Thesis (M.Sc.)-Cairo University- Faculty of Pharmacy - f Department of Pharmaceutics

Bibliography: p. 147-156.

Pioglitazone Hydrochloride (PGZ) is a is BCS class II antidiabetic drug that suffers from poor aqueous solubility (0.015 mg/ ml in water) that causes a delayed onset of action with a negative impact on its dissolution rate leading to subtherapeutic plasma drug levels. It was chosen as a model drug for this study as there was no previous published work for PGZ SNEDDS formulation solidified to produce an orally disintegrating tablet (ODT). Self-nanoemulsifying drug delivery systems (SNEDDS) are isotropic mixtures of oil, surfactant, cosurfactant and drug, that spontaneously form thermodynamically stable oil-in-water (o/w) emulsion once agitated with aqueous phase upon a low energy requirement. It introduces the drug in a form of fine nanosized emulsion droplets, less than 200 nm. thus, achieving a faster release all over the GI tract. Besides ease of manufacture, maximized drug entrapment capacity and decreased cost of production, being liquid in nature may limit the applications of SNEDDS as they should be incorporated in soft/hard gelatin or HPMC capsules, which might be associated with problems such as, incompatibility with capsule shell components, formulation leakage and drug precipitation during manufacture or on storage at low temperature. Accordingly, solidification of liquid SNEDDS was the proper solution to overcome such limitations associated with SNEDDS. Production of solidified SNEDDS powder (S-SNEDDS) using different adsorbents offered several advantages, such as, high product stability, accurate dosing, better patient compliance, flexibility for further dosage production. However, another dosage form that became into research field interests was the orally disintegrating tablets (ODT) with its various synonyms such as, fast disintegrating tablets, quick dissolving tablets, orodispersible tablets, porous tablets and rapimelts. The basic approach in the development of ODT is the distinctive use of hydrophilic in nature, highly porous excipients in that can provide rapid disintegration to present the drug as a solution or suspension form once placed in the mouth. This in turn could be beneficial many patients who have difficulties to administer conventional tablets such as, geriatric, bedridden, mentally retarded nauseous or noncompliant patients, also travelling patients or those who have no access to water.