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.

Pharmaceutics
|January 21, 2023
PubMed

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.

Related Concept Videos

Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
177
Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

Factors Affecting Dissolution: Particle Size and Effective Surface Area

Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
929
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
363