Hospital 3D-printed cyclophosphamide printlets for paediatric patients.

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Paediatric Formulations

Background:

• Cyclophosphamide (CPA) is vital in paediatric oncology, but limited oral formulations hinder flexible dosing.
• The World Health Organization (WHO) has outlined a Target Product Profile (TPP) for paediatric CPA, emphasizing age-appropriate solid dosage forms.

Purpose of the Study:

• To develop and characterize a 3D-printed, chewable cyclophosphamide (CPA) formulation meeting WHO TPP and clinical needs.
• To create a flexible, dose-adapted oral formulation for paediatric cancer treatment.

Main Methods:

• Formulation of a 10% (w/w) CPA starch-polyol ink for semi-solid extrusion (SSE) 3D printing.
• Development of a discrete dose library (7-40 mg) based on prescription analysis.
• Systematic evaluation of printlet quality, dissolution, and stability (2-8°C, ambient).

Main Results:

• The 3D-printed dose library accommodated most prescribed CPA doses.
• All printlets met pharmacopeial standards, exhibiting rapid, immediate-release dissolution.
• Printlets demonstrated physicochemical stability for at least 6 months under refrigeration, with low water activity and crystalline drug content.

Conclusions:

• 3D printing enables personalized, hospital-based oral cyclophosphamide (CPA) formulations for paediatric patients.
• The developed formulation principles are applicable to other hydrolysis-sensitive cytotoxic drugs.
• This approach addresses the need for flexible, stable, and age-appropriate paediatric drug delivery.