Continuous twin screw granulation: Influence of process and formulation variables on granule quality attributes of model formulations

Portier, Christoph; Pandelaere, K.; Delaet, Urbain; Vígh, Tamás; Kumar, Ashish; Pretoro, G. Di; Beer, Thomas De; Vervaet, Chris

doi:10.1016/j.ijpharm.2019.118981

Cited by 39 publications

(26 citation statements)

References 25 publications

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“…The kneading zones were each made up of six kneading elements (0.25 L/D-ratio) in a forward stagger angle of 60 • . After the second kneading block, conveying and size control elements were added, both having a length of 3.0 L/D-ratio [17]. The screw speed was set at 500 rpm.…”

Section: Preparation Of Granulesmentioning

confidence: 99%

“…Binders are often included in the formulation to facilitate the granulation process (e.g., granule nucleation and growth). As the binder type affected granule quality [10,16,17], binder selection for continuous TSG should rely on a scientific approach to obtain efficient formulation development. This starts with a profound understanding of the raw material attributes influencing the granulation process because knowledge of attributes helps to predict their impact on functionality.…”

Section: Introductionmentioning

confidence: 99%

“…However, only a single type of binder (hydroxypropyl cellulose (HPC)) was used to confirm these observations [21]. Other studies have assessed the binder types' effect (e.g., hydroxypropyl methylcellulose (HPMC), polyvinylpyrrolidone (PVP), HPC, native and pregelatinized starches, maltodextrins, and vinylpyrrolidone-vinyl acetate copolymer) on granule quality for TSG [9,10,17,20,[22][23][24][25][26][27][28][29]. Nevertheless, the use of different formulations is hindering the comparison on binder efficiency between different studies, as the other components also contributed to the binding performance, affecting the granulation process [30].…”

Section: Introductionmentioning

confidence: 99%

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Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process

et al. 2021

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The suitability of pharmaceutical binders for continuous twin-screw wet granulation was investigated as the pharmaceutical industry is undergoing a switch from batch to continuous manufacturing. Binder selection for twin-screw wet granulation should rely on a scientific approach to enable efficient formulation development. Therefore, the current study identified binder attributes affecting the binder effectiveness in a wet granulation process of a highly soluble model excipient (mannitol). For this formulation, higher binder effectiveness was linked to fast activation of the binder properties (i.e., fast binder dissolution kinetics combined with low viscosity attributes and good wetting properties by the binder). As the impact of binder attributes on the granulation process of a poorly soluble formulation (dicalcium phosphate) was previously investigated, this enabled a comprehensive comparison between both formulations in current research focusing on binder selection. This comparison revealed that binder attributes that are important to guide binder selection differ in function of the solubility of the formulation. The identification of critical binder attributes in the current study enables rational and efficient binder selection for twin-screw granulation of well soluble and poorly soluble formulations. Binder addition proved especially valuable for a poorly soluble formulation.

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Section: Preparation Of Granulesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process

et al. 2021

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“…Continuous manufacturing techniques have rapidly gained interest in the pharmaceutical industry in the last ten years, due to their widely recognized advantages ( Figure 1 ). Most importantly, continuous manufacturing techniques often eliminate the necessity of scaling up between initial clinical manufacturing and the final commercial production, because development is already performed on commercial scale equipment [ 1 , 2 , 3 ]. As the amount of material processed in continuous manufacturing can easily be adapted by changing the duration of production, this accounts for the rapid response to changing market demand [ 4 , 5 ].…”

Section: Introductionmentioning

confidence: 99%

Continuous Twin Screw Granulation: A Review of Recent Progress and Opportunities in Formulation and Equipment Design

Portier

Vervaet

2021

Pharmaceutics

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Continuous twin screw wet granulation is one of the key continuous manufacturing technologies that have gained significant interest in the pharmaceutical industry as well as in academia over the last ten years. Given its considerable advantages compared to wet granulation techniques operated in batch mode such as high shear granulation and fluid bed granulation, several equipment manufacturers have designed their own manufacturing setup. This has led to a steep increase in the research output in this field. However, most studies still focused on a single (often placebo) formulation, hence making it difficult to assess the general validity of the obtained results. Therefore, current review provides an overview of recent progress in the field of continuous twin screw wet granulation, with special focus on the importance of the formulation aspect and raw material properties. It gives practical guidance for novel and more experienced users of this technique and highlights some of the unmet needs that require further research.

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“…Twin-screw wet granulation is a granulation method, which enables continuous manufacturing and thereby is an auspicious manufacturing technique. Many studies dealt with the influence of different process parameters like liquid-to-solid ratio (L/S) or the barrel fill level affected by the variation of powder feed and screw speed [2,[6][7][8][9][10][11][12]. Moreover, equipment parameters like the influence of different screw elements and their arrangement were frequently examined [13][14][15][16].…”

Section: Introductionmentioning

confidence: 99%

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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Continuous twin screw granulation: Influence of process and formulation variables on granule quality attributes of model formulations

Cited by 39 publications

References 25 publications

Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process

Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process

Continuous Twin Screw Granulation: A Review of Recent Progress and Opportunities in Formulation and Equipment Design

Evaluation of Binders in Twin-Screw Wet Granulation

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