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Development strategies for herbal products reducing the influence of natural variance in dry mass on tableting properties and tablet characteristics
* 1, 2 , 1 , 2 , 2 , 2 , 1
1  Laboratoire de Conception et d´Application de Molécules Bioactives, Phaculty of Pharmacy, University of Strasbourg, CNRS 7199, 74 route du Rhin, 67400 Illkirch, France
2  Product Development Pharma, Bioforce AG, Roggwil (TG), Switzerland

Abstract: One "Quality by Design" approach is the focus on the variability of the properties of the active substance. This is crucially important for active substances that are obtained from natural recourses such as herbal plant material and extracts. In this paper we present various strategies for the development of herbal products taking into account especially the natural batch to batch variability (mainly of the dry mass) for tablets that contain a fixed amount of tincture. The following steps of the development have been evaluated for the out come of the physico-chemical properties of the resulting tablets and intermediates: Concentration of the tincture extracted from Echinacea fresh plant, loading of the concentrate onto an inert carrier, the respective wet granulation and drying step, including milling, and the adjuvant excipients for tablet compression step. The responses that were investigated are the mean particle size of the dried and milled granulates, compaction properties and disintegration time of the tablets. Increased particle size has been shown to significant increase of the disintegration time and decrease of the compaction properties. In addition, our results exhibited that the particle size has a great dependency on the ratio of liquid to carrier during the wet granulation process. Thus, the performed strategy of the extracted tincture in correlation to its dry mass and its relation to the amount of carrier used influenced the variability on the respective parameters tested. In order to optimize those parameters, a good strategy has to be carefully chosen.
Keywords: Herbal remedies; liquid fresh plant extract; development strategies of herbal products; Echinacea purpurea; wet granulation.