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Homogeneity and mechanical properties of orodispersible films loaded with pellets
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Homogeneity and mechanical properties of orodispersible films loaded with pellets

Orodispersible films loaded with pellets provide a convenient and patient-friendly approach for drug administration. They dissolve quickly in the mouth, eliminating the need for water and making them ideal for children, elderly patients, and people with swallowing difficulties. Furthermore, combining films with pellets adds the benefits of controlled release and dose flexibility.

Challenges in Formulating Orodispersible Films Loaded with Pellets

Formulating orodispersible films loaded with pellets remains challenging. Large pellets at high concentrations often reduce film homogeneity and weaken mechanical strength. As a result, maintaining tear resistance while ensuring rapid disintegration is essential. Therefore, optimizing the balance between pellet content and film properties is critical for successful formulations.

Study Objective and Method

This study aimed to create fast-disintegrating ODFs with uniformly distributed pellets without compromising mechanical integrity. We used hypromellose films incorporating placebo pellets of 100 µm and 200 µm in concentrations from 20% to 45% w/w. A planetary mixer (Thinky) effectively prepared a uniform suspension before solvent casting. Consequently, the films achieved a consistent pellet distribution and smooth texture.

Effects of Pellet Size and Concentration

Pellet size and concentration significantly influenced film properties. Notably, only 100 µm pellets above 40% reduced tear resistance. In contrast, the presence of pellets accelerated disintegration. Moreover, larger particles shortened disintegration time by up to 60%. Thus, selecting the right pellet size and concentration can improve film performance without sacrificing strength.

Homogeneity and Film Quality

Achieving uniform pellet distribution is crucial for dosing accuracy and overall quality. Films cast at 500 µm and 800 µm gap heights showed excellent homogeneity, with an even number of particles per unit area. Therefore, proper casting and mixing strategies ensure consistent orodispersible films loaded with pellets that meet pharmaceutical standards.

Conclusion

Orodispersible films loaded with pellets combine rapid disintegration, mechanical strength, and dose flexibility. By carefully controlling pellet size, concentration, and casting parameters, manufacturers can produce reliable, patient-friendly ODFs. Ultimately, this approach strengthens ODFs’ potential as a next-generation drug delivery system.

Reference

This article on homogeneity and mechanical properties of orodispersible films loaded with pellets was published on Oct 20 2024 on ScienceDirect.

Document information

Pellet materials

Pellets in two different sizes: CELLETS® 100 and CELLETS® 200, composed of 100% microcrystalline cellulose, were used as model spherical granules.

Authors

Katarzyna Centkowska, Martyna Szadkowska, Marta Basztura, Małgorzata Sznitowska

Source

published on Oct 20 2024 on ScienceDirect under CC BY 4.0 license.

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Modified release Gamma-Hydroxybutyrateadobe firefly
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Patent on modified-release Gamma-Hydroxybutyrate formulations having improved pharmacokinetics

The patent application titled “Modified Release Gamma-Hydroxybutyrate (GHB) Formulations Having Improved Pharmacokinetics” (US20240148685) focuses on improving the delivery of GHB, a substance used for treating sleep disorders like narcolepsy, through modified-release formulations. The goal is to optimize GHB’s absorption, enhancing patient convenience and compliance by reducing the need for multiple nightly doses.

The key innovation in the patent is the use of CELLETS®, microcrystalline spheres often employed as a neutral core for drug layering. In this application, CELLETS® act as carriers for the active ingredient, allowing precise control over the release profile of GHB. These small spherical particles, made from microcrystalline cellulose, offer uniform size and high mechanical strength, ensuring consistent drug loading and a controlled release rate.

In this patent, the CELLETS® are coated with various layers of GHB and release-modifying agents, enabling a predictable and sustained release of the active substance. This modified release profile allows GHB to be administered in a once-nightly dose rather than requiring the patient to wake up for a second dose, which was a limitation with previous immediate-release formulations. This extended-release mechanism helps maintain stable plasma concentrations of GHB over an 8-hour period, improving both the efficacy of the treatment and patient compliance.

The innovation emphasizes addressing the shortcomings of existing GHB formulations by ensuring a better pharmacokinetic profile—particularly regarding absorption, bioavailability, and minimizing drug levels in the bloodstream after the therapeutic effect has been achieved. In this specific patent, the following MCC Sphere types are recommended: CELLETS® 90, CELLETS® 100, CELLETS® 127.

Document information

Document Type and Number: (“Modified release Gamma-Hydroxybutyrate formulations having improved pharmacokinetics”)
Kind Code: A1

Inventors:

Dubow, Jordan (Lyon, FR)
Guillard, Hervé (Villeurbanne, FR)
Mégret, Claire (Lyon, FR)
Dubuisson, Jean-françois (Lyon, FR)

Disclaimer

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

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