Oral dissolvable film that includes plant extract
Inventors
Allen, Eric • Davidson, Robert • LaRosa, Tony • Reid, David
Assignees
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Publication Number
US-11266625-B2
Publication Date
2022-03-08
Expiration Date
Abstract
Films (ODFs) that include botanical extract are provided, as well as methods of making and using the same.
Core Innovation
The invention relates to oral dissolvable films and oral thin films that incorporate raw botanical extracts, including cannabis extracts, into a dry film that is non-sticky and easily handled for oral delivery. The stated problem is that direct incorporation of viscous raw botanical extracts into dosage forms is difficult and can create handling and dosing challenges. The film is positioned for placement in the oral cavity, including buccal and sublingual delivery.
The composition includes water, a binder selected from pectin and microcrystalline cellulose or a combination, a lipid selected from cocoa butter and lecithin or a combination, and an emulsifier selected from glycerin, propylene glycol, and polyethylene glycol or combinations. A cannabis extract is encapsulated by the lipid in the oral dissolvable film, and flavoring agent and sweetener are also included to support oral use.
The oral dissolvable film enables quick dissolving dosage forms and includes release profile options such as immediate release and sustained release, as well as delayed, modified, extended, and controlled release. The film is also described as optionally including additional components such as powder coating, dyes or pigments, preservatives, and dough conditioner, and as being used with packaging as an anti-sticking system.
Claims Coverage
The independent claim set coverage is centered on one independent claim defining an oral dissolvable film formulation and encapsulation of a cannabis extract by a lipid, with multiple dependent claims refining configuration, dissolution behavior, entity scope for the cannabis extract, additional components, and release profile options. The inventive features that define the core claimed structure and function are the formulation composition ranges and the encapsulation relationship between the lipid and cannabis extract.
Oral dissolvable film comprising defined formulation ranges
An oral dissolvable film consisting essentially of about 2–24 wt. % water, about 40–50 wt. % binder selected from pectin, microcrystalline cellulose, and a combination, about 0.1–22 wt. % lipid selected from cocoa butter, lecithin, and a combination, about 3–22 wt. % emulsifier selected from glycerin, propylene glycol, polyethylene glycol, and combinations, at least about 25 wt. % cannabis extract, greater than about 1 wt. % to about 10 wt. % flavoring agent selected from mint, spearmint, peppermint, and combinations, and greater than about 1 wt. % to about 40 wt. % sweetener selected from sucralose, acesulfame potassium, and combinations.
Encapsulation of cannabis extract by lipid
The cannabis extract is encapsulated by the lipid in the oral dissolvable film.
Across the independent-claim core, the claimed subject matter is an oral dissolvable film defined by specific wt.% formulation ranges, where the cannabis extract is encapsulated by a lipid, together supporting oral dissolvable delivery with defined flavoring and sweetness.
Stated Advantages
Provides a quick-dissolving dosage form that is stable and durable.
Enables dosing accuracy.
Supports patients with swallowing issues and nausea issues.
Allows quicker onset at lower doses.
Enables targeting sensitive actives.
Provides a non-sticky, easily handled film.
Documented Applications
Oral delivery of botanical extracts including cannabis extracts using an oral dissolvable film for buccal and sublingual administration.
Use of the film to provide release profile options including sustained release, delayed release, modified release, extended release, or controlled release.
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