Vishnu, Prasad (2013) Formulation and Evaluvation of Fast Dissolving Films of Isosorbide Mononitrate. Masters thesis, Ultra College of Pharmacy, Madurai.
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Abstract
This Study Formulation and Evaluation of fast dissolving oral film of Isosorbide mononitrate of initiated with determination of max using UV spectroscopy and it was found that max & it obeys Beer’s Lamberts law.The FTIR characterization of Isosorbide mononitrate and the physical mixture of drug and polymer indicate the absence of interaction between them. Initial placebo trials of polymers were taken to optimize the concentration of polymer and composition. Fast dissolving oral thin films with selected polymer concentration, films with HPMC, PVA and combination of both PVA and HPMC were formulated by solvent casting method. Sucralose and pineapple flavour were used to improve the palatability of films. All the formulation were evaluated for the uniformity of weight, thickness of film, drug content, content uniformity, tensile strength, percentage elongation, folding endurance, surface pH, Invitro dispersion time and Invitro dissolution studies. The weight of films with HPMC, PVA and combination of both PVA and HPMC were about 40.51±0.63, 45.83±0.95 and 43.43±1.26 mg respectively. In all the films the calculated standard deviation values are very low which suggest that, the prepared films were uniform in thickness. All films exhibited folding endurance above proving the flexible nature of the film. The oral thin films of Isosorbide mononitrate prepared with HPMC, PVA and combination films prepared by solvent casting method possesses good mechanical properties. Results of texture analysis proved that films with PVA showed higher tensile strength than other two formulations. The standard deviation values of surface pH indicate that all the films all the films were uniform and as close to salivary pH. The drug content and content uniformity results suggesting that drug was uniformly dispersed throughout all films. The Invitro dispersion time of all the films were within 30 sec .The dissolution results indicate that rate and extent of films formulated with HPMC was greater than other two formulations. Hence film formulated with HPMC was selected as a final formula. Film dosage form typically the size of a postage stamp that dissolves or disintegrates quickly in the oral cavity resulting in solution or suspension without the need for the administration of water is known as an oral fast dispersing dosage form. There is an unmet need in the art for an oral dosage form which includes Isosorbide mononitrate which can be administered conveniently without requiring water for ingestion, which can disintegrate rapidly, and which has a decrease potential for a patients to expel the dosage form after administration and placement of the dosage form in the oral cavity. This dosage form is convenient for the geriatric patients and bedridden patients are unwilling to take solid do solid dosage form. Isosorbide mononitrate is not available as patient compliance orally disintegrating dosage form. Thus present attempt of developing Isosorbide mononitrate oral thin film was successful and the developed Isosorbide mononitrate oral thin film is a viable alternative for Isosorbide mononitrate immediate release tablets.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Fast Dissolving Films; Isosorbide Mononitrate |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ravindran C |
| Date Deposited: | 09 Oct 2017 05:20 |
| Last Modified: | 09 Oct 2017 05:20 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/3633 |
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