Research internship report at Bluepharma Indústria Farmacêutica, S.A.

• Autor(a) principal: Fernandes, Mariana Amaral
• Data de Publicação: 2021
• Tipo de documento: Dissertação
• Idioma: eng
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: http://hdl.handle.net/10773/32117
• topic: Biorelevance; Long-Acting Injectables (LAI); Extended-release; Characterization techniques; In vitro release

This report intends to describe the work developed during the internship at Bluepharma Indústria Farmacêutica, S.A., in Research and Innovation sector. The first aim of this internship was to complete a review about long-acting injectables (LAI) and their characterization, as well as in vitro release. Thus, an overview of LAIs, their characterization methods, including in vitro release methods, possible membranes or barriers, and biorelevant characteristics is presented. The second aim was to support the development of the most appropriate methodology for assessing the release profile of LAI technology with an extended release of at least 96 hours develop internally. So, a description of developed activities is stated, presenting the rationale behind the choice of the method, the analytical development of the HPLC-PDA method to quantification of the drug substance (DS) and its pre-validation according to the authorities guidelines. Although the analytical method is already studied, the formulation development was not completed until the end of the internship, whereby the analytical method as well as the chosen method (including apparatus, barrier, ect.) to assess the in vitro release could need optimization with the final drug product.