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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Bibliographic Details
Published in:Pharmaceutics 2023-05, Vol.15 (6), p.1575
Main Authors: Cupone, Irma Elisa, Roselli, Giuliana, Marra, Fabio, Riva, Marika, Angeletti, Silvia, Dugo, Laura, Spoto, Silvia, Fogolari, Marta, Giori, Andrea Maria
Format: Article
Language:English
Subjects:
Acids
Analysis
Bioavailability
Dextrins
Drug dosages
Food
food supplement
Iron
maltodextrin
Methods
Older people
orodispersible film
patient acceptability
Pharmaceuticals
Physiology
Rheology
Teenagers
Viscosity
Vitamin B
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Summary: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 , T and C ) 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.
ISSN:1999-4923
1999-4923
DOI:10.3390/pharmaceutics15061575