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Published on: February 3, 2023
Formulation and Characterisation of Carbamazepine Orodispersible 3D-Printed Mini-Tablets for Paediatric Use
Jiayu Hu1, Rawan Fitaihi1,2, Shorooq Abukhamees1,3
1Pharmaceutics Department, School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
Insights
Developing child-appropriate orodispersible mini-tablets (ODMTs) using 3D printing for carbamazepine (CBZ) delivery effectively addresses paediatric swallowing difficulties. Optimized formulations ensure good drug release and mask bitterness, improving medicine acceptability and clinical outcomes.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Paediatric Formulations
Background:
- Swallowing difficulties are a major challenge in paediatric drug administration, impacting treatment efficacy.
- Developing child-friendly dosage forms is crucial for improving medication adherence and clinical outcomes in children.
Purpose of the Study:
- To develop and optimize a child-appropriate dosage form, specifically orodispersible mini-tablets (ODMTs), for carbamazepine (CBZ) delivery.
- To utilize 3D printing via semi-solid extrusion for manufacturing these novel paediatric dosage forms.
Main Methods:
- Formulation optimization using Design of Experiments (DoE) for ODMTs containing carbamazepine.
- Characterization of ODMTs including hardness, disintegration time, friability, drug loading, and drug release kinetics.
- Assessment of drug-excipient compatibility and taste masking efficacy using E-tongue technology.
Main Results:
- An optimized formulation containing 40% SSG and 5% PVP K30 was selected.
- The resulting ODMTs exhibited favorable characteristics: 18.5 N hardness, 84 s disintegration time, acceptable friability, and 90.56% drug loading.
- Drug release in 0.1 M HCl reached 68.3% at 45 min, with good drug-excipient compatibility and effective bitterness masking.
Conclusions:
- 3D-printed ODMTs are a promising child-appropriate dosage form for carbamazepine delivery.
- This approach effectively overcomes challenges associated with paediatric drug administration, enhancing acceptability and potential clinical outcomes.
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.
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