Analysis of Pharmaceutical Tablet Coating Uniformity by Laser-Induced Breakdown Spectroscopy (LIBS)

Dubey, Aditi; Keyvan, Golshid; Hsia, Richard; Saranteas, Kostas; Brone, Dean; Misra, Tushar; Muzzio, Fernando J.

doi:10.1007/s12247-011-9103-9

Cited by 25 publications

(18 citation statements)

References 34 publications

(34 reference statements)

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“…It has been shown in previous studies that the tablet-totablet coating variability is inversely proportional to the square root of weight gain (28) or coating time (3,6,30). In this study, the evolution of the RSD as a function of square root of weight gain for all lots is displayed in Fig.…”

Section: Effect Of Coating Weight Gainmentioning

confidence: 72%

“…Another sample set, referred to as set M1, was used to develop the analytical method. Complete ANOVA and variance calculations for the method development study are not presented here, but can be found in Dubey et al (28). Set M1 consisted of 100 tablets sampled from five production batches with 20 tablets per batch.…”

Section: Methodsmentioning

confidence: 99%

“…The details of the analytical method development and optimization can be found in (28). This study aims to build upon those findings.…”

Section: Development Of Libs-based Analytical Methodsmentioning

confidence: 99%

“…The highest variability (largest LIBS RSD) was observed during the initial trials. Information from the sample set M1 from a previous study (28) can also be included for comparison. During these trials, the coating process was characterized, and an initial DOE was conducted to examine the effect of coating parameters.…”

Section: Comparison Of Validation and The Pre-validation Batchesmentioning

confidence: 99%

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Improvement of Tablet Coating Uniformity Using a Quality by Design Approach

et al. 2012

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Abstract. A combination of analytical and statistical methods is used to improve a tablet coating process guided by quality by design (QbD) principles. A solid dosage form product was found to intermittently exhibit bad taste. A suspected cause was the variability in coating thickness which could lead to the subject tasting the active ingredient in some tablets. A number of samples were analyzed using a laserinduced breakdown spectroscopy (LIBS)-based analytical method, and it was found that the main variability component was the tablet-to-tablet variability within a lot. Hence, it was inferred that the coating process (performed in a perforated rotating pan) required optimization. A set of designed experiments along with response surface modeling and kriging method were used to arrive at an optimal set of operating conditions. Effects of the amount of coating imparted, spray rate, pan rotation speed, and spray temperature were characterized. The results were quantified in terms of the relative standard deviation of tablet-averaged LIBS score and a coating variability index which was the ratio of the standard deviation of the tablet-averaged LIBS score and the weight gain of the tablets. The data-driven models developed based on the designed experiments predicted that the minimum value of this index would be obtained for a 6% weight gain for a pan operating at the highest speed at the maximum fill level while using the lowest spraying rate and temperature from the chosen parametric space. This systematic application of the QbD-based method resulted in an enhanced process understanding and reducing the coating variability by more than half.

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