Feasibility of Raman spectroscopy as PAT tool in active coating

Joshua Müller, Klaus Knop, Jochen Thies, Carsten Uerpmann, Peter Kleinebudde
Drug Development and Industrial Pharmacy 2010, 36 (2): 234-43

BACKGROUND: Active coating is a specific application of film coating where the active ingredient is comprised in the coating layer. This implementation is a challenging operation regarding the achievement of desired amount of coating and coating uniformity. To guarantee the quality of such dosage forms it is desirable to develop a tool that is able to monitor the coating operation and detect the end of the process.

METHOD: Coating experiments were performed at which the model drug diprophylline is coated in a pan coater on placebo tablets and tablets containing the active ingredient itself. During the active coating Raman spectra were recorded in-line. The spectral measurements were correlated with the average weight gain and the amount of coated active ingredient at each time point. The developed chemometric model was tested by monitoring further coated batches. Furthermore, the effects of pan rotation speed and working distance on the acquired Raman signal and, hence, resulting effect of the chemometric model were examined.

RESULTS: Besides coating on placebo cores it was possible to determine the amount of active ingredient in the film when coated onto cores containing the same active ingredient. In addition, the method is even applicable when varying the process parameters and measurement conditions within a restricted range.

CONCLUSION: Raman spectroscopy is an appropriate process analytical technology too.

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