In-line and Real-time Monitoring of Resonant Acoustic Mixing by Near-infrared Spectroscopy Combined with Chemometric Technology for Process Analytical Technology Applications in Pharmaceutical Powder Blending Systems

Tanaka, Ryoma; Takahashi, Naoyuki; Nakamura, Y.; Hattori, Yusuke; Ashizawa, Kazuhide; Otsuka, Makoto

doi:10.2116/analsci.33.41

Cited by 19 publications

(5 citation statements)

References 28 publications

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“…This mixer has been used effectively in the pharmaceutical industry for applications such as uniform and non-destructive blending, cocrystal formation, and dry coating [27][28][29]. Moreover, it is highlighted that the cocrystal formation by RAG are applicable to in situ monitoring and scale-up because these production systems using same resonant acoustic mixer have been reported [30,31]. We hypothesized that the resonant acoustic mixer would be able to blend a combination of materials energetically to induce the simultaneous cocrystal and granule formations even if a nonreactive drug and coformer were used.…”

Section: Introductionmentioning

confidence: 99%

Complete Cocrystal Formation during Resonant Acoustic Wet Granulation: Effect of Granulation Liquids

et al. 2021

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The manufacturing of solid pharmaceutical dosage forms composed of cocrystals requires numerous processes during which there is risk of dissociation into parent molecules. Resonant acoustic wet granulation (RAG) was devised in an effort to complete theophylline–citric acid (THPCIT) cocrystal formation during the granulation process, thereby reducing the number of operations. In addition, the influence of granulation liquid was investigated. A mixture of anhydrous THP (drug), anhydrous CIT (coformer), and hydroxypropyl cellulose (granulating agent) was processed by RAG with water or ethanol as a granulation liquid. The purposes were to (i) form granules using RAG as a breakthrough method; (ii) accomplish the cocrystallization during the integrated unit operation; and (iii) characterize the final solid product (i.e., tablet). The RAG procedure achieved complete cocrystal formation (>99%) and adequately sized granules (d50: >250 μm). The granulation using water (GW) facilitated formation of cocrystal hydrate which were then transformed into anhydrous cocrystal after drying, while the granulation using ethanol (GE) resulted in the formation of anhydrous cocrystal before and after drying. The dissolution of the highly dense GW tablet, which was compressed from granules including fine powder due to the dehydration, was slower than that of the GE tablet.

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Section: Introductionmentioning

confidence: 99%

Complete Cocrystal Formation during Resonant Acoustic Wet Granulation: Effect of Granulation Liquids

et al. 2021

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“…The preparation of cocrystals comprises diverse strategies: refs. [48,227,293] dissolutive cocrystallization methods, antisolvent addition, slurry conversion, sublimation, vapor digestion, hot-stage microscopy melt interface, supercritical fluids, sonic slurrying, melt extrusion, wet compression, dry compression, microwave synthesis, and various solid-state synthetic methods, including NG, LAG, POLAG [293], TSE [48,182,183,294,295], resonant acoustic mixing (RAM) [296][297][298][299], ultrasound methods, etc. TSE offers a unique opportunity not found in grinding or milling approaches because they are difficult to scale up to manufacture large amounts of the desired cocrystal [298].…”

Section: Diverse Preparation Methods Of Pharmaceutical Cocrystalsmentioning

confidence: 99%

Mechanochemistry: A Green Approach in the Preparation of Pharmaceutical Cocrystals

et al. 2021

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Mechanochemistry is considered an alternative attractive greener approach to prepare diverse molecular compounds and has become an important synthetic tool in different fields (e.g., physics, chemistry, and material science) since is considered an ecofriendly procedure that can be carried out under solvent free conditions or in the presence of minimal quantities of solvent (catalytic amounts). Being able to substitute, in many cases, classical solution reactions often requiring significant amounts of solvents. These sustainable methods have had an enormous impact on a great variety of chemistry fields, including catalysis, organic synthesis, metal complexes formation, preparation of multicomponent pharmaceutical solid forms, etc. In this sense, we are interested in highlighting the advantages of mechanochemical methods on the obtaining of pharmaceutical cocrystals. Hence, in this review, we describe and discuss the relevance of mechanochemical procedures in the formation of multicomponent solid forms focusing on pharmaceutical cocrystals. Additionally, at the end of this paper, we collect a chronological survey of the most representative scientific papers reporting the mechanochemical synthesis of cocrystals.

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“…Remarkably, this balancing of forces enables the mixer to accelerate materials from 1 g up to 100 g (acceleration due to gravity) depending on the load mass by adjusting the amplitude of the mechanical vibration induced via the springs. The physics in play during the RAM process has been discussed in more detail by a number of researchers. − …”

Section: Introductionmentioning

confidence: 99%

Resonant Acoustic Mixing Method to Produce Lipid-Based Liquid-Crystal Nanoparticles

et al. 2021

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Production of large-scale batches is one of the bottlenecks in nanoscience translation, and there is a significant gap between academic and industrial production settings. There is a great need and urgency to develop methods that can easily and quickly scale up nanomaterial laboratory production processes at a large scale. In this study, we report for the first time a fast and easily scalable methodology for the fabrication of lipid-based liquid-crystal (LLC) nanoparticles. We have shown that large volume solutions of cubosomes, liposomes, and hexosomes can be produced (500 mL at 60 mg/mL lipid concentration) in a matter of minutes without the need for any cosolvents. Straightforward synthesis from 5 to 500 mL has been exemplified using resonant acoustic mixing to produce these LLC nanoparticles. The technique is amenable to various container types and may eliminate the need to use cosolvents for the production of such materials due to the excellent mixing potential. We have found that when compared to traditional sonication-based methods, the use of resonant acoustic mixing allows for large-scale synthesis of nanoparticle solutions and the formation of LLC nanoparticles of desirable sizes. We believe this new technique will facilitate the development of lyotropic mesophase materials and new methodologies for the fabrication of nanoparticles. The technique will have a significant impact in shaping the future of nanoscience, providing a rapid and efficient mixing/fabrication platform for a range of materials from cosmetics to therapeutics to vaccines.

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In-line and Real-time Monitoring of Resonant Acoustic Mixing by Near-infrared Spectroscopy Combined with Chemometric Technology for Process Analytical Technology Applications in Pharmaceutical Powder Blending Systems

Cited by 19 publications

References 28 publications

Complete Cocrystal Formation during Resonant Acoustic Wet Granulation: Effect of Granulation Liquids

Complete Cocrystal Formation during Resonant Acoustic Wet Granulation: Effect of Granulation Liquids

Mechanochemistry: A Green Approach in the Preparation of Pharmaceutical Cocrystals

Resonant Acoustic Mixing Method to Produce Lipid-Based Liquid-Crystal Nanoparticles

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