Estudo da qualidade dos frascos multidose dos colírios: adequação, segurança e melhorias

• Autor(a) principal: Costa, Alexandre Xavier Da [UNIFESP]
• Data de Publicação: 2021
• Tipo de documento: Tese
• Idioma: por
• Título da fonte: Repositório Institucional da UNIFESP
• dARK ID: ark:/48912/00130000148nn
• Texto Completo: https://sucupira.capes.gov.br/sucupira/public/consultas/coleta/trabalhoConclusao/viewTrabalhoConclusao.jsf?popup=true&id_trabalho=11170710; https://repositorio.unifesp.br/handle/11600/68330
• topic: Drug Delivery Systems; Administration, Ophthalmic; Ophthalmic Solutions; Quality Management; Ophthalmology; Sistemas De Liberação De Medicamentos; Administração Oftálmica; Soluções Oftálmicas; Gestão Da Qualidade; Oftalmologia

Objectives: The purpose of this thesis was to contribute to quality improvement of multidose eyedrops by analyzing factors related to appropriate eyedrop packaging, identifying safety issues and user perceptions of eyedrop usability, assessing drop volume variability and the impact of eyedrop bottle tip geometry and instillation angle on contamination rates, with the aim of encouraging specification of requirements for topical ophthalmic products. Methods: From the identification of the multidose eyedrops marketed in Brazil, 297 packages and package inserts were analyzed for informational content, alongside an analysis of the variability of the drop volume and the correlation of the mass per drop measured in five samples of five lubricant eyedrop brands and an evaluation of the performance of five samples of six eyedrops on an airplane during varying altitudes. Risk of cross contamination of six samples from nine brands of multidose eyedrops that were contaminated exclusively on the exterior side of rounded versus sharp tips was measured at instillation angles of 45° and 90° degrees. A survey aiming at a qualitative analysis of the perception, knowledge, usability and consumption trends of eyedrop was administered to 1.003 consumers. Results: Eyedrops represent 91.6% of ophthalmic drugs currently sold in Brazil. The mean drop volume reported by the manufacturers was 36.9 ± 7 µL, ranging from 25.6 to 71.4 µL. Instructions for using eyedrops are uneven and not illustrative, and some products were found to have inadequate package inserts. In the performance test at high altitude, one brand presented leakage and an irregular efflux of drops in all samples. An increased risk of infection transmission was observed in vials with a rounded tip versus a sharp tip [69.4% vs. 22.2%, P=0.001], especially when inclined at an instillation angle of 45° versus 90° [83.3% vs. 44.4%, P=0.005]. Among the 1,003 survey respondents, 84.6% indicated experiencing a part of the eyedrop running over the face upon instillation and 76.2% preferred to have information regarding the total number of drops contained in the eyedrop bottles. Conclusions: The data indicate a possible inadequacy and lack of standardization of eyedrop packaging and bottles, which yield drops of excess volume for the human eye. Moreover, eyedrop bottles with perpendicular platform tips showed greater safety than those with rounded nozzles. Manufacturers should inform the total number of drops in each product, in addition to total net volume. A review of user instructions and requirements for quality standards for the registration of ophthalmic products is recommended.