Improved Process Understanding of Tablet Film Coating
Background
Terahertz pulsed imaging (TPI) was first introduced in 2007 to non-destructively measure the coating thickness of pharmaceutical tablets. Ever since then, there has been a concerted research effort throughout the PSSRC to further develop and exploit this technique for improving the quality of pharmaceutical coatings and to shed light on the intricacies behind the pharmaceutical tablet coating process.
Film preparations for oral drug delivery
Introduction
Oral films have gained interest in the last couple of years. Films for oral application offer an interesting new approach for drug administration. Active pharmaceutical ingredients (API) can be implemented in thin-sheeted polymer film matrices. These dosage forms are intended to be placed in mouth to dissolve in the saliva without the need of additional liquid and without swallowing of a solid dosage form.
Experimental and Numerical Analysis of an Active Coating Process
Introduction
The inter-tablet coating uniformity is a critical quality attribute in active coating processes. In this project an active coating process is performed in order to produce a fixed dose combination of a sustained release formulation in the tablet core and an immediate release dose in the coating layer. The tablet cores consist of a push-pull osmotic system containing nifedipine as API (Adalat GITS). They are coated with Candesartan cilexetil as a second API. As the inter-tablet coating uniformity is a critical quality attribute to comply with regulatory requirements, the purpose of this work is to enhance the process understanding and to optimize the coating process with regard to the coating uniformity. Besides experimental investigations, PAT tools such as Raman spectroscopy [1] and terahertz pulsed imaging [2] have been applied to study this active coating process. In recent years, numerical simulations of coating processes have been gaining interest as analytical tool [3]. The discrete element method (DEM) in particular is suitable to simulate the tablet motion [4]. In this project, both experimental and numerical analysis of an active coating process is combined to investigate the influence of different process parameters with respect to the optimization of the coating uniformity.
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