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 sufficien...
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| Format: | Article |
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MDPI AG
2024-12-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/17/1/23 |
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| author | Nika Kržišnik Blaž Grilc Robert Roškar |
| author_facet | Nika Kržišnik Blaž Grilc Robert Roškar |
| author_sort | Nika Kržišnik |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-0989e115c0bb405c85988707aaa4ae10 |
| institution | Kabale University |
| issn | 1999-4923 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj-art-0989e115c0bb405c85988707aaa4ae102025-01-24T13:45:36ZengMDPI AGPharmaceutics1999-49232024-12-011712310.3390/pharmaceutics17010023Enteric Coated Pellets with Lactoferrin for Oral Delivery: Improved Shelf Life of the ProductNika Kržišnik0Blaž Grilc1Robert Roškar2Faculty of Pharmacy, University of Ljubljana, Aškerčeva Cesta 7, 1000 Ljubljana, SloveniaFaculty of Pharmacy, University of Ljubljana, Aškerčeva Cesta 7, 1000 Ljubljana, SloveniaFaculty of Pharmacy, University of Ljubljana, Aškerčeva Cesta 7, 1000 Ljubljana, SloveniaBackground/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.https://www.mdpi.com/1999-4923/17/1/23lactoferrinpelletsenteric coatinggastric digestionstabilityshelf life |
| spellingShingle | Nika Kržišnik Blaž Grilc Robert Roškar Enteric Coated Pellets with Lactoferrin for Oral Delivery: Improved Shelf Life of the Product Pharmaceutics lactoferrin pellets enteric coating gastric digestion stability shelf life |
| title | Enteric Coated Pellets with Lactoferrin for Oral Delivery: Improved Shelf Life of the Product |
| title_full | Enteric Coated Pellets with Lactoferrin for Oral Delivery: Improved Shelf Life of the Product |
| title_fullStr | Enteric Coated Pellets with Lactoferrin for Oral Delivery: Improved Shelf Life of the Product |
| title_full_unstemmed | Enteric Coated Pellets with Lactoferrin for Oral Delivery: Improved Shelf Life of the Product |
| title_short | Enteric Coated Pellets with Lactoferrin for Oral Delivery: Improved Shelf Life of the Product |
| title_sort | enteric coated pellets with lactoferrin for oral delivery improved shelf life of the product |
| topic | lactoferrin pellets enteric coating gastric digestion stability shelf life |
| url | https://www.mdpi.com/1999-4923/17/1/23 |
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