Utilization of supercritical CO2 gas antisolvent (GAS) for production of Capecitabine nanoparticles as anti-cancer drug: Analysis and optimization of the process conditions

Amani, Mitra; Ardestani, Nedasadat Saadati; Majd, Navid Yeganeh

doi:10.1016/j.jcou.2021.101465

Cited by 59 publications

(28 citation statements)

References 83 publications

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“…Gas antisolvent processing variables such as pressure, temperature, and agitation rate may potentially affect the solid-state, particle size, and morphology of API particles produced. , This study used a three-factor, two-level DoE with two additional points to study the influence of the pressure, the temperature of the high-pressure vessel and stirring rate. The minimum and maximum values for the variables were selected according to the pressure limit (20 MPa) of the GAS equipment used and the temperature requirement to have CO 2 in the supercritical state, as established for Long et al Additionally, the effect of two different solvents, acetone and ethyl acetate, and of the presence of the additive poloxamer 407 were also explored.…”

Section: Methodsmentioning

confidence: 99%

“…Crystallization methods based on the antisolvent role of supercritical CO 2 tend to promote the formation of metastable polymorphic forms of APIs, and have also been reported to generate polymorphic forms that other techniques are not able to reproduce. − Supercritical CO 2 antisolvent techniques present several attractive characteristics which include the use of mild processing temperatures, easily tunable processing conditions, no risk of forming hydrates (contrarily to liquid antisolvent methods which use water as the antisolvent), and allow the formation of solvent-free dried products, as the remaining organic solvent(s) is/are removed from the final product during flushing with CO 2 after the crystallization process is completed. − Specifically, the gas antisolvent (GAS) crystallization method has been reported in the literature for the production of micron and nanosized particles of APIs. − Contrarily to other techniques that also use supercritical CO 2 as an antisolvent (e.g., supercritical antisolvent crystallization (SAS), expanded liquid antisolvent (ELAS), atomization and antisolvent crystallization (AAS)), GAS does not involve an atomization step . Furthermore, the polymorphism of APIs is challenging to control using the GAS method as during the experimental process, the crystallization occurs in a transitory regime since both the pressure and concentration vary.…”

Section: Introductionmentioning

confidence: 99%

“… 12 − 14 Supercritical CO 2 antisolvent techniques present several attractive characteristics which include the use of mild processing temperatures, easily tunable processing conditions, no risk of forming hydrates (contrarily to liquid antisolvent methods which use water as the antisolvent), and allow the formation of solvent-free dried products, as the remaining organic solvent(s) is/are removed from the final product during flushing with CO 2 after the crystallization process is completed. 15 − 18 Specifically, the gas antisolvent (GAS) crystallization method has been reported in the literature for the production of micron and nanosized particles of APIs. 18 − 23 Contrarily to other techniques that also use supercritical CO 2 as an antisolvent (e.g., supercritical antisolvent crystallization (SAS), expanded liquid antisolvent (ELAS), atomization and antisolvent crystallization (AAS)), GAS does not involve an atomization step.…”

Section: Introductionmentioning

confidence: 99%

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Controlling the Polymorphism of Indomethacin with Poloxamer 407 in a Gas Antisolvent Crystallization Process

et al. 2022

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The polymorphic control of active pharmaceutical ingredients (APIs) is a major challenge in the manufacture of medicines. Crystallization methods that use supercritical carbon dioxide as an antisolvent can create unique solid forms of APIs, with a particular tendency to generate metastable polymorphic forms. In this work, the effects of processing conditions within a gas antisolvent (GAS) crystallization method, such as pressure, stirring rate, and temperature, as well as the type of solvent used and the presence of an additive, on the polymorphism of indomethacin were studied. Consistent formation of the X-ray powder diffraction-pure α polymorphic form of indomethacin by GAS was only achieved when a polymer, poloxamer 407, was used as an additive. Using the GAS method in combination with poloxamer 407 as a molecular additive enabled full control over the polymorphic form of indomethacin, regardless of the processing conditions employed, such as pressure, temperature, stirring rate, and type of solvent. A detailed molecular modeling study provided insight into the role of poloxamer 407 in the polymorphic outcome of indomethacin and concluded that it favored the formation of the α polymorph.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Controlling the Polymorphism of Indomethacin with Poloxamer 407 in a Gas Antisolvent Crystallization Process

et al. 2022

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“…Here rapid reduction in the solvent power of the SCF without any substantial change in pressure is achieved by interacting solution of solutes (drug and CoM) in SCF with an inert gas like nitrogen or helium in which the solutes are insoluble 2,68 . The inert gas, which acts as an antisolvent for solutes, may be kept at pressure par to that of solute solution in SCF 3,4 Here the solution of CoM and active(s) in SCF maintained at high pressure, in a vessel 2,4 .…”

Section: Gas Processmentioning

confidence: 99%

Dry-Coating of Powder Particles is Current Trend in Pharmaceutical Field

Alli¹

2021

J. Drug Delivery Ther.

608

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Modification of surface attributes of particles, usually accomplished by coating, is desirous to enhance and maintain their usability. Coating is a multi-step process involves application of the coating material (CoM) onto the substrate, herein powder particles, where the process along with device/ equipment monitors surface attributes of the applied coating. Nowadays competitive market calls for cost cutting to survive product(s). Thus saving of energy and time, minimising number and quantity of additives, reducing and shortening process steps; consequently minimising the coating process cost are main goals while developing coating process for powder particle. Innovation of processes for dry-powder coating (DPC) along with their further development and refinement finds solution to said issues. Further, DPC process does not calls for liquid solvent or solution thus are viewed as cost-effective and environmentally safe, DPC process uses thermo-mechanical methods like mechanofusion, magnetic assisted impaction coating (MAIC), hybridization, rotating fluid-bed process, theta-composer, hot-melt coating (HMC), and many others. Besides these available are non-thermo-mechanical methods namely electrostatic coating; supercritical fluids (SCF) based methods like rapid expansion of supercritical fluid (RESF), gas anti-solvent (GAS), SCF anti-solvent, gas-saturated solution (GSS); vapour coating; and others. Basing on said thermo-mechanical and non-thermo-mechanical principle several DPC methods/ process had been reported in scientific literatures and patents. Said DPC method founds multidisciplinary applications like drug delivery and drug development. Diverse devices are there for the DPC process; their method of working, principle, limitations and benefits along with their applicability in pharmaceutical field are discussed and presented in this article. Keywords: Dry, particle, coating, pharmaceutical, process

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“…Herein rapid reduction in SCF's solvent power is resulted by its interaction with an inert gas, without any substantial changes in pressure 1,3 . The process basis is interacting solution of CM and substrate in SCF with an inert gas that is non-solvent for CM and substrate 3,48 . The inert gas may be kept at pressure par to that of said solution 1,16 .…”

Section: Gas Anti-solvent Processmentioning

confidence: 99%

Specialised Coating Processes Finding Pharmaceutical Applicability

Saikh¹,

Mohapatra²

2021

J. Drug Delivery Ther.

256

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The manuscript aims at furnishing comprehensive information pertaining specialised coating technology/ processes. Solid dosage forms and solid particulates (SDFSP) are the major contributing group in the solid pharmaceuticals (SoPs). SDFSP exhibit peculiar physico-chemical properties and interaction behaviour which create problems/ issues during their handling, processing, storage, and use. Modifying and/or engineering surface attributes of SDFSP are advocated as powerful tool to modify their interaction behaviour and realise their worthy applications and functionalities. In this regard coating their surfaces with coating material (CM) is novel approach. Said approach involves wet and dry process for realising deposition of CM onto the surface of SDFSP substrates. Both the processes modify and/or alter innate properties of SDFSP substrates either physically or chemically. Basing on involved wet or dry process the coating method is either dry coating method (DCM) or wet coating method (WCM). Accordingly nowadays there available number of specialised devices, that bases on diverse technologies. Amongst them some involves state-of-art process/ technology like Supercell coating technology (SCT), Chemical vapour deposition (CVD), Atomic/molecular layer deposition (AMLD), Electrostatic deposition, Thermo-mechanical process, Resonant acoustic technology, Fluidised-bed process, Supercritical fluid (SCF) technology, and others. These foundational for commercially availability of specialised equipments like Magnetically Assisted Impaction Coater (MAIC), Resodyn acoustic mixer, Hybridizer®, Theta-composer®. Mechanofusion®, and others. Working and working principle, applicability, benefits, pros and limitations of specialised coating processes and technologies are herein discussed and presented. Contained information hoped to be beneficent for pharmaceutical professionals and technocrats and professionals of allied field. Keywords: Coating, composite product, modification, specialised, surface.

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Utilization of supercritical CO2 gas antisolvent (GAS) for production of Capecitabine nanoparticles as anti-cancer drug: Analysis and optimization of the process conditions

Cited by 59 publications

References 83 publications

Controlling the Polymorphism of Indomethacin with Poloxamer 407 in a Gas Antisolvent Crystallization Process

Controlling the Polymorphism of Indomethacin with Poloxamer 407 in a Gas Antisolvent Crystallization Process

Dry-Coating of Powder Particles is Current Trend in Pharmaceutical Field

Specialised Coating Processes Finding Pharmaceutical Applicability

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