Orally disintegrating mini-tablets (ODMTs)--a novel solid oral dosage form for paediatric use

Eur J Pharm Biopharm. 2011 Aug;78(3):462-9. doi: 10.1016/j.ejpb.2011.02.005. Epub 2011 Feb 13.


The new European regulations on paediatric medicines and recent WHO recommendations have induced an increased need for research into novel child-appropriate dosage forms. The aim of this study was the development of orally disintegrating mini-tablets (ODMTs) as a suitable dosage form for paediatric patients. The suitability of five commercially available ready-to-use tableting excipients, Ludiflash, Parteck ODT, Pearlitol Flash, Pharmaburst 500 and Prosolv ODT, to be directly compressed into mini-tablets, with 2 mm in diameter, was examined. All of the excipients are based on co-processed mannitol. Drug-free ODMTs and ODMTs with a child-appropriate dose of hydrochlorothiazide were investigated. ODMTs could be produced with all investigated excipients. ODMTs with a sufficient crushing strength >7 N and a low friability <1% could be obtained, as well as ODMTs with a short simulated wetting test-time <5 s. ODMTs made of Ludiflash showed the best results with crushing strengths from 7.8 N up to 11.8 N and excellent simulated wetting test-times from 3.1 s to 5.0 s. For each excipient, ODMTs with accordance to the pharmacopoeial specification content uniformity could be obtained. The promising results indicate that orally disintegrating mini-tablets may serve as a novel platform technology for paediatrics in future.

MeSH terms

  • Administration, Oral
  • Antihypertensive Agents / administration & dosage
  • Antihypertensive Agents / chemistry
  • Child
  • Child, Preschool
  • Compressive Strength
  • Drug Carriers / chemistry*
  • Drug Compounding / methods
  • Drug Delivery Systems*
  • Excipients / chemistry
  • Humans
  • Hydrochlorothiazide / administration & dosage
  • Hydrochlorothiazide / chemistry
  • Lubricants
  • Particle Size
  • Powders
  • Solubility
  • Surface-Active Agents / chemistry
  • Tablets / chemistry*


  • Antihypertensive Agents
  • Drug Carriers
  • Excipients
  • Lubricants
  • Powders
  • Surface-Active Agents
  • Tablets
  • Hydrochlorothiazide