Formulation and Characterisation of Carbamazepine Orodispersible 3D-Printed Mini-Tablets for Paediatric Use
![Formulation and Characterisation of Carbamazepine Orodispersible 3D-Printed Mini-Tablets for Paediatric Use](https://www.pharmaexcipients.com/wp-content/uploads/2023/01/Formulation-and-Characterisation-of-Carbamazepine-Orodispersible-3D-Printed-Mini-Tablets-for-Paediatric-Use.jpg)
Abstract
One of the main challenges to paediatric drug administration is swallowing difficulties, hindering the acceptability of the medicine and hence clinical outcomes. This study aims at developing a child-appropriate dosage form, the orodispersible mini-tablet (ODMT), using the model drug carbamazepine (CBZ). This dosage form was prepared and 3D-printed via a semi-solid extrusion technique. Design of Experiment methods were applied for optimising the formulation. The formulation with 40% (w/w) of SSG (superdisintegrant) and 5% (w/w) of PVP K30 (binder) was selected and loaded with CBZ. The drug-loaded tablets were characterised by a mean hardness of 18.5 N and a disintegrating time of 84 s, along with acceptable friability. The mean drug loading ratio of the tablets was tested as 90.56%, and the drug release rate in 0.1 M HCl reached 68.3% at 45 min. Excipients showed proper compatibility with the drug in physical form analysis. Taste assessment via an E-tongue was also conducted, where the drug did not show bitter taste signals at a low concentration in the taste assessment, and the sweetener also blocked bitterness signals in the testing. To this end, ODMTs were found to be potential candidates for child-appropriate dosage forms delivering CBZ.
Introduction
![Pharmaceutics 15 00250 g001 550](https://www.mdpi.com/pharmaceutics/pharmaceutics-15-00250/article_deploy/html/images/pharmaceutics-15-00250-g001-550.jpg)
2.1. Materials
CBZ was purchased from Thermo Fisher Scientific (Waltham, MA, USA). Other excipients used in the formulation include lactose monohydrate from Foremost Farms (Middleton, WI, USA); Ac-Di-Sol® (Grade: SD-711) from FMC Biopolymer (Philadelphia, PA, USA) and also kindly gifted from Dupont (Billingstad, Norway); Kollidon 30 from BASF (Ludwigshafen, Germany); Sucralose and D-Mannitol from Sigma-Aldrich (St. Louis, MO, USA); Glycolys® (Sodium starch glycolate) kindly gifted from Roquette (Lestrem, France). Reagents used in E-tongue testing include tartaric acid, potassium chloride (KCl), potassium hydroxide (KOH), monosodium glutamate and tannic acid were purchased from Sigma-Aldrich (Dorset, UK), and silver chloride (AgCl) was obtained from Insent (Atsugi-shi, Japan). Hydrochloric acid (HCl) used in all experiments was obtained from Fisher Chemicals (Loughborough, UK). Acetone was obtained from Sigma-Aldrich (Dorset, UK).
Download the full study as PDF here: Formulation and Characterisation of Carbamazepine Orodispersible 3D-Printed Mini-Tablets for Paediatric Use
or read it here
Hu, J.; Fitaihi, R.; Abukhamees, S.; Abdelhakim, H.E. Formulation and Characterisation of Carbamazepine Orodispersible 3D-Printed Mini-Tablets for Paediatric Use. Pharmaceutics 2023, 15, 250.
https://doi.org/10.3390/pharmaceutics15010250
Watch also the interesting video on the use of galenIQ™ for ODMT: