-
Multi-step Flow Synthesis of the Anthelmintic Drug Praziquantel
24 Apr 2024 | 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....
-
Validation of a continuous granulation process using a twin-screw extruder
09 Jun 2023 | Contributor(s):: Van Melkebeke, B., Vervaet, C., Remon, J. P.
Using twin-screw granulation as particle size enlargement technique, the effect of modifying the screw configuration (number of mixing zones, configuration of kneading block) on granule quality, tablet properties and mixing efficiency was investigated. The amount of oversized agglomerates and...
-
Towards a Greener Pharmacy by More Eco Design
09 Jun 2023 | Contributor(s):: Baron, M
This review proposes an overview of the main trends explored by the pharmaceutical industry in order to develop a greener and smarter pharmacy minimizing any negative impact to the environment, and using more sustainable processes and drugs. If many drugs have their origin in nature, many active...
-
The Evolving State of Continuous Processing in Pharmaceutical API Manufacturing: A Survey of Pharmaceutical Companies and Contract Manufacturing Organizations
09 Jun 2023 | Contributor(s):: McWilliams, JC, Allian, ADOpalka, SM, May, SA, Journet, M, Braden, TM
This manuscript provides the results of an in-depth survey assessment of the capabilities, experience, and perspectives on continuous processing in the pharmaceutical sector, with respondents from both pharmaceutical companies and Contract Manufacturing Organizations (CMOs). The survey includes...
-
Kilogram-scale prexasertib monolactate monohydrate synthesis under continuous-flow CGMP conditions
09 Jun 2023 | Contributor(s):: Cole, Kevin, Groh, Jennifer McClary, Johnson, Martin D., Burcham, Christopher L., Campbell, Bradley M., Diseroad, William D., Heller, Michael R., Howell, John R., Kallman, Neil J., Koenig, Thomas M., May, Scott A., Miller, Richard D., Mitchell, David, Myers, David P., Myers, Steven S., Phillips, Joseph L., Polster, Christopher S., White, Timothy D., Cashman, Jim, Hurley, Declan, Moylan, Robert, Sheehan, Paul, Spencer, Richard D., Desmond, Kenneth, Desmond, Paul., Gowran, Olivia
Advances in drug potency and tailored therapeutics are promoting pharmaceutical manufacturing to transition from a traditional batch paradigm to more flexible continuous processing. Here we report the development of a multistep continuous-flow CGMP (current good manufacturing practices) process...
-
Granulation development in batch-to-batch and continuous processes from a quality by design perspective
09 Jun 2023 | Contributor(s):: Ko, Seung Jin, Lee, Ju-Hyun, Kang, Chin-Yang, Park, Jun-Bom
The process of quality by design (QbD) is of great importance in drug development. This review describes the design of experiments (DoE) method, which is an important component of QbD. DoE is predominantly divided into a screening phase and an optimization phase. The screening phase uses...
-
Continuous, one-step synthesis of pharmaceutical cocrystals via hot melt extrusion from neat to matrix-assisted processing - State of the art
09 Jun 2023 | Contributor(s):: Gajda, Maciej, Nartowski, Karol P., Pluta, Janusz, Karolewicz, Bożena
Use of hot melt extrusion (HME) as continuous manufacturing process in the cocrystal synthesis is of increasing interest from both industrial and academic perspective and it is seen as a newly developing branch of mechanochemistry with possible broad application in single step synthesis and...
-
Breaking Through Barriers to Continuous Manufacturing
09 Jun 2023 | Contributor(s):: Markarian, Jennifer
Pharmaceutical manufacturing is inching towards implementing more efficient and sustainable processes, including continuous manufacturing (CM) of solid-dosage drugs. Advantages of CM include the potential for faster development, easier technical transfer, and more efficient and flexible...
-
Application of continuous twin screw granulation for the metformin hydrochloride extended release formulation
09 Jun 2023 | Contributor(s):: Kim, Su-Hyeon, Hwang, Kyu-Min, Cho, Cheol-Hee, Nguyen, Thi-Tram, Seok, Su Hyun, Hwang, Kyu-Mok, Kim, Ju-Young, Park, Chun-Woong, Rhee, Yun-Seok, Park, Eun-Seok
This study focuses on evaluating the potential of transferring from a batch process to continuous process for manufacturing of the extended release formulation. Metformin hydrochloride (HCl) was used in the model formulation which was intended to contain the high amount of hydrophilic drug. The...
-
A Practical and Robust Multistep Continuous Process for Manufacturing 5-Bromo-N-(tert-butyl)pyridine-3-sulfonamide
09 Jun 2023 | Contributor(s):: Yu, M, Strotman, NASavage, SA, Leung, S, Ramirez, A
A multistep continuous flow process involving (1) magnesium-halogen exchange, (2) sulfonylation with sulfuryl chloride, and (3) reaction with tert-butylamine was developed for the synthesis of an arylsulfonamide pharmaceutical intermediate in the synthesis of BMS-919373. The process was...