Many pharmaceutical companies are switching their products from tablets to fast dissolving oral thin films (OTFs). Films have all the advantages of tablets (precise dosage, easy administration) and those of liquid dosage forms (easy swallowing, rapid bioavailability). Statistics have shown that four out of five patients prefer orally disintegrating dosage forms over conventional solid oral dosages forms. Pediatric, geriatric, bedridden, emetic patients and those with Central Nervous System disorders, have difficulty in swallowing or chewing solid dosage forms. Many of these patients are non-compliant in administering solid dosage forms due to fear of choking. OTFs when placed on the tip or the floor of the tongue are instantly wet by saliva. As a result, OTFs rapidly hydrate and then disintegrate and/or dissolve to release the medication for local and/or systemic absorption. This technology provides a good platform for patent non- infringing product development and for increasing the patent life-cycle of the existing products. The application of fast dissolving oral thin films is not only limited to buccal fast dissolving system, but also expands to other applications like gastroretentive, sublingual delivery systems. This review highlights the composition including the details of various types of polymers both natural and synthetic, the different types of manufacturing techniques, packaging materials and evaluation tests for the OTFs.
The present investigation was undertaken with the objective of formulating taste-masked orally-disintegrating films of the bitter levocetirizine dihydrochloride to enhance the convenience and compliance by the elderly or paediatric or bedridden and non-cooperative patients due to its ease of administration. Scope of this study was to explore the film forming properties of various film formers like modified starch, pullulan, hydroxypropyl methylcellulose and polyvinyl alcohol-polyethylene glycol based polymers. Plasticizers like glycerin, propylene glycol, sorbitol and polyethylene glycol 400 were evaluated by studying their effect on folding endurance, peelablity and in vitro disintegration time. Films were prepared by solvent casting method. Drug-loaded films, which composed of the selected polymers with the suitable plasticizer showed excellent film forming capacity along with good folding endurance, in vitro disintegration time within 22 s and >95% drug release in 10 min as compared to marketed immediate release tablets, which showed on 30.4% at the end of 10 min The films prepared were 30-40 mg in weight with pleasant taste with bitter active being successfully taste masked by a mixture of sucralose and monoammonium glycerrhizinate producing an extended sweetness profile. Furthermore, the orally disintegrating films were stable for at least 3 mon when stored at 40° and 75% relative humidity. The formulation developed is simple, easy to prepare and economical with great applicability during the emergency cases such as allergic reactions, whenever immediate onset of action is desired.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.