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Review
. 2022 Sep 22;14(10):2011.
doi: 10.3390/pharmaceutics14102011.

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

Irma E Cupone  1 , Andrea Sansone  2 , Fabio Marra  1 , Andrea M Giori  3 , Emmanuele A Jannini  2
Affiliations
Review

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

Irma E Cupone et al. Pharmaceutics. .

Abstract

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.

Keywords: drug; film; maltodextrin; orodispersible; sildenafil; therapy; treatment; vitamin D.

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Conflict of interest statement

A.S. declares no conflict of interest. E.A.J. is or has been paid speaker and/or consultant for Bayer, IBSA, Menarini, Otsuka, Pfizer, Viatris. I.E.C., F.M. and A.M.G. are employees of IBSA. The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Maltodextrin: chemical structure and the main characteristics (n = glucose units per chain).
Figure 2
Figure 2
Typical composition of ODFs based on maltodextrins.
Figure 3
Figure 3
Description of industrial manufacturing process of ODF. The solvent-casting method, used to manufacture orodispersible films, consists of several steps. 1: During the first step, a liquid mixture is prepared; temperature and stirring speed are the critical process parameters. 2: Afterwards, the mixture is spread and dried in a drying tunnel by controlling temperature, air circulation, humidity and coating speed. 3: The dried and spread mixture is wound to form a big roll, called a Jumbo roll. 4: The jumbo roll is unwound to undergo two consecutive cutting phases, where the size of the film strips is selected and the final dosage is defined. 5: In the last step, the films are punched, pouched and sealed in suitable single-dose sachets.
Figure 4
Figure 4
Manufacturing of orodispersible films of varying size. The jumbo roll is cut in reels of two different widths. Each reel is cut in films of two different dimensions.
See this image and copyright information in PMC

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