The development of orodispersible mini-tablets (ODMTs) for paediatric use has gained importance within recent years as European authorities set up regulations for developing suitable and palatable dosage forms for paediatric patients. Polyols like mannitol and isomalt are frequently used in the manufacture of tablets where sensory properties have to be taken into account. In literature, ODTMs based on a commercialized co-processed excipient based on mannitol (Ludiflash®) have been already described. Isomalt is known for its pleasant sensory properties and therefore appears to be a good candidate for ODMTs. The feasibility of the direct compression grade of isomalt for the manufacture of ODMTs was assessed and compared to Ludiflash®. Hydrochlorothiazide and enalapril maleate were chosen as model drugs and compressed to 2 mm mini-tablets. ODMTs could be obtained fulfilling the criteria of Ph.Eur. with disintegration times of 180 s or even the FDA limit of 30 s. Dissolution studies and mass variation were fulfilled for all mini-tablets. Acceptance values (AV) ≤ 15 were achieved for formulations based on both isomalt and Ludiflash®. Stability data showed the change of disintegration time and tensile strength as a function of storing time, condition and excipient. Both excipients showed their potential for ODMTs for paediatric use.
Keywords: Functionalized excipients; Isomalt; Ludiflash®; Orodispersible mini-tablet; Paediatrics; Stability.
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