Palanisamy, Arnesh, Martinez Heredia, Lizbeth, Adler, Camille and Gururajan, Bindhu (2023) COMPARATIVE ANALYSIS OF POROSITY MEASUREMENT TECHNIQUES USING PHARMACEUTICAL MATERIALS. 10th International Granulation Workshop.

Abstract

Roller compaction or dry granulation is one of the techniques used to improve the flow properties of pharmaceutical materials where direct compaction of tablets is not possible. It is often preferred over wet granulation due to faster processing times, handling moisture sensitive compounds and lower energy consumption. Ribbons are produced during roller compaction and ribbon porosity is considered a critical intermediate attribute. Ribbon porosity measurements are often used to scale-up, transfer processes and validate roller compactor modelling and simulations. Various ribbon porosity measurement techniques exist, each with it is own advantages and challenges. The most used techniques in the pharmaceutical industry for ribbon porosity measurements are envelope volume using the Geopyc technique, mercury porosimeter and X-ray Microtomography. However, there are ongoing research activities to find innovative techniques which are simple, faster, non-destructive, precise and accurate. In this study, the Laser triangulation technique is used for the evaluation of the ribbon porosity and results are compared with the commonly used technique for comparison of the results and its suitability as an at-site measurement technique. In the initial experiments, riblets were manufactured using a Stylone compaction simulator using Microcrystalline Cellulose (MCC) as the model excipient. In this investigation, ribbons were produced using commercially available roller compactors namely Gerteis Minipactor and Bepex Pharmapactor. Ribbons were manufactured using a roller compactor using MCC for further evaluation of the techniques. Experimental compound A was used in the active formulation and further studies were carried out in pilot and launch scales to generate ribbons for further comparison of the technique and assess the suitability of each measuring technique to quantify the porosity data. This paper discusses in detail the importance of the roller compaction process and ribbon porosity as critical intermediate material attributes, different porosity measurement techniques, results obtained and comparative analysis of the data generated.

Item Type:	Article
Keywords:	Roller compaction; Porosity; Laser triangulation; GeoPyc; Pharmaceutical development; Material Science.
Date Deposited:	25 Oct 2023 12:15
Last Modified:	25 Oct 2023 12:15
URI:	https://oak.novartis.com/id/eprint/49629