Feeding of particle-based materials in continuous solid dosage manufacturing: a material science perspective.

The pharmaceutical industry today is experiencing a paradigm shift from batch to continuous manufacturing, which promises greater flexibility to target diverse populations, as well as more-consistent product quality to ensure best efficacy. However, shifting to continuous processing means that even basic process steps, such as feeding, can become unexpected but are crucially important. In this review, we will present the fundamental differences between dispensing (batch) and feeding (continuous) and how they impact the formulation design space. We will further outline our rational development approach, applicable to continuous unit operations in general, which includes standardized material and process characterization, as well as predictive modeling based on advanced, multidomain simulation tools.

[1]  William Engisch,et al.  Using Residence Time Distributions (RTDs) to Address the Traceability of Raw Materials in Continuous Pharmaceutical Manufacturing , 2015, Journal of Pharmaceutical Innovation.

[2]  Changquan Calvin Sun.  Materials science tetrahedron--a useful tool for pharmaceutical research and development. , 2009, Journal of pharmaceutical sciences.

[3]  Justin Whiting,et al.  Real-time acoustic emission monitoring of powder mass flow rate for directed energy deposition. , 2018, Additive manufacturing.

[4]  Fernando J. Muzzio,et al.  Feedrate deviations caused by hopper refill of loss-in-weight feeders , 2015 .

[5]  W. Schlindwein,et al.  Pharmaceutical excipients properties and screw feeder performance in continuous processing lines: a Quality by Design (QbD) approach , 2018, Drug development and industrial pharmacy.

[6]  V. Vanhoorne,et al.  Impact of material properties and process variables on the residence time distribution in twin screw feeding equipment. , 2019, International journal of pharmaceutics.

[7]  Neil Dawson,et al.  Manufacturing classification system in the real world: factors influencing manufacturing process choices for filed commercial oral solid dosage formulations, case studies from industry and considerations for continuous processing , 2018, Pharmaceutical development and technology.

[8]  Fernando J. Muzzio,et al.  Method for characterization of loss-in-weight feeder equipment , 2012 .

[9]  P. Kleinebudde,et al.  Granule size distributions after twin-screw granulation - Do not forget the feeding systems. , 2016, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[10]  Anssi-Pekka Karttunen,et al.  Measurement of residence time distributions and material tracking on three continuous manufacturing lines , 2019, International journal of pharmaceutics.

[11]  Indrajeetsinh K. Yadav,et al.  Development of feed factor prediction models for loss-in-weight powder feeders , 2020 .

[12]  A. Crean,et al.  Continuous powder feeding for pharmaceutical solid dosage form manufacture: a short review , 2018, Pharmaceutical development and technology.

[13]  Fernando J. Muzzio,et al.  Using a material property library to find surrogate materials for pharmaceutical process development , 2018, Powder Technology.

[14]  Lawrence X. Yu,et al.  Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production , 2015, Journal of Pharmaceutical Innovation.

[15]  Michael Leane,et al.  A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms , 2015, Pharmaceutical development and technology.

[16]  Jenny M. Vargas,et al.  Process analytical technology in continuous manufacturing of a commercial pharmaceutical product. , 2018, International journal of pharmaceutics.

[18]  Johannes Khinast,et al.  Detailed modeling and process design of an advanced continuous powder mixer , 2018, International journal of pharmaceutics.

[19]  Furqan Tahir,et al.  Influence of material properties and equipment configuration on loss-in-weight feeder performance for drug product continuous manufacture , 2019, Powder Technology.

[20]  Stephan Laske,et al.  A Review of PAT Strategies in Secondary Solid Oral Dosage Manufacturing of Small Molecules. , 2017, Journal of pharmaceutical sciences.

[21]  Managing active pharmaceutical ingredient raw material variability during twin‐screw blend feeding , 2019, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[22]  Fernando J. Muzzio,et al.  Loss-in-Weight Feeding Trials Case Study: Pharmaceutical Formulation , 2014, Journal of Pharmaceutical Innovation.

[23]  Yifan Wang,et al.  Development and Applications of a Material Library for Pharmaceutical Continuous Manufacturing of Solid Dosage Forms. , 2019, International journal of pharmaceutics.

[25]  Fernando Muzzio,et al.  Enabling real time release testing by NIR prediction of dissolution of tablets made by continuous direct compression (CDC). , 2016, International journal of pharmaceutics.