Extrusion–spheronisation of microcrystalline cellulose pastes using a non-aqueous liquid binder

Mascia, Salvatore; Seiler, Christian; Fitzpatrick, Shaun; Wilson, D.I.

doi:10.1016/j.ijpharm.2009.12.058

Cited by 23 publications

(15 citation statements)

References 27 publications

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“…The observed differences in pellet properties were attributed to changes in the extent of both intra-and inter-molecular hydrogen bonding within the hydroxyl groups of the MCC (10) and in the extent of inter-particulate bonding (9). Microstructure of freeze-dried MCC pastes, prepared using different liquids, was analyzed by Mascia et al (11).…”

Section: Introductionmentioning

confidence: 99%

Moistening Liquid-Dependent De-aggregation of Microcrystalline Cellulose and Its Impact on Pellet Formation by Extrusion–Spheronization

Sarkar

Liew

2014

AAPS PharmSciTech

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Abstract. The wet-state particle size of microcrystalline cellulose (MCC) dispersed in different moistening liquids was characterized to elucidate the effect of moistening liquid type on the extent of MCC particle deaggregation. Cohesive strength of moistened MCC masses was also assessed and pellet production by extrusion-spheronization attempted. MCC dispersed in alcohol or water-alcohol mixtures with higher alcohol proportions generally had larger particle sizes. Moistened mass cohesive strength decreased and poorer quality pellets were obtained when water-alcohol mixtures with higher alcohol proportions were used as the moistening liquid. MCC comprise aggregates of small sub-units held together by hydrogen bonds. As MCC particle de-aggregation involves hydrogen bond breaking, moistening liquids with lower polarity, such as water-alcohol mixtures with higher alcohol proportions, induced lesser de-aggregation and yielded MCC with larger particle sizes. When such water-alcohol mixtures were employed during extrusion-spheronization with MCC, the larger particle size of MCC and lower surface tension of the moistening liquid gave rise to moistened masses with lower cohesive strength. During pelletization, agglomerate growth by coalescence and closer packing of components by particle rearrangement would be limited. Thus, weaker, less spherical pellets with smaller size and wider size distribution were produced.

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Section: Introductionmentioning

confidence: 99%

Moistening Liquid-Dependent De-aggregation of Microcrystalline Cellulose and Its Impact on Pellet Formation by Extrusion–Spheronization

Sarkar

Liew

2014

AAPS PharmSciTech

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“…Similar results observed when isopropyl alcohol was used as granulating liquid. However, ethyl alcohol containing 5% water led to the formation of pellets, but on drying pellets crumbled due to lack of cohesion [16].…”

Section: Granulating Agentmentioning

confidence: 99%

Preparation and Evaluation of Multi-Particulate System (Pellets) of Prasugrel Hydrochloride

Kanwar¹,

Kumar²,

Sinha³

2015

PHARMSCI

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Multiparticulate systems (pellets) of prasugrel hydrochloride were prepared by extrusion spheronization method using MCC (micro crystalline cellulose). Optimum spheronization time and method of drying were selected as the process parameters for the preparation of final batches. Various pellet properties were evaluated like size & shape analysis, flow properties, bulk & tapped density, friability, moisture content, drug content, in vitro release rate and in vivo pharmacodynamic studies. All pellet batches showed a narrow particle size distribution, good sphericity and excellent flow properties. Drug content and moisture content of different pellet batches were found in specified limits. The release kinetics of drug loaded MCC pellets followed Peppas model with Fickian diffusion of prasugrel from the pellets. In vivo pharmacodynamic studies exhibited improved bleeding time in pellet group when compared with the marketed tablet formulation.

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“…spheronisation). Mascia et al (2010) recently showed that the affinity of MCC for water arises from solvent-polymer interactions, such that other highly polar solvents such as dimethyl sulphoxide can be used to plasticise MCC. Not all APIs can be processed with the standard grade of MCC (e.g.…”

Section: E-s Aidsmentioning

confidence: 99%

Extrusion–spheronisation of highly loaded 5-ASA multiparticulate dosage forms

Pretoro¹,

Zema²,

Gazzaniga³

et al. 2010

International Journal of Pharmaceutics

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The aim of the current work was to develop an extrusion-spheronisation (E-S) route to manufacture pellets with a high loading (≥90wt%) of 5-aminosalicylic acid (5-ASA). Ram extrusion studies, supported by centrifuge testing, were employed to investigate the effect of the chemical (acidity) and physical (particle size and shape) characteristics of 5-ASA on the ability of microcrystalline cellulose (MCC)-based pastes to retain water when subjected to pressure. Liquid phase migration (LPM) within the paste during the extrusion, and hence variation in water content of extrudates and reproducibility of the final E-S product, was generally observed. The extent of LPM was found to be related to both the drug loading and its physical properties, most notably the particle shape (needle-like). A reduction in particle size, combined with a change in the shape of the 5-ASA particles, allowed LPM to be reduced considerably or eliminated. The performance of colloidal grades of MCC (Avicel RC591 and CL611) as alternative extrusion aids to the standard Avicel PH101 was also investigated: these proved to be superior aids for the highly loaded 5-ASA pastes as their greater water retention capacity mitigated LPM. Combining these results yielded a route for manufacturing pellets with 5-ASA loading ≥90wt%.

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Extrusion–spheronisation of microcrystalline cellulose pastes using a non-aqueous liquid binder

Cited by 23 publications

References 27 publications

Moistening Liquid-Dependent De-aggregation of Microcrystalline Cellulose and Its Impact on Pellet Formation by Extrusion–Spheronization

Moistening Liquid-Dependent De-aggregation of Microcrystalline Cellulose and Its Impact on Pellet Formation by Extrusion–Spheronization

Preparation and Evaluation of Multi-Particulate System (Pellets) of Prasugrel Hydrochloride

Extrusion–spheronisation of highly loaded 5-ASA multiparticulate dosage forms

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