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Pharmacel® 101

Mikrokristalline Zellulose

Hohe Konsistenz von Charge zu Charge

Starkes Bindemittel für Nass- und Trockengranulatformulierungen

Orale feste Darreichungsformen

Produktinformation

Pharmacel® 101 Mikrokristalline Cellulose (MCC) wurde speziell als Schlüsselkomponente für nass- und trockengranulierte Formulierungen entwickelt. DFE Pharma bietet Pharmacel® 101 aus zwei hochqualitativen Produktionsstätten an.

Konsistenz

Pharmacel® ist branchenführend mit einer hohen Konsistenz der funktionellen Eigenschaften von Charge zu Charge, was Ihnen ein geringes Risiko während der Produktion und bei der Entwicklung Ihrer Formulierung ermöglicht.

Pharmacel 101 Consistency Graph 1 (1) (1)

Pharmacel 101 Consistency Graph 2 (1) (1)

Pharmacel® und Laktoseformulierungen

DFE Pharma ist weltweit der einzige Hersteller von Hilfsstoffen, der seinen Kunden sowohl Laktose als auch mikrokristalline Cellulose für die Entwicklung von pharmazeutischen Formulierungen anbietet. Die Kombination von Pharmacel® mit einer der von DFE Pharma angebotenen Laktosequalitäten bietet zusätzliche Vorteile für die Formulierungen, da eine perfekte Kombination von sprödem und plastischem Hilfsstoffverhalten erreicht wird.

Nass-Granulierung

Pharmacel® 101 mikrokristalline Cellulose (MCC) wurde speziell als Schlüsselkomponente für Nassgranulationsformulierungen entwickelt. Der Einsatz von Pharmacel® 101 sorgt für eine gleichmäßige Verteilung der Granulierflüssigkeit und damit für gleichmäßige Granulier- und Trocknungsprozesse. Die Nassgranulation mit Pharmacel® 101 ist ein zuverlässiger, leicht wiederholbarer und robuster Prozess. Tabletten, die mit Pharmacel® 101 hergestellt werden, weisen hervorragende Verdichtungs- und Zerfallseigenschaften auf.

Trockene Granulierung

Pharmacel® 101 mikrokristalline Cellulose (MCC) ist auch ein idealer Hilfsstoff für die Verwendung in trocken granulierten Formulierungen. Die Bänder bleiben bei der Walzenverdichtung nicht an den Verdichtungswalzen haften, und die Trockengranulierung kann in Formulierungen mit einer hohen Wirkstoffdosierung verwendet werden. Für die Trockengranulation eröffnet Pharmacel® 101 wichtige Produktionssynergien. In Verbindung mit einem spröden Hilfsstoff wie SuperTab® 21AN wasserfreie Lactose ergibt sich eine ideale Kombination aus hoher Tablettenfestigkeit und Unempfindlichkeit gegenüber Rückverdichtung, die zu besonders robusten Trockengranulatformulierungen führt.

Verpackung

- 25 kg Mehrschichtiger Papiersack mit PE-Folie

- Probengröße: 500g

Produktionsstandort

Nagpur und Cuddalore, Indien

: Mikrokristalline Zellulose
Funktionalität des Hilfsstoffs: Füllstoff-Bindemittel, Verdünnungsmittel, Bindemittel, Zerfallsmittel
Empfohlenes Verfahren: Direkttablettierung, Nassgranulation, Extrusionsspheronisation, Trockengranulierung
Darreichungsformen: Tablette, Kapsel (orale Feststoffdosis), oral zerfallende Tablette

Typische Produktdaten

Partikelgrößenverteilung (μm)

X10: 25
X50: 60
X90: 120

Rohdichte (g/L)

Rohdichte (g/L): 280

Hausner-Verhältnis (-)

Hausner-Verhältnis (-): 1.57

LOD (% w/w)

LOD (% w/w): 3,8

Dokumentation

ALBA Pharmacel
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Oral Solid Dose Brochure Ansehen
Kontaminanten-Erklärung Pharmacel
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Lebensmittelerklärung MCC
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GMO-Erklärung Mikrokristalline Cellulose
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GMP DFE Pharma Indien Nagpur
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ISO 14001 DFE Pharma Indien Cuddalore
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ISO 9001 DFE Indien Cuddalore
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ICHQ3D - Elementare Verunreinigungen MCC
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Inhaltsstoffdeklaration Laktose
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Inhaltsstoffdeklaration Pharmacel
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Koscher-Zertifikat DFE Pharma Indien Cuddalore
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Sicherheitsdatenblatt Pharmacel
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Nährwertangaben Pharmacel
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DFE Pharma Leaflet Pharmacel 101 Ansehen
Produktspezifikation Pharmacel 101
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Prozessablaufplan Pharmacel 101
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cGMP-Erklärung
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Bestrahlungsfrei
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Verunreinigungen und Rückstände Laktose
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Inhaltsstoffdeklaration Pharmacel sMCC
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Abwesenheit von Melamin Pharmacel, SuperStarch, Zerfallsmitteln
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Welt-Anti-Doping-Code
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Ungefährlicher Stoff
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BSE-Erklärung Pharmacel®
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Restliches Lösungsmittel Pharmacel
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Haltbarkeitsangabe Pharmacel
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Re-compaction properties of lactose and mcc Ansehen
Roller compaction of anhydrous lactose and mcc Ansehen
MCC Effect of Increasing Pharmacel Concentration on the Tableting Properties of DC Diluents Ansehen
Impact of excipient and blend properties on feeding consistency for continuous manufacturing Ansehen
Choosing the optimal lactose and MCC grade for formulating moisture sensitive drugs Ansehen