Compartmental approach for modelling twin-screw granulation using population balances

Ismail, Hamza Y.; Shirazian, Saeed; Singh, Mehakpreet; Whitaker, Darren; Albadarin, Ahmad B.; Walker, Gavin

doi:10.1016/j.ijpharm.2019.118737

Cited by 39 publications

(20 citation statements)

References 33 publications

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“…Caused by a higher amount of water, more powder particles could be wetted or solved, more liquid bridges were formed, and therefore agglomeration was enhanced. An increase of granule sizes at higher L/S was also observed in former studies of twin-screw granulation [9,11,29,31,32]. Moreover, bimodal PSDs were observed at lower L/S.…”

Section: Determination Of Useful Process Settingssupporting

confidence: 83%

Evaluation of Binders in Twin-Screw Wet Granulation

2021

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The binders povidone (Kollidon 30), copovidone (Kollidon VA64), hypromellose (Pharmacoat 606), and three types of hyprolose (HPC SSL‑SFP, HPC SSL, and HPC SL‑FP) were evaluated regarding their suitability in twin-screw wet granulation. Six mixtures of lactose and binder as well as lactose without binder were twin-screw granulated with demineralized water at different barrel fill levels and subsequently tableted. A screening run with HPC SSL determined the amount of water as an influential parameter for oversized agglomerates. Subsequent examination of different binders, especially Kollidon 30 and Kollidon VA64 resulted in large granules. All binders, except Pharmacoat 606, led to a reduction of fines compared to granulation without a binder. The molecular weight of applied hyproloses did not appear as influential. Tableting required an upstream sieving step to remove overlarge granules. Tableting was possible for all formulations at sufficient compression pressure. Most binders resulted in comparable tensile strengths, while Pharmacoat 606 led to lower and lactose without a binder to the lowest tensile strength. Tablets without a binder disintegrated easily, whereas binder containing tablets of sufficient tensile strength often nearly failed or failed the disintegration test. Especially tablets containing Pharmacoat 606 and HPC SL‑FP disintegrated too slowly.

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Section: Determination Of Useful Process Settingssupporting

confidence: 83%

Evaluation of Binders in Twin-Screw Wet Granulation

2021

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“…Furthermore, the implemented system can produce a predetermined target particle size by changing the process and formulation parameters. Ismail et al [49] developed a compartment population balance model to predict the PSD in a co-rotating TSG. The model is based on the liquid-solid ratio and screw speed, which represent the main process parameters of TSG.…”

Section: Sfv Measurementmentioning

confidence: 99%

Granulation process analysis technologies and potential applications in traditional Chinese medicine

Cui

Hou

Feng

et al. 2022

Acupuncture and Herbal Medicine

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Pharmaceutical production is changing from batch production to continuous production, during which granulation is one of the most important unit operations. The quality of mass-produced products is traditionally guaranteed by conducting off-line testing, which cannot meet the demand of continuous production for real-time monitoring of critical process parameters and critical quality attributes (CQAs) of the pharmaceutical granulation technology. Since the U.S. Food and Drug Administration proposed process analytical technology (PAT) in 2004, many PAT tools have been developed to monitor the granulation process and provide information regarding the granulation operation conditions and endpoint determination. In this article, we review the recent research and application of two PAT modes in the granulation process, namely, single CQA and multi-CQA PAT, with the aim to provide references for comprehensively improving the technological level of the pharmaceutical granulation process. Furthermore, the potential applications in traditional Chinese Medicine are discussed.

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“… 91 It can granulate powders to granules in a short time and efficiently mix API and excipient. 92 TSG includes three main components, respectively conveying elements, kneading blocks and comb mixer elements. To enhance the manufacturing efficiency of TSG, it is important to comprehensively study the impact of formulation and process parameters on the granule attributes.…”

Section: Application Of Multivariate Modeling Techniques In Tablet Ma...mentioning

confidence: 99%

Pharmaceutical application of multivariate modelling techniques: a review on the manufacturing of tablets

et al. 2021

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Compartmental approach for modelling twin-screw granulation using population balances

Cited by 39 publications

References 33 publications

Evaluation of Binders in Twin-Screw Wet Granulation

Evaluation of Binders in Twin-Screw Wet Granulation

Granulation process analysis technologies and potential applications in traditional Chinese medicine

Pharmaceutical application of multivariate modelling techniques: a review on the manufacturing of tablets

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