Pharmaceutical industry perspectives on flow chemocatalysis and biocatalysis

09 Jun 2023 | Contributor(s): Martin, LL, Peschke, TVenturoni, F, Mostarda, S

In response to a growing demand for more sustainable and cost-effective synthetic processes, the pharmaceutical industry is increasingly relying on continuous manufacturing as a valuable alternative to conventional batch processing. Particularly, flow processing may enable process intensification...

Pharmaceutical manufacturing and the quality by design (QBD), process analytical technology (PAT) approach

09 Jun 2023 | Contributor(s): Murphy, Trevor, O’ Mahony, Niall, Panduru, Krishna, Riordan, Daniel, Walsh, Joseph

This paper is the result of a literature review focusing on the application of process analytical technology (PAT) for the pharmaceutical industry in conjunction with the quality by design (QBD) framework. PAT and the QBD framework put forward by the FDA, offer a holistic approach to...

Pharmaceutical Quality System

09 Jun 2023

Guideline acts as a combination of the previous two guidelines (Q8 and Q9), giving vontext to the concepts. A Pharmaceutical Quality System is explained for practical application across all manufacturing platforms in an effort to maintain quality.

Pharmaceutical spray drying: solid-dose process technology platform for the 21st century

09 Jun 2023 | Contributor(s): Snyder, HE

Requirement for precise control of solid-dosage particle properties created with a scalable process technology are continuing to expand in the pharmaceutical industry. Alternate methods of drug delivery, limited active drug substance solubility and the need to improve drug product stability under...

PharmaPy: An object-oriented tool for the development of hybrid pharmaceutical flowsheets

09 Jun 2023 | Contributor(s): Casas-Orozco, Daniel, Laky, Daniel Wang, Vivian Abdi, Mesfin, Feng, X., Wood, E., Laird, Carl, Reklaitis, Gintaras V., Nagy, Zoltan K.

Process design and optimization continue to provide computational challenges as the chemical engineering and process optimization communities seek to address more complex and larger scale applications. Software tools for digital design and flowsheet simulation are readily available for...

Plantwide design and economic evaluation of two Continuous Pharmaceutical Manufacturing (CPM) cases: Ibuprofen and artemisinin

09 Jun 2023 | Contributor(s): Jolliffe, HG, Gerogiorgis, DI

Increasing Research Article and Development (R&D) costs, growing competition from generic manufacturers and dwindling market introduction rates for novel drug products bolster the efforts of pharmaceutical firms to secure competitiveness by investigating Continuous Pharmaceutical Manufacturing...

Points to Consider: ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation

09 Jun 2023

Note highlgihts major components of three ICH guidelines (Q8, Q9, Q10), demonstrating their reliance on one another in order to be successfully applied across pharmaceutical manufacturing operations.

Polymorphism in Solid Dispersions

09 Jun 2023 | Contributor(s): Ortiz, KS, Espinell, JRHTorres, DO, Lopez-Mejias, V, Stelzer, T

Solid dispersions embed active pharmaceutical ingredients in polymeric carriers to improve their solubility. Three solid dispersion preparation techniques are typically employed: solvent evaporation, solventfusion, and fusion methods. Although these are also widely recommended as preparative...

Population Balance Model Development Verification and Validation of Cooling Crystallization of Carbamazepine

09 Jun 2023 | Contributor(s): Liu, Yiqing C., Acevedo, David Yang, Xiaochuan Naimi, Sean, Wu, Wei-Lee, Pavurala, Naresh, Nagy, Zoltan K., O'Connor, Thomas F.

Using process modeling to understand process dynamics and potentially explore the design space of a crystallization process is difficult because of its complex nature with many factors at play, such as initial concentration, supersaturation, seeding strategy, and flow pattern. In this work, a...

Population balance model-based multiobjective optimization of a multisegment multiaddition (MSMA) continuous plug-flow antisolvent crystallizer

09 Jun 2023 | Contributor(s): Ridder, Bradley J., Majumder, Aniruddha, Nagy, Zoltan K.

Crystallization is a major separation process in the pharmaceutical industry. Most crystallizations are performed batchwise, but there is great incentive for converting them to continuous operations. This paper investigates the modeling, simulation, and optimization of a special antisolvent...

Population Balance Modeling to Predict Particle Size Distribution upon Scale-Up of a Combined Antisolvent and Cooling Crystallization of an Active Pharmaceutical Ingredient

09 Jun 2023 | Contributor(s): Rosenbaum, Tamar, Tan, Li Dummeldinger, Michael Mitchell, Niall, Engstrom, Joshua

Herein, a population balance model (PBM) for a combined cooling and antisolvent crystallization process for an active pharmaceutical ingredient (API) has been developed and utilized to predict the product particle size distribution (PSD) for two sets of four ∼35 kg scale plant batches, with...

Powder composition monitoring in continuous pharmaceutical solid-dosage form manufacturing using state estimation-Proof of concept

09 Jun 2023 | Contributor(s): Destro, Francesco, Munoz, Salvador Garcia, Bezzo, Fabrizio, Barolo, Massimiliano

In continuous solid-dosage form manufacturing, the powder feeding system is responsible for supplying downstream the correct formulation of the drug product ingredients. The composition of the powder delivered by the feeding system is inferred from the measurements of powder mass flow from the...

Powder Fineness

09 Jun 2023

Standard reviews the properties of powder including fineness, providing important information for continuous manufacturing as powder is required to continuously flow through the system.

Perspectives on the flexibility analysis for continuous pharmaceutical manufacturing processes

09 Jun 2023 | Contributor(s): Yang, WH, Qian, WXYuan, ZH, Chen, BZ

Pharmaceutical continuous manufacturing, especially under the context of COVID-19 pandemic, is regarded as an emerging technology that can guarantee the adequate quality assurance and mitigate process risk while guaranteeing the desirable economic performance. Flexibility analysis is one approach...

pH and Conductivity Control in an Integrated Biomanufacturing Plant

09 Jun 2023 | Contributor(s): Lu, Amos E, Paulson, Joel A Braatz, Richard D, Fellow, Ieee

This paper designs pH and conductivity control systems for a biomanufacturing platform that specializes in the production of biologically derived medicines on demand. Dynamic models and control strategies are presented for a buffer mixing unit that must produce high quality buffers for use within...

Pharmaceutical Dosage Forms

09 Jun 2023 | Document

Standard highlghts aspects of pharmaceutical tablets.

Pharmaceutical application of multivariate modelling techniques: a review on the manufacturing of tablets

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Shi, Guolin, Lin, Longfei, Liu, Yuling, Chen, Gongsen, Luo, Yuting, Wu, Yanqiu, Li, Hui

The tablet manufacturing process is a complex system, especially in continuous manufacturing (CM). It includes multiple unit operations, such as mixing, granulation, and tableting. In tablet manufacturing, critical quality attributes are influenced by multiple factorial relationships between...

Pharmaceutical Applications of Hot-Melt Extrusion: Continuous Manufacturing, Twin-Screw Granulations, and 3D Printing

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Maniruzzaman , Mohammed

Recently, hot-melt extrusion (HME) techniques have been presented as innovative platforms to produce various pharmaceuticals. HME is an emerging processing technology used primarily for the manufacture of pharmaceutical solid dispersions. It also combines the advantages of a solvent-free process...

Pharmaceutical Cocrystal Drug Products: An Outlook on Product Development

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Shaikh, Rahamatullah, Singh, Ravendra Walker, Gavin M, Croker, Denise M

Active pharmaceutical ingredients (APIs) are most commonly formulated and delivered to patients in the solid state. Recently, an alternative API solid-state form, namely the pharmaceutical cocrystal, has witnessed increasing academic and industrial interest due to its potential to deliver bespoke...

Pharmaceutical cocrystallization techniques. Advances and challenges

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Rodrigues, M, Baptista, BLopes, JA, Sarraguca, MC

Cocrystals are homogenous (single-phase) crystalline structures composed by two or more components in a definite stoichiometric ratio bonded together by noncovalent bonds. Pharmaceutical industry has been showing interest in cocrystals due to their ability to improve active pharmaceutical...

Pharmaceutical crystallisation processes from batch to continuous operation using MSMPR stages: Modelling, design, and control

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Su, Qinglin, Nagy, Zoltan K., Rielly, Chris D.

In pharmaceuticals manufacturing, the conversion of conventional batch crystallisations to continuous mode has the potential for intensified, compact operation and more consistent production via quality-by-design. A pragmatic conversion approach is to utilise existing stirred tank batch...

Pharmaceutical Crystallization

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Chen, J, Sarma, BEvans, JMB, Myerson, AS

Crystallization is crucial in the pharmaceutical industry as a separation process for intermediates and as the final step in the manufacture of active pharmaceutical ingredients (APIs). In this perspective article to celebrate 10 years of Crystal Growth & Design, we focus on three areas related...

Pharmaceutical Development

09 Jun 2023 | Document

Guideline lays the foundation for developing pharmaceutical manufacturing processes, intoducing concepts such as QbD and PAT as key components of a successful pharmaceutical manufacturing operation.

Pharmaceutical excipients properties and screw feeder performance in continuous processing lines: a Quality by Design (QbD) approach

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Santos, Bianca, Carmo, Flavia, Schlindwein, Walkiria, Muirhead, Gordon, Rodrigues, Carlos, Cabral, Lucio, Westrup, Julian, Pitt, Kendal

Screw feeder performance is a critical aspect in continuous manufacturing processes. Pharmaceutical excipients, such as mannitol, microcrystalline cellulose, lactose monohydrate, and anhydrous dibasic calcium phosphate can present problems in ensuring a continuous stable feed rate due to their...

Pharmaceutical formulation and manufacturing using particle/powder technology for personalized medicines

09 Jun 2023 | Peer-reviewed journal | Contributor(s): Tahara, Kohei

Particle/powder technology is used in the manufacture of many pharmaceutical products, and Research Article on the physical properties of particles in the nano- to micro-particle range is important in the pharmaceutical field. The concept of precision medicine will require an increasing shift in...