Abstract

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.

Highlights

  • In pharmaceutical manufacturing, film coating on solid oral dosage forms, especially for tablets, is typically performed as the last steps of secondary manufacturing value chain

  • Results of the analysis indicated that the terahertz parameters were not indicative of the drug release performance for these pellet dosage forms possibly because of a non-diffusion drug release mechanism through the film coating structure

  • Terahertz pulsed imaging (TPI) can reveal structural defects in enteric coatings where the combination of coating thickness, coating uniformity, terahertz electric field peak strength (TEFPS) and terahertz interface index (TII) information can infer on the physiochemical properties of the coating and acid resistance [31]

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Summary

Introduction

Film coating on solid oral dosage forms, especially for tablets, is typically performed as the last steps of secondary manufacturing value chain. The process of film coating is widely used to ensure colour uniformity, light protection and taste masking of the dosage forms. Active coatings contain an API in the coat They are applied to realise different fixed dose combinations and to prevent interaction of different drugs or to combine different release behaviour in one single solid dosage form. Dosage forms with a targeted release profile are very sensitive to cracks and other imperfections Such defects in the coating can lead to dose dumping, a spontaneous release of the drug leading to possible. The tablet coating process used is commonly a batch process using a perforated pan-coater Such a unit operation has been performed for many decades, initially starting out as sugar coating, there is still a lack of process understanding and control to ensure productions of coatings with low coating variability and imperfections under stringent time requirements. In this review we will look back on the use of TPI, pertaining to pharmaceutical coatings, highlighting the main findings, as well as the challenges ahead

Instrumentation
Coating Thickness Analysis
Off-Line Measurement
Defects Identification
Comparison and Calibration of PAT
Process Understanding
In-Line Measurement
Findings
Conclusions and Future Challenges
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