Design, Development and Evaluation of Orally Disintegrating Mini-tablets (ODMTs) Containing Cefixime for Paediatric Use: A Novel Approach

Abstract

Objectives

The study aimed to combine instant-release and mini-tablet methodologies to develop novel orally disintegrating mini-tablets (ODMTs) for a frequently pescribed antibiotic, cefixime trihydrate (CT), in paediatric patients.

Materials and Methods

CT-loaded microcapsules were prepared using Eudragit^® EPO and Hydroxy Propyl Methyl Cellulose E50 by spray drying technique. The optimized microcapsules were mixed with co-processed ready-to-use tableting excipients, Ludiflash and Pearlitol 200SD, in different proportions and then compressed into ODMTs and evaluated.

Results

The particle size of CT microcapsules was found to be between 111.8 and 225.87 µm, suitable for oral delivery. The entrapment efficiency was found to be between 94.8% and 95.45%. Pre-compression and post-compression parameters indicated suitability for formulation. In vitro evaluation of ODMTs showed immediate disintegration within 15 seconds in the oral cavity as soon as they came in contact with saliva. Upon swallowing these microcapsules, the microcapsules completely dissolve in the gastrointestinal tract, releasing 100% of the drug (CT) within 15 minutes. The release kinetics of ODMTs were found to follow Hixson-Crowell kinetics for Eudragit^® EPO and Korsmeyer-Peppas kinetics for Hydroxy Propyl Methyl Cellulose E50 microcapsules. Scanning electron microscopy images demonstrated that the microcapsules were intact even after compression into ODMTs. Stability studies proved that the formulations were stable as per the International Council for Harmonisation guidelines.

Conclusion

A novel solid oral dosage form of CT ODMTs of 2 mm diameter was successfully developed using Eudragit^® EPO and Hydroxy Propyl Methyl Cellulose E50 in combination with co-processed ready-to-use tableting excipients such as Ludiflash and Pearlitol 200SD.

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Materials

The drug CT was obtained as a gift sample from Karnataka Antibiotics Pvt. Ltd. (Bangalore, Karnataka). The ready-to-use tablet excipients Ludiflash and Pearlitol 200SD were received as a gift sample from Evonik Industries (Mumbai, Maharashtra), the lubricants Sodium Stearyl Fumarate (SSF) and Magnesium Stearate were purchased from Loba Chemie Pvt. Ltd. (Mumbai, Maharashtra). Polymers EPO and HPMC E50 were purchased from Rolex Chemical Industries (Bangalore, Karnataka). Solvents dichloromethane (DCM) and ethanol were purchased from Welchem Chemicals (Bangalore, Karnataka), cherry flavour was purchased from Keva Flavours (Mumbai, Maharashtra), and tablet compression facilities were availed at Apotex Research Pvt. Ltd. (Bangalore, Karnataka).

Setty V, Joshi VG, Chandrasekar SB. Design, Development and Evaluation of Orally Disintegrating Mini-tablets (ODMTs) Containing Cefixime for Paediatric Use: A Novel Approach. Turk J Pharm Sci. 2025 Sep 5;22(4):279-293. doi: 10.4274/tjps.galenos.2025.50149. PMID: 40916444; PMCID: PMC12415662.