Active Tablet Coating with Amorphous Solid Dispersion of Ibuprofen-HPMCAS from Organic Solution

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Formulation Science

Background:

• Active coating of tablets is an under-investigated strategy for creating fixed-dose combinations with amorphous solid dispersions of poorly soluble drugs.
• Optimizing solvent selection is crucial for controlling coating properties and process efficiency.

Purpose of the Study:

• To investigate the feasibility of active tablet coating for drug loading using ibuprofen as a model drug.
• To evaluate the impact of different organic solvents (acetone, acetonitrile, DMSO) on coating characteristics, residual solvent content, and drug dosing uniformity (accuracy and precision).

Main Methods:

• Ibuprofen-HPMCAS coating was applied to placebo tablets using a laboratory pan-coater with a two-component nozzle.
• Three organic solvents with varying boiling points and evaporation rates were employed.
• Residual solvents were quantified using gas chromatography, and dosage uniformity was assessed pharmacopoeially.

Main Results:

• Residual acetone and acetonitrile were below the limit of detection (LOD), while DMSO content was 1.5 wt.%.
• Drug dosing accuracy decreased with increasing solvent boiling point (acetone/acetonitrile > DMSO).
• Drug dosing precision improved with longer coating times and higher boiling point solvents, fitting a power function (R² = 0.9843).

Conclusions:

• Proper drug dosing, in terms of both accuracy and precision, is achievable through active tablet coating using the investigated equipment and methods.
• The duration of the coating process can be adjusted to meet desired dose precision requirements.