الفهرس 
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Abstract
Ketotifen fumarate is a non-specific mast cell stabilizer and a relatively selective non-competitive H1-preceptor antagonist. Ketotifen inhibits the release of mediators from cells involved in hypersensitivity reactions that has been used as a long-term anti-asthmatic prophylactic agent, for children and adults by stabilizing the membrane of the mast cells, it is commercially available as tablets and eye DROPs.
Ketotifen fumarate ophthalmic solution is an antihistaminic drug that is used to treat itching of the eye caused by allergy. However, its commercial preparation (Zaditen® eye DROPs; Novartis Pharma-Egypt) has an acidic pH of 4.4 to 5.5 that affects patient compliance by causing irritation to the eye. The main object of this study was to develop an aqueous ketotifen eye DROP at the physiological pH, consequently decreasing the irritation to the eye.
The oral bioavailability of ketotifen fumarate is only 50% due to extensive first-pass metabolism. The sublingual route of administration produces faster onset of action than orally ingested tablets and the portion absorbed through the sublingual blood vessels by passes the hepatic first pass processes. The aim of this thesis is to formulate ketotifen fumarate in two different preparations, i.e. eye DROPs and fast disintegrating sublingual tablets. Thus, the work is divided into two main parts.
Part I: Formulation and Evaluation of Ketotifen Fumarate Eye DROPs
Part II: Formulation, Evaluation, Stability and Pharmacokinetic Studies of Ketotifen Fumerate Fast Disintegrating Sublingual Tablets