Monitoring of a Hot Melt Coating Process via a Novel Multipoint Near-Infrared Spectrometer

Hohl, Roland; Scheibelhofer, Otto; Stocker, Elena; Behzadi, Sharareh Salar; Haack, Detlev; Koch, Kai Henning; Kerschhaggl, Peter; Lochmann, Dirk; Sacher, Stephan; Zimmer, Andreas

doi:10.1208/s12249-016-0504-4

Cited by 10 publications

(7 citation statements)

References 27 publications

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“…The particle size and the viscosity of meltable materials and the temperatures of the inlet-air and the product endpoint significantly influence performance of HMC process 24,38 . Increased meltable material content increases coating thickness decreases dissolution rate of active 38,39 . The temperatures of the inlet-air and the product endpoint have more pronounced effect on parameters of coatings 2,3,36,39 .…”

Section: Hmc Using Fluid-bed Processormentioning

confidence: 99%

Dry-Coating of Powder Particles is Current Trend in Pharmaceutical Field

Alli¹

2021

J. Drug Delivery Ther.

525

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Modification of surface attributes of particles, usually accomplished by coating, is desirous to enhance and maintain their usability. Coating is a multi-step process involves application of the coating material (CoM) onto the substrate, herein powder particles, where the process along with device/ equipment monitors surface attributes of the applied coating. Nowadays competitive market calls for cost cutting to survive product(s). Thus saving of energy and time, minimising number and quantity of additives, reducing and shortening process steps; consequently minimising the coating process cost are main goals while developing coating process for powder particle. Innovation of processes for dry-powder coating (DPC) along with their further development and refinement finds solution to said issues. Further, DPC process does not calls for liquid solvent or solution thus are viewed as cost-effective and environmentally safe, DPC process uses thermo-mechanical methods like mechanofusion, magnetic assisted impaction coating (MAIC), hybridization, rotating fluid-bed process, theta-composer, hot-melt coating (HMC), and many others. Besides these available are non-thermo-mechanical methods namely electrostatic coating; supercritical fluids (SCF) based methods like rapid expansion of supercritical fluid (RESF), gas anti-solvent (GAS), SCF anti-solvent, gas-saturated solution (GSS); vapour coating; and others. Basing on said thermo-mechanical and non-thermo-mechanical principle several DPC methods/ process had been reported in scientific literatures and patents. Said DPC method founds multidisciplinary applications like drug delivery and drug development. Diverse devices are there for the DPC process; their method of working, principle, limitations and benefits along with their applicability in pharmaceutical field are discussed and presented in this article. Keywords: Dry, particle, coating, pharmaceutical, process

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Section: Hmc Using Fluid-bed Processormentioning

confidence: 99%

Dry-Coating of Powder Particles is Current Trend in Pharmaceutical Field

Alli¹

2021

J. Drug Delivery Ther.

525

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“…Additionally, an inline multi-probe near-infrared (NIR) spectrometer for the monitoring of the coating amount was evaluated. 54,55 The detailed characteristics of the HMC process were evaluated afterwards via PFMECA and HACCP. 49…”

Section: Process Flowchart: Characterization Of the Hmc Processmentioning

confidence: 99%

“…Within the coating step, a preventive control of the CMA "coating amount [% (wt/wt)]" by an in-line NIR spectrometer was evaluated. 54,55 The amount of coating on the particles should be within the range of 25-40 [% (wt/wt)] to ensure that the specification limits of the CQAs are not exceeded. The monitoring procedure is based on an off-line HPLC analysis to determine the API amount, while corrective actions include an adaptation of spray rate, atomization air pressure, and air flow rate within defined process ranges.…”

Section: Hazard Analysis and Critical Control Pointsmentioning

confidence: 99%

“…These data were used for the development of an in-line monitoring method to determine the optimal end-point during processing. 54,55 As summarized by Hohl et al, 54 off-line and in-line spectroscopic NIR reference measurements can be used as optional methods for verification. In addition to the HACCP system, the results of the FTA give an overview of all events causing "coating amount out of specification," supporting further process up-scaling, control strategy development, and meeting good manufacturing practiceecompliant manufacturing process requirements.…”

Section: Hazard Analysis and Critical Control Pointsmentioning

confidence: 99%

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Application of ICH Q9 Quality Risk Management Tools for Advanced Development of Hot Melt Coated Multiparticulate Systems

Stocker

Becker

Hate

et al. 2017

Journal of Pharmaceutical Sciences

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This study aimed to apply quality risk management based on the The International Conference on Harmonisation guideline Q9 for the early development stage of hot melt coated multiparticulate systems for oral administration. N-acetylcysteine crystals were coated with a formulation composing tripalmitin and polysorbate 65. The critical quality attributes (CQAs) were initially prioritized using failure mode and effects analysis. The CQAs of the coated material were defined as particle size, taste-masking efficiency, and immediate release profile. The hot melt coated process was characterized via a flowchart, based on the identified potential critical process parameters (CPPs) and their impact on the CQAs. These CPPs were prioritized using a process failure mode, effects, and criticality analysis and their critical impact on the CQAs was experimentally confirmed using a statistical design of experiments. Spray rate, atomization air pressure, and air flow rate were identified as CPPs. Coating amount and content of polysorbate 65 in the coating formulation were identified as critical material attributes. A hazard and critical control points analysis was applied to define control strategies at the critical process points. A fault tree analysis evaluated causes for potential process failures. We successfully demonstrated that a standardized quality risk management approach optimizes the product development sustainability and supports the regulatory aspects.

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“…Currently, particle coating technology is mainly used in materials science and pharmaceutical industry, including drug layering, modified release coating, physical and chemical protection, esthetic purposes, and taste masking, enhanced identification of drugs. [ 26 ] Particle coating technology utilizes external force to combine several drugs or excipients particles to form composite according to certain structural models to change property of drug. [ 27 ] Among them, the most commonly used is core-shell structure model.…”

Section: Introductionmentioning

confidence: 99%

A novel strategy for bitter taste masking of gankeshuangqing dispersible tablets based on particle coating technology

Han

Zhang

et al. 2017

Phcog Mag

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Background:Currently, acute upper respiratory tract infections (AURTIs) are increasingly becoming a significant health burden. Gankeshuangqing dispersible tablets (GKSQDT) which have a good effect on treating AURTIs. GKSQDT is composed of baicalin and andrographolide. However, its severe bitterness limits application of patients. Due to the addition of plentiful accessories, common masking methods are unsuitable for GKSQDT. It is thus necessary to develop a new masking method.Materials and Methods:The Previous study showed that baicalin was less bitter than andrographolide. Thus, particle coating technology was adapted to prepare composite particles that baicalin coated on the surface of andrographolide to decrease bitterness. Initially, particle size of baicalin and coating time of composite was investigated to prepare composite. Then, scanning electron microscopy, wettability, and infrared (IR) spectrogram were used to characterize the microstructure of composite. Furthermore, electronic tongue test, animal preference experiment, and human sensory test were applied to evaluate the masking effect.Results:To produce composite, baicalin should be ground in vibromill for 6 min. Then, andrographolide fine powder was added to grind together for 6 min. Contact angle of composite was smaller than mixture, and more similar to baicalin. Other physical characterization including microstructure, wettability, and IR also suggested that andrographolide was successfully coated by baicalin superfine. Furthermore, taste-masking test indicated taste-masked tablets was less bitter than original tablets.Conclusion:The study indicated that particle coating technology can be used for taste masking of GKSQDT without adding other substance. Moreover, it provides a new strategy of taste masking for national medicine.SUMMARY A new strategy to mask bitterness without adding any other substance based on coating technology was providedThe masking effect was confirmed by electronic tongue test, animal preference experiment and human sensory test. Abbreviations used: AURTIs: Acute Upper Respiratory Tract Infections; GSQDT: Gankeshuangqing Dispersible Tablets; IR: Infrared Spectrogram; LHPC: Low-substituted Hydroxypropyl Cellulose; CAs: Contact Angles; FTIR: Fourier Transform Infrared Spectra.

show abstract

Monitoring of a Hot Melt Coating Process via a Novel Multipoint Near-Infrared Spectrometer

Cited by 10 publications

References 27 publications

Dry-Coating of Powder Particles is Current Trend in Pharmaceutical Field

Dry-Coating of Powder Particles is Current Trend in Pharmaceutical Field

Application of ICH Q9 Quality Risk Management Tools for Advanced Development of Hot Melt Coated Multiparticulate Systems

A novel strategy for bitter taste masking of gankeshuangqing dispersible tablets based on particle coating technology

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