الفهرس 
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Abstract
1- In this chapter suppositories of one gram each containing 50mg. tramadol hydrochloride were prepared using different bases, namely cacao butter, witepsol H15, witepsol E76, suppocire D, emulcire, PEG (three different formulations) and glycerogelatin.
2- The suppositories were stored for six months at room temperature, in a refrigerator and in incubator at 37.5±1ºC.
3- Quality control for both fresh and stored suppositories was investigated. It was clear that several signs of ageing have occurred during storage conditions. The most stable type was witepsol H15 in refrigerator.
4- The in-vitro release of tramadol hydrochloride from fresh suppositories was studied in Sorensen’s phosphate buffer pH7.4 at 37±0.5ºC. The release of tramadol hydrochloride from different suppository bases could be arranged as follows: Witepsol H15 > PEG formula 1 > Cacao butter >PEG formula 3 > PEG formula 2 > glycerogelatin bases > suppocire D >emulcire > witepsol E76. It is obvious that the release rate was most rapid from oleaginous bases due to the hyDROPhilic nature of tramadol hydrochloride.
5- In-vitro release of stored tramadol hydrochloride suppositories was studied in Sorensen’s phosphate buffer pH 7.4 at 37±0.5ºC. The release of tramadol hydrochloride from different bases was affected greatly by the stability of the bases. It was obvious that witepsol H15 base stored at refrigerator temperature for six months gave the most proper release.
6- Analysis of data by linear regression indicated that, the release of tramadol hydrochloride from different suppository bases followed mainly diffusion model.
CHAPTER TWO
In-Vivo Evaluation of the Selected Suppository Formulations of Tramadol HCl.
In this chapter, three suppository formulations, each containing 30mg. tramadol hydrochloride were selected according to the higher release in Sorensen’s phosphate buffer pH 7.4. The selected bases were witepsol H15, cacao butter and PEG formula1.
1- The drug plasma levels were compared to those obtained after oral administration of the same dose of tramadol hydrochloride. The Cmax of tramadol HCl was 920±77ng/ml, 639±51ng/ml and 415±53ng/ml one hour after the administration of oral solution, witepsol H15 and cacao butter suppositories, respectively while incase of PEG1 it was 370±24ng/ml after half an hour of administration.
2- The calculated AUC for oral solution, witepsolH15, cacao butter, and PEG formula1 suppositories were found to be 1319±83, 901±107, and 878±135 and 746.4±61 ng.hr/ml. respectively.
3- The comparative bioavailability of tramadol hydrochloride from witepsol H15, cacao butter and PEG formula 1 were 68.3%, 66.5% and 56.5% respectively, in relation to that result of oral solution.