Orodispersible Film (ODF) Platform Based on Maltodextrin for Therapeutical Applications

Orodispersible film (ODF) is a new dosage form that disperses rapidly in the mouth without water or swallowing. The main ingredient of an ODF is a polymer that can be both of natural or synthetic origin. Maltodextrin is a natural polymer, mainly used in pharmaceutical and nutraceutical fields. This review aims to examine the literature regarding ODFs based on maltodextrin as the platform for developing new products for therapeutical application. ODFs based on maltodextrin contain plasticizers that enhance their flexibility and reduce their brittleness. Surfactants; fillers, such as homopolymer and copolymer of vinylacetate; flavour and sweetener were introduced to improve ODF characteristics. Both water-soluble and insoluble APIs were introduced up to 100 mg per dosage unit. The solvent casting method and hot-melt extrusion are the most useful techniques for preparing ODFs. In particular, the solvent casting method allows manufacturing processes to be developed from a lab scale to an industrial scale. ODFs based on maltodextrin are characterized in terms of mechanical properties, dissolution rate, taste and stability. ODFs made of maltodextrin, developed by IBSA, were tested in vivo to evaluate their bioequivalence and efficacy and were demonstrated to be a valid alternative to the marketed oral dosage forms.

Advantages of orodispersible films (ODF) in comparison to traditional oral dosage forms.

Dissolve rapidly in the saliva
They do not have to be swallowed
Suitable for paediatric and geriatric patients
Suitable for disabled patients, dysphagic patients, patients suffering from Parkinson disease, mucositis or nausea
Ideal for people who do not have continuous access to water
Flexible but still robust compared to orodispersible tablets
Accurate dosing compared with syrup or drops
Improved bioavailability because of a potential oromucosal absorption
Improve therapy adherence in patients

Excipients	Examples of Excipients
Natural polymer	pullulan, gelatin, maltodextrin, hydroxypropyl methyl cellulose, chitosan, sodium alginate
Synthetic polymer	carboxymethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone
Plasticizers	Glycerin, sorbitol, mannitol, propylene glycol, triacetin, citrate ether
Surfactants	Sorbitan oleate, glyceril monolinoleate
Taste-masking agents	Essential oil, natural or synthetic flavours, cyclodextrin
Other: Sweeteners, Color, Saliva stimulators	sucrose, fructose, sucralose, saccharin, cyclamate, acesulfame K, titanium dioxide, citric acid, malic acid, tartaric acid

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Article by: Cupone, I.E.; Sansone, A.; Marra, F.; Giori, A.M.; Jannini, E.A. Orodispersible Film (ODF) Platform Based on Maltodextrin for Therapeutical Applications. Pharmaceutics 2022, 14, 2011. https://doi.org/10.3390/pharmaceutics14102011