Clinical study on adults

In a clinical study on adults with difficulty swallowing tablets, 98 % of the subjects stated that it was easier to swallow tablets coated with MEDCOAT® compared to identical uncoated tablets. The study also showed that MEDCOAT® could completely camouflage the taste of a bitter-flavoured tablet for 100 % of the subjects. The study has been published in the journal Pharmacy World & Science / International Journal of Clinical Pharmacy (Pharm World Sci 2010;32:420–423).

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Data from the clinical study on adults
Source: Pharm World Sci 2010;32:420–423

Clinical study on children

A clinical study at Karolinska University Hospital on sick children aged 2–17 years with difficulties taking their medication found that MEDCOAT® made it easier to swallow tablets for 87 % of the children and improved palatability for 85 %. The study has been published in the journal Acta Paediatrica (Acta Paediatrica 2015;104:956–961).

The study included 78 children at Astrid Lindgren Children's Hospital. For 86 % of the children, taking their medication became easier, and the effect was the same regardless of the child's age.

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Study regarding risk for interaction

A literature search concerning risks for interaction between the ingredients in MEDCOAT® and drugs has been performed by Folke Sjöqvist, professor emeritus in clinical pharmacology at Karolinska Institutet, in cooperation with the Karolinska Drug Information Center (Karolic) at Karolinska University Hospital. The study did not find any risks that the ingredients in MEDCOAT® would interact with drugs in a way that could affect the drug's effect. (Sjöqvist F: Regarding possible risks for interactions between drugs and substances in the tablet coating developed by Med Coat. Division of Clinical Pharmacology, Karolinska Institutet. March 2005.)

Study regarding disintegration

A study performed at the Department of Pharmacy at Uppsala University showed that the MEDCOAT® coating disintegrates quickly after swallowing (on average 47 seconds) and therefore does not hinder the uptake of the drug. (Alderborn G, Olsson C: An investigation of the effect of a coating applied by the MedCoat coating device on the disintegration time of some preparations. Dept of Pharmacy, Uppsala University. Dec 2009.)

Norwegian study regarding difficulties swallowing tablets

In a Norwegian study of 6,158 persons visiting a general practitioner, 30 % of the women and 15 % of the men stated that they had difficulty swallowing tablets. (Andersen Ø, Zweidorf O-K, Hjelde T, Rødland EA: Problemer med å svelge tabletter [Problems when swallowing tablets. A questionnaire study from general practice]. Tidsskr Nor Laegeforen 1995;115:947–9.)

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German study regarding difficulties swallowing tablets

A German study of 1,051 patients visiting general practices revealed that 37.4 % reported having had problems swallowing solid drugs at some time, and 27.2 % had swallowing difficulties with their current tablets and capsules. 9.4 % of the affected patients indicated that they were non-adherent with their medication due to their swallowing difficulties. Only 6.7 % of all patients had ever been asked about such problems by their doctor, and 4.1 % by their pharmacist. (Eur J Clin Pharmacol. 2013 Apr;69(4):937–48.)

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MEDCOAT® is safe to use

MEDCOAT® contains only common food ingredients (approx. 0.2 g per coating) and is classified and sold as a food product. A study has been performed at the Drug Research and Information Centre at Karolinska University Hospital in Stockholm to verify that none of the ingredients in MEDCOAT® are known to interact with medicines. The study found no risk of interaction. Furthermore, disintegration tests show that the coating dissolves quickly from the tablet after swallowing and will therefore not hinder the release of the drug. Since the product was launched, millions of tablets have been coated with MEDCOAT® without any adverse events.

For healthcare professionals

MEDCOAT® can be used when patients:

  • Have difficulty swallowing (dysphagia) or feel discomfort swallowing tablets
  • Should take big and/or hard-to-swallow tablets, especially when they should not be crushed
  • Should take bad-tasting medicine (e.g. cortisone, antibiotics, metformin, etc.)
  • Suffer from dry mouth (xerostomia) causing difficulties swallowing tablets

MEDCOAT® can help healthcare professionals:

  • Fewer tablets must be crushed and mixed with food (can save time during administration)
  • Reduced need for alternative, often expensive, dosage forms
  • Eliminates the risks associated with crushing tablets
  • Can improve compliance

The high frequency of difficulties swallowing tablets is reflected in the common practice of crushing tablets. However, many tablets must not be crushed (e.g. enteric-coated or sustained-release tablets), and crushed tablets often taste very bad. Difficulties taking tablets not only cause inconvenience for a large proportion of the population; they can also have a negative impact on patient compliance, which in turn decreases the effect of the medication.

Download

Download the MEDCOAT® brochure (PDF, 4 pages)

References

  1. Uloza V, Ulozienė I, Gradauskienė E. A randomized cross-over study to evaluate the swallow-enhancing and taste-masking properties of a novel coating for oral tablets. Pharm World Sci. 2010;32:420–3.
  2. El Edelbi R, Eksborg S, Lindemalm S. In situ coating makes it easier for children to swallow and tolerate tablets and capsules. Acta Paediatrica. 2015;104:956–961.
  3. Sjöqvist F, et al. Regarding possible risks for interactions between drugs and substances in the tablet coating developed by Med Coat. Division of Clinical Pharmacology, Karolinska Institutet. March 2005.
  4. Alderborn G, Olsson C. An investigation of the effect of a coating applied by the MedCoat coating device on the disintegration time of some preparations. Dept of Pharmacy, Uppsala University. Dec 2009.
  5. Andersen Ø, Zweidorf O-K, Hjelde T, Rødland EA. Problemer med å svelge tabletter. Tidsskr Nor Laegeforen. 1995;115:947–9.
  6. Overgaard A, Højsted J, Hansen R, Møller-Sonnergaard J, Christrup L. Patients' evaluation of shape, size and colour of solid dosage forms. Pharm World Sci. 2001;5:185–8.
  7. Eur J Clin Pharmacol. 2013 Apr;69(4):937–48.