“MCC SANAQ®burst”—A New Type of Cellulose and its Suitability to Prepare Fast Disintegrating Pellets

Abstract

Introduction 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. Materials 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. Methods 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 DiscussionThe 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. Conclusion MCC SANAQ®burst is a promising pelletization aid providing disintegrating and fast-dissolving pellets.

Influence of storage condition on properties of MCC II-based pellets with theophylline-monohydrate

“…The disintegration times determined with the modified disintegration tester were below 7 min for all formulations. The formulation containing 20% MCC II (C II_Theo80) showed the fastest disintegration (0.7 min), and the formulation containing 50% MCC II (C II_Theo50) showed the slowest disintegration (6.6 min); the high standard deviations of the results can be traced back to the used disintegration method, which was discussed before [4,6].…”

“…The standard pelletization aid for the wet-extrusion/spheronization process is microcrystalline cellulose I (MCC I) [3]. Recently its polymorph MCC II, characterized by a different crystalline structure, was established as new pelletization aid [4]. Pellets made of MCC II as pelletization aid by wetextrusion/spheronization disintegrate in water.…”

“…However, the manufacturing of the MCC II-based formulations is more challenging than for the MCC I-based pellets caused, e.g. by a reduced optimal water content of the wet extrudates and pellets, respectively [4,5]. Furthermore, the disintegration performance is influenced by the storage condition.…”

Miniaturization in Pharmaceutical Extrusion Technology: Feeding as a Challenge of Downscaling

“…Seventy percent lactose in MCC for example required 56.6% to 70% water content in order to obtain cylindrical extrudates. Lower amounts of MCC required lower water content; moreover, the moisture range leading to extrudates became narrower too (39). Based on this, the robustness of the formulation is decreasing while fluctuations in the powder feeder become important.…”

Assessment of co-processing of cellulose II and silicon dioxide as a platform to enhance excipient functionality

“…Thus,grades 101,102,200,301, corresponds to 50, 100, 180, 50, 100, 50 µm and bulk densities of 0. 26 -0.31, 0.28 -0.33, 0.29 -0.36, 0.34 -0.45, 0.35 -0.46, and 0.13 -0.23 g/cm 3 , respectively (Krueger et al, 2010). This material is used as a diluent, a binder and a rapidly disintegrating material for direct compression, dry and wet granulation and as a diluent for hard gelatin capsules.…”