“MCC SANAQ®burst”—A New Type of Cellulose and its Suitability to Prepare Fast Disintegrating Pellets
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Microcrystalline cellulose (MCC) is the commonly used pelletization aid in wet extrusion-spheronization processes. MCC has the structure of cellulose I and is denoted as MCC I. Recently, MCC II, a different polymorphic type of MCC, became commercially available, known under the name MCC SANAQ®burst. Due to the fact, that MCC II can be used as a filler and a disintegrant in tableting, MCC SANAQ®burst was investigated as new pelletization aid with the goal to prepare disintegrating pellets.
MCC II pellets were compared to the corresponding conventional pellets, manufactured on the basis of MCC I, namely Avicel® PH 102. Formulations with 10%, 20%, and 50% of either MCC I or MCC II as pelletization aids were produced.
One series of binary mixtures, contained lactose monohydrate as filler and a second series chloramphenicol as model drug. All pellets were characterized by their yield, aspect ratio, equivalent diameter, water content, tensile strength, disintegration behavior and—if applicable—drug release.
Results and Discussion
The production of pellets with sufficient quality properties by addition of 10%, 20%, and 50% of MCC II as pelletization aid was possible. In contrast to MCC I pellets, MCC II-based pellets showed disintegration resulting in a much faster drug release.
MCC SANAQ®burst is a promising pelletization aid providing disintegrating and fast-dissolving pellets.
KeywordsExtrusion-spheronization Pellet Cellulose II MCC SANAQ®burst Pelletization aid Disintegration Fast dissolving
The authors acknowledge the financial support and the gift of MCC SANAQ®burst from Pharmatrans SANAQ Ltd, Basel, Switzerland. Furthermore, the authors are grateful to SciConcept for their support regarding crystal structure analyses.
- 2.Okada S, Nakahara H, Isaka H. Adsorption of drugs on microcrystalline cellulose suspended in aqueous solutions. Chem Pham Bull. 1987;35:761–8.Google Scholar
- 6.Dukic´-Ott A, Thommes M, Remon JP, Kleinebudde P, Vervaet C. Production of pellets via extrusion—spheronisation without the incorporation of microcrystalline cellulose: a critical review. Eur J Pharm Biopharm 2009; 71 (1) 38–46.Google Scholar
- 9.Lanz M, Pharmaceutical powder technology: towards a science based understanding of the behavior of powder systems, Dissertation, University of Basel, 2006.Google Scholar
- 17.Merck Index “Different Monographs” in: The Merck Index—an Encyclopedia of Chemicals, Drugs and Biologicals; Merck & Co Rahway, NJ, USA 1989.Google Scholar
- 18.Sanderson H, Thomsen M. Comparative analysis of pharmaceuticals versus industrial chemicals acute aquatic toxicity classification according to the United Nations classification system for chemicals. Assessment of the (Q)SAR predictability of pharmaceuticals acute aquatic toxicity and their predominant acute toxic mode-of-action. Toxicol Lett. 2009;187:84–93.CrossRefPubMedGoogle Scholar
- 21.Langguth P, Fricker G, Wunderli-Allenspach H. Biopharmazie. Weinheim: Wiley; 2004.Google Scholar
- 23.Höpner T, Jayme G, Ulrich JC. Bestimmung des Wasserrückhaltevermögens (Quellwertes) von Zellstoffen. Das Papier. 1955;19/20:476–82.Google Scholar
- 27.Reynolds AD. A new technique for the production of spherical particles. Manuf Chemist. 1970;41:40–3.Google Scholar
- 29.Krässig HA. Cellulose: structure, accessibility and reactivity. Yverdon: Gordon and Breach Science Publisher; 1993.Google Scholar
- 30.Cambridge Structural Database (CSD), The Cambridge Crystallographic Data Centre; 12 Union Road, Cambridge, UK.Google Scholar
- 35.Nishiyama Y. Structure and properties of the cellulose microfibril. J Wood Sci 2009 (in press).Google Scholar