Croscarmellose Sodium as Pelletization Aid in Extrusion-Spheronization

Only few excipients are known to be suitable as pelletization aids. In this study, the potential use of croscarmellose sodium (CCS) as pelletization aid was investigated. Furthermore, the impact of cations on extrusion-spheronization (ES) of CCS was studied and different grades of CCS were tested. The influence of different cations on the swelling of CCS was investigated by laser diffraction. Mixtures of CCS with lactose monohydrate as filler with or without the inclusion of different cations were produced.

The mixtures were investigated by mixer torque rheometry and consequently extruded and spheronized. Resulting pellets were analyzed by dynamic image analysis. In addition, mixtures of different CCS grades with dibasic calcium phosphate anhydrous (DP) and a mixture with praziquantel (PZQ) as filler were investigated. Calcium and magnesium cations caused a decrease of the swelling of CCS and influenced the use of CCS as pelletization aid since they needed to be included for successful ES. Aluminum, however, led to an aggregation of the CCS particles and to failure of extrusion.

The inclusion of cations decreased the uptake of water by the mixtures which also reduced the liquid-to-solid-ratio (L/S) for successful ES. This was shown to be dependent on the amount of divalent cations in the mixture. With DP or PZQ as filler, no addition of cations was necessary for a successful production of pellets, however the optimal L/S for ES was dependent on the CCS grade used. In conclusion, CCS can be used as a pelletization aid.

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Five different CCS grades were used as received: Primellose® (PL, DFE Pharma, Germany), Ac-Di-Sol® SD-711 (ADS, IFF, USA), Solutab® A (SA, Roquette, France), Solutab® EDP (SE, Roquette, France) and Vivasol® (VS, JRS Pharma, Germany). Dibasic calcium phosphate anhydrous (DP, DI-CAFOS® A12, Budenheim, Germany), praziquantel (PZQ, Bayer AG, Germany) and lactose monohydrate (Lac, GranuLac® 200, Meggle, Germany) were used as fillers. PZQ was chosen due to its low solubility and not for the use as a model API. Sodium chloride (Na), calcium chloride dihydrate (Ca), magnesium chloride hexahydrate (Mg) and aluminum chloride hexahydrate (Al) were of analytical grade.

Siebel, F., Kleinebudde, P. Croscarmellose Sodium as Pelletization Aid in Extrusion-Spheronization. AAPS PharmSciTech 25, 147 (2024).

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