20.500.12556/RUL-166300 Enteric coated pellets with lactoferrin for oral delivery improved shelf life of the product Background/Objectives: Lactoferrin (Lf), a multifunctional iron-binding protein, has considerable potential for use as an active ingredient in food supplements due to its numerous positive effects on health. As Lf is prone to degradation, we aimed to develop a formulation that would ensure sufficient stability of Lf in the gastrointestinal tract and during product storage. Methods: A simple, efficient, and well-established technology that has potential for industrial production was used for the double-coating of neutral pellet cores with an Lf layer and a protective enteric coating. Results: The encapsulation efficiency was 85%, which is among the highest compared to other reported Lf formulations. The results of the dissolution tests performed indicated effective protection of Lf from gastric digestion. A comprehensive stability study showed that the stability was similar regardless of the neutral pellet core used, while a significant influence of temperature, moisture, product composition, and packaging on the stability of Lf were observed, and were therefore considered in the development of the final product. The experimentally determined shelf life is extended from 15 to almost 30 months if the product is stored in a refrigerator instead of at room temperature, which ensures the commercial applicability of the product. Conclusion: We successfully transferred a technology commonly used for small molecules to a protein-containing product, effectively protected it from the destructive effects of gastric juice, and achieved an acceptable shelf life. lactoferrin pellets enteric coating gastric digestion stability shelf life laktoferin pelete enterična obloga želodčna prebava stabilnost rok trajanja zdravila true false true Angleški jezik Slovenski jezik Članek v reviji 2025-01-07 03:48:02 2025-01-08 11:34:21 2025-11-24 14:55:01 0000-00-00 00:00:00 2025 0 0 17 str. iss. 1, art. 23 Vol. 17 2025 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 615 1999-4923 10.3390/pharmaceutics17010023 220930563 pharmaceutics-17-00023-v2.pdf pharmaceutics-17-00023-v2.pdf 1 CFD9C06063755FE3657AD1901F316C45 1a7e2090e617e50598b29615e3837d83556004f460eaa9f8373e9ff2487ada86 adad6eef-ccd9-11ef-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=197828 https://www.mdpi.com/1999-4923/17/1/23 1 1ffda214-cca1-11ef-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=197811 Fakulteta za farmacijo 0 0 0