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Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling Development
Contributor(s):: Ottoboni, S, Coleman, SJSteven, C, Siddique, M, Fraissinet, M, Joannes, M, Laux, A, Barton, A, Firth, P, Price, CJ, Mulheran, PA
Developing a continuous isolation process to produce a pure, dry, free-flowing active pharmaceutical ingredient (API) is the final barrier to the implementation of continuous end-to-end pharmaceutical manufacturing. Recent work has led to the development of continuous filtration and washing...
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The effect of lubrication on density distributions of roller compacted ribbons
Contributor(s):: Miguelez-Moran, A. M, Seville, J. P. K.
Roller compaction is a continuous dry granulation process for producing free flowing granules in order to increase the bulk density and uniformity of pharmaceutical formulations. It is a complicated process due to the diversity of powder blends and processing parameters involved. The properties...
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Simplified end-to-end continuous manufacturing by feeding API suspensions in twin-screw wet granulation
Contributor(s):: Schmidt, A, de, Waard, HMoll, KP, Kleinebudde, P, Krumme, M
This study focussed on investigating the coupling of continuous manufacturing of drug substance and continuous manufacture of drug product. An important step in such an integrated end-to-end continuous manufacturing was envisioned by dosing the API as suspension into a twin-screw wet granulation...
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Single-crystal Drying: Development of a Continuous Drying Prototype to Optimize Particle Flow and Residence Time Distribution
Contributor(s):: Zettl, M, Aigner, IHauser, C, Mannschott, T, van, der, Wel, P, Schrottner, H, Khinast, J, Krumme, M
Purpose In the pharmaceutical industry, there has been a growing interest in continuous manufacturing in recent years. Many efforts have been made to implement new process equipment for various production steps. One step which is not yet covered well is the continuous drying of the active...
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Process intensification through continuous spherical crystallization using a two-stage mixed suspension mixed product removal (MSMPR) system
Contributor(s):: Peña, Ramon, Nagy, Zsombor K.
Of utmost importance in the crystallization of active pharmaceutical ingredients (APIs) in the pharmaceutical industry is to produce crystals of good physical, processing, and biopharmaceutical properties. The definition of good physical properties depends on what the end goal and the drug...
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Particle Engineering of an Active Pharmaceutical Ingredient for Improved Micromeritic Properties
Contributor(s):: Sowa, M, Klapwijk, AROstendorf, M, Beckmann, W
A range of particle-engineering techniques were applied to modify unfavorable bulk solid properties of an active pharmaceutical ingredient (API), with the solid-state form of the compound remaining constant. The compound under investigation has been crystallized as needle-like particles, which...
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Industrial-Scale Continuous Vacuum Drying of Active Pharmaceutical Ingredient Paste: Determination of the Process Window
Contributor(s):: Aigner, I, Zettl, MSchroettner, H, van, der, Wel, P, Khinast, JG, Krumme, M
Many efforts have been made in recent years to adopt and implement continuous processing into the pharmaceutical production chain, driven by the desire to optimize the process efficacy and cost as well as the product quality. In the current challenging times, the need for fast adaptable processes...
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Employing Constant Rate Filtration To Assess Active Pharmaceutical Ingredient Washing Efficiency
Contributor(s):: Shahid, M, Faure, COttoboni, S, Lue, L, Price, C
Washing is a key step in pharmaceutical isolation to remove unwanted crystallization solvents and dissolved impurities (mother liquor) from the active pharmaceutical ingredient (API) filter cake to ensure the purity of the product whilst maximizing yield. It is therefore essential to avoid both...
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Effect of High Shear Blending Protocols and Blender Parameters on the Degree of API Agglomeration in Solid Formulations
Contributor(s):: Llusa, M, Sturm, K, Sudah, O, Stamato, H, Goldfarb, DJ, Ramachandruni, H, Hammond, S, Smith, MR, Muzzio, FJ
This paper examines the effect of three protocols with several units and blender parameters on the mitigation of active pharmaceutical ingredient (API) agglomeration in solid formulations. The three protocols either preblend API with a portion of excipients in a high shear unit followed by...
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Development of a Novel Continuous Filtration Unit for Pharmaceutical Process Development and Manufacturing
Contributor(s):: Ottoboni, S, Price, CJSteven, C, Meehan, E, Barton, A, Firth, P, Mitchell, A, Tahir, F
The lack of a commercial laboratory, pilot and small manufacturing scale dead end continuous filtration and drying unit it is a significant gap in the development of continuous pharmaceutical manufacturing processes for new active pharmaceutical ingredients (APIs). To move small-scale...
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Developing a Batch Isolation Procedure and Running It in an Automated Semicontinuous Unit: AWL CFD25 Case Study
Contributor(s):: Ottoboni, S, Shahid, MSteven, C, Coleman, S, Meehan, E, Barton, A, Firth, P, Sutherland, R, Price, CJ
A key challenge during the transition from laboratory/small batch to continuous manufacturing is the development of a process strategy that can easily be adopted for a larger batch/continuous process. Industrial practice is to develop the isolation strategy for a new drug/process in batch using...
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Crystal Population Balance Formulation and Solution Methods: A Review
Contributor(s):: Omar, Hecham M., Rohani, Sohrab
Crystallization is an important part of many chemical industries. Efforts are being invested to improve the performance of the crystallization process by designing novel crystallizers. An important aspect in the development of new crystallizers is the ability to describe the behavior of such...
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Continuous granulation in the pharmaceutical industry
Contributor(s):: Vervaet, C, Remon, JP
Traditionally the manufacturing of pharmaceutical dosage forms has been a batch-wise process and continuous processes have limited applications in a pharmaceutical manufacturing plant. However, several factors (reduction of cost, improved process efficiency, optimal use of equipment, flexibility...
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Assessment of blending performance of pharmaceutical powder mixtures in a continuous mixer using Discrete Element Method (DEM)
Contributor(s):: Behjani, MA, Motlagh, YGBayly, AE, Hassanpour, A
This study proposes a new sample-independent mixing index, termed the Coefficient of Blending Performance (CBP), for monitoring the formation of undesired API (Active Pharmaceutical Ingredient) agglomerates in continuous mixing processes. The proposed index is examined for the blending of...
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Application of Model-Free and Model-Based Quality-by-Control (QbC) for the Efficient Design of Pharmaceutical Crystallization Processes
Contributor(s):: Szilagyi, Botond, Eren, Ayse Quon, Justin L. Papageorgiou, Charles D., Nagy, Zoltan K.
The design of pharmaceutical crystallization processes is a challenging engineering problem because of the specific and versatile quality requirements of the end-product, amplified by the tight regulatory standards. The current industrial standard for crystallization process design is based on...