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Continuous direct compression: Development of an empirical predictive model and challenges regarding PAT implementation.
Bekaert, B; Van Snick, B; Pandelaere, K; Dhondt, J; Di Pretoro, G; De Beer, T; Vervaet, C; Vanhoorne, V.
Afiliação
  • Bekaert B; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
  • Van Snick B; Oral Solid Dosage, Drug Product Development, Discovery Product Development and Supplies, Pharmaceutical Research and Development, Division of Janssen Pharmaceutica, Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium.
  • Pandelaere K; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
  • Dhondt J; Oral Solid Dosage, Drug Product Development, Discovery Product Development and Supplies, Pharmaceutical Research and Development, Division of Janssen Pharmaceutica, Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium.
  • Di Pretoro G; Oral Solid Dosage, Drug Product Development, Discovery Product Development and Supplies, Pharmaceutical Research and Development, Division of Janssen Pharmaceutica, Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium.
  • De Beer T; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
  • Vervaet C; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
  • Vanhoorne V; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
Int J Pharm X ; 4: 100110, 2022 Dec.
Article em En | MEDLINE | ID: mdl-35024605
Palavras-chave
#BP, Number of blade passes; #RMB1, Number of radial mixing blades of the main blender; API, Active pharmaceutical ingredient; API_sd, Spray dried API; BRT, Bulk residence time; BU, Blend uniformity; CDC, Continuous direct compression; CDC-50; CU, Content uniformity; C_P, Caffeine anhydrous powder; Continuous direct compression; Continuous manufacturing; DCP, Dicalcium phosphate / Emcompress AN; FD, Fill depth; HM1/HM2, Hold-up mass main blender/Hold-up mass lubricant blender; Imp1, Impeller speed main blender; LC, Percentage label claim; MCF, Main compression force; MCH, Main compression height; MPT_µ, Metoprolol micronized; MgSt, Magnesium stearate/Ligamed MF-2-V; Multivariate data-analysis; NIR, Near infrared; PAT; PAT, Process Analytical Technology; PC, Principle component; PCA, Principle component analysis; PCD, Pre-compression displacement; PCF, Pre-compression force; PCH, Pre-compression height; PH101, Microcrystalline cellulose / Avicel PH-101; PH200, Microcrystalline cellulose / Avicel PH-200; PLS, Partial least squares; P_DP, Paracetamol dense powder; P_P, Paracetamol powder; P_µ, Paracetamol micronized; Predictive modeling; Q2, Goodness of prediction; R2Y, Goodness of fit; RMSEcv, Root mean squared error of cross validation; RSDTW, Relative standard deviation of tablet weight; SD100, Mannitol / Pearlitol 100 SD; T80, Lactose / Tablettose 80; T_P, Theophylline anhydrous powder; rpm, Revolutions per minute; σForce, Main compression force variability; σPCD, Variability in pre-compression displacement

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Prognostic_studies / Risk_factors_studies Idioma: En Revista: Int J Pharm X Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Bélgica

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Prognostic_studies / Risk_factors_studies Idioma: En Revista: Int J Pharm X Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Bélgica
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