Pullulan based oral thin film formulation of zolmitriptan: Development and optimization using factorial design

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems
• Materials Science

Background:

• Oral Thin Films (OTFs) offer an alternative drug delivery route for improved patient compliance.
• Zolmitriptan is commonly used for migraine treatment, but its oral administration can be challenging.
• Developing stable and palatable OTFs is crucial for effective drug delivery.

Purpose of the Study:

• To formulate and characterize pullulan-based oral thin films (OTFs) containing zolmitriptan.
• To optimize the formulation using a 3^2 factorial design, evaluating the impact of plasticizer and sweetener.
• To assess the physical, mechanical, and drug release properties of the developed OTFs.

Main Methods:

• Solvent casting method was employed for OTF preparation.
• Polyethylene glycol 400 (PEG 400) and sucralose were used as plasticizer and sweetener, respectively.
• A 3^2 factorial design investigated the effects of PEG 400 and sucralose on film properties and drug release.

Main Results:

• The optimized batch (F4) exhibited rapid in-vitro and in-vivo disintegration times (20.70s and 21.58s).
• High in-vitro drug release (95.53% at 5 min) and satisfactory mechanical properties were achieved.
• SEM studies confirmed uniform ingredient distribution, and the films demonstrated good stability.

Conclusions:

• Pullulan, PEG 400, and sucralose can be effectively combined to create palatable and stable zolmitriptan OTFs.
• The developed OTFs show potential for improved drug delivery and patient compliance.
• The formulation strategy provides a promising approach for orally disintegrating drug delivery systems.