Extended release formulations of cannabinoids

Pending Publication Date: 2020-02-13
GLATT GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention is about making medication containing cannabinoids in the form of solid oral dosage forms like capsules, tablets, or sachets. These medications can be taken once a day, which makes them easier for patients to manage. The medication is made in a way that provides a steady release of the active ingredient over a period of up to a full day. This helps to make the medication more effective and reliable. The medication is also made to have a consistent distribution in the stomach and intestines, which helps to ensure the medication is working properly. This patent also mentions that the medication can be made in a way that targets a specific area of the body or provides a more consistent release of the active ingredient.

Problems solved by technology

However, the effects of Cesamet® have been reported to persist for a variable and unpredictable period of time following its oral administration; for example, adverse psychiatric reactions from using Cesamet® can persist for 48 to 72 hours following cessation of treatment.
Due to this short duration of action, THC products administered orally have poor or partial response, requiring a patient to rely on multiple daily dosing regimen.
Additionally, opioids are associated with higher risk of overdose leading to death.
Unfortunately, this mode of administration has adverse effects on the lungs.
Cannabis smoke carries more tar and other particulate matter than tobacco, and may be a cause of lung diseases including lung cancer.
Smoking may also negatively impact cannabinoids absorption.
Moreover, many patients may find the act of smoking unappealing, as well as generally unhealthy.

Method used

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  • Extended release formulations of cannabinoids
  • Extended release formulations of cannabinoids
  • Extended release formulations of cannabinoids

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0069]A study was performed to assess two different extended release compositions (Example Compositions A and B) of particles comprising an inert core and a coating having the following: a surrogate active ingredient, probucol; two or more release-controlling polymers; and a release-accelerating polymer. Table 1 provides a summary of these compositions, including the quantity of each component.

[0070]To prepare the compositions, the probucol was mixed with ethanol and water (50:50) in a glass beaker to form a homogenous dispersion. The release-controlling polymers (Eudragit® RS and Ethocel® E-10 in Example Composition A; Eudragit® RS, Eudragit® RL, and Ethocel® E-10 in Example Composition B) and release-accelerating polymer (Kollidon® K30) were added to the mixture, and a vortex mixer was used to form a homogenous mixture. The mixture was then applied onto Cellets® (Glatt GmBH, Germany) in a beaker and the coated pellets were dried.

[0071]A dissolution test was conducted on Example Co...

example 2

[0075]A study was performed to compare an immediate release composition (Reference Composition A) and an extended release composition (Example Composition C) of particles comprising an inert core and a coating having cannabinoid THC. The coating for the particles of the extended release composition additionally comprise release-controlling polymers Eudragit® RS 30D and Eudragit® RL 30D. Table 4 provides a summary of these compositions, including the quantity of each component.

[0076]To prepare the immediate release Reference Composition A, the THC was mixed with methanol in a glass beaker to form a homogenous dispersion. The dispersion was then applied onto Suglets® 40 / 45 in a beaker and the coated pellets were dried.

[0077]To prepare the extended release Example Composition C, the THC was mixed with methanol in a glass beaker to form a homogenous dispersion. The Eudragit® RS 30D and Eudragit® RL 30D were added to the mixture, and a vortex mixer was used to form a homogenous mixture. ...

example 3

[0081]A study was performed to compare an immediate release composition (Reference Composition B) and an extended release composition (Example Composition D) of particles comprising an inert core and a coating having cannabinoid CBD. The coating for the particles of the extended release composition additionally comprise release-controlling polymers Eudragit® RS 30D and Eudragit® RL 30D. Table 6 provides a summary of these compositions, including the quantity of each component.

[0082]To prepare the immediate release Reference Composition B, the CBD was mixed with ethanol in a glass beaker to form a homogenous dispersion. The dispersion was then applied onto Suglets® 40 / 45 in a beaker and the coated pellets were dried.

[0083]To prepare the extended release Example Composition D, the CBD was mixed with ethanol in a glass beaker to form a homogenous dispersion. The Eudragit® RS 30D and Eudragit® RL 30D were added to the mixture, and a vortex mixer was used to form a homogenous mixture. Th...

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Abstract

Compositions for the extended release of one or more cannabinoids, in which the compositions comprise a population of particles. Each particle may comprise the one or more cannabinoids, one or more drug-releasing agents, and a core. The APIs may be a cannabinoid, such as cannabidiol or Δ9-tetrahydrocannabinol. The core may comprise an inert material. The one or more cannabinoids may comprise Δ9-tetrahydrocannabinol, cannabidiol, or a combination thereof.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application Ser. No. 62 / 700,107 filed on Jul. 18, 2018, the entirety of which is herein incorporated by reference.FIELD OF INVENTION[0002]The present invention relates to an extended release, multiparticulate drug delivery platform for the oral administration of one or more cannabinoids. The drug delivery system of the present invention achieves a targeted pharmacokinetic profile and provides a uniform drug distribution in the gastrointestinal tract. The delivery system of the present invention can be administered as capsules, tablets, sprinkles, or a stick pack for convenience in administration and handling.BACKGROUND OF THE INVENTION[0003]Cannabis, the plant genus that includes both hemp and marijuana, possesses many medicinal and psychoactive properties that reportedly alleviate a wide range of symptoms experienced in connection with serious medical conditions, while providing saf...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/352A61K31/05A61K9/00
CPCA61K31/05A61K31/352A61K9/1676A61K9/0053A61K9/1635A61K9/1652A61K9/2086A61K9/4808A61K9/009A61K9/1611A61K9/1623A61K9/1664A61K9/0056A61K9/1617A61K9/1658A61K9/48A61K36/185
Inventor NOWAK, REINHARDIQBAL, ZAFARCHAVAN, NEHA
Owner GLATT GMBH
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