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

Abstract

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 5 th Edition. The analytical method used was validated to confirm the assays. The gastroresistant 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, gastroresistant coated tablets. INTRODUCTIONHarpagophytum procumbens DC. belongs to the family Pedaliaceae. This perennial herbaceous plant, popularly known as "devil's claw", grows naturally in the Kalahari desert and in the steppe region of Namibia in southwestern Africa. Its secondary tubular roots, commonly associated with the term "devil's claw" by its shape, have been widely used in traditional medicine with several therapeutic indications, especially as antiinflammatory and analgesic (Baghdikian et al., 1997 exclusive use of vegetal active raw materials whose safety and effectiveness are based on data of safe and effective use published in the technical-scientific literature, and which are designed to be used without supervision by a physician for diagnostic, prescription or monitoring purposes". Thus, in Brazil, the dry extract produced from the roots of the H. procumbens DC. plant species, standardized on harpagoside, is classified as a traditional herbal product, and indicated for the relief of moderate joint pain and acute low back pain, according to the ethnopharmacological use described in the literature. In addition, advances in the scientific area have allowed the development of proven medicines and herbal products of safety and efficacy, as well as an increase in the population's search for less aggressive therapies for primary health care (Ribeiro et al., 2005). Given the importance of herbal medicines worldwide, the study of plant species such as H. procumbens DC. has been considered to be of extreme relevance for the development of new therapeutic alternatives with efficacy and low adverse effects compared to synthetic drugs. H. procumbens DC. extract has been constantly investigated as a potential therapeutic agent because of its analgesic and anti-inflammatory activities, and favorable adverse effects profile compared to available synthetic alternatives such as non-steroidal antiinflammatory drugs (Ahmed et al., 2005)....

From Bush Medicine to Modern Phytopharmaceutical: A Bibliographic Review of Devil’s Claw (Harpagophytum spp.)

“…Almajdoub described a freeze-dried aqueous extract of H. procumbens encapsulated in lipid vesicles by using a dry film hydration technique with and without further alginate coating for optimal (delayed) release and small intestine absorption [278]. Development of a gastro-resistant coated tablet prepared from a standardized hydroethanolic root extract for the purpose of more effective delivery and consequent dose reduction was reported by Lopes et al [279].…”