[eBook Code] Chemical Engineering in the Pharmaceutical Industry (eBook Code, 2nd)

List of Contributors ix

Preface xv

Unit Conversions xvii

Part I Introduction 1

1 Chemical Engineering in the Pharmaceutical Industry: An Introduction 3
David J. am Ende and Mary T. am Ende

Part II Drug Product Design, Development, and Modeling 19

2 Design of Solid Dosage Formulations 21
Kevin J. Bittorf, Tapan Sanghvi, and Jeffrey P. Katstra

3 Powder Process Challenges and Solutions 53
Thomas Baxter and James Prescott

4 Design and Scale-up of Dry Granulation Processes 81
Howard J. Stamato and Omar L. Sprockel

5 Model-based Development of Roller Compaction Processes 119
Gavin Reynolds

6 Wet Granulation Processes 147
Karen P. Hapgood and James D. Litster

7 Toward a Generic Model for Twin-screw Wet Granulation 173
Daan Van Hauwermeiren, Maxim Verstraeten, Michaël Ghijs, Kai Lee, Neil Turnbull, Mary T. am Ende, Pankaj Doshi, David Wilsdon, Thomas De Beer, and Ingmar Nopens

8 Modeling a Dosator Capsule Filling Process for Hard-shell Capsules 187
Peter Loidolt, Eva Faulhammer, and Johannes G. Khinast

9 Powder Compaction: Process Design and Understanding 203
David Wilson, Ron Roberts, and John Blyth

10 Punch Sticking: Factors and Solutions 227
Daryl M. Simmons

11 Spray Atomization Modeling for Tablet Film Coating Processes 245
Alfred Berchielli, Pankaj Doshi, Alberto Aliseda, and Juan C. Lasheras

12 Spray Drying and Amorphous Dispersions 267
Kristin J.M. Ploeger, Pavithra Sundararajan, Pedro C. Valente, Kenneth J. Rosenberg, João G. Henriques, and Paige Adack

13 The Freeze Drying Process: The Use of Mathematical Modeling in Process Design, Understanding, and Scale-up 293
Venkat Koganti, Sumit Luthra, and Michael J. Pikal

14 Sterilization Processes in the Pharmaceutical Industry 311
Piero M. Armenante and Otute Akiti

15 Controlled Release Technology and Design of Oral Controlled Release Dosage Forms 381
Avinash G. Thombre, Xiao Yu (Shirley) Wu, and Mary T. am Ende

16 Process Design and Development for Novel Pharmaceutical Dosage Forms 409
Leah Appel, Joshua Shockey, Matthew Shaffer, and Jennifer Chu

17 Multiscale Modeling of a Pharmaceutical Fluid Bed Coating Process Using CFD/DEM and Population Balance Models to Predict Coating Uniformity 419
Avik Sarkar, Dalibor Jajcevic, Peter Böhling, Peter Toson, Matej Zadravec, Brian Shoemaker, Pankaj Doshi, Johannes Khinast, and Mary T. am Ende

18 Process Design of Topical Semisolids: Application of Fundamental Concepts in Pharmaceutical Engineering to PEG Ointment Development 451
Amanda Samuel, Thean Yeoh, Rolf Larsen, and Avik Sarkar

19 Achieving a Hot Melt Extrusion Design Space for the Production of Solid Solutions 469
Luke Schenck, Gregory M. Troup, Mike Lowinger, Li Li, and Craig Mckelvey

20 Drug Product Process Modeling 489
Mary T. am Ende, William Ketterhagen, Andrew Prpich, Pankaj Doshi, Salvador García-Muñoz, and Rahul Bharadwajh

Part III Continuous Manufacturing 527

21 Continuous Manufacturing in Secondary Production 529
Martin Warman

22 Continuous Direct Compression Using Portable Continuous Miniature Modular & Manufacturing (PCM&M) 547
Daniel O. Blackwood, Alexandre Bonnassieux, and Giuseppe Cogoni

23 Process Control Levels for Continuous Pharmaceutical Tablet Manufacturing 561
Niels Nicolaï, Ingmar Nopens, Maxim Verstraeten, and Thomas De Beer

Part IV Applied Statistics and Regulatory Environment 585

24 Multivariate Analysis for Pharmaceutical and Medical Device Development 587
Frederick H. Long

25 Pharmaceutical Manufacturing: The Role of Multivariate Analysis in Design Space, Control Strategy, Process Understanding, Troubleshooting, and Optimization 601
Theodora Kourti

26 Quality by Design: Pilot to Reality-The Honeymoon Phase to the Stormy Years 631
Mary T. am Ende and Christine B. Seymour

Index 645