Characterization of orodispersible films formulated with natural flavors

Abstract

The oral route is one of the most used for the administration of solid dosage forms because it is convenient, economical and easy to administer, however, it may present as limitations the difficulty of swallowing for some patients. Orodispersible films (ODF) constitute a pharmaceutical form, innovative, practical, versatile and easy to administer. They are characterized by thin, flexible polymeric films developed for oral drug administration and can overcome the swallowing difficulties associated with solid dosage forms such as tablets and capsules. In addition to the drug, orodispersible dosage forms have in their composition film-forming polymers, plasticizers, sweeteners, saliva stimulating agents, flavoring agents, coloring agents, stabilizers, thickeners, permeation enhancers and disintegrants. Sweeteners, flavors and flavorings give ODF a sweet taste and pleasant odor and can contribute to masking excessively bitter drugs. The present study aimed to develop and evaluate the physicochemical and organoleptic properties of ODF formulated with two different flavorings so that they can be used to deliver drugs with oral absorption potential. Two samples were produced using the essential oils of Sicilian lemon and tangerine. The samples were submitted to a preliminary stability test and evaluated in terms of appearance, color, odor, flavor, pH, disintegration time and average weight. The results revealed potential in the use of Sicilian lemon and tangerine essential oils in the development of ODF, however, in the preliminary stability study, very noticeable changes were observed for the samples stored under different temperature conditions. Although other more in-depth studies should be conducted in the characterization of the samples produced, the approach adopted in this study can contribute to the construction of a scientific basis for the development of preparations involving ODF.