Quality control evaluation of paediatric chocolate-based dosage forms: 3D printing vs mold-casting method

Int J Pharm. 2022 Aug 25:624:121991. doi: 10.1016/j.ijpharm.2022.121991. Epub 2022 Jul 7.

Abstract

Pharmaceutical compounding is a core activity in the preparation of patient-specific dosage forms. In the current study we aimed to investigate whether 3D printing could be employed for the preparation of pediatric-friendly personalized dosage forms that fulfil the acceptance criteria specified in the pharmacopoeias for conventional dosage forms. We then compared the 3D printed dosage forms with the same formulations prepared with mold-casting, a method frequently applied during pharmaceutical compounding. The molded dosage forms failed to pass most of the quality control tests, including the mass uniformity and content uniformity tests, as well as dose accuracy, contrary to the 3D printed, which not only passed all tests but also enabled precision overdose adjustment. Hence, 3D printing of chocolate-based dosage forms may effectively serve as an acceptable alternative method to mold casting in compounding patient-specific medication at the point-of-care.

Keywords: 3D printing; Chocolate dosage forms; Mold-casting; Paediatric drug delivery; Patient compliance; Pharmaceutical compounding.

MeSH terms

  • Child
  • Chocolate*
  • Dosage Forms
  • Drug Compounding / methods*
  • Drug Compounding / standards
  • Humans
  • Pharmaceutical Preparations
  • Printing, Three-Dimensional*
  • Quality Control
  • Technology, Pharmaceutical / methods*
  • Technology, Pharmaceutical / trends

Substances

  • Dosage Forms
  • Pharmaceutical Preparations