Orodispersible Film Based on Maltodextrin: A Convenient and Suitable Method for Iron Supplementation

Orodispersible film (ODF) is an innovative dosage form used to administer drugs and nutrients, designed to disintegrate or dissolve in the oral cavity without needing water. One of the advantages of ODF is that it is suitable for administration in older people and children who have difficulty swallo...

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Autores principales: Cupone, Irma Elisa, Roselli, Giuliana, Marra, Fabio, Riva, Marika, Angeletti, Silvia, Dugo, Laura, Spoto, Silvia, Fogolari, Marta, Giori, Andrea Maria
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10303362/
https://www.ncbi.nlm.nih.gov/pubmed/37376024
http://dx.doi.org/10.3390/pharmaceutics15061575
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author Cupone, Irma Elisa
Roselli, Giuliana
Marra, Fabio
Riva, Marika
Angeletti, Silvia
Dugo, Laura
Spoto, Silvia
Fogolari, Marta
Giori, Andrea Maria
author_facet Cupone, Irma Elisa
Roselli, Giuliana
Marra, Fabio
Riva, Marika
Angeletti, Silvia
Dugo, Laura
Spoto, Silvia
Fogolari, Marta
Giori, Andrea Maria
author_sort Cupone, Irma Elisa
collection PubMed
description Orodispersible film (ODF) is an innovative dosage form used to administer drugs and nutrients, designed to disintegrate or dissolve in the oral cavity without needing water. One of the advantages of ODF is that it is suitable for administration in older people and children who have difficulty swallowing because of psychological or physiological deficiencies. This article describes the development of an ODF based on maltodextrin, which is easy to administer, has a pleasant taste, and is suitable for iron supplementation. An ODF containing 30 mg of iron as pyrophosphate and 400 µg of folic acid (iron ODF) was developed and manufactured on an industrial scale. The kinetic profile for serum iron and folic acid upon consumption of ODF compared with a Sucrosomial(®) iron capsule (known for its high bioavailability) was evaluated in a crossover clinical trial. The study was conducted in nine healthy women, and the serum iron profile (AUC(0–8), T(max,) and C(max)) of both formulations was defined. Results showed that the rate and extent of elemental iron absorption with iron ODF was comparable to that obtained using the Sucrosomial(®) iron capsule. These data represent the first evidence of iron and folic acid absorption concerning the newly developed ODF. Iron ODF was proven to be a suitable product for oral iron supplementation.
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spelling pubmed-103033622023-06-29 Orodispersible Film Based on Maltodextrin: A Convenient and Suitable Method for Iron Supplementation Cupone, Irma Elisa Roselli, Giuliana Marra, Fabio Riva, Marika Angeletti, Silvia Dugo, Laura Spoto, Silvia Fogolari, Marta Giori, Andrea Maria Pharmaceutics Article Orodispersible film (ODF) is an innovative dosage form used to administer drugs and nutrients, designed to disintegrate or dissolve in the oral cavity without needing water. One of the advantages of ODF is that it is suitable for administration in older people and children who have difficulty swallowing because of psychological or physiological deficiencies. This article describes the development of an ODF based on maltodextrin, which is easy to administer, has a pleasant taste, and is suitable for iron supplementation. An ODF containing 30 mg of iron as pyrophosphate and 400 µg of folic acid (iron ODF) was developed and manufactured on an industrial scale. The kinetic profile for serum iron and folic acid upon consumption of ODF compared with a Sucrosomial(®) iron capsule (known for its high bioavailability) was evaluated in a crossover clinical trial. The study was conducted in nine healthy women, and the serum iron profile (AUC(0–8), T(max,) and C(max)) of both formulations was defined. Results showed that the rate and extent of elemental iron absorption with iron ODF was comparable to that obtained using the Sucrosomial(®) iron capsule. These data represent the first evidence of iron and folic acid absorption concerning the newly developed ODF. Iron ODF was proven to be a suitable product for oral iron supplementation. MDPI 2023-05-23 /pmc/articles/PMC10303362/ /pubmed/37376024 http://dx.doi.org/10.3390/pharmaceutics15061575 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Cupone, Irma Elisa
Roselli, Giuliana
Marra, Fabio
Riva, Marika
Angeletti, Silvia
Dugo, Laura
Spoto, Silvia
Fogolari, Marta
Giori, Andrea Maria
Orodispersible Film Based on Maltodextrin: A Convenient and Suitable Method for Iron Supplementation
title Orodispersible Film Based on Maltodextrin: A Convenient and Suitable Method for Iron Supplementation
title_full Orodispersible Film Based on Maltodextrin: A Convenient and Suitable Method for Iron Supplementation
title_fullStr Orodispersible Film Based on Maltodextrin: A Convenient and Suitable Method for Iron Supplementation
title_full_unstemmed Orodispersible Film Based on Maltodextrin: A Convenient and Suitable Method for Iron Supplementation
title_short Orodispersible Film Based on Maltodextrin: A Convenient and Suitable Method for Iron Supplementation
title_sort orodispersible film based on maltodextrin: a convenient and suitable method for iron supplementation
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10303362/
https://www.ncbi.nlm.nih.gov/pubmed/37376024
http://dx.doi.org/10.3390/pharmaceutics15061575
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