Schizophrenia is a medical condition that describes a major psychiatric disorder that alters an individual's perception, thought, affect, and behaviour. Statistics from WHO show 1 out of 300 people is affected by Schizophrenia worldwide. The trend is increasing especially in urban areas and more young people tend to get schizophrenia. Quetiapine, an anti-psychotics which is widely prescribed to patients to improve their mental condition. Conventionally, quetiapine is produced in tablet form and in oral suspension form. This has brought a big challenge to the medical personnel like nurses as well as the patient's family members as most schizophrenic patients are uncooperative and suffer from dysphagia. Bitter taste and big size of the tablet have also contributed to low compliance issues. This results in rehospitalisation, a higher risk of suicide, and poor mental performance. Our invention is an oral disintegration film containing quetiapine fumarate. The film has a size similar to a postage stamp and disintegrates when in contact with saliva within a very short period of time. The product is packed in a container adopting the concept of a correction tape that allows easy dispensing of unit dose to the patient. The film is produced by solvent casting method using quetiapine fumarate as an active ingredient, starch as the film polymer, glycerine as a plasticizer, and stevia as a sweetener. The formulation process is as follows: Starch is measured and added with water. The mixture is then heated until a viscous solution is formed. Quetiapine, glycerin, stevia, citric acid and colouring agents are added into the solution and mixed homogenously. The solution is poured into the casting mold and dried in oven. The dried film is cut into desired size. The characterisation of an oral disintegrating film is that it allows fast dissolving of drug. According to laboratory tests conducted, it dissolves in water within 40 seconds. The sweet taste of the film would increase patient compliance. It also helps to solve issues in uncooperative patients as it is convenient for administration. The film can be folded more than 200 times and it shows a good flexibility. Each film is averagely 0.92mm thick and has good uniformity. It also has a good mechanical strength which can handle weight around 0.005kPa. This product is a novel product as there is no such product on the market yet. The way to produce this film is pretty simple and it is cost effective. With this formulation and pack into roller design, it is easy to handle, suitable for all ages and all kinds of patients. The packaging is a brand new game to bring up in the pharmaceutical field. This research is conducted in collaboration with Duopharma Biotech Berhad and Dong Foong Manufacturing Sdn. Bhd. together with University of Cyberjaya upholding the equal aim to extend research into the novel approach of a patient-convenient drug delivery system. Our research team has been working on orally disintegrating film for more than 3 years and have published multiple papers in international journals.
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