Scale-Up and In-line Monitoring During Continuous Melt Extrusion of an Amorphous Solid Dispersion

Haser, Abbe; Haight, Brian; Berghaus, A; Machado, Augie; Martin, Charlie; Zhang, Feng

doi:10.1208/s12249-018-1162-5

Cited by 21 publications

(11 citation statements)

References 21 publications

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“…Moreover, the following five main directions of development of the extrusion optimization and scaling-up can be distinguished: improvement of the models of extrusion processes which are the basis for optimization/scale-up procedures, and which could be based on the very promising concept of the coupled (DEM/CFD) modeling using the Discrete Element Method (DEM) for modeling of solid conveying and Computational Fluid Dynamics (CFD) for modeling of melting/melt flow [ 5 ]; coupling the models of starve fed extrusion and flood fed extrusion which would allow a smooth transition between them; extending the use of optimization/scale-up procedures to more demanding extrusion processes, e.g., extrusion of polymer blends, composites, filled polymers, reactive extrusions, and others; improvement of optimization procedures which was recently discussed in the literature [ 154 ]; extending the use of optimization/scale-up procedures to food processing [ 155 ], as well as to pharmaceutical industry [ 156 , 157 ], and 3D printing [ 158 ]. …”

Section: Future Perspectivesmentioning

confidence: 99%

Optimization and Scale-Up for Polymer Extrusion

Nastaj

Wilczyński

2021

Polymers

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A review paper is presented on optimization and scale-up for polymer extrusion, both single screw and twin screw extrusion. Optimization consists in obtaining a multidimensional space of process output variables (response surface) on the basis of an appropriate set of input data and searching for extreme values in this space. Scaling consists in changing the scale of the process according to specific criteria, that is, changing the process while maintaining the scaling parameters at a level that is as close to the reference process parameters as possible. It consists in minimizing the differences between the parameters characterizing the reference process and the resulting process. This may be obtained by using optimization techniques leading to the minimization of discrepancies between the parameters of scaled processes. In the paper, it was stated that optimization and scale-up based on process simulation are more effective than those based on experimentation which is time consuming and expensive. The state-of-the-art on extrusion process modeling which is the basis of optimization and scale-up has been presented. Various optimization techniques have been discussed, and the Genetic Algorithms have been identified as powerful and very efficient. Optimization and scale-up based on the process simulation using Genetic Algorithms have been broadly reviewed and discussed. It was concluded that, up to date, there is a lack of optimization studies on the counter-rotating twin screw extrusion, although the global models of this process are known. There is also a lack of process simulation-based scaling-up studies, both on the counter-rotating twin screw extrusion and on the starve fed single screw extrusion. Finally, development perspectives in this field have been discussed.

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Section: Future Perspectivesmentioning

confidence: 99%

Optimization and Scale-Up for Polymer Extrusion

Nastaj

Wilczyński

2021

Polymers

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“…Amid the chaos and uncertainty precipitated by the COVID-19 pandemic, we remain hopeful and have reason to celebrate progress in pharmaceutical engineering of continuous manufacturing. Many faculty members in NIPTE member institutions have successfully advanced technologies and engineering platforms for continuous pharmaceutical manufacturing, at C-COPs and other universities, such as those who contributed papers (8,13) to the Theme Issue. We also note the article contributing to developing methodologies for predictive and accelerated formulation design and development (15).…”

Section: Pharmaceutical Engineering Pharmaceutical Science and Thermentioning

confidence: 99%

“…The AAPS PharmSciTech Theme Issue entitled "Team Science and Education for Pharmaceuticals -the NIPTE Model" curates nineteen papers (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19) listed in Table I and written before and amidst the COVID-19 pandemic. Another manuscript, currently in the editorial process, is expected to be the final paper in the Theme Issue.…”

Section: Introductionmentioning

confidence: 99%

Pharmaceutical Quality, Team Science, and Education Themes: Observations and Commentary on a Remarkable AAPS PharmSciTech Theme Issue

2021

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“…The study by Haser et al showed the possibility of in-line monitoring of the solubilization of meloxicam using a UV probe positioned at the die (149). UV-Vis can only provide limited chemical information, such as molecular interactions, when compared to NIR and Raman.…”

Section: In-line Process Monitoring Tools To Improve Processing Parammentioning

confidence: 99%

“…Analytical models based on the UV-Vis spectra obtained during the HME process were developed as a quantitative method to predict the concentration and content uniformity of piroxicam in Kollidon® VA 64 ( 139 ). The study by Haser et al showed the possibility of in-line monitoring of the solubilization of meloxicam using a UV probe positioned at the die ( 149 ). UV-Vis can only provide limited chemical information, such as molecular interactions, when compared to NIR and Raman.…”

Section: Recent Innovations In Hot-melt Extrusion To Prevent Thermal mentioning

confidence: 99%

Innovations in Thermal Processing: Hot-Melt Extrusion and KinetiSol® Dispersing

Tan

Davis

Miller³

et al. 2020

AAPS PharmSciTech

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Thermal processing has gained much interest in the pharmaceutical industry, particularly for the enhancement of solubility, bioavailability, and dissolution of active pharmaceutical ingredients (APIs) with poor aqueous solubility. Formulation scientists have developed various techniques which may include physical and chemical modifications to achieve solubility enhancement. One of the most commonly used methods for solubility enhancement is through the use of amorphous solid dispersions (ASDs). Examples of commercialized ASDs include Kaletra®, Kalydeco®, and Onmel®. Various technologies produce ASDs; some of the approaches, such as spray-drying, solvent evaporation, and lyophilization, involve the use of solvents, whereas thermal approaches often do not require solvents. Processes that do not require solvents are usually preferred, as some solvents may induce toxicity due to residual solvents and are often considered to be damaging to the environment. The purpose of this review is to provide an update on recent innovations reported for using hot-melt extrusion and KinetiSol® Dispersing technologies to formulate poorly water-soluble APIs in amorphous solid dispersions. We will address development challenges for poorly water-soluble APIs and how these two processes meet these challenges.

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Scale-Up and In-line Monitoring During Continuous Melt Extrusion of an Amorphous Solid Dispersion

Cited by 21 publications

References 21 publications

Optimization and Scale-Up for Polymer Extrusion

Optimization and Scale-Up for Polymer Extrusion

Pharmaceutical Quality, Team Science, and Education Themes: Observations and Commentary on a Remarkable AAPS PharmSciTech Theme Issue

Innovations in Thermal Processing: Hot-Melt Extrusion and KinetiSol® Dispersing

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