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6.9
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Pharmaceutics
Special Issues
Pharmaceutical Continuous Manufacturing: Then and Now
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Pharmaceutical Continuous Manufacturing: Then and Now

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmaceutical Technology, Manufacturing and Devices".

Deadline for manuscript submissions: closed (26 February 2024) | Viewed by 3776

Special Issue Editor

Dr. Mallorie Tourbin

E-Mail Website
Guest Editor
Laboratoire de Génie Chimique, Université de Toulouse, CNRS, 4 Allée Emile Monso, CEDEX 4, 31432 Toulouse, France
Interests: chemical engineering; particulate processes; spray-drying; nanoparticles for health; encapsulation

Special Issue Information

Dear Colleagues,

The pharmaceutical industry is constantly evolving towards more effective and personalized therapies. The manufacture plays an important role in the innovation strategy; however, the pharmaceutical industry has tended to innovate slower than other chemical industries, and therefore many of the technologies still operate with conventional batch processes. To remain competitive in the efficiency and constant quality of active pharmaceutical ingredients and end-products, several challenges remain and further research is needed on flow manufacturing processes. This Special Issue aims to highlight new research approaches and recent advances in continuous unit operations or in the development of end-to-end systems, e.g., based on process intensification, the development of process system engineering tools, or on-line control techniques for process analytical technology. Thus, we are pleased to invite you to submit articles covering the different aspects of pharmaceutical continuous manufacturing: synthesis in flow, mixing, powder blending, crystallization, purification (distillation, extraction, washing, etc.), filtration, drying (spray drying, freeze drying, etc.), shaping (milling, granulation, tableting, etc.), on-line control technologies, optimization and modelling of processes, supply chain, etc.

Dr. Mallorie Tourbin
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • continuous pharmaceutical manufacturing
  • pharmaceutical engineering
  • chemical engineering
  • particulate processes
  • process system engineering
  • on-line control technologies
  • synthesis in flow
  • continuous crystallization
  • drying
  • drug granulation
  • drug tableting

Published Papers (3 papers)

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Research

17 pages, 6023 KiB  
Article
Lubricant Sensitivity of Direct Compression Grades of Lactose in Continuous and Batch Tableting Process
by Gerald A. Hebbink, Pauline H. M. Janssen, Jurjen H. Kok, Lorenzo Menarini, Federica Giatti, Caterina Funaro, Salvatore Fabrizio Consoli and Bastiaan H. J. Dickhoff
Pharmaceutics 2023, 15(11), 2575; https://doi.org/10.3390/pharmaceutics15112575 - 03 Nov 2023
Viewed by 1123
Abstract
Modern pharmaceutical manufacturing based on Quality by Design and digitalisation is revolutionising the pharmaceutical industry. Continuous processes are promoted as they increase efficiency and improve quality control. Compared to batch blending, continuous blending is easier to scale and provides advantages for achieving blend [...] Read more.
Modern pharmaceutical manufacturing based on Quality by Design and digitalisation is revolutionising the pharmaceutical industry. Continuous processes are promoted as they increase efficiency and improve quality control. Compared to batch blending, continuous blending is easier to scale and provides advantages for achieving blend homogeneity. One potential challenge of continuous blending is the risk of over-lubrication. In this study, blending homogeneity and lubricant sensitivity are investigated for both batch and continuous processes. Given their distinct chemical structures and morphologies, anhydrous lactose and granulated lactose are expected to exhibit varying sensitivities to changes in process settings across both technologies. The findings suggest that both lactose grades provide highly stable blends that can be safely utilised in both batch and continuous modes. Optimisation should focus on process variables, such as the quality of loss-in-weight feeders used for dosing low doses of ingredients. The most significant process parameter for lubricant sensitivity was the type of lactose used. Anhydrous lactose produced harder tablets than the more porous granulated lactose but was more sensitive to lubrication at the same settings. The magnesium stearate content and its interaction with the type of lactose are also critical factors, with magnesium stearate having a counterproductive impact on tabletability. Full article
(This article belongs to the Special Issue Pharmaceutical Continuous Manufacturing: Then and Now)
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15 pages, 4237 KiB  
Article
Integrated Continuous Wet Granulation and Drying: Process Evaluation and Comparison with Batch Processing
by Seth P. Forster, Erin Dippold, Abbe Haser, Daniel Emanuele and Robin Meier
Pharmaceutics 2023, 15(9), 2317; https://doi.org/10.3390/pharmaceutics15092317 - 14 Sep 2023
Cited by 1 | Viewed by 1449
Abstract
The pharmaceutical industry is in the midst of a transition from traditional batch processes to continuous manufacturing. However, the challenges in making this transition vary depending on the selected manufacturing process. Compared with other oral solid dosage processes, wet granulation has been challenging [...] Read more.
The pharmaceutical industry is in the midst of a transition from traditional batch processes to continuous manufacturing. However, the challenges in making this transition vary depending on the selected manufacturing process. Compared with other oral solid dosage processes, wet granulation has been challenging to move towards continuous processing since traditional equipment has been predominantly strictly batch, instead of readily adapted to material flow such as dry granulation or tablet compression, and there have been few equipment options for continuous granule drying. Recently, pilot and commercial scale equipment combining a twin-screw wet granulator and a novel horizontal vibratory fluid-bed dryer have been developed. This study describes the process space of that equipment and compares the granules produced with batch high-shear and fluid-bed wet granulation processes. The results of this evaluation demonstrate that the equipment works across a range of formulations, effectively granulates and dries, and produces granules of similar or improved quality to batch wet granulation and drying. Full article
(This article belongs to the Special Issue Pharmaceutical Continuous Manufacturing: Then and Now)
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13 pages, 3255 KiB  
Article
Material Transport Characteristics in Planetary Roller Melt Granulation
by Tom Lang, Andreas Bramböck, Markus Thommes and Jens Bartsch
Pharmaceutics 2023, 15(8), 2039; https://doi.org/10.3390/pharmaceutics15082039 - 28 Jul 2023
Cited by 1 | Viewed by 733
Abstract
Melt granulation for improving material handling by modifying particle size distribution offers significant advantages compared to the standard methods of dry and wet granulation in dust reduction, obviating a subsequent drying step. Furthermore, current research in pharmaceutical technology aims for continuous methods, as [...] Read more.
Melt granulation for improving material handling by modifying particle size distribution offers significant advantages compared to the standard methods of dry and wet granulation in dust reduction, obviating a subsequent drying step. Furthermore, current research in pharmaceutical technology aims for continuous methods, as these have an enhanced potential to reduce product quality fluctuations. Concerning both aspects, the use of a planetary roller granulator is consequential. The process control with these machines benefits from the enhanced ratio of heated surface to processed volume, compared to the usually-applied twin-screw systems. This is related to the unique concept of planetary spindles flowing around a central spindle in a roller cylinder. Herein, the movement pattern defines the transport characteristics, which determine the energy input and overall processing conditions. The aim of this study is to investigate the residence time distribution in planetary roller melt granulation (PRMG) as an indicator for the material transport. By altering feed rate and rotation speed, the fill level in the granulator is adjusted, which directly affects the average transport velocity and mixing volume. The two-compartment model was utilized to reflect these coherences, as the model parameters symbolize the sub-processes of axial material transport and mixing. Full article
(This article belongs to the Special Issue Pharmaceutical Continuous Manufacturing: Then and Now)
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