Desenvolvimento de filmes orodispersíveis contendo diferentes insumos farmacêuticos ativos: controle de qualidade e estudos de estabilidade.

Abstract

Adherence to therapeutic treatment is a key issue that can be increased through the use of dosage forms appropriate to the population to be treated. Another factor that corroborates adherence to treatment is its individualization, when the regimen is patientcentered and the drug is appropriate to their needs. With this, we have the choice of innovative pharmaceutical forms such as orodispersible film, whose practicality of use may be a favorable factor for patient compliance. Orodispersible films are a solid pharmaceutical form intended for rapid release and absorption, with local or systemic action of active pharmaceutical ingredients (IFAs). These films are made up of watersoluble polymers that, when administered, adhere to the mucosa of the oral cavity, hydrate and dissolve rapidly without the need for concomitant water administration or chewing of the film. The objective of this work was to develop orodispersible films containing: 5-hydroxytryptophan (50 mg); bromopride (5 mg); coenzyme Q10 (20 mg); hydroxyzine (25 mg); melatonin (3 mg); resveratrol (5 mg); tadalafil (10 mg); vitamin B12 (1 mg); or vitamin D3 (2000 IU). These films were analyzed for weight variation, disintegration speed, content uniformity and stability of content and organoleptic characteristics and stored at room temperature. The films were manipulated, weighed and analyzed for content uniformity and content maintenance by High Performance Liquid Chromatography (HPLC) at times: initial (T = 0), 7 days (T = 7), 14 days (T = 14), 30 days (T = 30), 60 days (T = 60), 90 days (T = 90), 120 days (T = 120), 150 days (T = 150) and 180 days (T = 180). The films containing each of the evaluated IFAs were adequate in relation to the weight variation, and the average weight variation of the nine films equal to 109.1 mg. The disintegration velocity of the pharmaceutical form was in accordance with the standards established in the literature, with the average velocity being 46.94 seconds. The recovery percentage of the IFAs in the films, which should be between 90 and 110%, indicated the stability of the final products (IFA + vehicle) at room temperature as: 30 days for hydroxyzine, 90 days for vitamin D3, 150 days for 5- HTP and 180 days for bromopride, coenzyme Q10, melatonin, resveratrol, tadalafil and vitamin B12. Maintaining organoleptic characteristics was equivalent to maintaining the content. The quality control performed on orodispersible films shows that the pharmaceutical form complies with the standards set by regulatory agencies.