Melt granulation: A comparison of granules produced via high-shear mixing and twin-screw granulation

Steffens, Kristina E.; Brenner, Marvin B.; Hartig, Michael U.; Monschke, Marius; Wagner, Karl

doi:10.1016/j.ijpharm.2020.119941

Cited by 14 publications

(5 citation statements)

References 33 publications

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“…This relative protein particle area variation (calculated as CV in %) was taken as a descriptor for the protein particle distribution. Low levels in CV indicate a homogenous protein particle distribution, whereas high levels would represent a high variation of protein particle distribution, i.e., an inhomogenous particle distribution ( Steffens et al, 2020 ). For every formulation, three extrudate cross sections (Ø = 1 mm) were analyzed in total for mean value and standard deviation calculation of this distribution value.…”

Section: Methodsmentioning

confidence: 99%

Impact of process stress on protein stability in highly-loaded solid protein/PEG formulations from small-scale melt extrusion

Dauer

Werner

Lindenblatt

et al. 2023

International Journal of Pharmaceutics: X

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Section: Methodsmentioning

confidence: 99%

Impact of process stress on protein stability in highly-loaded solid protein/PEG formulations from small-scale melt extrusion

Dauer

Werner

Lindenblatt

et al. 2023

International Journal of Pharmaceutics: X

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“…with optimum flow and compressibility, without compromising their disintegration behavior and drug release so that tablets with better quality attributes can be prepared. Mechanical strength of granules is inversely proportional to their disintegration behavior and drug release [ 22 ]. Increase in mechanical strength of granules will decrease its disintegration behavior and vice versa.…”

Section: Resultsmentioning

confidence: 99%

Prediction of quality attributes (mechanical strength, disintegration behavior and drug release) of tablets on the basis of characteristics of granules prepared by high shear wet granulation

Khan

2021

PLoS ONE

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High shear wet granulation is commonly applied technique for commercial manufacturing of tablets. Granulation process for tablets manufacturing is generally optimized by hit and trial which involves preparation of granules under different processing parameters, compression of granules and evaluation of the resultant tablets; and adjustment is made in granulation process on the basis of characteristics of tablets. Objective of the study was to optimize the process of high shear wet granulation and prediction of characteristics of tablets on the basis of properties of granules. Atenolol granules were prepared by high shear wet granulation method, using aqueous solution of polyvinyl pyrrolidone (PVP k-30) as binder. Concentration of binder solution and granulation time were taken as process variables, both studied at three levels. Different combinations of process variables were determined by Design Expert software. Granules were evaluated for different parameters on the basis of SeDeM-ODT (Sediment Delivery Model-Oro Dispersible Tablets) expert system. Granules from all the trials were compressed using round (10.5 mm) flat faced punches at compression weight of 250 mg/tablet. Tablets were evaluated of different quality control parameters as per USP. Results showed that both the process variables had positive effect on mechanical strength of tablets and negative effect on disintegration and dissolution rate. Granule prepared with highest level of binder concentration (15%) and highest granulation time (60 sec) resulted in tablets with highest crushing strength (11.8 kg), specific crushing strength (0.328 kg/mm2), tensile strength (0.208 kg/mm2), lowest value of friability (0.19%) and highest disintegration time (10.9 min), as predicted from granules characteristics on the basis of SeDeM-ODT expert system. Drug release from Trial-13 (processed under highest level of both process parameters) was also lower than rest of the trials. It is concluded from the study that quality characteristics of tablets can be predicted from granules characteristics using SeDeM-ODT expert system. Furthermore, SeDeM-ODT expert system can also be used for optimization of the process of high shear wet granulation.

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“…Shear between the screws’ mixing sections and overflight regions results in very efficient mixing so that lower binder levels are required to achieve the same tablet strength and hydrophilic matrix gelling for sustained release, reducing the overall tablet size [ 13 ]. 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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Melt granulation: A comparison of granules produced via high-shear mixing and twin-screw granulation

Cited by 14 publications

References 33 publications

Impact of process stress on protein stability in highly-loaded solid protein/PEG formulations from small-scale melt extrusion

Impact of process stress on protein stability in highly-loaded solid protein/PEG formulations from small-scale melt extrusion

Prediction of quality attributes (mechanical strength, disintegration behavior and drug release) of tablets on the basis of characteristics of granules prepared by high shear wet granulation

Twin-Screw Melt Granulation for Oral Solid Pharmaceutical Products

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