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A estabilidade dos medicamentos de biotecnologia na farmácia comunitária: o caso da insulina
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Authors
Abstract(s)
Os medicamentos de biotecnologia são produzidos por tecnologia de DNA
recombinante, a partir de organismos vivos ou derivados destes. A tecnologia de DNA
recombinante, descoberta em 1973 por Stanley Cohen e Herbert Boyer, permitiu o
desenvolvimento de culturas microbianas capazes de produzir tanto proteínas expressas
pelo Ser Humano como, novas proteínas que vão além do que é codificado no genoma.
Um exemplo paradigmático é a insulina. A insulina foi a primeira proteína
humana recombinante comercializada. Para além da produção da insulina com a mesma
sequência de aminoácidos da insulina humana, pelo processo de tecnologia de DNA
recombinante, é possível introduzir modificações na sequência peptídica, que
constituem enormes vantagens terapêuticas, pela disponibilização de insulinas com
diferentes perfis farmacocinéticos.
Os medicamentos de biotecnologia de uma maneira geral, devido à sua
novidade, são de uso mais frequente nos cuidados de saúde diferenciados, mais ao nível
hospitalar. Contudo, alguns, de utilização mais bem estabelecida, estão também
disponíveis na farmácia comunitária. Tanto num caso como no outro, é de extrema
importância que o Farmacêutico conheça as suas características e particularidades para
melhor acompanhar a sua utilização.
O objetivo desta dissertação é efetuar uma revisão bibliográfica sobre alguns
aspetos da natureza, características e especificidades genéricas dos medicamentos de
biotecnologia. Presta-se particular atenção à insulina, enquanto medicamento de
biotecnologia de uso frequente no ambiente comunitário. Tendo em conta as
características particulares dos medicamentos de biotecnologia, é necessário, no caso,
perceber a estabilidade das insulinas em duas condições diferentes para além da normal
conservação recomendada a temperaturas de refrigeração: quando há rotura da cadeia
de frio e quando em uso normal. Para tal, desenvolveu-se um estudo de caso das
insulinas comercializadas pela Novo Nordisk, em Portugal, quanto à sua estabilidade.
Biotechnology medicinal products are obtained by recombinant DNA technology, from living organisms or derivates thereof. Recombinant DNA technology, discovered in 1973 by Stanley Cohen and Herbert Boyer, allowed the development of microbial cultures for producing proteins either expressed by humans or new entities that go beyond what is encoded in the genome. A paradigmatic example is insulin. Insulin was the first commercially available recombinant human protein. In addition to producing insulin with the same amino acid sequence as human insulin, using recombinant DNA technology, it’s possible to introduce changes in the peptide sequence, which constitute enormous therapeutic advantages, through the availability of insulins with different pharmacokinetic profiles. Biotechnology medicines in general, due to their novelty, are more frequently used in differentiated health care units, at the hospital level. However, some products, with well-established use, are also available in the community pharmacy. In either case, it is extremely important that the Pharmacist knows its characteristics and particularities to better monitor its use. The objective of this dissertation is to carry out a literature review on some aspects of the nature, characteristics and generic specificities of biotechnology medicines. Particular attention is paid to insulin, as a biotechnology medicinal products, frequently used in the community environment. Taking into account the particular characteristics of biotechnology medicines, it is necessary to understand the stability of insulins under two different conditions, in addition to the normal recommended storage at refrigerated temperatures: when the cold chain breaks and when in normal use. To this end, a case study of the insulins marketed by Novo Nordisk, in Portugal, was developed regarding their stability.
Biotechnology medicinal products are obtained by recombinant DNA technology, from living organisms or derivates thereof. Recombinant DNA technology, discovered in 1973 by Stanley Cohen and Herbert Boyer, allowed the development of microbial cultures for producing proteins either expressed by humans or new entities that go beyond what is encoded in the genome. A paradigmatic example is insulin. Insulin was the first commercially available recombinant human protein. In addition to producing insulin with the same amino acid sequence as human insulin, using recombinant DNA technology, it’s possible to introduce changes in the peptide sequence, which constitute enormous therapeutic advantages, through the availability of insulins with different pharmacokinetic profiles. Biotechnology medicines in general, due to their novelty, are more frequently used in differentiated health care units, at the hospital level. However, some products, with well-established use, are also available in the community pharmacy. In either case, it is extremely important that the Pharmacist knows its characteristics and particularities to better monitor its use. The objective of this dissertation is to carry out a literature review on some aspects of the nature, characteristics and generic specificities of biotechnology medicines. Particular attention is paid to insulin, as a biotechnology medicinal products, frequently used in the community environment. Taking into account the particular characteristics of biotechnology medicines, it is necessary to understand the stability of insulins under two different conditions, in addition to the normal recommended storage at refrigerated temperatures: when the cold chain breaks and when in normal use. To this end, a case study of the insulins marketed by Novo Nordisk, in Portugal, was developed regarding their stability.
Description
Keywords
Diabetes mellitus Estabilidade Insulina Medicamentos de biotecnologia.