Pharmacel® 112 - DFE Pharma Deutsch

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Produktinformation

Pharmacel® 112 ist eine direkt verpressbare mikrokristalline Cellulose mit niedrigem Feuchtigkeitsgehalt (LOD < 1,5 % w/w), die speziell für die Formulierung pharmazeutischer Wirkstoffe (APIs) mit hoher Feuchtigkeitsempfindlichkeit entwickelt wurde.

Pharmacel® 112 kann in einer Vielzahl von oralen festen Darreichungsformen (OSD) als Bindemittel, Kompressionsmittel, Verdünnungsmittel und/oder Zerfallshilfe verwendet werden. Sein niedriger Feuchtigkeitsgehalt kann zu einer verbesserten Stabilität des Arzneimittels führen, ohne die Leistung des Endprodukts zu beeinträchtigen.

Die hochgradig schützende Verpackung garantiert den vollständigen Schutz von Pharmacel® 112 vor Feuchtigkeitsaufnahme während der 4-jährigen Haltbarkeitsdauer.

Verpackung

-25kg schwerer und mehrschichtiger HDPE-Aluminium-Beutel mit LDPE-Beschichtung.

- Probengröße: 500g

Produktionsstandort

Cuddalore, Indien

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

Typische Produktdaten

Partikelgrößenverteilung (μm)

X10: 40
X50: 90
X90: 180

Rohdichte (g/L)

Rohdichte (g/L): 330

Hausner-Verhältnis (-)

Hausner-Verhältnis (-): 1.39

LOD (% w/w)

LOD (% w/w): 1,3

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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Produktspezifikation Pharmacel 112
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DFE Pharma Leaflet Pharmacel 112 Ansehen

Prozessablaufplan (PFS) Pharmacel® 112
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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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Dioxin-Erklärung Laktose
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Datenintegrität
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Eignungszertifikat
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Latexfrei-Erklärung
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Inhaltsstoffdeklaration Pharmacel sMCC
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Konformitätserklärung Verpackung
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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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Stability Summary Pharmacel®112
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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