Aquestive Therapeutics has filed a patent for an oral film that delivers one or more actives with a controlled dissolution profile. The film can be used to treat various diseases and conditions, such as epilepsy and seizures. The patent claims have been canceled. GlobalData’s report on Aquestive Therapeutics gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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According to GlobalData’s company profile on Aquestive Therapeutics, nanoparticle drug conjugates was a key innovation area identified from patents. Aquestive Therapeutics's grant share as of June 2023 was 1%. Grant share is based on the ratio of number of grants to total number of patents.
Oral film for controlled delivery of actives
A recently filed patent (Publication Number: US20230149304A1) describes a self-supporting oral film for delivering a specific amount of an active ingredient in a single unit dose. The film is composed of a water-soluble or water-swellable polymer matrix, with the active ingredient being clobazam. The active ingredient has an average particle size D90 of less than 160 microns, ensuring effective dissolution in a medium within approximately 4 minutes of placement.
The patent also specifies additional components that can be included in the film, such as sweeteners, flavors, fillers, plasticizers, dyes, pigments, permeation enhancers, buffers, preservatives, silicon dioxide, anti-tacking agents, or any combination thereof. These additives can enhance the sensory experience or stability of the film.
The average particle size of the active ingredient, clobazam, is further refined in subsequent claims. Claim 47 specifies an average particle size D90 of less than 120 microns, while claim 48 specifies an average particle size D50 of less than 30 microns. Claim 49 narrows it down even further, stating an average particle size D10 of less than 10 microns.
The individual unit dose of the oral film can contain between 2 mg to 20 mg of clobazam, as stated in claim 50. Claims 51, 52, and 53 provide specific examples of individual unit doses containing 5 mg, 10 mg, and 20 mg of clobazam, respectively.
The patent also includes a method claim (claim 54) that describes the use of the oral film for treating epilepsy and/or seizures in humans.
The water-soluble or water-swellable polymer matrix of the film can be composed of various polymers, as listed in claim 55. Examples include polyethylene oxide (PEO), pullulan, hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HPC), polyvinyl pyrrolidone, carboxymethyl cellulose, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methyl-methacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, or combinations thereof.
Claim 56 specifies that the polymer can be polyethylene oxide (PEO), with claim 57 stating that the PEO should have a molecular weight of at least 100,000. Claim 58 further refines the molecular weight range to be between 100,000 and 300,000.
Lastly, claim 59 provides a specific range for the average particle size D90 of the active ingredient, clobazam, stating it should be between 8 microns and no more than 160 microns.
In summary, the patent describes a self-supporting oral film for delivering a specific amount of clobazam, an active ingredient, in a single unit dose. The film is composed of a water-soluble or water-swellable polymer matrix and can include various additives. The average particle size of the active ingredient and the molecular weight of the polymer are specified, and the film can be used for treating epilepsy and/or seizures in humans.
To know more about GlobalData’s detailed insights on Aquestive Therapeutics, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies
