Ghb Formulation And Method For Its Manufacture
Patent No. US11364215 (titled "Ghb Formulation And Method For Its Manufacture") was filed by Us Bank Na on Apr 5, 2021.
What is this patent about?
’215 is related to the field of pharmaceutical formulations, specifically those designed for the controlled release of gamma-hydroxybutyrate (GHB). GHB, also known as oxybate, is used to treat conditions like narcolepsy, cataplexy, and excessive daytime sleepiness. Due to its short half-life, frequent dosing is typically required, which can be inconvenient. The patent addresses the need for a formulation that provides sustained therapeutic levels of GHB with less frequent administration.
The underlying idea behind ’215 is to create a controlled-release GHB formulation using ion-exchange resins. GHB is loaded onto these resins, forming a resinate. The release of GHB is then controlled by the exchange of GHB ions with other ions present in the gastrointestinal tract. This approach allows for a sustained release profile, reducing the need for multiple daily doses. The formulation can be further modified with coatings or other agents to fine-tune the release rate.
The claims of ’215 focus on methods of treating narcolepsy, cataplexy, or excessive daytime sleepiness by administering a single daily dose of GHB. This dose includes both controlled-release and immediate-release GHB-containing particles . The total amount of GHB in the single dose is equivalent to 4.0g to 12.0g of sodium gamma-hydroxybutyrate, and the combination of immediate and controlled release provides therapeutic levels for about 6-8 hours. The administration is specified to be with food or a caloric liquid.
In practice, the GHB resinate particles are designed to release GHB gradually as they travel through the digestive system. The immediate-release component provides an initial therapeutic dose, while the controlled-release component maintains therapeutic levels over an extended period. The rate of GHB release can be adjusted by varying the resin particle size, the degree of crosslinking in the resin, or by applying coatings that control the diffusion of ions into and out of the resin particles. The presence of food or caloric liquid further aids in gastric retention and sustained release.
’215 differentiates itself from prior approaches by utilizing ion-exchange resins to achieve controlled release of GHB, particularly in the context of a once-daily dosage. Unlike conventional extended-release tablets, this formulation can be administered as a liquid suspension or powder, potentially improving patient compliance. The use of GBL as a prodrug that converts to GHB within the resin matrix is another key aspect, potentially simplifying manufacturing and handling. The patent also recognizes the importance of the limited anion capacity in the gut and suggests strategies to overcome this limitation, such as including supplemental anions in the formulation.
How does this patent fit in bigger picture?
Technical landscape at the time
In the mid-2010s when ’215 was filed, modified-release formulations were often achieved through coatings or matrix systems, at a time when controlling drug release was typically implemented by manipulating the diffusion of the drug out of the dosage form, when hardware or software constraints made precise control over drug release profiles non-trivial.
Novelty and Inventive Step
Claims were amended during prosecution. Claims were objected to as being duplicates of other claims. Claims were rejected under 35 U.S.C. 112(b) as being indefinite and under 35 U.S.C. 103 as obvious. The application was given a final rejection.
Claims
This patent contains 15 claims, with claims 1 and 9 being independent. The independent claims are directed to methods of treating narcolepsy, cataplexy, or excessive daytime sleepiness by administering gamma-hydroxybutyrate formulations. The dependent claims generally specify particular doses, formulations, or modes of administration within the scope of the independent claims.
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Date
Description
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US11364215
- Application Number
- US17222579
- Filing Date
- Apr 5, 2021
- Status
- Granted
- Expiry Date
- Feb 18, 2036
- External Links
- Slate, USPTO, Google Patents