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A Perspective on Quality by Design: A Preclinical Opportunity
| Contributor(s):: Ajaz S. Hussain
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VENKATREDDY SUNKARA
Senior Regulatory Affairs Director with a demonstrated history of 18 years experience in Biologics/Pharmaceuticals (API & Drug Product) products registration with Global regulatory authorities...
https://cmkc.usp.org/members/1476
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Continuous Manufacturing of Solvent-Free Cyclodextrin Inclusion Complexes for Enhanced Drug Solubility via Hot-Melt Extrusion: A Quality by Design Approach
| Contributor(s):: Siva Ram Munnangi, Ahmed Adel Ali Youssef, Nagarjuna Narala, Preethi Lakkala, Sateesh Kumar Vemula, Rohit Alluri, Feng Zhang, Micheal A. Repka
Conventional cyclodextrin complexation enhances the solubility of poorly soluble drugs but is solvent-intensive and environmentally unfavorable. This study evaluated solvent-free hot-melt extrusion (HME) for forming cyclodextrin inclusion complexes to improve the solubility and dissolution of...
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Kirti Narsai
Kirti has 25 years’ experience in the healthcare industry and held board positions in several large organisations with Pan African interests & was a member of the African Regional...
https://cmkc.usp.org/members/1149
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The Future of Pharmaceutical Manufacturing Sciences
| Contributor(s):: Rantanen, Jukka, Khinast Johannes
The entire pharmaceutical sector is in an urgent need of both innovative technological solutions and fundamental scientific work, enabling the production of highly engineered drug products. Commercial-scale manufacturing of complex drug delivery systems (DDSs) using the existing technologies is...
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Real-Time Monitoring of Powder Mass Flowrates for Plant-Wide Control of a Continuous Direct Compaction Tablet Manufacturing Process
| Contributor(s):: Huang, Yan-Shu, Medina-González, Sergio Straiton, Benjamin Keller, Joshua, Marashdeh, Qussai, Gonzalez, Marcial, Nagy, Zoltan, Reklaitis, Gintaras V.
While measurement and monitoring of powder/particulate mass flow rate are not essential to the execution of traditional batch pharmaceutical tablet manufacturing, in continuous operation, it is an important additional critical process parameter. It has a key role both in establishing that the...
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Process Design and Control of a Twin Screw Hot Melt Extrusion for Continuous Pharmaceutical Tamper-Resistant Tablet Production
| Contributor(s):: Baronsky-Probst, J., Möltgen, C.-V., Kessler, W., Kessler, R.W.
Hot melt extrusion (HME) is a well-known process within the plastic and food industries that has been utilized for the past several decades and is increasingly accepted by the pharmaceutical industry for continuous manufacturing. For tamper-resistant formulations of e.g. opioids, HME is the most...
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Prediction of tablet weight variability in continuous manufacturing
| Contributor(s):: Razavi, Sonia M., Scicolone, James, Snee, Ronald D., Kumar, Ashish, Bertels, Johny, Cappuyns, Philippe, Van Assche, Ivo, Cuitino, Alberto M, Muzzio, Fernando
This paper provides a method for prediction of weight variability of tablets made in rotary tablet presses as a function of material attributes and processing parameters. The goal was to be able to predict whether or not a formulation is suitable for direct compaction continuous manufacturing...
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Part 3: Enhanced Approaches to the Development of the Control Strategy and its Implementation in the Manufacturing Process Description
| Contributor(s):: Popkin, ME, Omer, BASeibert, KD, Luciani, CV, Srivastava, S, Hobson, L, Lepore, JV
A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced Quality by Design (QbD) development of the active pharmaceutical ingredient (API) can lead to differentiated outcomes for elements such as the API...
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Near infrared spectroscopic calibration models for real time monitoring of powder density
| 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...
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Modeling and Control of Roller Compaction for Pharmaceutical Manufacturing. Part I: Process Dynamics and Control Framework
| Contributor(s):: Hsu, Shuo-Huan, Venkatasubramanian, Venkat, Reklaitis, Gintaras V.
We derive a dynamic model for roller compaction process based on Johanson’s rolling theory, which is used to predict the stress and density profiles during the compaction and the material balance equation which describes the roll gap change. The proposed model considers the relationship between...
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Melt Extrusion
| Contributor(s):: Haser, A, DiNunzio, JCMartin, C, McGinity, JW, Zhang, F
Techniques to overcome poor aqueous solubility of active pharmaceutical ingredients (APIs) continue to gain interest with a reported 30% of marketed compounds classified as BCS II and 10% classified as BCS IV. Approximately 70% of new chemical entities under development may be classified as BCS...
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In-line monitoring and optimization of powder flow in a simulated continuous process using transmission near infrared spectroscopy
| Contributor(s):: Alam, Md Anik, Shi, Zhenqi, Drennen, James K, Anderson, Carl A
In-line monitoring of continuous powder flow is an integral part of the continuous manufacturing process of solid oral dosage forms in the pharmaceutical industry. Specifically, monitoring downstream from loss-in-weight (LIW) feeders and/or continuous mixers provides important data about the...
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In-line UV-Vis Spectroscopy as a Fast-Working Process Analytical Technology (PAT) during Early Phase Product Development Using Hot Melt Extrusion (HME)
| Contributor(s):: Schlindwein, Walkiria, Bezerra, Mariana, Almeida, Juan, Berghaus, Andreas, Owen, Martin, Muirhead, Gordon
This paper displays the potential of an in-line PAT system for early phase product development during pharmaceutical continuous manufacturing following a Quality by Design (QbD) framework. Hot melt extrusion (HME) is used as continuous manufacturing process and UV–Vis spectroscopy as an in-line...
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Inline Determination of Residence Time distributionin Hot-Melt-Extrusion
| Contributor(s):: Wesholowski, Jens, Berghaus, Andreas, Thommes, Markus
In the framework of Quality-by-Design (QbD), the inline determination of process parameters or quality attributes of a product using sufficient process analytical technology (PAT) is a center piece for the establishment of continuous processes as a standard pharmaceutical technology. In this...
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Identifying overarching excipient properties towards an in-depth understanding of process and product performance for continuous twin-screw wet granulation
| Contributor(s):: Willecke, N., Szepes, A., Wunderlich, M., Remon, J. P., Vervaet, C., De Beer, T.
The overall objective of this work is to understand how excipient characteristics influence the process and product performance for a continuous twin-screw wet granulation process. The knowledge gained through this study is intended to be used for a Quality by Design (QbD)-based formulation...
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Granulation development in batch-to-batch and continuous processes from a quality by design perspective
| 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...
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Flowsheet Models Modernize Pharmaceutical Manufacturing Design and Risk Assessment
| Contributor(s):: Muzzio, Fernando, Singh, M Sebastian Escotet-Espinoza Ravendra, Lee Sau, Thomas O’Connor Marianthi, Ierapetritou, Lee Sharmista Chatterjee Rohit Ramachandran, Sen, Maitraye
The pharmaceutical industry has recognized the value of implementing a systematic approach to drug product development where quality is built into the product and process. The FDA initiative on quality by design (QbD) promotes the design of the product and manufacturing process using principles...
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Approach to establishment of control strategy for oral solid dosage forms using continuous manufacturing
| Contributor(s):: Ishimoto, Hayato, Kano, Manabu, Sugiyama, Hirokazu, Takeuchi, Hirofumi, Terada, Katsuhide, Aoyama, Atsushi, Shoda, Takuji, Demizu, Yosuke, Shimamura, Jinen, Yokoyama, Reiji, Miyamoto, Yuji, Hasegawa, Koji, Serizawa, Masaru, Unosawa, Kazuomi, Osaki, Kazuo, Asai, Naochika, Matsuda, Yoshihiro
As a result of the Research Article activities of the Japan Agency for Medical Research Article and Development (AMED), this document aims to show an approach to establishing control strategy for continuous manufacturing of oral solid dosage forms. The methods of drug development, technology...
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Application of a System Model for Continuous Manufacturing of an Active Pharmaceutical Ingredient in an Industrial Environment
| Contributor(s):: Diab, S, Bano, GChristodoulou, C, Hodnett, N, Benedetti, A, Andersson, M, Zomer, S
Purpose In pharmaceutical manufacturing, understanding and quantifying how process conditions impact product quality is pivotal to guaranteeing process profitability with sustained product yield. We describe an integrated system model for a commercial-scale continuous manufacturing process of a...
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A novel approach to support formulation design on twin screw wet granulation technology: Understanding the impact of overarching excipient properties on drug product quality attributes
| Contributor(s):: Willecke, N., Szepes, A., Wunderlich, M., Remon, J. P., Vervaet, C., De Beer, T.
The overall objective of this work is to understand how excipient characteristics influence the drug product quality attributes and process performance of a continuous twin screw wet granulation process. The knowledge gained in this study is intended to be used for Quality by Design (QbD)-based...