[Optimization of novel self-microemulsifying mouth dissolving films by response surface methodology]

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems

Background:

• Improving oral bioavailability of water-insoluble drugs remains a significant challenge in pharmaceutical development.
• Traditional oral dosage forms often exhibit poor patient compliance due to various factors.

Purpose of the Study:

• To develop and optimize self-microemulsifying mouth dissolving films (SMEDFs) as a novel dosage form.
• To enhance oral bioavailability and patient compliance for water-insoluble drugs.
• To investigate the impact of key formulation excipients on film properties and drug release.

Main Methods:

• A Box-Behnken design was employed for formulation optimization.
• The study evaluated the effects of microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and hypromellose.
• Key parameters assessed included film weight, disintegration time, particle size, stretchability, and in vitro drug release.

Main Results:

• Optimized SMEDFs demonstrated rapid disintegration within 17.09 ± 0.72 seconds.
• Achieved a microemulsified particle size of 28.81 ± 3.26 nm.
• Exhibited an in vitro cumulative release of 66.18 ± 1.94% at 2 minutes.

Conclusions:

• The developed SMEDFs offer a promising approach to improve oral bioavailability of poorly soluble drugs.
• These films exhibit excellent patient compliance, strong tensile properties, and rapid oral disintegration and release.
• SMEDFs present broad application prospects in pharmaceutical drug delivery.