title: Orally disintegrating mini-tablets (ODMTs)--a novel solid oral dosage form for paediatric use.
abstract: 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.
authors.affiliation: Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Düsseldorf, Germany. Ines.Stoltenberg@uni-duesseldorf.de
authors.forename: I
authors.initials: I
authors.lastname: Stoltenberg
authors.forename: J
authors.initials: J
authors.lastname: Breitkreutz
mesh_terms: D000284:Administration, Oral; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000737:chemistry; D002648:Child; D002675:Child, Preschool; D019245:Compressive Strength; D004337:Drug Carriers / Q000737:chemistry*; D004339:Drug Compounding / Q000379:methods; D016503:Drug Delivery Systems; D005079:Excipients / Q000737:chemistry; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000737:chemistry; D054327:Lubricants; D010316:Particle Size; D011208:Powders; D012995:Solubility; D013501:Surface-Active Agents / Q000737:chemistry; D013607:Tablets / Q000737:chemistry*
chemical_list: D000959:Antihypertensive Agents; D004337:Drug Carriers; D005079:Excipients; D054327:Lubricants; D011208:Powders; D013501:Surface-Active Agents; D013607:Tablets; D006852:Hydrochlorothiazide