Study of granule growth kinetics during<i>in situ</i>fluid bed melt granulation using in-line FBRM and SFT probes

Kukec, Simon; Hudovornik, Grega; Dreu, Rok; Vrečer, Franc

doi:10.3109/03639045.2013.791832

Cited by 14 publications

(3 citation statements)

References 16 publications

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“…The binder has to be warm enough and sprayed quickly enough to coat granules before cooling. Alternatively, the binder is blended into the batch and then gently heated to produce granules [ 19 , 20 ]. Comparing the same formulation, fluid-bed melt granulation (FBMG) produced larger, less dense, and rougher granules compared with HSMG [ 16 ].…”

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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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 characteristic allows accurate and precise water quantity evaluation, but at the same time, it can cause trouble when measuring other CQAs (22,29). Pharmaceutical applications of NIR spectroscopy also include quantification of active ingredients and particle size analysis (30)(31)(32)(33). Gupta et al (24) were the first to report the use of NIR spectroscopy for monitoring CQAs of the roller compaction process.…”

Section: Application Of Near-infrared Spectroscopy In Monitoring the Roller Compaction Processmentioning

confidence: 99%

Process analytical technology tools for process control of roller compaction in solid pharmaceuticals manufacturing

Vovko

Vrečer

2020

Acta Pharmaceutica

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This article presents an overview of using process analytical technology in monitoring the roller compaction process. In the past two decades, near-infrared spectroscopy, near-infrared spectroscopy coupled with chemical imaging, microwave resonance technology, thermal effusivity and various particle imaging techniques have been used for developing at-, off-, on- and in-line models for predicting critical quality attributes of ribbons and subsequent granules and tablets. The common goal of all these methods is improved process understanding and process control, and thus improved production of high-quality products. This article reviews the work of several researchers in this field, comparing and critically evaluating their achievements.

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“…A successful scale-up requires a holistic approach, integrating process optimization, equipment design considerations, and a thorough understanding of material behavior. The most relevant input variables for FHMG are binder content and binder particle size, inlet air temperature and/or flow rate, granulation time, and product endpoint temperature [ 19 , 23 , 24 , 25 ]. Monitored output variables include granule size, size distribution, and growth kinetics, as well as physical and technological properties of granules (shape, porosity, flowability, and compressibility) and tablets (resistance to crushing and dissolution) [ 19 , 20 , 23 , 26 ].…”

Section: Introductionmentioning

confidence: 99%

The Effect of Formulation Variables on the Manufacturability of Clopidogrel Tablets via Fluidized Hot-Melt Granulation—From the Lab Scale to the Pilot Scale

Kovács,

Tőkés,

Kelemen

et al. 2024

Pharmaceutics

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Solid pharmaceutical formulations with class II active pharmaceutical ingredients (APIs) face dissolution challenges due to limited solubility, affecting in vivo behavior. Robust computational tools, via data mining, offer valuable insights into product performance, complementing traditional methods and aiding in scale-up decisions. This study utilizes the design of experiments (DoE) to understand fluidized hot-melt granulation manufacturing technology. Exploratory data analysis (MVDA) highlights similarities and differences in tablet manufacturability and dissolution profiles at both the lab and pilot scales. The study sought to gain insights into the application of multivariate data analysis by identifying variations among batches produced at different manufacturing scales for this technology. DoE and MVDA findings show that the granulation temperature, time, and Macrogol type significantly impact product performance. These factors, by influencing particle size distribution, become key predictors of product quality attributes such as resistance to crushing, disintegration time, and early-stage API dissolution in the profile. Software-aided data mining, with its multivariate and versatile nature, complements the empirical approach, which is reliant on trial and error during product scale-up.

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Study of granule growth kinetics duringin situfluid bed melt granulation using in-line FBRM and SFT probes

Cited by 14 publications

References 16 publications

Twin-Screw Melt Granulation for Oral Solid Pharmaceutical Products

Twin-Screw Melt Granulation for Oral Solid Pharmaceutical Products

Process analytical technology tools for process control of roller compaction in solid pharmaceuticals manufacturing

The Effect of Formulation Variables on the Manufacturability of Clopidogrel Tablets via Fluidized Hot-Melt Granulation—From the Lab Scale to the Pilot Scale

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