Amorphous solid dispersions containing residual crystallinity: Influence of seed properties and polymer adsorption on dissolution performance

Moseson, Dana E.; Parker, Andrew S.; Beaudoin, Stephen P.; Taylor, Lynne S.

doi:10.1016/j.ejps.2020.105276

Cited by 47 publications

(84 citation statements)

References 62 publications

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“…Therefore, they argued that the desupersaturation of the solution is essentially governed by growth of those seeds, whereas nucleation kinetics can be neglected. A similar argumentation is proposed by a recent publication of Moseson et al (2020) .…”

Section: Introductionsupporting

confidence: 80%

The interplay of dissolution, solution crystallization and solid-state transformation of amorphous indomethacin in aqueous solution

Schneider

Kerkhoff

Danzer

et al. 2020

International Journal of Pharmaceutics: X

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Section: Introductionsupporting

confidence: 80%

The interplay of dissolution, solution crystallization and solid-state transformation of amorphous indomethacin in aqueous solution

Schneider

Kerkhoff

Danzer

et al. 2020

International Journal of Pharmaceutics: X

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“…Recently, Moseson et al, (2020) reported that Copovidone has strong crystal nucleation and growth inhibition properties through polymer adsorption onto the drug crystals. Such mechanism demonstrated to prevent the desupersaturation of the drug and translated into the sustained parachute in the dissolution profile (92).…”

Section: Copovidonementioning

confidence: 99%

Overview of Extensively Employed Polymeric Carriers in Solid Dispersion Technology

et al. 2020

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Solid dispersion is the preferred technology to prepare efficacious forms of BCS class-II/IV APIs. To prepare solid dispersions, there exist a wide variety of polymeric carriers with interesting physicochemical and thermochemical characteristics available at the disposal of a formulation scientist. Since the advent of the solid dispersion technology in the early 1960s, there have been more than 5000 scientific papers published in the subject area. This review discusses the polymeric carrier properties of most extensively used polymers PVP, Copovidone, PEG, HPMC, HPMCAS, and Soluplus® in the solid dispersion technology. The literature trends about preparation techniques, dissolution, and stability improvement are analyzed from the Scopus® database to enable a formulator to make an informed choice of polymeric carrier. The stability and extent of dissolution improvement are largely dependent upon the type of polymeric carrier employed to formulate solid dispersions. With the increasing acceptance of transfer dissolution setup in the research community, it is required to evaluate the crystallization/precipitation inhibition potential of polymers under dynamic pH shift conditions. Further, there is a need to develop a regulatory framework which provides definition and complete classification along with necessarily recommended studies to characterize and evaluate solid dispersions.

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“…In most cases, amorphous particles with spherical shape, small size, and narrow distribution were obtained at the suitable conditions. Fundamentally, the amorphous solid can minimize crystal packing energy by disrupting the drug crystal lattice, which usually achieves the highest level of solubility, and has a faster dissolution rate with respect to the crystalline state [73,74]. For example, in the study of Park et al [67], the mean particle size of obtained tadalafil/PVP solid dispersions varied from 200 nm to 900 nm, where the drug concentration C was the dominant experimental variable on the particle solid-state properties.…”

Section: Solid Dispersionsmentioning

confidence: 99%

Applications of Supercritical Anti-Solvent Process in Preparation of Solid Multicomponent Systems

Liu

Deng

2021

Pharmaceutics

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Solid multicomponent systems (SMS) are gaining an increasingly important role in the pharmaceutical industry, to improve the physicochemical properties of active pharmaceutical ingredients (APIs). In recent years, various processes have been employed for SMS manufacturing. Control of the particle solid-state properties, such as size, morphology, and crystal form is required to optimize the SMS formulation. By utilizing the unique and tunable properties of supercritical fluids, supercritical anti-solvent (SAS) process holds great promise for the manipulation of the solid-state properties of APIs. The SAS techniques have been developed from batch to continuous mode. Their applications in SMS preparation are summarized in this review. Many pharmaceutical co-crystals and solid dispersions have been successfully produced via the SAS process, where the solid-state properties of APIs can be well designed by controlling the operating parameters. The underlying mechanisms on the manipulation of solid-state properties are discussed, with the help of on-line monitoring and computational techniques. With continuous researching, SAS process will give a large contribution to the scalable and continuous manufacturing of desired SMS in the near future.

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Amorphous solid dispersions containing residual crystallinity: Influence of seed properties and polymer adsorption on dissolution performance

Cited by 47 publications

References 62 publications

The interplay of dissolution, solution crystallization and solid-state transformation of amorphous indomethacin in aqueous solution

The interplay of dissolution, solution crystallization and solid-state transformation of amorphous indomethacin in aqueous solution

Overview of Extensively Employed Polymeric Carriers in Solid Dispersion Technology

Applications of Supercritical Anti-Solvent Process in Preparation of Solid Multicomponent Systems

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