Novel use of insoluble particles as disintegration enhancers for orally disintegrating films

Abstract

The most important issue in the design of orally disintegrating films (ODFs) is the control of the ODFs' disintegration properties. A better understanding of the mechanisms of ingredients used to promote or disturb the disintegration time of ODFs would improve the development of ODF formulations. Here we focused on the advantage of adding insoluble particles (IPs) to improve the disintegration times of ODFs. We also verified the undesirable impact of the use of IPs on the mechanical properties of ODFs. We used hydroxyproplyl methylcellulose (HPMC), which is one of the most commonly used film-forming polymers for ODFs, as a film former. Films were prepared using the solution/solvent casting method. Microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and silica with different particle sizes and shapes were added in the film formulations as IPs. As expected, the addition of IPs shortened the disintegration times of the films. The larger particles had a greater impact compared to the smaller particles. However, the addition of larger particles decreased the films’ tensile strength. Our results demonstrate the effectiveness of IPs for shortening the disintegration times of HPMC films loaded with active pharmaceutical ingredients.