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Abstract This study aimed to find out the possible interactions between dietary Oats marketed<in Egypt and the United Kingdom. <The increasing attention towards healthy life style caused many patients to shift towards healthy breakfast composed mainly of dietary Oats. <Many studies highlighted the nutritional benefits of Oats due to their various phytoconstituents<e.g. β-glucan, carbohydrates, proteins and fats. Patients treated with oral chronic drugs e.g. oral antidiabetics, antiepileptics, antithyroid may be advised to take the Oatmeal as healthy diet. <This concomitant administration of Oatmeal with oral chronic drugs raised an important question towards the possible interactions at may occur between Oat and the co administered drugs. <The study aimed to point out the possible interaction that may occur. <Chapter one: <This chapter aimed to characterize different Oat samples purchased from the Egyptian markets and from those of the United Kingdom. < Literature survey showed studies performed on Oats to aid the food science fields. <Most of the described methods in literature lacked the correlation to the pharmaceutical field. < In addition, all methods are multistep complicated extractive methods for each phytochemical component. haracterizations were performed with different analytical techniques and rheological properties were studied as well. <The analytical techniques used were Middle Infra-red, near infra-red, Thin layer chromatography, High performance liquid chromatography and Ultra violet spectroscopy. Techniques were modified to aid the target of the thesis. The middle and near Infra - red techniques succeeded to characterize the samples of dietary Oats examined. <The finger prints for some phyto-constituents were similar to those obtained in the same technique described in literature. <Other analytical techniques confirmed that all samples of dietary Oats studied were qualitatively the same. < The high performance chromatographic methods were adopted from literature for the separation of drugs suspected to interact with dietary Oats. <HPLC methods succeeded to separate between peaks of Oat and the examined drugs for clear determination of the extent and percentage of interactions. <Rheological studies were performed in two adsorption media: water and acidic medium. Literature showed that the pharmacological effect of Oat in decreasing the level of cholesterol and hyperglycemia was directly correlated to the viscosity of β-glucan which is the main active constituent contributing to the beneficial pharmacological effect of Oat. The rheological behavior was set as a factor contributing in the interaction with the coadministered drugs. The experiment was designed to find out the rheological behaviour of the marketed Oat samples under study based on what was retrieved from literature. The study was performed in neutral pH (water) and acidic pH (0.1 N HCl). Samples of dietary Oats were all examined under the same conditions at 37°C. The experiment was performed with increasing speed up to 200 round per minute then the viscosity values were recorded at decreasing speed. Samples of dietary Oats (A-D) were cooked in the same way according to the labelled instructions stated on the pack to mimic the real behavior as the patients administer Oats. <Results revealed the all samples examined in 0.1 N HCl exhibited low viscosity values with and without changing the viscosity values on increasing and decreasing speed of rotation. <Rheological properties of samples examined in water were variable revealed that cooked samples of dietary Oat (A-D) exhibited high viscosity values due to the gelatinization of starch by the effect of heat in cooking the increased the resistance to flow. <Chapter two: <This chapter aimed to find out the possible interaction between samples of dietary Oat and selected drugs. Drugs selected on the basis of being chronically used and low or high dose potent drugs. < Two samples of Oat were selected for all adsorption studies (A) and (C). Sample (A) was in the form of raw Oat and sample (C) was in the form of biscuits. < The in- vitro adsorption studies were performed in water and 0.1 N HCL. Different categories of drugs were examined in both conditions, anti-thyroid, anti- diabetic, anti -epileptic, bronchodilators and drugs for the treatment of congestive heart failure. <The in-vitro interaction was studied by allowing the drug to digest in the selected medium either alone or in the presence of Oats. < The temperature and the time of the reaction were adjusted to mimic the physiological state as consumed by patients. <HPLC methods reported in literature were used for analysis of drugs in both media to detect the extent of adsorption. Many factors have been set to study the effect of these factors on the adsorptive effect of Oat on drugs. Factors studied were: increasing the volume of the medium to detect the effect of volume on adsorption of the selected drugs and the particle size of the adsorbent which is Oat. <Largest and smallest ranges were studied for their effect on adsorption. <Percentage of adsorption was calculated from the peak areas detected by the analytical methods.an attempt was performed to study the effect of β-glucan on adsorption of drugs. Marketed β-glucan capsules were purchased for the study. Results revealed the complete adsorption of some drugs as a result of interaction with Oats. <The change of the peak intensities of drugs denoted the extent of adsorption on dietary Oats. Different factors examined on one selected drug (Glimepiride) showed no difference in the exrtent of adsorption. Studies performed on β-glucan denoted its contribution in adsorption for some drugs e.g. Glibenclamide. <Chapter three: This chapter aimed to find out the percentage of availability of drugs under conditions specialized in USP dissolution tests specialized in drug tablets monograph. <Drugs were evaluated in absence and in presence of dietary Oats under the same conditions. <Two drug products were selected, Glimepiride hydrochloride and Drosperinone as both drugs showed the complete adsorption in results of chapter two. <The USP dissolution tester was used to study the percentage of drug available at different time intervals. Samples were withdrawn at different time intervals. The test was terminated according to the time stated in each monograph. < The analysis of drugs was performed using the analytical method adopted for their determination in the in-vitro studies Calculations of the percentage of the available drug were performed as described in the monograph of each drug product. The calculated percentages were used to construct the dissolution rate profile. <The profiles were used to compare the amount of available drug in the dissolution medium under both conditions (in absence and in presence of dietary Oat). <Results showed the significant decrease in the percentage of Drosperinone and Glimepiride available in presence of Oat in the dissolution vessel. < The drug was found to complex with Oat within the first 15 minutes after running the dissolution tester : < Chapter four: <This study was performed to detect the possible interaction of dietary Oats with selected oral antidiabetic drug products. < In-Vitro adsorption studies in chapter two, revealed possible adsorption of sulphonyl urea (glimepiride) tablets in contrast to metformin Hydrochloride) tablets. <They did not show adsorption. In-Vivo study on rats was performed to confirm such interaction. <The study was designed to be performed on diabetic rat models. Hyperglycemia was induced with streptozotocin hydrochloride. <Blood glucose level was determined as a marker for the effectiveness of oral hypoglycemic drug when administered alone or with dietary Oats. < Rats were allowed to administer the drugs after the intake of dietary Oats as their meals. < Rats were grouped in 7 groups to perform the comparison between groups, normo-glycemic, diabetic, glimepiride, metformin treated and groups treated with both Oat and drugs. <Results showed no effect of dietary Oat on the effectiveness of Metformin owing to its large dose used (500 mg) and water solubility. < However, the effectiveness of glimepiride was decreased for rats treated with glimepiride tablets after being fed with Oats. <This group was compared to the group treated with the drug alone where glimepiride showed significant decrease of the blood glucose level compared to the group treated with Oat and glimepiride. |