Verena Garsuch1, Jörg Breitkreutz. 1. Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University Düsseldorf, Germany.
Abstract
OBJECTIVES: The aim was to compare different film-forming materials used for the preparation of fast-dissolving oral films. METHODS: Films were prepared with and without caffeine and caffeine citrate as model drugs. The disintegration/dissolution behaviour of films was investigated using the newly developed slide frame method and Petri dish method. Films were also characterised by dynamic vapour sorption. KEY FINDINGS: All films dissolved within 40 s. Drug-loaded films disintegrated more slowly than the equivalent drug-free formulations. Disintegration/dissolution was fastest with films made from the carboxymethyl cellulose C 30 PA 09 (drug-free < 5 s, drug-loaded < 10 s). Dissolution times for drug-loaded oral films made from C 30 PA 09 and HM 6 PA 2910 (hydroxypropyl methyl cellulose) differed significantly (alpha= 0.05). Dynamic vapour sorption studies revealed higher water absorption ratios for carboxymethyl cellulose films, and these were sticky and difficult to handle. CONCLUSIONS: This case study showed that hydroxypropyl methyl cellulose was the most suitable film-forming material for drug-free and caffeine-loaded films, providing fast dissolution films that were not sticky and were easy to handle.
OBJECTIVES: The aim was to compare different film-forming materials used for the preparation of fast-dissolving oral films. METHODS: Films were prepared with and without caffeine and caffeine citrate as model drugs. The disintegration/dissolution behaviour of films was investigated using the newly developed slide frame method and Petri dish method. Films were also characterised by dynamic vapour sorption. KEY FINDINGS: All films dissolved within 40 s. Drug-loaded films disintegrated more slowly than the equivalent drug-free formulations. Disintegration/dissolution was fastest with films made from the carboxymethyl cellulose C 30 PA 09 (drug-free < 5 s, drug-loaded < 10 s). Dissolution times for drug-loaded oral films made from C 30 PA 09 and HM 6 PA 2910 (hydroxypropyl methyl cellulose) differed significantly (alpha= 0.05). Dynamic vapour sorption studies revealed higher water absorption ratios for carboxymethyl cellulose films, and these were sticky and difficult to handle. CONCLUSIONS: This case study showed that hydroxypropyl methyl cellulose was the most suitable film-forming material for drug-free and caffeine-loaded films, providing fast dissolution films that were not sticky and were easy to handle.