitors

[0045] A. Sumatriptan succinate lingual spray

preferredmost preferredAmountsamountamountsumatriptan succinate0.5-30    1-2010-15ethanol5-607.5-5010-20propylene glycol5-307.5-2010-15polyethylene glycol0-60 30-4535-40water5-307.5-2010-15flavors0.1-5   1-42-3

[0046] B. Sumatriptan succinate bite capsule

preferredmost preferredAmountsamountamountsumatriptan succinate0.01-5  0.05-3.5 0.075-1.75 polyethylene glycol25-7030-6035-50glycerin25-7030-6035-50flavors0.1-10 1-83-6

[0047] C. Clozepine lingual spray

preferredmost preferredAmountsamountamountClozepine0.5-30    1-2010-15ethanol5-607.5-5010-20propylene glycol5-307.5-2010-15polyethylene glycol0-60 30-4535-40water5-307.5-2010-15flavors0.1-5   1-42-3

[0048] D. Clozepine Non-Polar lingual spray with propellant

preferredmost preferredAmountsamountamou...

example 3

Sulfonylureas

[0052] A. Glyburide lingual spray

preferredmost preferredAmountsamountamountGlyburide0.25-25  0.5-200.75-15  ethanol5-607.5-5010-20propylene glycol5-307.5-2010-15polyethylene glycol0-60 30-4535-40water2.5-30    5-20 6-15flavors0.1-5   1-42-3

[0053] B. Glyburide non-polar bite capsule

preferredmost preferredAmountsamountamountGlyburide0.01-10  0.025-7.5 0.1-4 olive oil30-6035-55 30-50polyoxyethylated30-6035-55 30-50oleic glyceridesflavors0.1-5  1-4 2-3

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Abstract

Buccal aerosol sprays or capsule using polar and non-polar solvent have now been developed which provide biologically active compounds for rapid absorption through the oral mucosa, resulting in fast onset of effect. The buccal polar compositions of the invention comprises formulation I: aqueous polar solvent 30-99.89%, active compound 0.001-60%, optionally containing flavoring agent 0.1-10%. Propellant 2-10% The non polar composition of the invention comprises formulation II: non-polar solvent 20-85%, active compound 0.005-50%, and optionally flavoring agent 0.1-10% and propellant 50-80%.

Description

RELATED APPLICATIONS [0001] This application is a continuation in part of applicant PCT application PCT / US97 / 17899 filed Oct. 1, 1997.BACKGROUND OF THE INVENTION [0002] It is known that certain biologically active compounds are better absorbed through the oral mucosa than through other routes of administration, such as through the stomach or intestine. However, formulations suitable for such administration by these latter routes present their own problems. For example, the biologically active compound must be compatible with the other components of the composition such as propellants, solvents, etc. Many such formulations have been proposed. For example, U.S. Pat. No. 4,689,233, Dvorsky et al., describes a soft gelatin capsule for the administration of the anti-coronary drug nifedipine dissolved in a mixture of polyether alcohols. U.S. Pat. No. 4,755,389, Jones et al., describes a hard gelatin chewable capsule containing nifedipine. A chewable gelatin capsule containing a solution o...

Claims

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Application Information

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IPC IPC(8): A61K9/12A61F13/02A61K9/00A61K9/40A61K9/48A61K31/085A61K31/137A61K31/138A61K31/195A61K31/197A61K31/27A61K31/337A61K31/4178A61K31/421A61K31/433A61K31/4745A61K31/515A61K31/522A61K31/525A61K31/557A61K31/7076A61K38/00A61K38/13A61K38/43A61K39/00A61L9/04H02J7/00
CPCA61K9/0056A61K47/44A61K9/124A61K31/085A61K31/137A61K31/138A61K31/197A61K31/27A61K31/4178A61K31/421A61K31/433A61K31/7076A61K38/13A61K47/06A61K47/14A61K9/006A61P1/08
Inventor DUGGER, HARRY A. III
Owner DUGGER HARRY A III
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