BioHale® Sacarose (Inalação)

Inalação

Informação do produto

Com Biohale® Sucarose oferecemos os açúcares não redutores da mais alta pureza para uso em aplicações de inalação.

Existem múltiplas tecnologias disponíveis para a administração nasal e pulmonar de ingredientes farmacêuticos ativos. Para o desenvolvimento de formulações sem veículo, a secagem por pulverização emergiu como a tecnologia preferida. A secagem por pulverização pode ser usada para modificar a superfície, a forma e a densidade das partículas. Uma vantagem da secagem por pulverização é que excipientes, como os graus do Biohale®, podem ser incorporados para modificar as propriedades de aerossolização e fluxo, para modificar a liberação do medicamento.

Os excipientes de Biohale® são excipientes de alta pureza que podem ser usados com segurança para administração pulmonar e nasal. Trealose e sacarose estão listadas na USP-NF, FEur e JPE. Eles são listados e aprovados como GRAS para uso em formulações farmacêuticas parenterais e não parenterais.

Biohale® Sacarose e Biohale® Trealose di-hidratada são ambos dissacarídeos cristalinos não redutores. Os açúcares não redutores proporcionam maior compatibilidade sobre os açúcares redutores com aminoácidos e proteínas, e não são facilmente hidrolisados pelo ácido.

Uma vantagem adicional dos excipientes BioHale® é que eles podem ajudar moléculas complexas a manter sua conformação nativa. Existem várias teorias descrevendo os mecanismos por trás desse efeito de estabilização. Em sistemas secos, a formação de um vidro amorfo é considerada crítica tanto na teoria da vitrificação quanto na teoria da substituição de água.

Os excipientes Biohale® podem ser usados em processos de secagem por pulverização para modificar as propriedades físicas do pó resultante. Eles também são comumente usados em outras aplicações para a lioproteção e crioproteção de proteínas terapêuticas.

Embalagem

- Recipiente de PEAD de 1 kg (forro em PE)

- Tambor de PEAD de 20 kg (forro em PE)

Validade

24 meses

Tipos de Produto: Açúcares não redutores inaláveis
Funcionalidade: Portadora
Formas farmacêuticas: Inalação

Dados típicos do produto

: Plant, isolated from sugar beet

CAS number

CAS number: 57-50-1

Tg (°C)

Tg (°C): ~61

Documentação

Ausência de Melamina em Pharmacel, Superstarch e Desintegrantes
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Declaração de ausência de Aromas, Corantes, Adoçantes, Conservantes e Glicóis
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Declaração BSE BioHale (Sacarose, Trealose)
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Declaração coletiva Sacarose (alérgenos, látex etc)
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Compliance packaging
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Contaminantes Sacarose
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COS Sacarose
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País de origem Sacarose
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País de origem Sacarose
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Declaração de impurezas genotóxicas
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Declaração OGM Sacarose
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ICHQ3D impurezas elementares
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Declaração de ingredientes Sacarose
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Questionário IPEC sobre Nitrosaminas
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Nano materiais
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Ausência de exigência de US DMF
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Ausência de uso de PFC, DEHP, DINP e BPA
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Ausência de substâncias perigosas
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Declaração de estabilidade BioHale Sacarose
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Declaração de solventes residuais BioHale Sacarose
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Informações de segurança Sacarose
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