تاريخ مجلس الدراسات العليا

2019-09-25

اسم الطالب

كيلاني إسماعيل عبد عودة

ملخص الرسالة

Orally dissolving films (ODFs) have received much attention as potential drug delivery systems for oral administration of drugs for pediatric patients. With their unique properties and advantages, the technology offers improved patient compliance and wider acceptability, eliminated fear of choking, ease of administration and dosing convenience, without the requirement of water. The aim of this research project was the development of ODF formulations with suitable physicochemical and mechanical properties as a potential dosage form for pediatric use using two model drugs (ibuprofen and topiramate). ODFs were prepared using HPMC (hydroxy propyl methyl cellulose), guar gum, in combination with plasticizers such as glycerin and sorbitol as well as other excipients. Films were prepared via solvent casting method and then produced ODFs were evaluated for mechanical properties, disintegration time, dissolution time and dosage form uniformity. Initial studies focused on screening of different film-forming polymers used for the preparation of orally dissolving films in order to optimize and propose suitable polymers and plasticizers with a suitable manufacturing technique. The work also sought to improve the loading capacity and drug content uniformity of both hydrophilic (topiramate) and hydrophobic (ibuprofen) drugs into ODFs. Loading capacity varies between the two drugs, where maximum loading capacity of ibuprofen-HPMC ODFs was 54.4% with 20.7 mg ibuprofen per film, whereas topiramate load reached 58.95% with 25 mg topiramate per film (6 cm2). Both formulations demonstrated good disintegration time of below 60 seconds and dosage from uniformity which was assessed using weight variation and content uniformity. In conclusion, the ultimate goal of any drug delivery system is successful delivery of the drug to the body; however, patient compliance should not be overlooked. ODFs provide convenient drug delivery systems not only for special populations with swallowing difficulties, such as children and the elderly, but also for all patients. Therefore, the outcome of this research project could be a starting point for further work to optimize and assess ODFs for delivering other drugs via this formulation.