Phase equilibrium and micronization for flufenamic acid with supercritical carbon dioxide

Tsai, Cheng-Chou; Lin, Ho-mu; Lee, Ming‐Jer

doi:10.1016/j.jtice.2017.01.011

Cited by 24 publications

(9 citation statements)

References 18 publications

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“…The impact of these parameters on crystallization of an API should be well understood when designing a robust process. Specifically, the geometry of the nozzle/atomizer/capillary has been found to have the most profound impact on the final particle size distribution. ,, Although mixing is critical for process such as CSS outlined in the previous section, mixing is not applicable for the atomization-type SCF processes such as RESS, SAS, SEA, and atomization and antisolvent (AAS).…”

Section: Co-crystallization In Supercritical Fluidsmentioning

confidence: 99%

“…This includes reporting the input mass of solids (and mass or molar ratio for co-crystallization). For some processes such as RESS and CSS, it is crucial to differentiate between the input mass and dissolved mass, as there can be an initial extraction stage followed by a pre-expansion stage. ,, The pressure and temperature of the chamber can differ between these two steps, and thus the concentration of dissolved solids also varies. However, examples of the two-stage process in co-crystal reports to date were not found.…”

Section: Current Status and The Path Forwardmentioning

confidence: 99%

“…Nozzle type (orifice vs capillary), length, and diameter have been shown to yield different particle sizes. 33,87,88 The nozzle setup can change the PSD, even if all other parameters are kept constant. This is a key factor when designing scale-up systems or doing technology transfer.…”

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confidence: 99%

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Supercritical Carbon Dioxide for Pharmaceutical Co-Crystal Production

MacEachern

Kermanshahi-pour

Mirmehrabi³

2020

Crystal Growth & Design

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Pharmaceuticals in Biopharmaceutics ClassificationSystem (BCS) Class II (low solubility, high permeability) are often modified to improve kinetic solubility. Co-crystallization and micronization are common methods for improving kinetic solubility. The basis of understanding co-crystallization processes is solubility and phase stability. In the majority of cocrystallizations, conventional solvents are utilized. Co-crystallization using supercritical carbon dioxide as a co-solvent and antisolvent can offer advantages over conventional co-crystallization including a greener solvent choice and the production of small, uniform particles without additional micronization. Gas antisolvent is the most widely reported supercritical fluid (SCF) co-crystallization process possibly due to its versatility in solvent selection and similarities to conventional antisolvent processes. This review focused on exploring critical co-crystallization parameters and feasibility of SCF techniques. In this review, it was identified that solvent choice proves to be one of the most critical parameters, impacting morphology, yield, phase purity, or polymorph to different extents. It was also identified that a systematic study of solubility to design co-crystallization processes is needed to optimize SCF co-crystallization yield and throughput. Furthermore, a focus on solubility and modeling of multicomponent systems and development of ternary phase diagrams can lead to robust, tailored co-crystallization processes in SCF systems, transitioning this technology to become more common in industry.

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Section: Co-crystallization In Supercritical Fluidsmentioning

confidence: 99%

Section: Current Status and The Path Forwardmentioning

confidence: 99%

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Supercritical Carbon Dioxide for Pharmaceutical Co-Crystal Production

MacEachern

Kermanshahi-pour

Mirmehrabi³

2020

Crystal Growth & Design

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“…For example, the solubility of related compound in SC−CO 2 can determine the throughput of the micronization processes. 4,5 The solubilities of related drug in SC−CO 2 can also affect the partition coefficient of the drug between the SC−CO 2 phase and the polymeric phase in the impregnation process. 6 The solubilities of target compounds in SC−CO 2 can be determined by the experimental method.…”

Section: Introductionmentioning

confidence: 99%

“…To evaluate the feasibility of SC–CO 2 based technologies, the solubilities of concerned compounds in SC–CO 2 are always needed. For example, the solubility of related compound in SC–CO 2 can determine the throughput of the micronization processes. , The solubilities of related drug in SC–CO 2 can also affect the partition coefficient of the drug between the SC–CO 2 phase and the polymeric phase in the impregnation process …”

Section: Introductionmentioning

confidence: 99%

Solubility Determination and Correlation of Gatifloxacin, Enrofloxacin, and Ciprofloxacin in Supercritical CO₂

Shi

Feng

et al. 2017

J. Chem. Eng. Data

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The solubilities of gatifloxacin, enrofloxacin, ciprofloxacin in SC–CO2 were determined by the dynamic method under pressures of 12–36 MPa and temperature of 313, 323, and 333 K. The consistency of the resulting solubility data was verified by the Mendez-Santiago and Teja model, Chrastil model, Bartle model, and K-J model and these models give comparable AARDs (between 6.70% and 13.51%). The compressed gas model and modified expanded liquid model were also used to correlate the resulting solubilities of the three fluoroquinolone drugs. By introducing the reference solubility and calculating the fugacity coefficient of the solute using the Carnahan–Starling-VDW hard sphere equation of state (CS-VDW EoS), the compressed gas model gives the AARDs between 0.86% and 23.65%. The intrinsic proximity of the model parameters in this model is also confirmed for the structurally similar fluoroquinolone drugs. This intrinsic proximity can be used in mutual solubility prediction between the fluoroquinolone drugs once the reference solubilities were known. The modified expanded liquid model gives the AARDs between 10.88% and 16.65% in solubility correlation. However, the predictive capability of the modified expanded liquid model based on the group contribution method needs to be improved further.

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Impact of the Polymorphic Form of Drugs/NCEs on Preformulation and Formulation Development

Alsirawan

Paradkar

2019

Innovative Dosage Forms

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Phase equilibrium and micronization for flufenamic acid with supercritical carbon dioxide

Cited by 24 publications

References 18 publications

Supercritical Carbon Dioxide for Pharmaceutical Co-Crystal Production

Supercritical Carbon Dioxide for Pharmaceutical Co-Crystal Production

Solubility Determination and Correlation of Gatifloxacin, Enrofloxacin, and Ciprofloxacin in Supercritical CO₂

Impact of the Polymorphic Form of Drugs/NCEs on Preformulation and Formulation Development

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Phase equilibrium and micronization for flufenamic acid with supercritical carbon dioxide

Cited by 24 publications

References 18 publications

Supercritical Carbon Dioxide for Pharmaceutical Co-Crystal Production

Supercritical Carbon Dioxide for Pharmaceutical Co-Crystal Production

Solubility Determination and Correlation of Gatifloxacin, Enrofloxacin, and Ciprofloxacin in Supercritical CO2

Impact of the Polymorphic Form of Drugs/NCEs on Preformulation and Formulation Development

Contact Info

Product

Resources

About

Solubility Determination and Correlation of Gatifloxacin, Enrofloxacin, and Ciprofloxacin in Supercritical CO₂