MOOC I Control Strategy - Quality Control

29 Nov 2023 | Teaching Materials | Contributor(s): RCPE

MOOC I Feeding - Disturbances

29 Nov 2023 | Teaching Materials | Contributor(s): RCPE

MOOC I Feeding - Refill Strategy

29 Nov 2023 | Teaching Materials | Contributor(s): RCPE

MOOC I Feeding - Twin Screw Feeder

29 Nov 2023 | Teaching Materials | Contributor(s): RCPE

MOOC I Introduction - The Advantages and Challenges of Continuous Manufacturing in Pharmaceuticals

29 Nov 2023 | Teaching Materials | Contributor(s): RCPE

In this video, we start exploring the world of continuous manufacturing in the pharmaceutical industry. Discover how this innovative technology is revolutionizing the production of medicines, its advantages over traditional batch manufacturing, and the challenges it presents. Join us as we delve...

Multi-dimensional population balance modeling and experimental validation of continuous powder mixing processes

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Sen, Maitraye, Singh, Ravendra Vanarase, Aditya John, Joyce, Ramachandran, Rohit

It has been recognized that the application of quality by design (QbD) to continuous processing in the pharmaceutical industry leads to better process control, improved product quality and mitigates scale-up issues (Schaber et al., 2011), whereby a component of QbD involves the development...

Multi-Impurity Adsorption Model for Modeling Crystal Purity and Shape Evolution during Crystallization Processes in Impure Media

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Borsos, Akos, Majumder, Aniruddha, Nagy, Zoltan K.

The impurity effect on the crystal properties, such as particle size and shape distribution, is significant, having significant impact on the downstream processes as well as on the product effectiveness. Currently very few studies exist that provide a quantitative model to describe crystal purity...

Multi-scale flowsheet simulation of an integrated continuous purification-downstream pharmaceutical manufacturing process

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Sen, M, Chaudhury, ASingh, R, John, J, Ramachandran, R

Properties of active pharmaceutical ingredients influence the critical quality attributes (CQAs) of final solid dosage forms (e. g. tablets). In the last decade, continuous manufacturing has been shown to be a promising alternative to batch processing in the pharmaceutical industry. Therefore, a...

Multi-step Flow Synthesis of the Anthelmintic Drug Praziquantel

24 Apr 2024 | Peer-reviewed journal | Contributor(s): Phull, Manjinder Singh, Bohara, Chander Singh, Gundla, Rambabu, Mainkar, Prathama S., Jadav, Surender Singh

Praziquantel (PZQ; Brand name: Biltricide) is categorized as an anthelminthic drug, and it is used for the treatment of Schistosomiasis and other parasitic infections. The World Health Organization (WHO) has classified it as one of the essential and emergency medicines needed across the globe....

Multiobjective optimization of an unseeded batch cooling crystallizer for shape and size manipulation

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Acevedo, David, Tandy, Yanssen, Nagy, Zoltan K.

The optimization of unseeded batch cooling crystallization systems is studied in a multiobjective framework. The length mean size and target aspect ratio (AR) of final crystals were considered as objectives, which give rise to a set of optimal solutions known as Pareto-optimal solutions. Two...

Multiple Organolithium Generation in the Continuous Flow Synthesis of Amitriptyline

10 May 2024 | Peer-reviewed journal | Contributor(s): Kupracz, Lukas, Kirschning, Andreas

A continuous flow protocol for the preparation of the tricyclic antidepressant (TCA) amitriptyline is reported. The advantages of flow chemistry when handling organometallic agents as well as when performing reaction with gases are demonstrated. Continuous multilithiation combined with...

Multistep continuous-flow synthesis of (R)- and (S)-rolipram using heterogeneous catalysts

10 May 2024 | Peer-reviewed journal | Contributor(s): Tsubogo, Tetsu, Oyamada, Hidekazu, Kobayashi, Shū

Chemical manufacturing is conducted using either batch systems or continuous-flow systems. Flow systems have several advantages over batch systems, particularly in terms of productivity, heat and mixing efficiency, safety, and reproducibility. However, for over half a century, pharmaceutical...

Multivariate monitoring for the industrialisation of a continuous wet granulation tableting process

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Zomer, Simeone, Zhang, Jun, Talwar, Sameer, Chattoraj, Sayantan, Hewitt, Christopher

The pharmaceutical industry is undergoing a significant change in product development and manufacturing strategies with the progressive shift from batch to continuous processes. These typically feature vast volumes of data generated by the numerous sensors connected to several unit operations...

Nanofiltration-Enabled InSitu Solvent and Reagent Recycle for Sustainable Continuous-Flow Synthesis

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Fodi, T, Didaskalou, CKupai, J, Balogh, GT, Huszthy, P, Szekely, G

Solvent usage in the pharmaceutical sector accounts for as much as 90% of the overall mass during manufacturing processes. Consequently, solvent consumption poses significant costs and environmental burdens. Continuous processing, in particular continuous-flow reactors, have great potential for...

Native starch as in situ binder for continuous twin screw wet granulation

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Vandevivere, Lise, Portier, Christoph, Vanhoorne, Valerie, Hausler, Olaf, Simon, Denis, De Beer, Thomas, Vervaet, Chris

The use of native starch as in situ binder in a continuous twin screw wet granulation process was studied. Gelatinization of pea starch occurred in the barrel of the granulator using a poorly soluble excipient (anhydrous dicalcium phosphate), but the degree of gelatinization depended on the...

Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes

09 Jun 2023 | Peer-reviewed journal | Contributor(s): De Beer, Thomas, Burggraeve, Anneleen, Fonteyne, Margot, Saerens, Lien, Remon, Jean Paul, Vervaet, Chris;

Within the Process Analytical Technology (PAT) framework, it is of utmost importance to obtain critical process and formulation information during pharmaceutical processing. Process analyzers are the essential PAT tools for real-time process monitoring and control as they supply the data from...

Near Infrared Method Development for a Continuous Manufacturing Blending Process

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Colon, Yleana, Florian, Miguel, Acevedo, David, Mendez, Rafael, Romañach, Rodolfo

Purpose This study describes the validation of a near infrared spectroscopic method for monitoring a continuous manufacturing system. The achievement of this goal requires determining the near infrared (NIR) method’s accuracy, precision, obtaining an estimate of the sample volume analyzed, and...

Near infrared spectroscopic calibration models for real time monitoring of powder density

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Román-Ospino, Andrés, Singh, Ravendra, Ierapetritoua, Marianthi, Ramachandrana, Rohit, Mendez, Rafael, Ortega-Zuñiga, Carlos, Muzzio, Fernando, Romañach, Rodolfo

Near infrared spectroscopic (NIRS) calibration models for real time prediction of powder density (tap, bulk and consolidated) were developed for a pharmaceutical formulation. Powder density is a critical property in the manufacturing of solid oral dosages, related to critical quality attributes...

Near-infrared spectroscopic applications in pharmaceutical particle technology

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Razuc, M, Grafia, AGallo, L, Ramirez-Rigo, MV, Romanach, RJ

Near-infrared spectroscopy (NIRS) is nowadays an established analytical technique in the pharmaceutical industry. The aim of this review is to present the progress of NIRS in providing useful information for pharmaceutical particle technology. NIR methods are now developed to characterize a wide...

Near-Infrared Spectroscopy as Process Analytical Technology in Continuous Solid Dosage Form Manufacturing

09 Jun 2023 | Chapter Book | Contributor(s): Peeters, M., De Beer, T., Narang, Ajit S., Dubey, Atul., Kumar, A

In this chapter titled “Near-infrared Spectroscopy as Process Analytical Technology in Continuous Solid Dosage Form Manufacturing” the fundamentals of near-infrared spectroscopy (NIRS) and the mainstream and emerging NIRS analyzer technologies for process analytical technology (PAT) applications...

Near-infrared Spectroscopy for the In-line Characterization of Powder Voiding Part I: Development of the Methodology

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Ropero, Jorge, Beach, Lauren, Alcala, Manel, Rentas, Raizza, Dave, Rajesh N., Romanach, Rodolfo J.

In-line near-infrared spectroscopy (NIR) spectra were acquired and analyzed to assess the relationship between physical and chemical properties of voiding powders and their spectral changes. NIR spectra were obtained for powders voiding from a conical glass funnel while the powder flow was...

Near-Infrared Spectroscopy for the In-Line Characterization of Powder Voiding Part II: Quantification of Enhanced Flow Properties of Surface Modified Active Pharmaceutical Ingredients

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Beach, Lauren, Ropero, Jorge, Mujumdar, Ajit, Alcala, Manel, Romanach, Rodolfo J., Dave, Rajesh N.

In this work, dry-particle coating was used to modify the surface properties of active pharmaceutical ingredients (APIs) having extremely poor flow properties. Near-infrared (NIR) spectroscopy was utilized as a novel approach to characterize the improved flow behavior of APIs and their blends....

Near-Infrared Spectroscopy-Theory and Practice

09 Jun 2023 | Document

Standard highlights the important components of using NIR for process and product analysis.

New approach to optimizing risk management of the sticking problem using scale-independent critical material attributes and the quantitative process parameter

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Ando, Hirotaka, Hara, Yuko, Sato, Kazunari, Dohi, Masafumi, Hakomori, Tadashi, Yonemochi, Etsuo

In pharmaceutical manufacturing of solid formulations, blending with a lubricant is a key process in preventing sticking during compression. Sticking not only results in tablets with a disfigured appearance but also brings about the interruption of continuous operations. The aim of our study was...

New gravimetric dosing device for Continuous Manufacturing

18 Jan 2024 | Website | Contributor(s): VX management

"So far, it is mainly Loss in Weight feeders (LIW) that are used for this purpose, especially in the pharmaceutical industry, as they can handle smaller flow rates accurately enough. The mechanical concept of these is decades old and despite miniaturisation and improvements at detail...