Patent on modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics

The development of modified release gamma-hydroxybutyrate represents a major advancement in narcolepsy therapy, aiming to improve both patient compliance and treatment effectiveness. Traditional formulations of gamma-hydroxybutyrate (GHB) require multiple nightly doses, which can disrupt sleep and reduce overall quality of life. The patented formulation described in US11896572B2 introduces a novel modified release system that extends the duration of action, making it possible to achieve 6 to 8 hours of therapeutic benefit with a single bedtime dose.

How Modified Release Gamma-Hydroxybutyrate Works

This formulation combines immediate-release and delayed-release mechanisms to provide both rapid onset and sustained therapeutic effects. The immediate-release portion allows GHB to take effect quickly, while the delayed-release portion maintains drug levels over time, reducing abrupt concentration peaks and minimizing side effects. This dual-action delivery is designed to improve pharmacokinetics and ensure more consistent symptom control.

The Role of CELLETS® in Modified Release Gamma-Hydroxybutyrate Drug Release

A central innovation in this patent involves the use of CELLETS®, spherical microcrystalline cellulose particles that provide a stable foundation for modified release drug delivery. In the immediate-release portion, CELLETS® carry a coating of sodium oxybate combined with a binder such as povidone. Meanwhile, the delayed-release portion relies on specialized polymers and hydrogenated vegetable oil, which work together to control pH-dependent release in the gastrointestinal tract. Furthermore, CELLETS® maintain consistent particle size and predictable dissolution rates, which in turn improve absorption and strengthen the overall pharmacokinetic profile of modified release gamma-hydroxybutyrate.

The CELLETS® play a crucial role in maintaining particle size consistency, which is important for ensuring predictable dissolution and absorption rates, thereby enhancing the overall pharmacokinetic profile of the drug. This innovation represents an advancement over traditional formulations by offering more reliable and patient-friendly narcolepsy management. This specific patent, recommend the following MCC Sphere types: CELLETS® 90, CELLETS® 100 or CELLETS® 127.

Advantages for Narcolepsy Patients

The patented system combines immediate and delayed release. This design allows for a once-nightly dose, which improves adherence and convenience for patients. The innovation also ensures more restorative sleep. At the same time, it reduces the burden of frequent dosing. As a result, narcolepsy management becomes more reliable and patient-friendly.

By refining the pharmacokinetics of GHB, modified release gamma-hydroxybutyrate offers a significant improvement over traditional formulations.

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This text was generated by chatGPT engine version GPT‑4o, on Oct 21, 2024. Image was generated with Adobe Firefly.