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.