Aula 04 Excipientes
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INSUMOS FARMACÊUTICOS
Prof. Ma. Inaiara R. C. Gorski Farmacotécnica 2012
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INSUMOS INERTES DEVEM CUMPRIR AS SEGUINTES EXIGÊNCIAS :
Inér Inérci cia, a, incl inclui uind ndo o toxi toxici cida dade de
Tolerânci olerância a fisiológ fisiológica ica
Ausência Ausência de microorganismos microorganismos
Esta Estabi bili lida dade de quím químic ica, a, físi física ca e micr microb obia iana na
Libe iberaç ração e abs absorção rção do medi edicamen amento to
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INSUMOS INERTES DEVEM:
Faci Facililita tarr a admi admini nist stra raçã ção o
Melhor lhorar ar a eficá ficác cia
Assegurar estabilidade estabilidade e conservação conservação
Melh Melhor orar ar a apar aparên ênci cia a
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EXCIPIENTE - DEFINIÇÃO “qualquer substância, diferente do fármaco ou do
pró fármaco, que tem sua segurança avaliada => forma farmacêutica”:
possibilitar a preparação do medicamento; proteger, fornecer ou melhorar a estabilidade e a disponibilidade biológica do fármaco, além da
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EXCIPIENTE - DEFINIÇÃO propiciar a identificação do produto; melhorar ou promover qualquer outro atributo relacionado, não somente à segurança mas, também, com a efetividade do produto durante a
estocagem e/ou o uso.”
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SOLVENTES, DILUENTES E VEÍCULOS Solventes Substâncias usadas para dissolver outra substância na preparação de uma solução. Pode ser aquoso ou não. Diluentes Trata-se de material de enchimento “inerte” usado para produzir um volume, propriedade de fluxo e características de compressão desejáveis em cápsulas e comprimidos.
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EXCIPIENTE - CLASSIFICAÇÃO Acidificante Alcalinizante Adsorvente Propelente Removedor de
Flavorizante Umectante Levigante Plastificante Solvente
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SOLVENTES (EXEMPLOS) Água Álcool etílico etílico Álcool isopropílico
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DILUENTES (EXEMPLOS) Amido 9005-25-8 Celulose microcristalina 9004-34-6
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VEÍCULOS (EXEMPLO) Xarope simples Sacarose 85g Água purificada q.s.p.
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VEÍCULOS (EXEMPLO)
Água Água potável
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VEÍCULOS (EXEMPLO)
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VEÍCULOS (EXEMPLO)
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UBRIFICANTES DESLIZANTES E ANTI L UBRIFICANTES
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FLAVORIZANTES
vanilina,
mentol,
óleo de laranja,
óleo de canela,
óleo de anis,
óleo de menta,
cacau
...
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EDULCORANTES Quanto a capacidade nutritiva: Não nutritivo: Acessulfame, Ciclamato, Esteviosídeo, Sacarina, Sucralose, Neotame. Nutritivo: Aspartame, Taumatina, Sacarose
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C ARACTERÍSTICAS DE ALGUNS EDULCORANTES
Edulcorante Edulcorante Acessulfame K Aspartame Ciclamato Frutose Glicose Glicerol Maltitol Neotame Sacarina Sacarina sódica
Poder NumeroE / CAS Farmacopéias Farmacopéias 180-200 E 950 180-200 E 951 FF,USP 30 E 952 FE, FF 1,2 FB, FE, FF, FA, FJ, USP 0,7 FB, FE, FF, FA, FJ, USP 0,6 E 422 FB, FE, FF, FA, FJ, USP 0,8 FA, USP 8000 165450-17-9 500 E 954 FB, FF, USP 300 E 954 FB, FE, FF, FA, FJ, USP
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SUSPENSORES ORES AGENTES SUSPENS
bentonita,, bentonita
carbopol,
CMC-Na,, CMC-Na
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EMULSIFICANTE AGENTE EMULSIFICANTE
acácia,
álcool cetílico,
monoestearato de glicerila,
monooleato de sorbitan
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TENSOATIVOS VOS AGENTES TENSOATI
cloreto de benzalcôni benzalcônio, o, polisorbato 80 (Tween 80),
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UMECTANTES
glicerina, propilenoglicol,
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AGENTE DE VISCOSIDADE
bentonita,, bentonita
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AGENTE DE CONSISTÊNCIA
álcool cetílico, parafina,
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BASE PARA SUPOSITÓRIOS
manteiga de cacau polietilenoglicol
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