Gummi Formulations Comprising Amenamevir Solid Dispersions with Polyvinyl Alcohol

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems

Background:

• Poorly water-soluble drugs present challenges in oral dosage forms.
• Solid dispersions (SDs) offer a strategy to improve drug solubility and bioavailability.
• Gummi formulations are a popular but complex dosage form for drug delivery.

Purpose of the Study:

• To investigate the applicability of solid dispersions (SDs) for poorly water-soluble drugs in gummi formulations.
• To identify optimal polyvinyl alcohol (PVA) carriers for amenamevir SDs within a gummi matrix.
• To evaluate the dissolution, stability, and in vivo absorption of amenamevir SDs in gummies.

Main Methods:

• Utilized Design of Experiments (DOE) to optimize gummi formulation composition (gelatin and water content).
• Prepared amenamevir solid dispersions using various polyvinyl alcohols (PVA 66, PVA 80, PVA 88, PVA 66/88).
• Assessed dissolution profiles, stability under storage, and oral absorption in canine models.

Main Results:

• An optimized gummi base (10.5% gelatin, 22.8% water) was established for amenamevir SDs.
• PVA 66, PVA 66/88, and PVA 80 demonstrated suitability for dissolution, stability, and in vivo absorption, respectively.
• PVA 80 exhibited the highest oral absorption of amenamevir in dogs.

Conclusions:

• Polyvinyl alcohol (PVA) solid dispersions are applicable to gummi formulations for poorly water-soluble drugs.
• PVA 80 is the most suitable carrier for amenamevir SDs in gummies, maximizing oral absorption.
• This study demonstrates a viable approach for developing enhanced gummi-based drug delivery systems.