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Dispensing Oral Temozolomide in Children: Precision and Stability of a Novel and Ready to Use Liquid Formulation in

Caroline Lemarchand1, Hugues Bienaymé1, André Rieutord2

  • 1ORPHELIA Pharma, 75005 Paris, France.

Pharmaceutics
|December 23, 2023
PubMed

Insights

Mixing temozolomide (TMZ) capsules with food leads to inaccurate dosing in children. A new liquid formulation (Ped-TMZ) ensures accurate temozolomide delivery, improving pediatric cancer treatment safety.

Area of Science:

  • Pediatric Oncology
  • Pharmaceutical Sciences
  • Drug Formulation

Background:

  • Temozolomide (TMZ) is crucial for pediatric cancer therapy.
  • Existing oral TMZ capsules are unsuitable for pediatric administration.
  • Need for accurate and stable pediatric formulations.

Purpose of the Study:

  • Evaluate dose accuracy and stability of TMZ from capsules mixed with food.
  • Compare capsule-based preparations with a novel pediatric liquid formulation (Ped-TMZ).
  • Assess impact of food vehicles on TMZ content and degradation.

Main Methods:

  • Dose accuracy testing of TMZ capsules mixed with apple juice, apple sauce, cream, milk, and mashed potatoes.
  • Chemical stability assessment of TMZ in food vehicles.
  • Comparison with a ready-to-use liquid formulation (Ped-TMZ).
  • Analysis of temozolomide (TMZ) and amino-imidazole-carboxamide (AIC) content against predefined acceptance criteria.

Main Results:

  • Ped-TMZ (KIZFIZO) demonstrated accurate dosing (96.6 ± 1.2%) within criteria.
  • Capsule preparations with apple juice (91.0 ± 1.5%) and apple sauce (91.6 ± 1.4%) showed significant underdosing (p < 0.0001).
  • Food vehicles significantly affected TMZ stability (p = 0.0042), increasing AIC levels over time.
  • Only 1 out of 72 capsule preparations met acceptance criteria, unlike Ped-TMZ.

Conclusions:

  • Mixing temozolomide capsules with food results in unreliable dosing and potential underexposure for pediatric cancer patients.
  • The novel liquid formulation (Ped-TMZ) provides accurate and stable temozolomide delivery.
  • Ped-TMZ offers a safer and more effective alternative for pediatric temozolomide administration.

Keywords:
canceroral administrationsolutionstabilitytemozolomide

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