Studies in Solid Solution Formation between Acetaminophen and Povidone and Mouth-dissolving Strip Formulation.

Area of Science:

• Pharmaceutical Sciences
• Materials Science

Background:

• Novel solid-state solubilization of Acetaminophen (ACM) within Povidone (PVP K30) achieved.
• First-time report of solid solution (SS) formation between ACM and PVP K30.

Purpose of the Study:

• To develop a stable solid dispersion (SD) of Acetaminophen (ACM) using Povidone (PVP K30).
• To create an optimized oral strip formulation for improved drug delivery.

Main Methods:

• Investigated various ratios of PVP K30:ACM for solid dispersion (SD) preparation.
• Utilized computational prediction, FTIR, and DSC to confirm solid solution (SS) formation.
• Developed and optimized an oral strip formulation using Polyvinyl alcohol.

Main Results:

• Transparent solid dispersions (SDs) indicated solid solution (SS) formation.
• A minimum PVP K30:ACM ratio of 1.25:1 was required for stable SS.
• The oral strip formulation exhibited optimal physicochemical properties, rapid drug dissolution, and effective taste masking.

Conclusions:

• The developed oral strip is suitable for pediatric Acetaminophen (ACM) delivery (100-150 mg).
• The solid solution (SS) can be formulated into various dosage forms (tablets, capsules, ODTs) for adult use.
• Formulation advancements offer potential for improved therapeutic benefits and patient compliance.