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3D printed hydroxyurea for pediatric use: toward personalized formulations and reduced exposure risk
Jean Laverdière1, Carlos Bendicho-Lavilla2, Louiza Mahrouche1
1Platform of Biopharmacy, Université de Montréal, 2940 Chem. de Polytechnique, Montréal H3T 1J4, Canada.
Insights
This study introduces a 3D-printed, chewable hydroxyurea formulation for children with sickle cell anemia. This innovative approach enhances drug delivery and adherence for pediatric patients requiring lifelong treatment.
Area of Science:
- Pharmacology
- Drug Delivery Systems
- Pediatric Medicine
Background:
- Sickle cell anemia is a severe monogenic disorder with global prevalence, particularly in Sub-Saharan Africa.
- Current hydroxyurea treatment for infants requires early initiation and lifelong adherence, challenged by a lack of age-adapted formulations.
- Pediatric patients face difficulties with long-term adherence due to unpalatable medication forms.
Purpose of the Study:
- To develop a customizable, pediatric-friendly 3D-printed hydroxyurea formulation for improved medication adherence.
- To create a chewable dosage form suitable for children capable of solid oral intake.
- To address challenges in long-term hydroxyurea adherence for pediatric sickle cell anemia patients.
Main Methods:
- Developed a pectin-based "pharma-ink" incorporating 30% hydroxyurea by weight.
- Utilized a semi-solid extrusion 3D printer to create gummy-like chewable tablets (200-600 mg hydroxyurea).
- Characterized printlets using United States Pharmacopeia standards, including in vitro release, drug loading, and stability studies. Conducted pharmacokinetic studies in Beagle dogs.
Main Results:
- Achieved nearly 100% drug loading with no detectable hydroxyurea degradation.
- In vitro release testing met United States Pharmacopeia specifications for immediate-release formulations.
- In vivo pharmacokinetic profiles in dogs were comparable to conventional hydroxyurea suspensions.
- Demonstrated 90-day stability under ambient conditions without degradation or altered drug release.
Conclusions:
- The 3D-printed hydroxyurea formulation is a stable, effective, and potentially more palatable option for pediatric sickle cell anemia patients.
- This novel approach offers accurate dosing and may reduce preparation risks compared to current compounding methods.
- Further clinical studies are warranted to validate occupational exposure reduction and clinical efficacy.
Abstract:
Sickle cell anemia is one of the most frequent severe monogenic disorders in the world, with the highest prevalence in Sub-Saharan Africa, India, the Middle East, and in populations with ancestry from these regions. Currently, hydroxyurea is recommended as a primary prevention from 9 to 12 months of age in infants affected by this condition, with doses adjusted upon weight and biological parameters. Because treatment is initiated early and maintained throughout life, the lack of age-adapted, palatable formulations poses major challenges to long-term adherence. To address this issue in children able to chew solid dosage forms, we developed a customizable, pediatric-friendly 3D printed hydroxyurea formulation. Hydroxyurea was incorporated at 30 % weight/weight into a pectin-based chewable "pharma-ink" and successfully printed into gummy-like chewable tablets containing 200-600 mg hydroxyurea using a semi-solid extrusion 3D printer. The resulting printlets were comprehensively characterized according to the United States Pharmacopeia recommendations. They demonstrated nearly 100 % drug loading with no detectable degradation, ensuring accurate dose delivery. In vitro release testing confirmed compliance with the United States Pharmacopeia specifications for immediate-release hydroxyurea. In vivo pharmacokinetic profiles in Beagle dogs were comparable to those of conventional hydroxyurea suspensions. A 90-day stability study under ambient conditions revealed no degradation or change in hydroxyurea release. Although occupational exposure was not directly quantified, the workflow design plausibly reduces preparation risks compared with current compounding practices, an aspect that will be addressed in future clinical studies.
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