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Abstract

Extracts of hawthorn (Crateagus sp.) have been indicated in the treatment of cardiovascular diseases, however, tablets produced from dry extract due to a multiple of factors such as inconsistent botanical ingredients, moisture content and hygroscopicity turn to be hard with prolong disintegration. Dissolution test is increasingly being employed for the assessment of solid herbal medicinal dosage form due to its ability to predict the bioavailability of active therapeutic agent from herbal products. The aim of this study was to formulate coated tablets containing dry extracts of hawthorn leafs and flowers and to develop and validate a reverse phase high performance liquid chromatography (RP-HPLC) method for assessing in vitro dissolution profile of hawthorn tablet. Comparative extraction procedure studies showed that percolating the plant material with ethanol and extracting with ethyl acetate produce extract with the highest amount of total flavonoids calculated either as rutin or hyperoside and the highest hyperoside content. Assessment of two disintegrating agents; Sodium starch glycolate (SSG) and cross-linked polyvinyl pyrrolidone (PVPP) showed that PVPP was a better agent for this formulation. Disintegration time also improved when distilled water was used as granulation fluid compared to alcoholic solutions. The disintegration time of coated tablets (CT), CT 1 and CT 2 were 8.83±0.41min and 9.33±0.52min respectively. The RP-HPLC method was validated as per ICH guidelines. The validation studies demonstrated that the proposed method is simple, selective, accurate and reliable and can be used for routine dissolution analyses of hawthorn tablets. The dissolution profile of the formulated tablets showed Q-values of 89.952% and 86.3765% for CT 1 and CT 2 respectively. INTRODUCTION: Tablets of Hawthorn (Crataegus pinnatifida Bge (Rosaceae)), extract is indicated in chest constrictions, stabbing pericardial pain, angina pectoris and palpitation 1. The use of hawthorn in cardiovascular diseases has been shown to be common in most cultures 2. It has also been shown to have anti diabetic, antioxidant, anti-inflammatory and a mild to moderate sedative effect 3-7. These biological activities have been attributed to the phenolic component such as quercetin, isoquercitrin, chlorogenic acid, vitexin-4 //-Oglucoside, vitexin-2 //-O-rhamnoside, vitexin, rutin and hyperoside 8-10 .