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Estudo comparativo da produção contínua, descontínua e manipulação, na individualização terapêutica
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Abstract(s)
Ao longo da história do medicamento é evidente a evolução a nível científico e tecnológico que ao longo dos anos veio alterar a prática farmacêutica e consequentemente a produção de medicamentos.
A preparação de medicamentos manipulados (MM) é a atividade originalmente desenvolvida pelos Farmacêuticos, que devido à evolução e industrialização no setor farmacêutico acabou por ser um pouco abandonada em meados do século passado. No entanto, nem todas as necessidades terapêuticas existentes são colmatadas pela Indústria Farmacêutica, assim, os medicamentos manipulados, ainda hoje, apresentam um papel de destaque no que respeita ao tratamento de determinadas patologias e especificidades de alguns grupos. Os medicamentos manipulados permitem personalizar dosagens e formas farmacêuticas, bem como mascarar ou substituir um excipiente para o qual o indivíduo apresente intolerância. Podem criar-se formas contendo associações de substâncias ativas (“polypill”), o que é particularmente útil em doentes polimedicados. Os MM continuam assim a apresentar-se como uma ferramenta muito importante no que respeita à individualização da terapêutica.
Recentemente, e graças à evolução científica e tecnológica, a produção de medicamentos pela indústria farmacêutica ganhou um forte impacto. O principal tipo de produção adotado pelas empresas no fabrico de medicamentos têm sido essencialmente, a produção descontínua ou em ‘lote’, que consiste tradicionalmente na separação do processo pelas diferentes operações unitárias (etapas com diferenças espaciais e temporais).
Atualmente uma das grandes questões da indústria farmacêutica centra-se na adoção da produção em contínuo, na qual, os equipamentos encontram-se centralizados e o processo não é interrompido. A implementação desta tecnologia possibilita a redução dos custos e do tempo de cada ciclo de produção com consequente aumento da rentabilidade, segurança e flexibilidade.
Associado a este último tipo de produção, existem ainda vários desafios associados no que diz respeito a nível regulamentar e científico, para os quais as entidades reguladoras criaram ferramentas complementares como Process Analytical Technology (PAT) integrada no conceito de Quality by Design (QbD).
Throughout the history of medicine, it is evident the evolution at scientific and technological level that over the years has changed pharmaceutical practice and consequently the production of medicines. The preparation of compounded medicines (MM) is the activity originally developed by Pharmacists, which due to the evolution and industrialization in the pharmaceutical sector ended up being somewhat abandoned in the middle of the last century. However, not all therapeutic needs are met by the pharmaceutical industry, so the compounded drugs, even today, have an important role in the treatment of certain diseases and specificities of some groups. Compounded drugs allow the customization of dosages and pharmaceutical forms, as well as the masking of unfavorable organoleptic characteristics or the substitution of an excipient to which the individual is intolerant. Pharmaceutical forms containing combinations of active substances ("polypill") can also be created, which is particularly useful for polymedicated patients. MM thus continue to present themselves as a very important tool about individualization of therapy. Recently, and thanks to scientific and technological developments, the production of drugs by the pharmaceutical industry has gained a strong impact. The main type of production adopted by companies in the manufacturing of drugs has been essentially discontinuous or 'batch' production, which traditionally consists of the separation of the process by different unit operations (steps with spatial and temporal differences). Currently, one of the biggest issues in the pharmaceutical industry is the adoption of continuous production, in which the equipment is centralized, and the process is not interrupted. The implementation of this technology allows the reduction of costs and time of each production cycle with consequent increase in profitability, safety, and flexibility. Associated with this last type of production, there are also several associated challenges at the regulatory and scientific level, for which the regulatory entities have created complementary tools such as Process Analytical Technology (PAT) embodied in the Quality by Design (QbD) concept.
Throughout the history of medicine, it is evident the evolution at scientific and technological level that over the years has changed pharmaceutical practice and consequently the production of medicines. The preparation of compounded medicines (MM) is the activity originally developed by Pharmacists, which due to the evolution and industrialization in the pharmaceutical sector ended up being somewhat abandoned in the middle of the last century. However, not all therapeutic needs are met by the pharmaceutical industry, so the compounded drugs, even today, have an important role in the treatment of certain diseases and specificities of some groups. Compounded drugs allow the customization of dosages and pharmaceutical forms, as well as the masking of unfavorable organoleptic characteristics or the substitution of an excipient to which the individual is intolerant. Pharmaceutical forms containing combinations of active substances ("polypill") can also be created, which is particularly useful for polymedicated patients. MM thus continue to present themselves as a very important tool about individualization of therapy. Recently, and thanks to scientific and technological developments, the production of drugs by the pharmaceutical industry has gained a strong impact. The main type of production adopted by companies in the manufacturing of drugs has been essentially discontinuous or 'batch' production, which traditionally consists of the separation of the process by different unit operations (steps with spatial and temporal differences). Currently, one of the biggest issues in the pharmaceutical industry is the adoption of continuous production, in which the equipment is centralized, and the process is not interrupted. The implementation of this technology allows the reduction of costs and time of each production cycle with consequent increase in profitability, safety, and flexibility. Associated with this last type of production, there are also several associated challenges at the regulatory and scientific level, for which the regulatory entities have created complementary tools such as Process Analytical Technology (PAT) embodied in the Quality by Design (QbD) concept.
Description
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2022, Universidade de Lisboa, Faculdade de Farmácia.
Keywords
Medicamentos manipulados Produção contínua Produção descontínua Produção individualizada Mestrado integrado - 2022