Disintegration time of orally dissolving films: various methodologies and in-vitro/in-vivo correlation

Area of Science:

• Pharmaceutics
• Drug Delivery Systems

Background:

• Orodispersible films (ODF) are increasingly popular, particularly for pediatric and geriatric use.
• Accurate disintegration time measurement is vital for ODF quality and safety.
• Existing methods, like the USP disintegration apparatus, are inadequate for ODFs, failing to predict in-vivo performance.

Purpose of the Study:

• To develop and evaluate novel disintegration protocols for ODFs.
• To identify a method that accurately reflects in-vivo disintegration time.
• To compare new methods against established procedures.

Main Methods:

• Formulation of ODFs using varying hydroxypropylmethyl cellulose (HPMC) viscosity grades.
• Evaluation of mechanical properties using texture analysis and film folding endurance.
• Comparison of novel methods (frame, cell, agar plate) with existing ones (clamp, modified USP).

Main Results:

• The cell method showed no significant difference from in-vivo results for low-viscosity polymers (p>0.05).
• The cell method demonstrated the highest correlation (R² = 0.999) with in-vivo disintegration time across all viscosity grades.
• Mechanical properties of ODFs were assessed.

Conclusions:

• The cell method is a suitable and reliable approach for predicting the in-vivo disintegration time of low-viscosity polymeric ODFs.
• This method offers improved accuracy over traditional disintegration testing apparatus.
• Further validation may be beneficial for broader applications.