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Técnicas de secagem para estabilização de produtos biofarmacêuticos
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Abstract(s)
O avanço da área da tecnologia farmacêutica aliada ao desenvolvimento de novos
fármacos desencadeou a introdução no mercado de produtos biofarmacêuticos, como
anticorpos monoclonais, vacinas, hormonas, fatores de crescimento, entre outros. Estes
apresentam características que os tornam imprescindíveis no tratamento de diversas
patologias severas como cancro, doenças autoimunes, diabetes, etc. A obtenção destes
produtos é feita através de tecnologia de DNA recombinante em culturas de
Saccharomyces cervisiac ou E. coli ou ainda através da extração em animais, no entanto,
esta prática é cada vez menos usada. Os produtos biofarmacêuticos, no entanto, são
sensíveis a variações de fatores como o pH e temperatura, devido à sua origem
essencialmente proteica. Isto representa um problema de estabilidade, principalmente em
solução, visto que esta forma de apresentação evidencia uma maior mobilidade estrutural
e o facto de sofrerem ação hidrolítica pela água. Assim, a secagem dos produtos
farmacêuticos transformando-os em formas farmacêuticas sólidas é uma estratégia para
aumentar a sua estabilidade. A secagem, sendo um processo de desidratação, pode ser
efetuada por diferentes técnicas como a atomização, a eletropulverização, a secagem a
vácuo, a secagem em leito de espuma, a liofilização com e sem atomização e a secagem
supercrítica. Apesar do aumento de estabilidade dos produtos farmacêuticos através da
secagem, este é um processo que gera diferentes fontes de instabilidade dependente do
método utilizado. É assim necessário garantir a sua estabilidade durante a secagem, bem
como durante o armazenamento até à sua administração. Para tal, podem adicionar-se
excipientes estabilizantes como açúcares, agentes surfactantes e aminoácidos que através
de mecanismos específicos aumentam a estabilidade dos produtos biofarmacêuticos. O
objetivo deste trabalho é dissertar sobre a importância da aplicação de diferentes técnicas
de secagem na estabilização de produtos biofarmacêuticos. Serão descritos diferentes
produtos biofarmacêuticos existentes no mercado e os processos de instabilidade física e
química a que estão sujeitos. Fundamentalmente, os processos de desidratação e
estabilizantes utilizados na secagem de produtos biofarmacêuticos serão escrutinados.
The advances in pharmaceutical technology combined with the development of new drugs triggered the market of biopharmaceutical products, such as monoclonal antibodies, vaccines, hormones, growth factors, among others. It has characteristics that make it indispensable in the treatment of several severe pathologies such as cancer, autoimmune diseases, diabetes, etc. The obtaining of these products is performed by recombinant DNA technology in cultures of Saccharomyces cervisiac or E. coli or even by extraction in animals, however, this practice is less and less used. Biopharmaceutical products, however, are sensitive to variations in factors such as pH and temperature due to their essentially protein origin. This represents a problem of stability, especially in solution, since this form of presentation evidences greater structural mobility and may undergo hydrolytic action by water. Thus, the drying of pharmaceutical products turning it into solid dosage forms is a strategy to increase its stability. Drying, being a dehydration process, can be performed by different techniques such as spray-drying, electrospraying, vacuum drying, foam drying, lyophilization, spray freeze-drying and supercritical drying. Despite the increased stability of pharmaceutical products through drying, this is a process that generates different sources of instability dependent on the method used. It is therefore necessary to ensure its stability during drying, as well as during storage until its administration. To this end, stabilizing excipients such as sugars, surfactant agents and amino acids can be added, which through specific mechanisms increase the stability of biological drugs. The objective of this work is to discuss the importance of applying different drying techniques in the stabilization of biopharmaceutical products. Different biopharmaceutical products available on the market, and the processes of physical and chemical instability to which they are subject are described. Fundamentally, the dehydration processes and stabilizers used in the drying of biopharmaceutical products will be scrutinized.
The advances in pharmaceutical technology combined with the development of new drugs triggered the market of biopharmaceutical products, such as monoclonal antibodies, vaccines, hormones, growth factors, among others. It has characteristics that make it indispensable in the treatment of several severe pathologies such as cancer, autoimmune diseases, diabetes, etc. The obtaining of these products is performed by recombinant DNA technology in cultures of Saccharomyces cervisiac or E. coli or even by extraction in animals, however, this practice is less and less used. Biopharmaceutical products, however, are sensitive to variations in factors such as pH and temperature due to their essentially protein origin. This represents a problem of stability, especially in solution, since this form of presentation evidences greater structural mobility and may undergo hydrolytic action by water. Thus, the drying of pharmaceutical products turning it into solid dosage forms is a strategy to increase its stability. Drying, being a dehydration process, can be performed by different techniques such as spray-drying, electrospraying, vacuum drying, foam drying, lyophilization, spray freeze-drying and supercritical drying. Despite the increased stability of pharmaceutical products through drying, this is a process that generates different sources of instability dependent on the method used. It is therefore necessary to ensure its stability during drying, as well as during storage until its administration. To this end, stabilizing excipients such as sugars, surfactant agents and amino acids can be added, which through specific mechanisms increase the stability of biological drugs. The objective of this work is to discuss the importance of applying different drying techniques in the stabilization of biopharmaceutical products. Different biopharmaceutical products available on the market, and the processes of physical and chemical instability to which they are subject are described. Fundamentally, the dehydration processes and stabilizers used in the drying of biopharmaceutical products will be scrutinized.
Description
Keywords
Atomização Biofármaco Degradação Estabilidade Estabilizante Liofilização Proteína terapêutica Secagem