Primojel®

Glicolato de Amido de Sódio tipo A

Excepcional desempenho de dilatação garante rápida desintegração

Funcionalidade robusta em uma variedade de processos

Dose Sólida Oral

Informação do produto

Primojel® glicolato de amido sódico é um superdesintegrante adequado para várias formulações de comprimidos e cápsulas. Em concentrações mais elevadas, Primojel® pode atuar como um agente de aumento de dissolução. Primojel® é altamente eficaz quando usado intragranular e/ou extragranular em processos de granulação seca/úmida. 

Primojel® ocupa mais de 20 vezes o seu próprio peso de água. A rápida penetração de água nos comprimidos e a poderosa dilatação resultam em rápida desintegração. Estudos mostram que o Primojel® consome mais água do que os produtos comparáveis no mercado e desenvolve uma forte força de desintegração, tornando-o um produto altamente eficaz.

A fonte botânica, o grau de reticulação e o grau de substituição de Primojel® foram otimizados para permitir a rápida absorção de água pelo polímero sem a formação de um gel viscoso que possa impedir a penetração de água no comprimido. A manutenção da estrutura esferoide nativa dos grãos de fécula de batata suporta as propriedades de fluxo ideais de Primojel®

Embalagem

- Tambor de 50Kg com revestimento em PE

- Tamanho da amostra: 500g

Validade

5 anos

Local de produção

Foxhol, Holanda

Tipos de Produto: Glicolato de amido sódico
Funcionalidade: Desintegrante
Processo recomendado: Compressão direta, Granulação seca, Mistura seco, Granulação úmida
Formas farmacêuticas: Comprimidos, Cápsula (Dose Oral Sólida), Comprimido de desintegração oral

Dados típicos do produto

: Potato starch

pH

pH: 6,7

Mecanismo de desintegração

Mecanismo de desintegração: Swelling and wicking

Documentation

ALBA Primojel
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Brochura de Dose Oral Sólida Ver
Declaração de contaminantes de Primojel
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Declaração GMO Primojel
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ICHQ3D Impurezas Elementares Superdesintegrantes
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Kosher DFE Foxhol
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MSDS Primojel
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Informação Nutricional Primojel
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Especificação de produto Primojel
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DFE Pharma Leaflet OSD Primojel Ver

Fluxograma de processo Primojel®
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Lactose livre de enfermidade de mão e boca
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Declaração de segurança viral de Lactose
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Declaração cGMP
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Declaração de BSE de Superdesintegrantes
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Livre de irradiação
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Declaração de local de fabricação
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Integridade de dados
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Certificado de Suitability
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Declaração Látex free
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Impurezas Genotoxicas
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Compliance packaging
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Declaração REACH
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Ausência de Melamina em Pharmacel, Superstarch e Desintegrantes
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Declaração de Shelf-Life Primojel e Primellose
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Impact of excipient and blend properties on feeding consistency for continuous manufacturing Ver
Use of Primojel and Primellose in wet granulation Ver

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