(443e) Impact of Key Formulation Parameters on Properties and Performance of Strip Films Loaded with Griseofulvin Nanoparticles

Authors: 
Krull, S. M., Office of Testing and Research, U. S. Food and Drug Administration
Patel, H., New Jersey Institute of Technology
Li, M., New Jersey Institute of Technology
Bilgili, E., New Jersey Institute of Technology
Dave, R. N., New Jersey Institute of Technology

Polymer strip films have been shown to be an ideal delivery form for poorly water-soluble drugs. Specifically for active pharmaceutical ingredient (API) particles that have been reduced in size to enhance their solubility and dissolution rate, polymer strip films provide a means by which these nano/micro-size particles can be delivered relatively quickly while retaining their nano/micro size upon delivery. However, the ability to intelligently manipulate various properties and dissolution rate of such films for the delivery of poorly water-soluble API nanoparticles has yet to be investigated, and it is still a common misconception that strip films are limited to “low” API loading in the final dosage. To this end, hydroxypropyl methylcellulose (HPMC) films loaded with model API, griseofulvin, nanoparticles were prepared, consisting of various API loadings, plasticizers, and HPMC molecular weights. API loadings up to 50 wt% were achieved in HPMC-E15 films, while noticeable decreases in film ductility and dissolution rate were observed above 30 wt%. Addition of glycerin, triacetin, and polyethylene glycol as plasticizers successfully reduced film strength and increased film elasticity with no significant impact on dissolution rate. Increasing the molecular weight of the polymeric film-former generally produced stronger films that exhibited slower dissolution rates. Elucidation of the roles of API loading, plasticizer and content, and film-forming polymer molecular weight on film properties and dissolution will allow for intelligent film formulation design for targeted applications.