Fast Dissolving Oral Film Analysis

Fast dissolving oral film,a new kind of drug delivery system, is a stamp-style drug loaded polymer film with rapid disintegration and dissolution in the saliva ,self‑administration without water or chewing. It offers higher compliance against swallowing difficulty of conventional solid dosage form,especially suitable for patients who have fear of choking such as pediatric and geriatric patients. However,fast dissolving oral film is not suitable for poorly soluble drug because of the grittiness taste and the poorly oral absorption. As the carrier of drugs, fast dissolving oral film with light weight has limits on the variety and dosage of excipients. On the other hand, children have higher request on the taste of preparation, both responsible for the harsh requirements on the taste-masking technology of the fast dissolving oral film.How to mask the terrible taste of the active pharmaceutical ingredient is also a key issue to be solved. In view of the above problems, suspension intermediate and liposome intermediate were prepared respectively for the preparation of two kinds of fast dissolving oral
An Box-Behnken design (BBD) was used for the optimization of the prescription and craft. The selected independent variables in prescription optimization were amount of Poloxamer 188, phospholipid and ethanol while the dependent variables were particle size, particle size uniformity, content uniformity of fast dissolving oral film and 15 minute cumulative release of fast dissolving oral film. The selected independent variables in process optimization were temperature, stirring speed and stirring time.Then, single factor experiment was taken for determination of pressure and cycle of high pressure homogeneous. Suspension intermediate with a mean particle size of (1.45±0.11)μm and a particle size uniformity of (0.681±0.052)was