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Lactohale® 201

Feine Laktose

Gemahlen mit unregelmäßig geformten Partikeln

Ideal zur Optimierung von Fluss und Leistung der Formulierung

Inhalation

Produktinformation

Gemahlene Inhalationslaktose ist eine sehr konsistente kristalline Laktose mit unregelmäßig geformten Partikeln und kohäsiven Fließeigenschaften. Die Laktose wird mechanisch gemahlen und weist eine unterschiedliche Partikelgröße auf. Auf diese Weise können Pharmaunternehmen die beste Qualität für ihre Formulierungsanforderungen auswählen.

Die strenge und hochgradig konsistente Partikelgrößenkontrolle während der Produktion in Kombination mit modernsten Partikelgrößenmesstechniken bilden die Grundlage für den Erfolg unserer inhalationsgemahlenen Sorten. Bei DFE Pharma sind Lactohale® und Respitose® die Marken für gemahlene Inhalationslaktosequalitäten.

Laser Diffraction Particle Size Graph Lactohale 201

Partikelgröße und Fließverhalten

Die gemahlenen Lactohale®- und Respitose®-Laktosequalitäten bestehen aus unregelmäßig geformten Partikeln mit einer kontrollierten Partikelgröße. Gemahlene Laktose hat in der Regel eine breite Partikelgrößenverteilung mit einer geringeren mittleren Partikelgröße als gesiebte Laktose. Aufgrund ihrer feinen Beschaffenheit und relativ großen Oberfläche wird die Fließfähigkeit von gemahlener Laktose als kohäsiv bis sehr kohäsiv eingestuft. Gemahlene Laktose wird z. B. typischerweise wegen ihrer Kohäsivität in der Membranabfülltechnik oder zur Ermöglichung der Pfropfenbildung in der Kapselabfülltechnik verwendet.

Durch die Kombination verschiedener Laktosequalitäten können Fließfähigkeit und Feinanteil der Formulierung auf eine optimale Produktleistung ausgerichtet werden. DFE Pharma bietet eine breite Palette von gemahlenen und gesiebten Laktosequalitäten für die Inhalation an, die als Lactohale® und Respitose® bezeichnet werden. Werfen Sie einen Blick auf unser komplettes Portfolio, um herauszufinden, welche Sorte für Ihre Formulierungsanforderungen geeignet ist, oder informieren Sie sich über unsere Möglichkeiten der kundenspezifischen Anpassung.

Erfüllt die Anforderungen von Ph.Eur., USP-NF und JP.

Verpackung

- 20 kg Karton NL (Alu-/PE-Auskleidung)

Haltbarkeitsdauer

3 Jahre

Produktionsstandort

Borculo, die Niederlande

: Gemahlene Laktose
Funktionalität des Hilfsstoffs: Trägermaterial
Darreichungsformen: Inhalation

Typische Produktdaten

Partikelgrößenverteilung (μm)

D10: 3,3
D50: 22
D90: 56

Rohdichte (g/L)

Rohdichte (g/L): 500

Gestopfte Dichte (g/L)

Gestopfte Dichte (g/L): 700

Carr-Index (-)

Carr-Index (-): >25

Dokumentation

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GMP+ DMV - Fonterra Excipients B.V. Borculo
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Halal DFE Pharma B.V. Borculo
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ICHQ3D Elementare Verunreinigungen Inhalation Lactose - Lactohale® (EU)
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Dry Powder Inhalation Brochure Ansehen

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2. The document will be displayed in your web browser. If a login window to MasterControl appears, please use an incognito/private window, or clear the cache of your browser.
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The PDFs are technically modified by DFE Pharma’s controlled documentation system. Please follow the instructions to download and save our documents:
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4. This will open a new browser window with an empty document. Click on "Save". The document will be saved to your computer.
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Restlösungsmittel Laktose
IMPORTANT: PLEASE READ BEFORE VIEWING OR SAVING DOCUMENTS
View documents

Please follow the instructions to see our documents:
1. Click on "Download document"
2. The document will be displayed in your web browser. If a login window to MasterControl appears, please use an incognito/private window, or clear the cache of your browser.
Save documents

The PDFs are technically modified by DFE Pharma’s controlled documentation system. Please follow the instructions to download and save our documents:
1. Click on "Download document"
2. The document will open in Master Control, in a window of your browser. Click on Download>PDF
3. This will open a new browser window with an empty document. Click on "Save". The document will be saved to your computer.
4. This will open a new browser window with an empty document. Click on "Save". The document will be saved to your computer.
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Haltbarkeitsangabe Lactose
IMPORTANT: PLEASE READ BEFORE VIEWING OR SAVING DOCUMENTS
View documents

Please follow the instructions to see our documents:
1. Click on "Download document"
2. The document will be displayed in your web browser. If a login window to MasterControl appears, please use an incognito/private window, or clear the cache of your browser.
Save documents

The PDFs are technically modified by DFE Pharma’s controlled documentation system. Please follow the instructions to download and save our documents:
1. Click on "Download document"
2. The document will open in Master Control, in a window of your browser. Click on Download>PDF
3. This will open a new browser window with an empty document. Click on "Save". The document will be saved to your computer.
4. This will open a new browser window with an empty document. Click on "Save". The document will be saved to your computer.
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Particle size measurement of lactose for dry powder inhalers Ansehen
The influence of lactose particle size on DPI performance Ansehen
Designing inhalation grade lactose Ansehen
Exploring the design space for dry powder inhalers Ansehen
Effect of Lactose Processing on Dry Powder Inhaler Dispersion Ansehen
Different Types of Lactose Fines have an impact on different dry powder inhalers properties Ansehen
Effect of Loaded Dose on Delivered Dose in DPI Ansehen
Measurement of Lactose from DPI in Impactors Ansehen

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