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Advisor(s)
Abstract(s)
A produção aditiva, também conhecida por impressão 3D começou a ser recentemente
ponderada para o ramo farmacêutico devido ao potencial que oferece em relação à manufactura
tradicional, nomeadamente a possibilidade de produzir pequenos lotes de produtos com
geometrias complexas e personalizadas que atendem às necessidades de cada indivíduo a um
custo relativamente reduzido.
Até à data deste artigo, nenhuma agência reguladora se pronunciou quanto à utilização
desta tecnologia na produção de medicamentos e apenas um medicamento utilizando esta
tecnologia foi aprovado: o Spritam® (levetiracetam) em comprimido orodispersível.
Apesar das leis e orientações vigentes serem aplicáveis à produção aditiva de
medicamentos, questiona-se se são adequadas ao uso desta tecnologia. Primeiramente, há a
considerar a grande variabilidade de impressoras 3D e consequentemente os diferentes
processos de manufactura com diferentes pontos críticos e limitações. Esta tecnologia é
potencialmente disruptiva devido à possibilidade da personalização e descentralização da
produção de medicamentos recorrendo às impressoras 3D, que devido ao término das patentes
estão a tornar-se mais acessíveis ao público. Pondera-se as suas consequências e benefícios da
produção aditiva sabendo que esta tem vários produtos, nomeadamente, impressoras, CAD,
produtos intermédios e finais. A construção das impressoras, a segurança do software e a
qualidade dos produtos obtidos precisará de atenção das agências reguladoras. Os diferentes
produtos não regulados da impressão 3D e sobre em qual ou quais dos intervenientes recai o
ónus da responsabilidade é outra questão a rever. Pesa-se ainda a necessidade de propriedade
intelectual e outras medidas de proteção à contrafação.
Espera-se o crescimento da produção aditiva, e que desempenhe um papel relevante na
indústria farmacêutica, no entanto não se espera que esta venha a substituir inteiramente a
manufactura tradicional. De momento a impressão 3D ainda não é amplamente utilizada e
persistem incertezas quanto a todo o seu potencial, mas sabe-se que esta tecnologia consegue
dar resposta a situações que previamente dificilmente eram atendidas.
Additive manufacturing, also known as 3D printing has recently begun to be considered for the pharmaceutical industry because of the potential it offers over traditional manufacturing, namely the ability to produce small batches of products with complex, customized geometries that meet the needs of each individual at a relatively low cost. As of the date of this article, no regulatory agency has ruled on the use of this technology in pharmaceutical manufacturing and only one medicine using this technology has been approved: the Spritam® (levetiracetam) orodispersible tablet. Although the current laws and guidelines are applicable to additive manufacturing of pharmaceuticals, one wonders if they are prepared for this technology. First, there is to consider the great variability of 3D printers and consequently the different manufacturing processes with different critical points and limitations. This technology is potencially disruptive because of personalized and decentralized production of medicines using 3D printers, which due to the expiration of patents are becoming more accessible to the public. One ponders its consequences and benefits of additive manufacturing knowing that it has several products, namely, printers, CAD files, and intermediate and final products. The construction of the printers, the safety of the software, and the quality of the products obtained will possibly need attention from regulatory agencies. The different unregulated products of 3D printing and on which party or parties bears the liability burden is another issue to review. Also weighed is the need for intellectual property and other counterfeiting protection measures. Additive manufacturing is expected to grow and play an important role in the pharmaceutical industry, but it is not expected to entirely replace traditional manufacturing. At the moment 3D printing is not yet widely used and uncertainties remain about its full potential, but it is known that this technology can answer situations that were previously difficult to meet.
Additive manufacturing, also known as 3D printing has recently begun to be considered for the pharmaceutical industry because of the potential it offers over traditional manufacturing, namely the ability to produce small batches of products with complex, customized geometries that meet the needs of each individual at a relatively low cost. As of the date of this article, no regulatory agency has ruled on the use of this technology in pharmaceutical manufacturing and only one medicine using this technology has been approved: the Spritam® (levetiracetam) orodispersible tablet. Although the current laws and guidelines are applicable to additive manufacturing of pharmaceuticals, one wonders if they are prepared for this technology. First, there is to consider the great variability of 3D printers and consequently the different manufacturing processes with different critical points and limitations. This technology is potencially disruptive because of personalized and decentralized production of medicines using 3D printers, which due to the expiration of patents are becoming more accessible to the public. One ponders its consequences and benefits of additive manufacturing knowing that it has several products, namely, printers, CAD files, and intermediate and final products. The construction of the printers, the safety of the software, and the quality of the products obtained will possibly need attention from regulatory agencies. The different unregulated products of 3D printing and on which party or parties bears the liability burden is another issue to review. Also weighed is the need for intellectual property and other counterfeiting protection measures. Additive manufacturing is expected to grow and play an important role in the pharmaceutical industry, but it is not expected to entirely replace traditional manufacturing. At the moment 3D printing is not yet widely used and uncertainties remain about its full potential, but it is known that this technology can answer situations that were previously difficult to meet.
Description
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2023, Universidade de Lisboa, Faculdade de Farmácia.
Keywords
Produção aditiva Impressão 3D Legislação Descentralização Controlo de qualidade Mestrado Integrado - 2023