Abstract

Personalized Orodispersible Films Compounded with OrPhyllo™ Ready-to-use Base: API Compatibility and Evidence-Based Beyond-Use Dates

Author(s): Kegele Carolina Schettino, Marianni Bruna, Polonini Hudson

Issue: Nov/Dec 2025 - Volume 29, Number 6

Page(s): 495-504

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  • Personalized Orodispersible Films Compounded with OrPhyllo™ Ready-to-use Base: API Compatibility and Evidence-Based Beyond-Use Dates Page 1
  • Personalized Orodispersible Films Compounded with OrPhyllo™ Ready-to-use Base: API Compatibility and Evidence-Based Beyond-Use Dates Page 2
  • Personalized Orodispersible Films Compounded with OrPhyllo™ Ready-to-use Base: API Compatibility and Evidence-Based Beyond-Use Dates Page 3
  • Personalized Orodispersible Films Compounded with OrPhyllo™ Ready-to-use Base: API Compatibility and Evidence-Based Beyond-Use Dates Page 4
  • Personalized Orodispersible Films Compounded with OrPhyllo™ Ready-to-use Base: API Compatibility and Evidence-Based Beyond-Use Dates Page 5
  • Personalized Orodispersible Films Compounded with OrPhyllo™ Ready-to-use Base: API Compatibility and Evidence-Based Beyond-Use Dates Page 6
  • Personalized Orodispersible Films Compounded with OrPhyllo™ Ready-to-use Base: API Compatibility and Evidence-Based Beyond-Use Dates Page 7
  • Personalized Orodispersible Films Compounded with OrPhyllo™ Ready-to-use Base: API Compatibility and Evidence-Based Beyond-Use Dates Page 8
  • Personalized Orodispersible Films Compounded with OrPhyllo™ Ready-to-use Base: API Compatibility and Evidence-Based Beyond-Use Dates Page 9
  • Personalized Orodispersible Films Compounded with OrPhyllo™ Ready-to-use Base: API Compatibility and Evidence-Based Beyond-Use Dates Page 10

Abstract

This study aimed to evaluate the physicochemical stability of orodispersible films (ODFs) compounded with seven active pharmaceutical ingredients (APIs): caffeine, folic acid, curcumin, pyridoxine hydrochloride, vitamin B12, 5-hydroxytryptophan (5-HTP), and dehydroepiandrosterone (DHEA), using the OrPhyllo™ film-forming base. Analytical methods were validated for specificity, linearity, precision, and accuracy, and stability was monitored over 180 days under ambient conditions. Recovery values were used to determine the beyond-use date (BUD) for each formulation, based on the last time point with recovery within the acceptable range of 90–110%, as recommended by USP <795>. The results showed that the formulations containing 5-HTP 100 mg/mL, curcumin 50 mg/mL and 100 mg/mL, DHEA 10 mg/mL, and pyridoxine hydrochloride 5 mg/mL remained stable for the full 180-day period. Formulations with 5-HTP 25 mg/mL, caffeine 20 mg/mL, folic acid 5 mg/mL, vitamin B12 0.1 mg/mL, and vitamin B12 1 mg/mL were stable for up to 150 days. Caffeine 2.5 mg/mL and DHEA 100 mg/mL showed acceptable recovery only up to 60 and 90 days, respectively. Pyridoxine hydrochloride 1 mg/mL maintained stability for 90 days, while folic acid 1 mg/mL was stable for 150 days. These findings confirm the reliability and robustness of OrPhyllo™ as a compounding base for personalized ODFs. These findings confirm the reliability and robustness of OrPhyllo™ as a compounding base for personalized ODFs. The base demonstrated consistent performance across a wide range of formulations and stability profiles, supporting extended beyond-use dates. OrPhyllo™ is currently the only film-forming base with a comprehensive stability data available, reinforcing its applicability and value in pharmaceutical compounding practices.

Related Keywords

  • Bracketing study
  • Compounded formulations
  • Transdermal drug delivery
  • Physicochemical stability
  • Microbiological safety

Related Categories

  • PEER-REVIEWED
  • STABILITIES, COMPATIBILITIES
  • DOSAGE FORMS/DRUG CARRIERS

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