Comparative investigations on different polymers for the preparation of fast‐dissolving oral films

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 (α= 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.