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

Area of Science:

• Pharmaceutical Compounding
• Drug Delivery Systems
• Physical Pharmacy

Background:

• Orodispersible films (ODFs) offer an alternative dosage form for administering active pharmaceutical ingredients (APIs).
• The development of stable ODF formulations requires a robust film-forming base.
• OrPhyllo™ is a novel film-forming base intended for compounding personalized ODFs.

Purpose of the Study:

• To evaluate the physicochemical stability of ODFs compounded with seven diverse APIs using the OrPhyllo™ base.
• To determine the beyond-use date (BUD) for each API-loaded ODF formulation.
• To assess the suitability of OrPhyllo™ as a versatile compounding base.

Main Methods:

• Seven APIs (caffeine, folic acid, curcumin, pyridoxine hydrochloride, vitamin B12, 5-HTP, DHEA) were compounded into ODFs using OrPhyllo™.
• Validated analytical methods were employed to assess stability over 180 days under ambient conditions.
• Beyond-use dates (BUDs) were established based on recovery values within the 90-110% range (USP <795>).

Main Results:

• Formulations with 5-HTP (100 mg/mL), curcumin (50-100 mg/mL), DHEA (10 mg/mL), and pyridoxine hydrochloride (5 mg/mL) demonstrated stability for the full 180 days.
• Other formulations showed varying stability, with BUDs ranging from 60 to 150 days.
• OrPhyllo™ exhibited consistent performance across different APIs and concentrations.

Conclusions:

• OrPhyllo™ is a reliable and robust film-forming base for compounding personalized ODFs.
• The base supports extended beyond-use dates for multiple APIs, demonstrating its practical value.
• Comprehensive stability data for OrPhyllo™ reinforces its applicability in pharmaceutical compounding.