Ghb Formulation And Method For Its Manufacture
Patent No. US11077079 (titled "Ghb Formulation And Method For Its Manufacture") was filed by Us Bank Na on Dec 10, 2020.
What is this patent about?
’079 is related to the field of pharmaceutical formulations, specifically those designed for the controlled release of gamma-hydroxybutyrate (GHB), also known as oxybate. GHB is used to treat narcolepsy and other sleep disorders, but its short half-life requires frequent dosing. This patent addresses the need for a formulation that provides sustained release, reducing the frequency of administration and improving patient compliance.
The underlying idea behind ’079 is to create a GHB formulation using ion-exchange resins to control the drug's release. Instead of directly releasing GHB, the drug is bound to the resin, and its release is governed by the exchange of GHB ions with other anions present in the gastrointestinal tract. This approach allows for a sustained release profile, potentially enabling once-daily dosing.
The claims of ’079 focus on methods of treating narcolepsy, cataplexy, or excessive daytime sleepiness by administering a single daily dose of oxybate. The oxybate is delivered via a sachet containing a solid formulation that is mixed with water before oral administration. Crucially, the formulation includes both an immediate release component and a controlled release component , providing both rapid onset and sustained therapeutic effect.
In practice, the invention involves loading GHB onto ion-exchange resin beads. These beads can then be formulated as a solid for reconstitution with water. The immediate release component could be achieved by using uncoated beads, while the controlled release component could be achieved by coating the beads with a polymer film or by manipulating the resin's properties, such as particle size or degree of crosslinking. The release rate is further influenced by the availability of anions in the gut, primarily chloride.
A key differentiation from prior approaches lies in the use of ion-exchange resins to manage GHB release, particularly in the context of high-dose, highly soluble drugs. The patent also explores the use of gamma-butyrolactone (GBL), a prodrug of GHB, which can be converted to GHB directly within the resin beads. This approach simplifies manufacturing and potentially allows for point-of-use preparation, avoiding the need to handle regulated GHB directly. The addition of supplemental anions can further modulate the release profile, ensuring adequate GHB release even when natural anion levels in the gut are low.
How does this patent fit in bigger picture?
Technical landscape at the time
In the mid-2010s when ’079 was filed, pharmaceutical formulations at a time when modified release formulations were typically implemented using polymer coatings or matrix embedding to control drug diffusion, when systems commonly relied on adjusting polymer properties to achieve desired release profiles, and when hardware or software constraints made precise control of drug release kinetics non-trivial.
Novelty and Inventive Step
The examiner allowed the claims because the prior art (Alshaikh, Luhn, Borgen and Allphin) did not teach or suggest administering a single daily dose of a solid oxybate formulation using a sachet. The examiner considered arguments and a declaration under 37 CFR 1.132 filed by the applicant.
Claims
This patent contains 18 claims, with claims 1 and 10 being independent. The independent claims focus on methods of treating narcolepsy, cataplexy, or excessive daytime sleepiness associated with narcolepsy by administering a single daily dose of a solid oxybate formulation. The dependent claims generally specify details and limitations to the methods described in the independent claims.
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Date
Description
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US11077079
- Application Number
- US17118041
- Filing Date
- Dec 10, 2020
- Status
- Granted
- Expiry Date
- Feb 18, 2036
- External Links
- Slate, USPTO, Google Patents