Compression behaviour of granules produced via twin-screw melt granulation: Effect of initial particle size on granulation efficiency

Steffens, Kristina E.; Wagner, Karl G.

doi:10.1016/j.powtec.2020.07.037

Cited by 11 publications

(4 citation statements)

References 32 publications

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“…Interestingly the lower SF of the formulation with CPV did not influence the TS of the tablets in a large extent. This can be explained with high plasticity of the melt granules ( 61 ), maintaining the bonding capacity of the formulation.…”

Section: Discussionmentioning

confidence: 99%

Immediate-Release Formulations Produced via Twin-Screw Melt Granulation: Systematic Evaluation of the Addition of Disintegrants

Steffens

Wagner

2021

AAPS PharmSciTech

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The current study evaluated the effect of location and amount of various superdisintegrants on the properties of tablets made by twin-screw melt granulation (TSMG). Sodium-croscarmellose (CCS), crospovidone (CPV), and sodium starch glycolate (SSG) were used in various proportions intra- and extra-granular. Tabletability, compactibility, compressibility as well as friability, disintegration, and dissolution performance were assessed. The extra-granular addition resulted in the fasted disintegration and dissolution. CPV performed superior to CCS and SSG. Even if the solid fraction (SF) of the granules was lower for CPV, only a minor decrease in tabletability was observed, due to the high plastic deformation of the melt granules. The intra-granular addition of CPV resulted in a more prolonged dissolution profile, which could be correlated to a loss in porosity during tableting. The 100% intra-granular addition of the CPV resulted in a distinct decrease of the disintegration efficiency, whereas the performance of SSG was unaffected by the granulation process. CCS was not suitable to be used for the production of an immediate-release formulation, when added in total proportion into the granulation phase, but its efficiency was less impaired compared to CPV. Shortest disintegration (78 s) and dissolution (Q80: 4.2 min) was achieved with CPV extra-granular. Using CPV and CCS intra-granular resulted in increased disintegration time and Q80. However, at a higher level of appx. 500 s and appx. 15 min, only SSG showed a process and location independent disintegration and dissolution performance.

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Section: Discussionmentioning

confidence: 99%

Immediate-Release Formulations Produced via Twin-Screw Melt Granulation: Systematic Evaluation of the Addition of Disintegrants

Steffens

Wagner

2021

AAPS PharmSciTech

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“…Compared with high-shear melt granulation, twin-screw melt granulation produced elongated, more porous, larger granules [ 35 ] which form stronger tablets. [ 36 , 37 , 38 , 39 , 40 , 41 ] Modular screw and barrel design common among twin-screw extruders allows for flexibility to produce the target granule density and particle size.…”

Section: Melt Granulation Process Options Particularly Twin-screw Melt Granulation (Tsmg)mentioning

confidence: 99%

Twin-Screw Melt Granulation for Oral Solid Pharmaceutical Products

2021

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This article highlights the advantages of pharmaceutical continuous melt granulation by twin-screw extrusion. The different melt granulation process options and excipients are described and compared, and a case is made for expanded use of twin-screw melt granulation since it is a flexible and continuous process. Methods for binder selection are profiled with a focus on rheology and physical stability impacts. For twin-screw melt granulation, the mechanism of granulation and process impact on granule properties are described. Pharmaceutical applications of melt granulation ranging from immediate release of soluble and insoluble APIs, taste-masking, and sustained release formulation are reviewed, demonstrating the range of possibilities afforded by twin-screw melt granulation.

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“…The modular screw and barrel design, common among twin-screw extruders, allows for improved control of granule density and particle size. For more information, refer to recent reviews of continuous melt granulation [10,31] and process studies [33][34][35][36]. TSMG has similar process considerations to twin-screw wet granulation, which is comparatively more developed in the literature [37][38][39][40][41][42].…”

Section: Continuous Twin-screw Melt Granulation For Taste-maskingmentioning

confidence: 99%

Continuous Melt Granulation for Taste-Masking of Ibuprofen

Forster

Lebo

2021

Pharmaceutics

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Taste-masking of drugs, particularly to produce formulations for pediatric patients, can be challenging and require complex manufacturing approaches. The objective of this study was to produce taste-masked ibuprofen granules using a novel process, twin-screw melt granulation (TSMG). TSMG is an emerging, high-productivity, continuous process. Granules of ibuprofen embedded in a lipid matrix were produced across a range of process conditions, resulting in a range of output granule particle sizes. The ibuprofen appeared to be miscible with the lipid binder though it recrystallized after processing. The ibuprofen melt granules were tested in simulated saliva using a novel, small-volume dissolution technique with continuous acquisition of the ibuprofen concentration. The ibuprofen release from the granules was slower than the neat API and physical blend, beyond the expected residence time of the granules in the mouth. The ibuprofen release was inversely related to the granule size. A Noyes–Whitney dissolution model was used and the resulting dissolution rate constants correlated well with the granule size.

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Compression behaviour of granules produced via twin-screw melt granulation: Effect of initial particle size on granulation efficiency

Cited by 11 publications

References 32 publications

Immediate-Release Formulations Produced via Twin-Screw Melt Granulation: Systematic Evaluation of the Addition of Disintegrants

Immediate-Release Formulations Produced via Twin-Screw Melt Granulation: Systematic Evaluation of the Addition of Disintegrants

Twin-Screw Melt Granulation for Oral Solid Pharmaceutical Products

Continuous Melt Granulation for Taste-Masking of Ibuprofen

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