Pharmaceutics 2012, 4(4), 501-516; doi:10.3390/pharmaceutics4040501
Communication

Development Strategies for Herbal Products Reducing the Influence of Natural Variance in Dry Mass on Tableting Properties and Tablet Characteristics

1 Laboratoire de Conception et d´Application de Molécules Bioactives (UMR-7199), Faculté de Pharmacie, UdS-CNRS, 67400 Illkirch-Graffenstaden, France 2 Research and Development Pharma, Bioforce AG, 9325 Roggwil (TG), Switzerland
* Author to whom correspondence should be addressed.
Received: 14 May 2012; in revised form: 7 September 2012 / Accepted: 20 September 2012 / Published: 8 October 2012
(This article belongs to the Special Issue The 2nd Electronic Conference on Pharmaceutical Sciences)
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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 resources such as herbal plant material and extracts. In this paper, we present various strategies for the development of herbal products especially taking into account the natural batch-to-batch variability (mainly of the dry mass) of tablets that contain a fixed amount of tincture. The following steps in the development have been evaluated for the outcome 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 the 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 showed a significant increase of the disintegration time and a decrease of the compaction properties. In addition, our results showed that the particle size has a great dependency on the ratio of liquid to carrier during the wet granulation process. Thus, the variability of the respective parameters tested was influenced by the performed strategies, which is how the tincture correlated to its dry mass and the relation of the amount of carrier used. In order to optimize these parameters, a strategy considering the above-mentioned points has to be chosen.
Keywords: herbal material; liquid fresh plant extract; tableting properties; Echinacea purpurea; wet granulation; solid dosage form

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MDPI and ACS Style

Qusaj, Y.; Leng, A.; Alshihabi, F.; Krasniqi, B.; Vandamme, T. Development Strategies for Herbal Products Reducing the Influence of Natural Variance in Dry Mass on Tableting Properties and Tablet Characteristics. Pharmaceutics 2012, 4, 501-516.

AMA Style

Qusaj Y, Leng A, Alshihabi F, Krasniqi B, Vandamme T. Development Strategies for Herbal Products Reducing the Influence of Natural Variance in Dry Mass on Tableting Properties and Tablet Characteristics. Pharmaceutics. 2012; 4(4):501-516.

Chicago/Turabian Style

Qusaj, Ylber; Leng, Andreas; Alshihabi, Firas; Krasniqi, Blerim; Vandamme, Thierry. 2012. "Development Strategies for Herbal Products Reducing the Influence of Natural Variance in Dry Mass on Tableting Properties and Tablet Characteristics." Pharmaceutics 4, no. 4: 501-516.

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