Converting a batch based high-shear granulation process to a continuous dry granulation process; a demonstration with ketoprofen tablets
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CitationTaipale-Kovalainen, Krista. Ketolainen, Jarkko. Korhonen, Ossi. Ervasti, Tuomas. (2020). Converting a batch based high-shear granulation process to a continuous dry granulation process; a demonstration with ketoprofen tablets. European journal of pharmaceutical sciences, 151, 105381. 10.1016/j.ejps.2020.105381.
When one wishes to convert a batch based manufacturing process of an existing tablet product to a continuous process, there are several available strategies which can be adopted. Theoretically, the most straightforward way would be to proceed with the corresponding processing principles, for example to change a wet granulation (WG) batch process into its continuous WG counterpart. However, in some cases, the choice of roller compaction (RC) could be very attractive due to the notably simpler and inherently continuous nature of the RC manufacturing principle. The aim of this study was to examine a process conversion from batch based high-shear wet granulation (HSWG) to continuous RC manufacturing, without any significant formulation changes. An optimization of the formulation is often needed during the process conversion. However, our primary goal was to demonstrate the possibilities to perform this kind of process adaptation with minimal formulation changes. Furthermore, the effect of three different locations of lubrication feeding with two production rate levels was studied. An additional target was to identify possible over-lubrication with these manufacturing configurations, and to clarify which of these three possibilities steps produced a final product that conformed to the same quality requirements as HSWG tablets. Previously, the effects of lubrication only on compacted ribbons (Miguelez-Moran A.M, 2008) and final product with CDC (continuous direct compression) (Taipale-Kovalainen, et al., 2017; 2019) have been investigated. Here, the effect of lubrication on both ribbon and on final product was examined. No signs of over-lubrication were observed, but there was a clear effect of the feeding location of lubricant on the final product. On the basis of these results, it is concluded that in the future, if a good product/process understanding of the alternative manufacturing process with different techniques can be obtained, it will be possible to devise more flexible and effective ways to allow the pharmaceutical industry to switch from batch manufacturing towards CM.
Subjectsbatch process continuous manufacturing High-Shear wet granulation ketoprofen tablets process conversion roller compaction
Link to the original itemhttp://dx.doi.org/10.1016/j.ejps.2020.105381
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