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Continuous twin screw granulation: Robustness of lactose/MCC-based formulations.
Int J Pharm. 2020 Oct 15; 588:119756.IJ

Abstract

In recent years, significant progress has been made in the field of continuous twin screw granulation. However, only limited knowledge is currently available on the impact of active pharmaceutical ingredient (API) properties on granule quality and processability. In this study, the response behavior of four formulations containing APIs (5-10% drug load) with diverse characteristics was compared to the behavior of the corresponding placebo formulation consisting of lactose, microcrystalline cellulose (MCC) and hydroxypropylmethylcellulose (HPMC). API selection was based on extensive material characterization, combining conventional testing with in silico descriptors. For each formulation, a design of experiments was set up, evaluating the impact of liquid to solid (L/S) ratio and screw speed. Response ranges, response behavior and processability of each of the four formulations proved very similar to the placebo formulation when an appropriate center point L/S ratio was chosen. Hence, this robust placebo formulation could prove useful by decreasing drug product development time and consequently providing patients with a faster access to innovative medicine. Additionally, APIs with similar properties exhibited highly comparable response behavior at similar L/S ratios, indicating the potential use of surrogate APIs in novel drug product development.

Authors+Show Affiliations

Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.Pharmaceutical Research and Development, Division of Janssen Pharmaceutica, Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium.Pharmaceutical Research and Development, Division of Janssen Pharmaceutica, Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium.Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium. Electronic address: valerie.vanhoorne@ugent.be.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32783981

Citation

Portier, Christoph, et al. "Continuous Twin Screw Granulation: Robustness of lactose/MCC-based Formulations." International Journal of Pharmaceutics, vol. 588, 2020, p. 119756.
Portier C, De Vriendt C, Vigh T, et al. Continuous twin screw granulation: Robustness of lactose/MCC-based formulations. Int J Pharm. 2020;588:119756.
Portier, C., De Vriendt, C., Vigh, T., Di Pretoro, G., De Beer, T., Vervaet, C., & Vanhoorne, V. (2020). Continuous twin screw granulation: Robustness of lactose/MCC-based formulations. International Journal of Pharmaceutics, 588, 119756. https://doi.org/10.1016/j.ijpharm.2020.119756
Portier C, et al. Continuous Twin Screw Granulation: Robustness of lactose/MCC-based Formulations. Int J Pharm. 2020 Oct 15;588:119756. PubMed PMID: 32783981.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Continuous twin screw granulation: Robustness of lactose/MCC-based formulations. AU - Portier,Christoph, AU - De Vriendt,Charlotte, AU - Vigh,Tamas, AU - Di Pretoro,Giustino, AU - De Beer,Thomas, AU - Vervaet,Chris, AU - Vanhoorne,Valérie, Y1 - 2020/08/09/ PY - 2020/06/02/received PY - 2020/08/05/revised PY - 2020/08/07/accepted PY - 2020/8/14/pubmed PY - 2021/5/22/medline PY - 2020/8/14/entrez KW - Continuous manufacturing KW - Design of experiments KW - Formulation development KW - Platform formulation KW - Robustness KW - Twin screw granulation KW - Wet granulation SP - 119756 EP - 119756 JF - International journal of pharmaceutics JO - Int J Pharm VL - 588 N2 - In recent years, significant progress has been made in the field of continuous twin screw granulation. However, only limited knowledge is currently available on the impact of active pharmaceutical ingredient (API) properties on granule quality and processability. In this study, the response behavior of four formulations containing APIs (5-10% drug load) with diverse characteristics was compared to the behavior of the corresponding placebo formulation consisting of lactose, microcrystalline cellulose (MCC) and hydroxypropylmethylcellulose (HPMC). API selection was based on extensive material characterization, combining conventional testing with in silico descriptors. For each formulation, a design of experiments was set up, evaluating the impact of liquid to solid (L/S) ratio and screw speed. Response ranges, response behavior and processability of each of the four formulations proved very similar to the placebo formulation when an appropriate center point L/S ratio was chosen. Hence, this robust placebo formulation could prove useful by decreasing drug product development time and consequently providing patients with a faster access to innovative medicine. Additionally, APIs with similar properties exhibited highly comparable response behavior at similar L/S ratios, indicating the potential use of surrogate APIs in novel drug product development. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/32783981/Continuous_twin_screw_granulation:_Robustness_of_lactose/MCC_based_formulations_ DB - PRIME DP - Unbound Medicine ER -