Study · Molecules (Basel, Switzerland) · 2020Conflicts declared

Cholecalciferol orodispersible film developed and tested for stability

What it found

A new 2000 IU cholecalciferol film that dissolves in the mouth was made and tested in the lab.

It broke down in under 1 minute and released most of the vitamin D3 within 15 minutes.

What they found

Film dissolves quickly

The film disintegrated in less than 1 minute in lab tests. More than 85% of the vitamin D3 was released within 15 minutes.

Vitamin D3 stays stable

After 3 months at 40 °C, the amount of vitamin D3 in the film remained at 122.1% of the claimed value. Vitamin C and vitamin E helped protect it from breaking down.

Mechanical properties

The film's strength and stretchiness were linked to its water content. A water content between 8.0% and 11.0% gave the film the right flexibility and strength for manufacturing and handling.

Microbial safety

Water activity stayed below 0.600, which helps prevent microbial growth. Microbiological tests confirmed the film met safety limits for oral products.

Industrial production

The film was successfully made at industrial scale, producing about 300,000 films of 2000 IU each from one batch. The process was transferred from lab to factory.

What the authors conclude

“An orodispersible film with suitable properties and containing 2000 IU of vitamin D3 was developed and manufactured as innovative dosage form for vitamin D3 supplementation.”
Cupone IE, Dellera E, Marra F, Giori AM, 2020

Also in their conclusions

  • They state that an orodispersible film with suitable properties and containing 2000 IU of vitamin D3 was developed and manufactured as an innovative dosage form for vitamin D3 supplementation.
  • They note that the manufactured films are flexible, easy to handle, have a pleasant taste, and are free of organic solvent.
  • They say that such properties allow good compliance for specific groups such as children and the elderly.

How it was done

Many people do not get enough vitamin D from sunlight and diet alone, so there is a need for supplements that are easy to take, especially for children and the elderly who may have trouble swallowing pills.

Scientists made a thin film containing 2000 IU of cholecalciferol using food-grade ingredients like maltodextrin. They tested its strength, how fast it dissolved, and how well the vitamin D3 held up over 3 months at different temperatures and humidities.

What it can’t tell you

  • This study did not test the film in people, so it cannot show how well the vitamin D3 is absorbed or whether it improves vitamin D levels in the body.
  • The stability tests lasted only 3 months, so longer-term storage beyond that period is not known from this paper.

The paper

Title
Development and Characterization of an Orodispersible Film for Vitamin D3 Supplementation
Type
Study
Summarised from
Full text
Cite
Cupone IE, Dellera E, Marra F, Giori AM (2020). Development and Characterization of an Orodispersible Film for Vitamin D3 Supplementation. Molecules (Basel, Switzerland). doi:10.3390/molecules25245851Free full textPubMed 33322282DOI

Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error