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Assessment of spatial heterogeneity in continuous twin screw wet granulation process using three-compartmental population balance model.
Liu, Huolong; Galbraith, Shaun C; Park, Seo-Young; Cha, Bumjoon; Huang, Zhuangrong; Meyer, Robert Frederick; Flamm, Matthew H; O'Connor, Thomas; Lee, Sau; Yoon, Seongkyu.
Afiliação
  • Liu H; a Department of Chemical Engineering , University of Massachusetts Lowell , Lowell , MA , USA.
  • Galbraith SC; a Department of Chemical Engineering , University of Massachusetts Lowell , Lowell , MA , USA.
  • Park SY; a Department of Chemical Engineering , University of Massachusetts Lowell , Lowell , MA , USA.
  • Cha B; a Department of Chemical Engineering , University of Massachusetts Lowell , Lowell , MA , USA.
  • Huang Z; a Department of Chemical Engineering , University of Massachusetts Lowell , Lowell , MA , USA.
  • Meyer RF; b Pharmaceutical Technology , Merck & Co., Inc , West Point , PA , USA.
  • Flamm MH; b Pharmaceutical Technology , Merck & Co., Inc , West Point , PA , USA.
  • O'Connor T; c Food and Drug Administration , Center for Drug Evaluation and Research, Office of Generics Drug , Silver Spring , MD , USA.
  • Lee S; c Food and Drug Administration , Center for Drug Evaluation and Research, Office of Generics Drug , Silver Spring , MD , USA.
  • Yoon S; a Department of Chemical Engineering , University of Massachusetts Lowell , Lowell , MA , USA.
Pharm Dev Technol ; 24(1): 105-117, 2019 Jan.
Article em En | MEDLINE | ID: mdl-29336653
ABSTRACT
In this study, a novel three-compartmental population balance model (PBM) for a continuous twin screw wet granulation process is developed, combining the techniques of PBM and regression process modeling. The developed model links screw configuration, screw speed, and blend throughput with granule properties to predict the granule size distribution (GSD) and volume-average granule diameter. The granulator screw barrel was divided into three compartments along barrel length wetting compartment, mixing compartment, and steady growth compartment. Different granulation mechanisms are assumed in each compartment. The proposed model therefore considers spatial heterogeneity, improving model prediction accuracy. An industrial data set containing 14 experiments is applied for model development. Three validation experiments show that the three-compartmental PBM can accurately predict granule diameter and size distribution at randomly selected operating conditions. Sixteen combinations of aggregation and breakage kernels are investigated in predicting the experimental GSD to best judge the granulation mechanism. The three-compartmental model is compared with a one-compartmental model in predicting granule diameter at different experimental conditions to demonstrate its advantage. The influence of the screw configuration, screw speed and blend throughput on the volume-average granule diameter is analyzed based on the developed model.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Química Farmacêutica / Tecnologia Farmacêutica / Modelos Teóricos Tipo de estudo: Prognostic_studies Idioma: En Revista: Pharm Dev Technol Assunto da revista: FARMACIA Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Química Farmacêutica / Tecnologia Farmacêutica / Modelos Teóricos Tipo de estudo: Prognostic_studies Idioma: En Revista: Pharm Dev Technol Assunto da revista: FARMACIA Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos