Fundamental Discussion on Preparation of an Oral Acetaminophen Film that is Expected to Improve Medication Administration:

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  • Ito Ikumi
    Department of Practical Pharmacy, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences
  • Ito Akihiko
    Department of Medicinal Therapy Research, Meiji Pharmaceutical University
  • Unezaki Sakae
    Department of Practical Pharmacy, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences

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  • Effects of Plasticizer and Polymer on an Oral Film

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We investigated the effects of plasticizers and polymers on the physical properties and drug dissolution capabilities of films containing a high drug dosage of in order to find formulations that would be easy for patients to swallow. In this study, acetaminophen (AA) was used as the model drug, and glycerin (GL) and polyethylene glycol 400 (PEG) were used as plasticizers. Carboxy methylcellulose sodium (CMC) and hydroxypropyl methylcellulose (HPMC) were used as polymers. Adding GL decreased the strength and tended to increase the elasticity of films made with either polymer. Adding PEG changed the characteristics of each polymer film differently. For CMC films, strength increased and elasticity did not change. In HPMC films, strength did not change, and elasticity increased. The level of adhesiveness can effect proper swallowing. Adding GL increased adhesiveness for CMC film only, while adding PEG increased adhesiveness in both polymers. In GL containing films, a relationship was observed between adhesiveness and elasticity, as elasticity seems to be a good indicator of adhesiveness. However, in films containing PEG, there was no consistent relationship, therefore both characteristics may require separate evaluation. Drug dissolution from all films was almost 100% after 30 minutes, and was not influenced by the plasticizers. For preparing AA films for drug administration purposes, we suggest that GL is suitable for CMC and PEG is suitable for HPMC. GL seems to be useful as a plasticizer because it has a moderate effect on both polymer matrices.

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