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

Author:

Cupone Irma Elisa1ORCID,Roselli Giuliana2ORCID,Marra Fabio1ORCID,Riva Marika2,Angeletti Silvia3,Dugo Laura4ORCID,Spoto Silvia5,Fogolari Marta3ORCID,Giori Andrea Maria2ORCID

Affiliation:

1. Ibsa Farmaceutici Italia, Cassina de’ Pecchi, 20051 Milan, Italy

2. Ibsa Farmaceutici Italia, 26900 Lodi, Italy

3. Operative Research Unit of Clinical Laboratory, University of Rome Campus Bio-Medico, 00128 Rome, Italy

4. Department of Science and Technology for Sustainable Development and One Health, University Campus Bio-Medico of Rome, 00128 Rome, Italy

5. Department of Diagnostic and Therapeutic Medicine, University Campus Bio-Medico of Rome, 00128 Rome, Italy

Abstract

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 (AUC0–8, Tmax, and Cmax) 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.

Publisher

MDPI AG

Subject

Pharmaceutical Science

Reference51 articles.

1. World Health Organization (2001). Iron Deficiency Anaemia: Assessment, Prevention and Control: A Guide for Programme Managers, World Health Organization.

2. FAO, and WHO (2004). Report of a Joint FAO/WHO Expert Consultation on Human Vitamin and Mineral Requirements. Vitamin and Mineral Requirements in Human Nutrition, Food and Agriculture Organization of the United Nations.

3. Review on iron and its importance for human health;Abbaspour;J. Res. Med. Sci.,2014

4. Iron deficiency in sports—Definition, influence on performance and therapy;Cordes;Swiss Med. Wkly.,2015

5. Iron deficiency in the elderly population, revisited in the hepcidin era;Busti;Front. Pharmacol.,2014

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