Production of gastro-resistant coated tablets prepared from the hydroethanolic standardized roots extract of Harpagophytum procumbens DC.

This project aimed at developing a gastro-resistant coated tablet using traditional herbal medicine dry extract from the secondary roots of the plant species Harpagophytum procumbens DC. (Pedaliaceae), standardized in harpagoside 20%, popularly known as "devil's claw". The tablets were produced by direct compression and coated with the gastro-resistant dispersion. Accelerated and long-term stability studies were performed to define the period of use and validity. The tablets present a high dose of chemical markers differently from the usual pharmaceutical forms, diminishing the daily doses to 1 or 2 tablets. The hardness, friability, weigh and thickness were in agreement with the Brazilian Pharmacopeia 5th Edition. The analytical method used was validated to confirm the assays. The gastro-resistant coated tablets, obtained from the dried extract of H. procumbens DC., standardized in harpagoside 20%, was stable after the accelerated study and the analytical methodology was validated. Key words: Pedaliaceae, Harpagophytum procumbens DC., devil's claw, traditional herbal medicine, gastro-resistant coated tablets.