Crystal growth of drug materials by spherical crystallization

Szabó‐Révész, Piroska; Hasznos-Nezdei, Magdolna; Farkas, Bálint; Goczo, Hajnalka; Pintye‐Hódi, Klára; Erös, I.

doi:10.1016/s0022-0248(01)02237-0

Cited by 17 publications

(11 citation statements)

References 5 publications

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“…Crystal engineering may also involve the production of spheronized particles (i.e., avoid needle‐like crystals) to improve flow properties for tableting and avoid difficulties in washing, filtering and drying during primary manufacturing. A ‘radical solution’ has been proposed to produce API agglomerates by ‘spherical crystallization’ to solve lot‐to‐lot variations and compression problems 166–168. Another aspect involves improving the ability of crystals to consolidate and bond under pressure and maintain interparticulate bonds upon ejection from tablet presses.…”

Section: Crystallization Of Active Pharmaceutical Ingredientsmentioning

confidence: 99%

Engineering of Pharmaceutical Materials: An Industrial Perspective

Chow

Tong

Lum

et al. 2008

Journal of Pharmaceutical Sciences

127

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Section: Crystallization Of Active Pharmaceutical Ingredientsmentioning

confidence: 99%

Engineering of Pharmaceutical Materials: An Industrial Perspective

Chow

Tong

Lum

et al. 2008

Journal of Pharmaceutical Sciences

127

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“…There has also been a wide range of studies on the physiochemical, mechanical, and micromeritic properties of the spherical agglomerates to assess the possibility of direct tableting of the agglomerates. [17][18][19][20][21][22][23][24] However, none of the aforementioned studies looked into the interplay between the operating conditions and the trade-off between the size distribution and properties of spherical agglomerates and the size distribution of constituting internal crystals. In almost all previous spherical crystallization systems, crystallization and 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 7 agglomeration occurred simultaneously; offering little or no control in tailoring the internal crystal size versus external agglomerate size.…”

Section: Introductionmentioning

confidence: 99%

Process Intensification through Continuous Spherical Crystallization Using a Two-Stage Mixed Suspension Mixed Product Removal (MSMPR) System

Peña

Nagy

2015

Crystal Growth & Design

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Of utmost importance in the crystallization of active pharmaceutical ingredients (APIs) in the pharmaceutical industry is to produce crystals of good physical, processing, and biopharmaceutical properties. The definition of good physical properties depends on what the end goal and the drug formulation that the crystals will be a part of, but often processing and biopharmaceutical properties are competing interests. In most cases, the crystallization process is tailored to improve downstream process efficiency rather than improve drug molecule efficacy in the human body. Herein a novel concept and method to help satisfy both processing and biopharmaceutical interests is proposed, which is based on performing crystallization and spherical agglomeration in a two-stage continuous mixed suspension mixed product removal (MSMPR) system. With the suitable operating mode, the system enables to decouple the nucleation and growth from the agglomeration mechanisms, while performing efficient continuous manufacturing of particles with desired properties. Decoupling will offer more degrees of freedom for the control of each mechanism. This in turn provides the means by which properties in the nucleation/growth stage can be tailored to those of most biopharmaceutical benefit and efficacy (e.g. bioavailability, dissolution, morphology) while allowing the agglomeration stage to be tailored to produce spherical agglomerates of the most processing efficiency (e.g. filtering, drying, friability).

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“…An adjustment factor of 1.064 corrected the perimeter for the effect of the corners produced by digitization of the image. When roundness value approaches one, the particle morphology is regarded spherical [24].…”

Section: Analysis Of Particle Size and Particle Roundnessmentioning

confidence: 99%

Characterization and Utilization of Starches Extracted from Florencia and Waxy Maize Hybrids for Tablet Formulation: Compaction Behaviour and Tablet Properties

Szepes¹,

Szabó‐Révész²,

Bajdik³

et al. 2014

AJPS

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The aim of this work is to analyze the particle characteristics, such as shape, roundness and size, of starches extracted from Florencia and waxy maize hybrids. The micromeritics and structural properties of the samples were examined. The evaluation of flow properties, densification and compression behaviour of the powders was carried out. Physical parameters and swelling characteristics of tablets containing Florencia and waxy maize starch were also studied. Starch samples were compared with respect to their applicability as excipients in tablet formulation. The samples exhibited identical structure and similar particle characteristics. Maize starch extracted from the Florencia dent hybrid showed better flowability and compressibility in tableting experiments, which resulted in better mechanical tablet properties. With regard to utilization as a disintegrant, Florencia starch indicated rapid and intensive swelling and proved to act more effectively in the swelling process than waxy maize starch.

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Crystal growth of drug materials by spherical crystallization

Cited by 17 publications

References 5 publications

Engineering of Pharmaceutical Materials: An Industrial Perspective

Engineering of Pharmaceutical Materials: An Industrial Perspective

Process Intensification through Continuous Spherical Crystallization Using a Two-Stage Mixed Suspension Mixed Product Removal (MSMPR) System

Characterization and Utilization of Starches Extracted from Florencia and Waxy Maize Hybrids for Tablet Formulation: Compaction Behaviour and Tablet Properties

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