الفهرس | Only 14 pages are availabe for public view |
Abstract The oral rapid dissolving film is a thin film that is simply placed on a patient’s tongue; instantly wet by saliva, the film rapidly hydrates, disintegrates and dissolves to release the medication for oramucosal absorption, or with formula modifications, will maintain the quick-dissolving aspect but allow for gastrointestinal absorption to be achieved when swallowed. Improved patient compliance is a primary benefit of the fast-dissolving drug delivery systems. Other benefits of fast-dissolving systems include ease of swallowing, no water necessary for administration, and accuracy of dosage. And so patients are able to take their medication anytime and anyplace under all circumstances. The main difference between the rapid dissolving films and most conventional fast-dissolving dosage forms is that it is not a tablet. Rather, it is a thin film that alleviates the fear of swallowing and the risk of choking commonly associated with a conventional tablet. The large surface area of the film which wets quickly when exposed to the moist oral environment leads to its fast-disintegrating and dissolving action. Many fast-dissolving tablets are soft, friable and often require specialized and expensive packaging and processing. These tablets are either very porous or inherently soft-molded matrices, or tablets compacted at very low compression forces in order to maximize tablet porosity and minimize oral dissolution/disintegration time. RDFs however, are tough, solid, soft, flexible films and do not require special packaging. Today, RDFs are a proven and accepted technology for the systemic delivery of ApIs for over-the-counter (OTC) medications and are in the early- to mid-development stages for prescription drugs. The film is well suited for the delivery of a wide range of pharmaceutically active ingredients via the buccal mucosa. Therapeutic agents which exhibit absorption problems due to solubility limitations, degradation in the gastro-intestinal tract, or extensive metabolism, are particularly well suited. Cetirizine dihydrochloride (CTZ–Cl) was chosen as model drug as it is already marketed and used as a common and safe drug for treatment of allergic reactions especially for children. But as CTZ-Cl has a bitter taste which is disadvantage in this dosage form, so formulating RDFs of CTZ-Cl poses challenge to formulator. Therefore, in this thesis, attempts have been made to develop and evaluate taste masked RDFs containing CTZ-Cl as active ingredient. |