Formulation Design of Orally Disintegrating Film Using Two Cellulose Derivatives as a Blend Polymer

Area of Science:

• Pharmaceutical Technology
• Materials Science

Background:

• Orally disintegrating films (ODFs) utilize water-soluble polymers for film formation.
• Optimizing ODF mechanical and disintegration properties often requires blending polymers.

Purpose of the Study:

• To evaluate hydroxypropyl methyl cellulose (HPMC) and hydroxypropyl cellulose (HPC) as blend film-forming agents for ODFs.
• To assess the impact of these blends on mechanical properties and disintegration behavior, with and without donepezil hydrochloride (DH).

Main Methods:

• Prepared placebo ODFs using various HPMC/HPC blend ratios (20-80% HPC).
• Evaluated mechanical properties (tensile strength, elastic modulus, elongation, folding endurance) and disintegration times.
• Assessed blend films containing donepezil hydrochloride (DH) for mechanical properties and disintegration.

Main Results:

• Successful formation of HPMC/HPC blend films was achieved.
• Blends with higher HPC content (over 40%) showed shorter disintegration times.
• Addition of DH reduced mechanical strength, but this effect was less pronounced in HPMC/HPC blends, indicating macro-miscibility.

Conclusions:

• HPMC/HPC blends are effective film-forming polymers for ODFs at suitable ratios.
• These blends mitigate the negative impact of active pharmaceutical ingredients on mechanical properties.
• The micro-immiscibility but macro-miscibility of HPMC/HPC blends is crucial for ODF performance.