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Use of a continuous twin screw granulation and drying system during formulation development and process optimization.
Eur J Pharm Biopharm. 2015 Jan; 89:239-47.EJ

Abstract

Since small scale is key for successful introduction of continuous techniques in the pharmaceutical industry to allow its use during formulation development and process optimization, it is essential to determine whether the product quality is similar when small quantities of materials are processed compared to the continuous processing of larger quantities. Therefore, the aim of this study was to investigate whether material processed in a single cell of the six-segmented fluid bed dryer of the ConsiGma™-25 system (a continuous twin screw granulation and drying system introduced by GEA Pharma Systems, Collette™, Wommelgem, Belgium) is predictive of granule and tablet quality during full-scale manufacturing when all drying cells are filled. Furthermore, the performance of the ConsiGma™-1 system (a mobile laboratory unit) was evaluated and compared to the ConsiGma™-25 system. A premix of two active ingredients, powdered cellulose, maize starch, pregelatinized starch and sodium starch glycolate was granulated with distilled water. After drying and milling (1000 μm, 800 rpm), granules were blended with magnesium stearate and compressed using a Modul™ P tablet press (tablet weight: 430 mg, main compression force: 12 kN). Single cell experiments using the ConsiGma™-25 system and ConsiGma™-1 system were performed in triplicate. Additionally, a 1h continuous run using the ConsiGma™-25 system was executed. Process outcomes (torque, barrel wall temperature, product temperature during drying) and granule (residual moisture content, particle size distribution, bulk and tapped density, hausner ratio, friability) as well as tablet (hardness, friability, disintegration time and dissolution) quality attributes were evaluated. By performing a 1h continuous run, it was detected that a stabilization period was needed for torque and barrel wall temperature due to initial layering of the screws and the screw chamber walls with material. Consequently, slightly deviating granule and tablet quality attributes were obtained during the start-up phase of the 1h run. For the single cell runs, granule and tablet properties were comparable with results obtained during the second part of the 1h run (after start-up). Although deviating granule quality (particle size distribution and Hausner ratio) was observed due to the divergent design of the ConsiGma™-1 unit and the ConsiGma™-25 system (horizontal set-up) used in this study, tablet quality produced from granules processed with the ConsiGma™-1 system was predictive for tablet quality obtained during continuous production using the ConsiGma™-25 system.

Authors+Show Affiliations

Laboratory of Pharmaceutical Technology, Ghent University, Belgium.Laboratory of Pharmaceutical Technology, Ghent University, Belgium.Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Belgium.Global Technical Services, Janssen Supply Chain, Janssen Pharmaceutica, Belgium.Department of Pharmaceutical Development, Johnson&Johnson Pharmaceutical Research and Development, Janssen Pharmaceutica, Belgium.Department of Pharmaceutical Development, Johnson&Johnson Pharmaceutical Research and Development, Janssen Pharmaceutica, Belgium.Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Belgium.Laboratory of Pharmaceutical Technology, Ghent University, Belgium.Laboratory of Pharmaceutical Technology, Ghent University, Belgium. Electronic address: Chris.Vervaet@UGent.be.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25528462

Citation

Vercruysse, J, et al. "Use of a Continuous Twin Screw Granulation and Drying System During Formulation Development and Process Optimization." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 89, 2015, pp. 239-47.
Vercruysse J, Peeters E, Fonteyne M, et al. Use of a continuous twin screw granulation and drying system during formulation development and process optimization. Eur J Pharm Biopharm. 2015;89:239-47.
Vercruysse, J., Peeters, E., Fonteyne, M., Cappuyns, P., Delaet, U., Van Assche, I., De Beer, T., Remon, J. P., & Vervaet, C. (2015). Use of a continuous twin screw granulation and drying system during formulation development and process optimization. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 89, 239-47. https://doi.org/10.1016/j.ejpb.2014.12.017
Vercruysse J, et al. Use of a Continuous Twin Screw Granulation and Drying System During Formulation Development and Process Optimization. Eur J Pharm Biopharm. 2015;89:239-47. PubMed PMID: 25528462.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Use of a continuous twin screw granulation and drying system during formulation development and process optimization. AU - Vercruysse,J, AU - Peeters,E, AU - Fonteyne,M, AU - Cappuyns,P, AU - Delaet,U, AU - Van Assche,I, AU - De Beer,T, AU - Remon,J P, AU - Vervaet,C, Y1 - 2014/12/17/ PY - 2014/03/14/received PY - 2014/12/09/revised PY - 2014/12/10/accepted PY - 2014/12/22/entrez PY - 2014/12/22/pubmed PY - 2015/12/15/medline KW - Continuous twin screw granulation and drying KW - Formulation development KW - Granule and tablet quality KW - Process optimization KW - Process scale-up KW - Repeatability SP - 239 EP - 47 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 89 N2 - Since small scale is key for successful introduction of continuous techniques in the pharmaceutical industry to allow its use during formulation development and process optimization, it is essential to determine whether the product quality is similar when small quantities of materials are processed compared to the continuous processing of larger quantities. Therefore, the aim of this study was to investigate whether material processed in a single cell of the six-segmented fluid bed dryer of the ConsiGma™-25 system (a continuous twin screw granulation and drying system introduced by GEA Pharma Systems, Collette™, Wommelgem, Belgium) is predictive of granule and tablet quality during full-scale manufacturing when all drying cells are filled. Furthermore, the performance of the ConsiGma™-1 system (a mobile laboratory unit) was evaluated and compared to the ConsiGma™-25 system. A premix of two active ingredients, powdered cellulose, maize starch, pregelatinized starch and sodium starch glycolate was granulated with distilled water. After drying and milling (1000 μm, 800 rpm), granules were blended with magnesium stearate and compressed using a Modul™ P tablet press (tablet weight: 430 mg, main compression force: 12 kN). Single cell experiments using the ConsiGma™-25 system and ConsiGma™-1 system were performed in triplicate. Additionally, a 1h continuous run using the ConsiGma™-25 system was executed. Process outcomes (torque, barrel wall temperature, product temperature during drying) and granule (residual moisture content, particle size distribution, bulk and tapped density, hausner ratio, friability) as well as tablet (hardness, friability, disintegration time and dissolution) quality attributes were evaluated. By performing a 1h continuous run, it was detected that a stabilization period was needed for torque and barrel wall temperature due to initial layering of the screws and the screw chamber walls with material. Consequently, slightly deviating granule and tablet quality attributes were obtained during the start-up phase of the 1h run. For the single cell runs, granule and tablet properties were comparable with results obtained during the second part of the 1h run (after start-up). Although deviating granule quality (particle size distribution and Hausner ratio) was observed due to the divergent design of the ConsiGma™-1 unit and the ConsiGma™-25 system (horizontal set-up) used in this study, tablet quality produced from granules processed with the ConsiGma™-1 system was predictive for tablet quality obtained during continuous production using the ConsiGma™-25 system. SN - 1873-3441 UR - https://www.unboundmedicine.com/medline/citation/25528462/Use_of_a_continuous_twin_screw_granulation_and_drying_system_during_formulation_development_and_process_optimization_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939-6411(14)00372-5 DB - PRIME DP - Unbound Medicine ER -