Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Dec 11;25(24):5851.
doi: 10.3390/molecules25245851.

Development and Characterization of an Orodispersible Film for Vitamin D3 Supplementation

Irma Elisa Cupone  1 , Eleonora Dellera  1 , Fabio Marra  1 , Andrea Maria Giori  1
Affiliations

Development and Characterization of an Orodispersible Film for Vitamin D3 Supplementation

Irma Elisa Cupone et al. Molecules. .

Abstract

Vitamin D plays a crucial and very well-known role in regulation of calcium homeostasis and bone metabolism and mineralization. However, a huge and more recent body of evidence supports the positive influence of vitamin D on the regulation of immune response, ranging from protection against respiratory tract infections to prevention and management of asthma. Nevertheless, vitamin D deficiency is a very common condition and there is an increasing need for suitable products for proper supplementation, allowing good compliance also in specific populations. Orally disintegrating tablets (ODT) were first developed to overcome the difficulty experienced by pediatric and geriatric patients of swallowing traditional oral dosage forms and, recently, orodispersible films (ODF) are gaining popularity as novel dosage form for assuming active pharmaceutical ingredients, vitamins, and ingredients for food supplements. This study describes a 2000 IU Vitamin D3 ODF for daily intake, consisting of hydrophilic polymers and suitable excipients, manufactured by film-casting process. Elongation-at-break (E%), Young's modulus (Y), and tensile strength (TS) were investigated using a dynamometer. Chemical stability was evaluated assaying the vitamin D3 in the films stored at different environmental conditions. In addition, in vitro disintegration and dissolution studies were performed. Correlation existed between the mechanical properties of the film and the residual water, acting as plasticizer. The stability study showed that vitamin D3 assay was ≥90% also after 3 months at 40 °C. The film disintegrated in less than 1 min and the vitamin D3 released was ≥75% after 15 min. An ODF with suitable properties can be manufactured and used as innovative dosage form for vitamin D3 food supplements.

Keywords: food supplement; immune system; innovative dosage form; mechanical properties; orodispersible film; vitamin D3.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Vitamin D3 orodispersible films: secondary packaging (a), primary packaging (b), and an oral film in the sachet (c).
Figure 2
Figure 2
Dissolution profile of vitamin D3 ODF.
Figure 3
Figure 3
Correlation between water content and mechanical properties of films. (a) Tensile strength and water content correlation; (b) elongation at break and water content correlation; (c) elastic modulus and water content correlation.
Figure 3
Figure 3
Correlation between water content and mechanical properties of films. (a) Tensile strength and water content correlation; (b) elongation at break and water content correlation; (c) elastic modulus and water content correlation.
Figure 4
Figure 4
Coating (a) and slitting (b) process.
Figure 5
Figure 5
Flow chart of manufacturing steps of vitamin D3 ODF.
See this image and copyright information in PMC

References

    1. Gil A., Diaz J.P., Mesa M.D. Vitamin D: Classic and novel actions. Ann. Nutr. Metab. 2018;72:87–95. doi: 10.1159/000486536. - DOI - PubMed
    1. Baeke F., Takiishi T., Korf H., Gysemans C., Mathieu C. Vitamin D: Modulator of the immune system. Curr. Opin. Pharmacol. 2010;10:482–496. doi: 10.1016/j.coph.2010.04.001. - DOI - PubMed
    1. Prietl B., Treiber G., Pieber T.R., Amrein K. Vitamin D and immune function. Nutrients. 2013;5:2502–2521. doi: 10.3390/nu5072502. - DOI - PMC - PubMed
    1. Weir E.K., Thenappan T., Bhargava M., Chen Y. Does vitamin D deficiency increase the severity of COVID-19? Clin. Med. 2020;20:107–108. doi: 10.7861/clinmed.2020-0301. - DOI - PMC - PubMed
    1. Bergman P., Lindh A.U., Bjorkhem-Bergman L., Lindh J.D. Vitamin D and Respiratory Tract Infections: A SystematicReview and Meta-Analysis of Randomized ControlledTrials. PLoS ONE. 2013;8:e65835. doi: 10.1371/journal.pone.0065835. - DOI - PMC - PubMed

MeSH terms