Pharmaceutical and Macromolecular Technologies in the Spirit of Industry 4.0

Marosi, György; Hirsch, Edit; Bocz, Katalin; Toldy, Andrea; Szolnoki, Beáta; Bodzay, Brigitta; Csontos, István; Farkas, Attila; Balogh, Attila; Démuth, Balázs; Nagy, Zsombor Kristóf; Pataki, Hajnalka

doi:10.3311/ppch.12870

Cited by 9 publications

(6 citation statements)

References 49 publications

(50 reference statements)

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“…ES is a well-known technique for the production of ASDs by applying high voltage on a solution containing an API and a polymer excipient (Figure ). − The pharmaceutical utilization of the technique is reported in a vast amount of literature, since the versatility of the available polymers allows the formation of ASDs with sustained, controlled, and ultrafast release. − …”

Section: Recent Progress In Continuous Pharmaceutical Technologiesmentioning

confidence: 99%

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Integrated Continuous Pharmaceutical Technologies—A Review

Domokos

Nagy

Szilágyi

et al. 2021

Org. Process Res. Dev.

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Innovation in the pharmaceutical industry has been limited for a long time to the research and development of new active compounds; meanwhile, the structure of the production, dominated by batchwise technologies, has not changed to date. As has already been demonstrated in several other industrial sectors, continuous manufacturing (CM) has many advantages over batch processes. Faster, cheaper, and more flexible production can be developed with a significantly higher level of quality assurance. In the recent years the main regulatory agencies recognized the need for a change in drug production and started to promote continuous technologies and encourage pharmaceutical companies to develop and adapt such processes. As a result, by today extensive research was conducted in the various fields of pharmaceutical technologies from drug substance to drug product manufacturing. Many publications deal with synthetic steps carried out in flow reactors and crystallizations implemented in a continuous manner, and on the formulation side continuous filtration, drying, granulation, and blending have all been studied to a lesser or greater extent. Moreover, besides the modification of these traditional processes to continuous operation, novel, intrinsically continuous technologies are being studied as well. In order to entirely exploit the advantages of CM, the mainly separately developed processes need to be integrated to form end-to-end systems from the raw materials to the final dosage forms. However, even the integration of two technological steps is a challenging task. The development of end-to-end systems requires deep process understanding and a holistic approach toward process development and optimization. The aim of this work is to give insight into the state-of-the-art and new directions in integrated continuous pharmaceutical technologies by critically reviewing the recent literature of the broad field.

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Section: Recent Progress In Continuous Pharmaceutical Technologiesmentioning

confidence: 99%

“…Concept of end-to-end continuous pharmaceutical manufacturing from raw materials to final products with real-time quality control (adapted from ref ).…”

Section: Recent Progress In Continuous Pharmaceutical Technologiesmentioning

confidence: 99%

Integrated Continuous Pharmaceutical Technologies—A Review

Domokos

Nagy

Szilágyi

et al. 2021

Org. Process Res. Dev.

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“…Solubility and permeability are the two key parameters for the correlation of in vitro dissolution and in vivo bioavailability results of pure active pharmaceutical ingredients (APIs). In case of poorly water-soluble APIs, the solubility might be altered when using solubilizing agents or formulating amorphous solid dispersions [1][2][3]. Recent studies demonstrate that not only solubility, but also effective permeability (P eff ) of the API may change due to the addition of formulation additives [4], and also there is a certain mathematical relation between the two parameters [5][6][7].…”

Section: Introductionmentioning

confidence: 99%

The Effect of Surfactants and pH Modifying Agents on the Dissolution and Permeation of Pimobendan

Tőzsér

Kovács²,

Kádár³

et al. 2023

Period. Polytech. Chem. Eng.

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Solubility and permeability are key parameters for establishing in vitro-in vivo correlation for poorly water-soluble active pharmaceutical ingredients (APIs). Recent studies demonstrate that not only solubility, but also effective permeability of the API may change due to the addition of solubilizing agents, and there is a certain mathematical relation between these physicochemical parameters. The aim of this study was to show the importance of early screening of solubility and permeability in presence of additives in order to achieve the expected bioavailability of the API. In this work, the effect of surfactants and microenvironmental pH modifiers were in focus, and pimobendan was chosen as model drug.In the case of pH modifiers, the equilibrium solubility of the API increased, while the permeability decreased significantly. No negative effect was observed for two surfactants at low additive levels, but these two additives also exhibited a slightly negative effect on permeability when used at higher concentrations. In the simultaneous dissolution-permeation studies the surfactants-containing formulation was found to have slightly higher flux than the pH-modifier-containing one. It can be due to the phenomenon that the dissolution of the active substance can be enhanced by these surfactants without any significant permeability reducing effect.The results obtained from the present study clearly demonstrate the importance of studying drug-additive interactions in every step of formulation development and based on these, the selection of the appropriate quality and quantity of additives. In addition, the results also underline the significance of performing simultaneous dissolution-permeation studies to predict bioavailability.

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“…The microencapsulation of flame retardants has various advantages [22] as it may improve the water-resistance of the active ingredients by isolating them [23,24], also improves the compatibility between the active component and the polymer matrix [25,26], prevents the formation of toxic gases [27][28][29], moreover, it can change the appearance and physical form of the flame retardant additive [30] and increase the pyrolysis temperature [13]. In the literature, ammonium-polyphosphate was encapsulated with several materials such as pentaerythritol [19], melamine-formaldehyde resin [31], cyclodextrin [32], resorcinol bis(diphenyl phosphate) [33] and bisphenol A epoxy resin (DGEBA) [34].…”

Section: Introductionmentioning

confidence: 99%

Development of Intumescent Flame Retardant for Polypropylene: Bio-epoxy Resin Microencapsulated Ammonium-polyphosphate

Thanh

Decsov

Bocz

et al. 2022

Period. Polytech. Chem. Eng.

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As polypropylene (PP) has no charring ability on its own due to the lack of hydroxyl functional groups, the flame retardant system needs the addition of carbonizing agent in a relatively great amount. Ammonium-polyphosphate (APP), a conventional flame retardant additive was modified by microencapsulation with a sorbitol-based bioepoxy resin shell to create an intumescent flame retardant system with enhanced charring ability for PP. The flame retardant efficiency of the microencapsulated additive, which contains all the components needed in an effective intumescent flame retardant system, was evaluated in PP matrix at different loadings.When compared to the physical mixture of the component, the microencapsuated form of APP (MCAPP) was found to have improved flame retardant efficiency in PP. The LOI values of the MCAPP containing PP samples increased by 8–11 V/V% besides achieved V-0 classification according to the UL94 test. During cone calorimeter tests, the burning intensity was reduced (peak of heat release rate decreased by 20–35% and shifted in time), increased amount of charred residue was obtained, and based on the calculated Flame Retardancy Index (FRI) “Excellent” fire performance was achieved when MCAPP was used. The improved flame retardant performance is attributed to the effective interaction between the APP core and the readily available carbonizing shell, which promoted the formation of increased amount of char accompanied with improved heat protecting and barrier efficiency.

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Pharmaceutical and Macromolecular Technologies in the Spirit of Industry 4.0

Cited by 9 publications

References 49 publications

Integrated Continuous Pharmaceutical Technologies—A Review

Integrated Continuous Pharmaceutical Technologies—A Review

The Effect of Surfactants and pH Modifying Agents on the Dissolution and Permeation of Pimobendan

Development of Intumescent Flame Retardant for Polypropylene: Bio-epoxy Resin Microencapsulated Ammonium-polyphosphate

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