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Transfer from high-shear batch to continuous twin screw wet granulation: a case study in understanding the relationship between process parameters and product quality attributes.
J Pharm Sci. 2014 Oct; 103(10):3075-82.JP

Abstract

A twin screw to high-shear batch granulation technology switch was evaluated for a pharmaceutical development project. Differences in granule (particle size distribution and porosity) and tablet (dissolution) quality attributes were analysed for both continuous and batch technologies. Liquid to solid (L/S) ratio, screw configuration and screw speed parameters on the twin screw granulator were varied, with output granule and tablet properties characterised. L/S and screw configuration were found to influence the granule particle size distribution, porosity and tablet dissolution. At 0.15 L/S, the particle size distribution showed a significant proportion of ungranulated material in the output granule. As the L/S is increased, the level of ungranulated material decreased. An increase in L/S and the number of kneader elements caused a decrease in granule porosity and tablet dissolution. Twin screw and batch granulation technologies generated different granule properties (size and shape) at a constant L/S. A lower L/S in twin screw granulation was needed to achieve similar tablet attributes. It is concluded that differences in liquid addition and therefore initial granule nucleation caused differences in granule properties, which impacted tablet attributes and manufacturability.

Authors+Show Affiliations

Pharmaceutical Development, AstraZeneca, Macclesfield, Cheshire, SK10 2NA, United Kingdom.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25044074

Citation

Beer, Paul, et al. "Transfer From High-shear Batch to Continuous Twin Screw Wet Granulation: a Case Study in Understanding the Relationship Between Process Parameters and Product Quality Attributes." Journal of Pharmaceutical Sciences, vol. 103, no. 10, 2014, pp. 3075-82.
Beer P, Wilson D, Huang Z, et al. Transfer from high-shear batch to continuous twin screw wet granulation: a case study in understanding the relationship between process parameters and product quality attributes. J Pharm Sci. 2014;103(10):3075-82.
Beer, P., Wilson, D., Huang, Z., & De Matas, M. (2014). Transfer from high-shear batch to continuous twin screw wet granulation: a case study in understanding the relationship between process parameters and product quality attributes. Journal of Pharmaceutical Sciences, 103(10), 3075-82. https://doi.org/10.1002/jps.24078
Beer P, et al. Transfer From High-shear Batch to Continuous Twin Screw Wet Granulation: a Case Study in Understanding the Relationship Between Process Parameters and Product Quality Attributes. J Pharm Sci. 2014;103(10):3075-82. PubMed PMID: 25044074.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Transfer from high-shear batch to continuous twin screw wet granulation: a case study in understanding the relationship between process parameters and product quality attributes. AU - Beer,Paul, AU - Wilson,David, AU - Huang,Zhenyu, AU - De Matas,Marcel, Y1 - 2014/07/08/ PY - 2014/03/11/received PY - 2014/06/02/revised PY - 2014/06/03/accepted PY - 2014/7/22/entrez PY - 2014/7/22/pubmed PY - 2015/6/2/medline KW - compression KW - continuous wet granulation KW - factorial design KW - formulation KW - high shear granulation KW - image analysis KW - principle component analysis KW - processing KW - quality attributes KW - twin screw granulation SP - 3075 EP - 82 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 103 IS - 10 N2 - A twin screw to high-shear batch granulation technology switch was evaluated for a pharmaceutical development project. Differences in granule (particle size distribution and porosity) and tablet (dissolution) quality attributes were analysed for both continuous and batch technologies. Liquid to solid (L/S) ratio, screw configuration and screw speed parameters on the twin screw granulator were varied, with output granule and tablet properties characterised. L/S and screw configuration were found to influence the granule particle size distribution, porosity and tablet dissolution. At 0.15 L/S, the particle size distribution showed a significant proportion of ungranulated material in the output granule. As the L/S is increased, the level of ungranulated material decreased. An increase in L/S and the number of kneader elements caused a decrease in granule porosity and tablet dissolution. Twin screw and batch granulation technologies generated different granule properties (size and shape) at a constant L/S. A lower L/S in twin screw granulation was needed to achieve similar tablet attributes. It is concluded that differences in liquid addition and therefore initial granule nucleation caused differences in granule properties, which impacted tablet attributes and manufacturability. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/25044074/Transfer_from_high_shear_batch_to_continuous_twin_screw_wet_granulation:_a_case_study_in_understanding_the_relationship_between_process_parameters_and_product_quality_attributes_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3549(15)30376-2 DB - PRIME DP - Unbound Medicine ER -
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