Patents US20240350437A1 and US20240350438A1 – Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state – cover pharmaceutical compositions and systems that deliver oral drugs in a controlled and consistent way. The invention tackles challenges in delayed or multi-stage drug release. This is especially important for active pharmaceutical ingredients (APIs) with complex absorption profiles or sensitivity to environmental factors, such as pH. Specifically, the formulation uses gamma-hydroxybutyrate (GHB) as the API. GHB belongs to sedatives and doctors approve it for treating narcolepsy with cataplexy in adults.
The patent focuses on multiparticulate formulations. Small spherical particles or granules carry APIs and polymers in coated layers. These coatings control drug release rates, enabling gradual, sustained, or targeted delivery in the gastrointestinal tract. As a result, the technology delivers precise therapeutic effects, reduces dosing frequency, and minimizes side effects caused by rapid drug release.
Moreover, the document highlights improvements in coating techniques and the use of stabilizing agents. These measures enhance the integrity and functionality of the drug delivery system. Additionally, the patent addresses scalability and manufacturing efficiency. Therefore, these formulations are suitable for large-scale production while maintaining consistent dosage and performance.
Potential applications include treatments for chronic conditions or drugs requiring precise dosing. The invention allows flexibility in formulating a range of APIs. This customization meets specific therapeutic needs. By enabling controlled drug release, the technology improves medication adherence and efficacy, benefiting both patients and healthcare providers.
What is the role of MCC pellets as drug carrier of gamma-hydroxybutyrate compositions?
This patent US20240350437A1 focuses on an innovative approach to creating multiparticulate pharmaceutical formulations for oral administration. It introduces CELLETS®, a key component of the drug delivery system. CELLETS® are small, uniform spherical particles made of inert microcrystalline cellulose (MCC). They act as carriers for active pharmaceutical ingredients (APIs). These particles provide an optimal surface for drug layering, which facilitates precise drug release profiles. In this patent, the following types of CELLETS® are used:
- CELLETS® 90
- CELLETS® 100
- CELLETS® 127
The invention tackles challenges in achieving controlled drug release, especially for APIs requiring multi-step or delayed absorption. By coating these MCC carriers with specific polymers and APIs, the system delivers drugs at targeted points in the gastrointestinal tract. This approach is particularly beneficial for drugs with narrow therapeutic windows or sensitivity to pH levels.
Furthermore, the patent highlights improvements in coating techniques and formulation stability. These advancements ensure high reproducibility and efficient manufacturing. Consequently, the multiparticulate system offers dosage flexibility, fewer side effects, and improved patient adherence compared to conventional tablets or capsules.
Additionally, the invention supports the development of treatments for chronic conditions, where consistent and predictable drug release is critical. Applying CELLETS® in this context demonstrates their versatility and potential to enhance both the efficacy and safety of oral drug delivery systems.
Document information
Document Type and Numbers:
- (“Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state”).
- US20240350438A1 (“Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state”).
Inventors:
Disclaimer
This text was partly generated by chatGPT engine version GPT‑4o, on Nov 21, 2024. Image was generated with Adobe Firefly.
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