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Starch Products as Candidate Excipients in a Continuous Direct Compression Line
09 Jun 2023 | Contributor(s):: Sonia M. Razavi, Yi Tao, James Scicolone, Tami Morker, Charles Cunningham, Ali Rajabi-Siahboomi, Douglas B. Hausner, Fernando J. Muzzio
Purpose Direct compression (DC) remains the most preferred technique to produce tablets, and its effectiveness is directly influenced by raw material attributes. Therefore, the selection of specific grades of excipients to achieve desirable powder flow and compression properties is of importance....
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Predicting feeder performance based on material flow properties
09 Jun 2023 | Contributor(s):: Yifan Wang, Benjamin J. Glasser, Fernando J. Muzzio
Purpose: Accurate and consistent delivery of materials by well-designed feeders ensures overall process stability. Importantly, feeding performance is strongly dependent on material flow properties. The purpose of this study is to develop a methodology that identifies predictive correlation...
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Pharmaceutical excipients properties and screw feeder performance in continuous processing lines: a Quality by Design (QbD) approach
09 Jun 2023 | 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...
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Near-infrared Spectroscopy for the In-line Characterization of Powder Voiding Part I: Development of the Methodology
09 Jun 2023 | 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...
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Loss-in-weight feeding, powder flow and electrostatic evaluation for direct compression hydroxypropyl methylcellulose (HPMC) to support continuous manufacturing
09 Jun 2023 | Contributor(s):: Allenspach, Carl, Timmins, Peter, Lumay, Geoffroy, Holman, James, Minko, Tamara
Minimizing variability in the feeding process is important for continuous manufacturing since materials are fed individually and can impact the final product. This study demonstrates the importance of measuring powder properties and highlights the need to characterize the feeding performance both...
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Impact of excipients on batch and continuous powder blending
09 Jun 2023 | Contributor(s):: Jaspers, M, de, Wit, MTWKulkarni, SS, Meir, B, Janssen, PHM, van, Haandel, MMW, Dickhoff, BHJ
Stimulated by Pharma 4.0, the pharmaceutical industry is changing from batch-wise to continuous manufacturing. Therefore, individual processing steps such as blending of the active pharmaceutical ingredient (API) with excipients have to be re-designed to continuous operations. In this study,...
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Flow and bulk density enhancements of pharmaceutical powders using a conical screen mill: A continuous dry coating device
09 Jun 2023 | Contributor(s):: Huang, ZH, Scicolone, JV, Gurumuthy, L, Dave, RN
The conical screen mill or Comil, a powder delumping device, was investigated due to its recent success as a continuously operated dry coater, The improvements in packing and flowability for different size grades of active pharmaceutical ingredients (APls) (acetaminophen, ibuprofen, and ascorbic...
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Flowsheet modeling of a continuous direct compression process
09 Jun 2023 | Contributor(s):: Yoon, Seongkyu, Galbraith, Shaun, Cha, Bumjoon, Liu, Huolong
Continuous manufacturing for the production of pharmaceutical products is emerging as a key technology due to the advantages it has over traditional batch manufacturing methods. Process systems engineering is critical in rolling out this technology within the industry since it allows for more...
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Effects of Shear and Electrical Properties on Flow Characteristics of Pharmaceutical Blends
09 Jun 2023 | Contributor(s):: Pingali, KC, Tomassone, MS, Muzzio, FJ
This article examines the effects and interactions of shear rate, shear strain on electrical and flow properties of pharmaceutical blends. An unexpectedly strong relation between the flow and passive electrical properties of powders is observed to depend on the shear history of the powder bed....
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Effects of Coating Materials and Processing Conditions on Flow Enhancement of Cohesive Acetaminophen Powders by High-Shear Processing With Pharmaceutical Lubricants
09 Jun 2023 | Contributor(s):: Wei, GG, Mangal, S, Denman, J, Gengenbach, T, Bonar, KL, Khan, RI, Qu, L, Li, TL, Zhou, Q
This study has investigated the surface coating efficiency and powder flow improvement of a model cohesive acetaminophen powder by high-shear processing with pharmaceutical lubricants through 2 common equipment, conical comil and high-shear mixer. Effects of coating materials and processing...
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Comparison between integrated continuous direct compression line and batch processing - The effect of raw material properties
09 Jun 2023 | Contributor(s):: Karttunen, AP, Wikstrom, HTajarobi, P, Fransson, M, Sparen, A, Marucci, M, Ketolainen, J, Folestad, S, Korhonen, O, Abrahmsen-Alami, S
There is a current trend in pharmaceutical manufacturing to shift from traditional batch manufacture to continuous manufacturing. The purpose of this study was to test the ability of an integrated continuous direct compression (CDC) line, in relation to batch processing, to achieve consistent...
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Characterization of a novel hydroxypropyl methylcellulose (HPMC) direct compression grade excipient for pharmaceutical tablets
09 Jun 2023 | Contributor(s):: Allenspach, Carl, Timmins, Peter, Sharif, Shasad, Minko, Tamara
Controlled release tablets are important dosage forms enabling a slower release of the drug and better pharmacokinetics for some drugs and hydrophilic matrix tablets utilizing hydroxypropyl methylcellulose (HPMC) are one of the most common types. One of the main challenges with using HPMC is its...