الفهرس 
OBJECTIVES OF THE THESISOnly 14 pages are availabe for public view
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Abstract
Despite of tremendous innovations in drug delivery, the oral route remains the most preferred and accepted route of drug administration by patients. Tablets, as one of solid dosage forms, have the most substantial and significant place among the entire pharmaceutical formulations . However, many patient groups such as the elderly, children, and patients who are mentally retarded, uncooperative, nauseated, or on reduced liquid/diets -intake have difficulties swallowing these dosage forms. Those also who are traveling or have little access to water are similarly affected. A need for new technology oral disintegrating systems, which offer increased convenience of administration with the potential to improve compliance in those patient populations, has evolved. Pharmaceutical formulators has responded to that need by developing a variety of dosage forms like chewable tablets, sublingual tablets, buccal patches, oral disintegrating tablets and others.
Oral disintegrating tablets are solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue. Many technologies have developed to produce ODT namely; freeze-drying (lyophilization), direct compression, molding, sublimation, spray-drying, sugar floss, phase transition, and mass extrusion technologies. The emergence of multiple ODT technology platforms created some regulatory challenges due to increasing variance in disintegration time where delayed oral disintegration would cause failure of the formulation to achieve the desired purpose. That’s why, the FDA responded with the 2008 publication of “Guidance for Industry: Orally Disintegrating Tablets” which stated an in vitro disintegration time of approximately 30 s or less (using United States Pharmacopeia disintegration test or equivalent).
Many challenges have been reported for preparing robust ODT with minimal oral disintegration time which included hygroscopicity, fragility of the tablets and need for special packaging. Moreover, the standard pharmacopoeal procedures of performing disintegration test for these dosage forms has several limitations and they neither suffice the measurement of very short disintegration times nor mimic disintegration in the mouth within saliva. That’s why; several procedures have been reported as alternatives to USP disintegration test; such as texture analyzer method, CCD camera method, rotatory shaft method and petri dish method which mimic in-vivo oral disintegration test.
The present thesis aims to utilize oral disintegrating tablets as delivery systems for some drug candidates in an attempt to improve their biopharmaceutical properties and enhance patient compliance to treatment. Not only rapid dissolving systems with enhanced bioavailability were produced, but also sustained release oral disintegrating formulae.