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Orally disintegrating, sublingual and buccal formulations

a technology of oral dissolution and oral cavity, applied in the direction of pharmaceutical delivery mechanism, plant/algae/fungi/lichens ingredients, organic active ingredients, etc., can solve the problems of delayed and unpredictable onset of effects, inconsistent dosing,

Pending Publication Date: 2022-08-04
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The formulation achieves rapid and uniform absorption of CBD and THC, reducing peak concentration variability and onset time, with effects occurring within minutes compared to traditional oral formulations which take hours.

Problems solved by technology

This can result in inconsistent dosing and delayed and unpredictable onset of effects.

Method used

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  • Orally disintegrating, sublingual and buccal formulations

Examples

Experimental program
Comparison scheme
Effect test

example 1

Solid Tablet CBD Formulation

[0041]This example describes a method of producing a solid tablet described herein. In particular, the solid tablet is fast-dissolving.

[0042]Procedure

[0043]Ensure correct environment is attained prior to tablet production

[0044]Temperature: 68-72° F.

[0045]Relative humidity: 44-50%

[0046]Cannabis Extract Mix

[0047]In a 100 mL beaker, slowly add 0.25 mL of cannabis extract (40 mg / mL MCT oil extraction) to 240.0 mg of silicon dioxide

[0048]Triturate the resulting mixture to ensure even absorption and distribution of cannabis extract in the silicon dioxide

[0049]Sieve mixture with #8 size sieve to ensure uniform powder

[0050]Inactive Ingredient Mix (“Core component mix”)

[0051]In a separate 100 mL beaker mix the following ingredients: 24.0 mg mannitol, 120.0 mg citric acid, 12.0 mg sodium bicarbonate, 40.0 mg of calcium carbonate, 200.0 mg dibasic calcium phosphate anhydrous, 0.3 mg menthol extract, and 40.0 mg sodium citrate

[0052]Combine these ingredients and tritu...

example 2

Orally Disintegrating / Sublingual / Buccal Formulations Provide Rapid Onset of Effects

[0060]This example demonstrates that oral formulations described herein provide rapid onset and peak effects of an active ingredient. The effects of exemplary oral formulations described herein were measured against a control. Subjects were assigned to receive either an active (n=7) or placebo (n=1) formulation lacking an active ingredient. The subject characteristics are described in the table below.

TABLE 2ActivePlaceboSex, n (%)Male4 (50.0)1 (100.0)Female3 (50.0)0 (0.0) Mean Age, years34.67 + / − 11.432.0 + / − 0.0Prior Cannabis UserYesYes

[0061]The effects of the formulations were measured over a 120 minute period. No subject was lost to follow up or excluded from the analysis.

[0062]The results of the analysis are provided in FIG. 1, which shows the effects of the active over time. As shown in the FIGURE, A=acidic ingredient, where A is citric acid, and B=basic ingredient, where B is sodium carbonate / ca...

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Abstract

The present invention is related to an orally disintegrating, sublingual or buccal formulation of active ingredient such as cannabidiol or tetrahydrocannabinol.

Description

FIELD OF THE INVENTION[0001]Provided herein is an orally disintegrating, sublingual or buccal formulation of an active ingredient such as cannabidiol or tetrahydrocannabinol.BACKGROUND OF THE INVENTION[0002]Active ingredients such as cannabidiol (CBD) and tetrahydrocannabinol (THC) may be helpful in providing relief for conditions including pain, decreasing opioid use, anxiety, epilepsy, glaucoma, HIV / AIDS symptoms, Irritable Bowel Syndrome, movement disorders such as Tourette Syndrome, Multiple Sclerosis, nausea and vomiting associated with chemotherapy, posttraumatic stress disorder, and sleep problems, and also have recreational uses. CBD and THC can be formulated into oral dosage forms, including chewable forms exemplified by gellans / gelatins like gummies, mints, and cookies. But ingesting the active ingredients in this form exposes them to the gastric contents and to first pass metabolism. This can result in inconsistent dosing and delayed and unpredictable onset of effects. Th...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K36/185A61K31/352A61K9/20A61K31/05A61K31/045A61K9/00
CPCA61K36/185A61K31/352A61K9/2018A61K31/05A61K9/2072A61K9/0056A61K9/2009A61K9/2013A61K31/045A61K2300/00
Inventor GONZALEZ, DANNY S.
Owner SEED EDIBLES