Continuous Twin Screw Wet Granulation and Drying—Control Strategy for Drug Product Manufacturing

Dahlgren, Gabriella M.; Tajarobi, Pirjo; Simone, Eric; Ricart, Brendon; Melnick, Jason P.; Puri, Vibha; Stanton, Courtney; Bajwa, Gurjit

doi:10.1016/j.xphs.2019.06.023

Cited by 14 publications

(5 citation statements)

References 63 publications

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“…According to ICH Q10 and Q13 guidelines, the quality of production could be ensured by establishing control strategies to maintain the process under control, in other words, to use process monitoring tools and control methods for the improvement of product quality, assuring the continued applicability and capability of processes [70].…”

Section: Process Controlmentioning

confidence: 99%

Pharmaceutical Application of Process Understanding and Optimization Techniques: A Review on the Continuous Twin-Screw Wet Granulation

Zhao

Tian

2023

Biomedicines

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Twin-screw wet granulation (TSWG) is a method of continuous pharmaceutical manufacturing and a potential alternative method to batch granulation processes. It has attracted more and more interest nowadays due to its high efficiency, robustness, and applications. To improve both the product quality and process efficiency, the process understanding is critical. This article reviews the recent work in process understanding and optimization for TSWG. Various aspects of the progress in TSWG like process model construction, process monitoring method development, and the strategy of process control for TSWG have been thoroughly analyzed and discussed. The process modeling technique including the empirical model, the mechanistic model, and the hybrid model in the TSWG process are presented to increase the knowledge of the granulation process, and the influence of process parameters involved in granulation process on granule properties by experimental study are highlighted. The study analyzed several process monitoring tools and the associated technologies used to monitor granule attributes. In addition, control strategies based on process analytical technology (PAT) are presented as a reference to enhance product quality and ensure the applicability and capability of continuous manufacturing (CM) processes. Furthermore, this article aims to review the current research progress in an effort to make recommendations for further research in process understanding and development of TSWG.

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Section: Process Controlmentioning

confidence: 99%

Pharmaceutical Application of Process Understanding and Optimization Techniques: A Review on the Continuous Twin-Screw Wet Granulation

Zhao

Tian

2023

Biomedicines

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“…Apart from the continuous fluid bed dryer by L.B. Bohle mentioned above, Freund Vector also has developed a continuous drying solution by implementing a spiral dryer in its Granuformer [ 110 , 111 ]. Currently, a limited number of studies has been published using these truly continuous techniques, potentially limiting their industrial implementation.…”

Section: Recommendations and Research Opportunitiesmentioning

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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“…direct compression. Direct compression can be challenging if the API and/or the formulation show poor flowability, sticking, segregation, compaction or bioavailability issues [11]. Applying a (wet) granulation technique can mask and improve such challenging attributes of the API, therefore it is reasonable to include granulation as an additional process step in that cases.…”

Section: Theoretical Aspectsmentioning

confidence: 99%

“…A continuous wet granulation technique is the twin screw wet granulation. Comparing this continuous wet granulation technique to traditional batch wet granulation techniques as high shear granulation or fluid bed granulation, twin screw wet granulation offers the advantage of no material intensive scale-up than observed for batch wet granulation processes [11].…”

Section: Theoretical Aspectsmentioning

confidence: 99%

See 1 more Smart Citation

Continuous twin screw granulation and fluid bed drying: A mechanistic scaling approach focusing optimal tablet properties

Menth

Maus

Wagner

2020

International Journal of Pharmaceutics

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Continuous Twin Screw Wet Granulation and Drying—Control Strategy for Drug Product Manufacturing

Cited by 14 publications

References 63 publications

Pharmaceutical Application of Process Understanding and Optimization Techniques: A Review on the Continuous Twin-Screw Wet Granulation

Pharmaceutical Application of Process Understanding and Optimization Techniques: A Review on the Continuous Twin-Screw Wet Granulation

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

Continuous twin screw granulation and fluid bed drying: A mechanistic scaling approach focusing optimal tablet properties

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