# US 11,439,595 B2 · Immediate release formulations of cannabinoids

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- Number: US 11,439,595 B2
- Document ID: US11439595B2
- Status: Granted
- Kind: B2
- Application number: 16/513,154
- Filed: 2019-07-16
- Published: 2020-02-27
- Granted: 2022-09-13
- Earliest claimed: 2018-07-18
- Assignees: Glatt GmbH
- Applicants: Glatt GmbH
- Inventors: Reinhard Nowak; Zafar Iqbal; Mohammed Taleb
- Web page: https://patentgrep.com/patent/US11439595B2

## CPC

- A61K 9/1652: {Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin (homeopathic globules A61K9/1623)}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/1611: {Inorganic compounds}
- A61K 9/1617: {Organic compounds, e.g. phospholipids, fats}
- A61K 9/1623: {Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules}
- A61K 9/1635: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/1658: {Proteins, e.g. albumin, gelatin}
- A61K 9/1664: {Compounds of unknown constitution, e.g. material from plants or animals (oils, fats, waxes, shellac A61K9/1617)}
- A61K 9/1676: {having a drug-free core with discrete complete coating layer containing drug (adsorbates of liquid drug formulations on inert powders without simultaneous granulation step A61K9/141; with further drug-free outer coating A61K9/5078; drug conjugated to non-active particles A61K47/6921)}
- A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)}
- A61K 31/352: condensed with carbocyclic rings, e.g. methantheline {(cannabinoids A61K31/658)}
- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 36/3482: {Cannabis}
- A61K 9/009: {Sachets, pouches characterised by the material or function of the envelope (with gastric retention A61K9/0065; sachets which are not administered but function merely as a container are classified according to the content, e.g. sachets comprising powder for reconstitution of a drink A61K9/0095)}
- A61K 9/2086: {Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat (active cores with a complete drug-free outer coat A61K9/28)}
- A61K 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

Compositions for the immediate release of one or more cannabinoids, in which the compositions comprise a population of particles. Each particle may comprise the one or more cannabinoids and one or more intra-granule excipients. Alternatively, each particle may comprise the one or more cannabinoids and a porous bead core. The composition may be prepared by a method that involves combining the one or more cannabinoids with the one or more intra-granule excipients, and then granulating the combination, such as through fluid bed granulation, shear-induced wet granulation, or spray granulation. The composition may also be prepared by a method that involves mixing the one or more cannabinoids with a population of porous bead cores.

## Claims

### Claim 1

A composition for immediate release of one or more cannabinoids, the composition comprising a population of particles, wherein each particle comprises:
(a) the one or more cannabinoids;
(b) one or more intra-granule excipients;
wherein about 80% of the particles is between about 20 μm and about 2000 μm in diameter; and
wherein the composition releases at least about 30% of the one or more cannabinoids over a period of about 30 minutes or less.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the one or more cannabinoids comprises Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD), or a combination thereof.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the one or more cannabinoids comprises a combination of THC and CBD.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the one or more intra-granule excipients comprises one or more diluents, one or more binders, one or more fillers, one or more surfactants/emulsifying agents, one or more disintegrants, or a combination thereof.

### Claim 5 (depends on 1)

The composition of claim 1, wherein the one or more intra-granule excipients comprises one or more cellulose derivatives.

### Claim 6 (depends on 5)

The composition of claim 5, wherein the one or more cellulose derivatives is selected from the group consisting of lactose, isomalt, cellulose, starch, cyclodextrin, mannitol, sorbitol, and a combination thereof.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the composition releases about 30% of the one or more cannabinoids over a period of about 30 minutes or less.

### Claim 8 (depends on 1)

The composition of claim 1, wherein about 70% of the particles is between about 100 μm and about 700 μm in diameter.