Silicified microcrystalline cellulose based pellets and their physicochemical properties

Abstract

Silicified microcrystalline cellulose (SMCC), Prosolv® SMCC 50 was used as spheronization aid to manufacture pellets by extrusion and spheronization. Different ratios of SMCC to lactose were used to manufacture pellets using appropriate levels of water as liquid binder. Avicel PH101 based pellets were also manufactured for comparison of their physical properties. The ratio of liquid binder to spheronization aid was critical to produce pellets of desired size and shape. Extrudates composed of 20% aid could withstand only smaller spheronization force in order to be shaped into pellets. The successful products fulfilled the quality of pellets such as narrow size distribution and spherical in shape. The highest surface tensile strength was observed in pellets with equal ratio of lactose to SMCC while pellets having 20% aid disintegrated rapidly within 15 minutes. Furthermore, Prosolv® SMCC 50 based pellets possessed a stronger surface tensile strength when compared with Avicel PH101 based pellets. In conclusion, Prosolv® SMCC 50 has showed to be a good spheronization aid for extrusion and spheronization when used in the range of 20 to 80% content.

Mixed solvent system as binder for the production of silicified microcrystalline cellulose‐based pellets

“…7 For blank pellets, except for A1 and A2, all other pellets recorded <10% fine or coarse fractions indicating the amount of liquid binder used was at appropriate level. Reasonable pellet yields were obtained when IPA content in the liquid binder was further increased.…”

“…Despite using a mixed solvent system, the optimal ratio of liquid binder to spheronization aid was found to be similar to those produced with water for Prosolv ® SMCC 50-based pellets. 7 For blank pellets, except for A1 and A2, all other pellets recorded <10% fine or coarse fractions indicating the amount of liquid binder used was at appropriate level. The typical IQR ranged 0.18-0.25 mm and this is similar to our previous studies.…”

“…The typical IQR ranged 0.18-0.25 mm and this is similar to our previous studies. 7,25 Based on Table I, except for A1, A2-A4 where decreasing proportion of water was employed (3/7, 3.5/6.5, 4/6 of IPA/water), median diameters of the pellets were only increased slightly indicating there was a modest pellet growth while there was an increase in the yields. This has showed that mixed solvent eased the production of pellets.…”

“…1 As MCC pellets have limited disintegration, it retards drug release to some extent. 7 Prosolv ® SMCC 90 has been selected as the key spheronization aid, which has not been studied. 4,5 An optimal elasticity of Prosolv ® SMCC-based wet masses can be produced 6 and Prosolv ® SMCC 50 has been used as an alternative aid to produce round pellets.…”

“…4,5 An optimal elasticity of Prosolv ® SMCC-based wet masses can be produced 6 and Prosolv ® SMCC 50 has been used as an alternative aid to produce round pellets. 7 Prosolv ® SMCC 90 has been selected as the key spheronization aid, which has not been studied. The mean size of Prosolv ® SMCC 90 is the double of SMCC ® 50.…”