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Respitose® ML001

Gemahlene Laktose

Mit einem festen Anteil an feinen Partikeln

Kohäsiv

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.

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 niedrigeren 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 Formulierung geeignet ist, oder informieren Sie sich über unsere Anpassungsmöglichkeiten.

Entspricht der Ph.Eur., USP-NF und JP.

Verpackung

- 50 kg HDPE-Fass (PE-Auskleidung)

Haltbarkeitsdauer

3 Jahre

Produktionsstandort

Veghel, die Niederlande

: Gemahlene Laktose
Funktionalität des Hilfsstoffs: Trägermaterial
Darreichungsformen: Inhalation

Typische Produktdaten

Partikelgrößenverteilung (μm)

D10: 4,7
D50: 48
D90: 147

Rohdichte (g/L)

Rohdichte (g/L): 570

Gestopfte Dichte (g/L)

Gestopfte Dichte (g/L): 880

Carr-Index (-)

Carr-Index (-): > 25

Dokumentation

ALBA Pharmazeutische Laktose
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GVO-Erklärung Laktose
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Sicherheitsdatenblatt Lactose-Monohydrat
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Nährwertangaben Laktose
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Kontaminantenangabe Pharmatose, Respitose und SuperTab (EU)
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FSSC 22000 FrieslandCampina DMV Veghel
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GMP+ FrieslandCampina DMV B.V. Veghel
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Halal FrieslandCampina DMV Veghel
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ISO 14001 FrieslandCampina DMV Veghel
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ICHQ3D Elementare Verunreinigungen Inhalation Laktose - Respitose® (EU)
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ISO 9001 FrieslandCampina DMV Veghel
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Dry Powder Inhalation Brochure Ansehen
Produktspezifikation Respitose ML001
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Frei von Maul- und Klauenseuche Laktose
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Welt-Anti-Doping-Code
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Virale Sicherheitserklärung Lactose
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Ungefährlicher Stoff
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cGMP-Erklärung
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BSE-Erklärung Laktose & Inhalation
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Bestrahlungsfrei
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Verunreinigungen und Rückstände Laktose
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Änderungsmanagement
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Erklärung zum Produktionsstandort
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Datenintegrität
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cGMP-Erklärung Respitose® & Lactohale®
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Inhaltsstoffdeklaration Pharmacel sMCC
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Konformitätserklärung Verpackung
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REACH-Erklärung
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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:
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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Erklärung zur Betriebskontinuitätsplanung
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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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Herkunft der Milch
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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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Abwesenheit von Melamin Laktose
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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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Restlösungsmittel Laktose
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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.
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
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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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