Evaluation of critical process parameters for inter-tablet coating uniformity of active-coated GITS using Terahertz Pulsed Imaging

Brock, Daniela; Zeitler, J. Axel; Funke, Adrian; Knop, Klaus; Kleinebudde, Peter

doi:10.1016/j.ejpb.2014.06.016

Cited by 22 publications

(9 citation statements)

References 26 publications

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“…Brock et al analysed the CPPs for inter tablet coating uniformity in an active pan coating process using Terahertz pulsed imaging [9] . In this work the coating uniformity was assessed by calculating the coefficient of variation (CV) of coating thickness and the CV of active pharmaceutical ingredient (API) content measured by high performance liquid chromatography (HPLC) [9] . Similarly, DOE methods were used to quantify the effects of changes in coating process conditions on the quality and performance of filmcoated tablets.…”

Section: Research Papermentioning

confidence: 99%

A Quality by Design Approach for Coating Process Parameter Optimization

Nayak¹,

Elchidana²,

Sahu³

2017

pharmaceutical-sciences

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Film coating is a thin polymer layer applied on to a solid dosage form. Quality by design approach was explored to optimize the tablet coating process using Opadry ® , an optimized one step film coating system. A central composite design was chosen by considering independent variables as inlet temperature, atomization air pressure, spray rate and dependent variables as weight gain and tablet surface roughness. Non-linear regression models were developed for response variables. The model was used to achieve an optimized response characteristic of weight gain, surface roughness with predicted input variables of inlet air temperature, atomization air pressure and spray rate. With optimized process parameters tablet has been coated and the suitability of the model determined. The results demonstrated the overall reliability and effectiveness of the proposed quality by design approach to the derived model and provides useful tool to help optimize the film coating process.

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Section: Research Papermentioning

confidence: 99%

A Quality by Design Approach for Coating Process Parameter Optimization

Nayak¹,

Elchidana²,

Sahu³

2017

pharmaceutical-sciences

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“…A high level of intra-tablet and inter-tablet coating uniformity are the desired quality attributes especially for modified-release coatings, where a high level of coating variability can potentially undermine the efficacy of the eventual product. TPI, owing to its relatively high spatial resolution, has shown to be a suitable tool for quantifying active coating thickness uniformity of tablets coated under varying process conditions [45,46]. In particular, using design of experiments covering a wide range of realistic coating process conditions for process parameters such as drum load, drum rotation speed, spray rate, spray pressure and coating duration, TPI was used to identify and optimise the critical process parameters for an active coating process of gastrointestinal therapeutic systems (GITS).…”

Section: Process Understandingmentioning

confidence: 99%

Review of Terahertz Pulsed Imaging for Pharmaceutical Film Coating Analysis

Alves-Lima

Song

et al. 2020

Sensors

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Terahertz pulsed imaging (TPI) was introduced approximately fifteen years ago and has attracted a lot of interest in the pharmaceutical industry as a fast, non-destructive modality for quantifying film coatings on pharmaceutical dosage forms. In this topical review, we look back at the use of TPI for analysing pharmaceutical film coatings, highlighting the main contributions made and outlining the key challenges ahead.

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“…TPI is used to identify structural defects within enteric coating tablets with poor acid resistance [74]. (v) TPI is used for evaluation of the intra tablet and inter tablet coating uniformity and identiication of critical process parameters in a coating process [75,76]. (vi) TPI can also be used in evaluating the efect of coating equipment on tablet ilm quality [77].…”

Section: Terahertz Spectroscopy -A Cutting Edge Technologymentioning

confidence: 99%

Terahertz Pulse Detection Techniques and Imaging Applications

Chen¹,

Guo²

2017

Terahertz Spectroscopy - A Cutting Edge Technology

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Recent years have witnessed successful developments of detection techniques of teraherz (THz) pulse radiation and its imaging applications such as security, medicine and environmental sensing, to name an important few. Progress of detection techniques has been made in many aspects, including detection sensitivity, real-time detection, roomtemperature operation, detection bandwidth and dynamic range, spatial (wavefront) and temporal proiles and so on. New detection techniques utilizing cuting-edge materials, sensors, systems and even novel detection mechanisms contribute to advances in teraherz pulse detection. While detection techniques continuously improve, teraherz pulsed imaging (TPI) also inds broad and intriguing applications. For instance, TPI has shown applications in nondestructive evaluation in pharmaceutics, biomedical characterization of tissues, medical diagnosis of cancers, identiication of explosive hazards and examination of art and archeology. The chapter highlights recent progress of teraherz pulse detection techniques and imaging applications.

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Evaluation of critical process parameters for inter-tablet coating uniformity of active-coated GITS using Terahertz Pulsed Imaging

Cited by 22 publications

References 26 publications

A Quality by Design Approach for Coating Process Parameter Optimization

A Quality by Design Approach for Coating Process Parameter Optimization

Review of Terahertz Pulsed Imaging for Pharmaceutical Film Coating Analysis

Terahertz Pulse Detection Techniques and Imaging Applications

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