“Success Depends on Your Backbone”—About the Use of Polymers as Essential Materials Forming Orodispersible Films

Olechno, Katarzyna; Basa, Anna; Winnicka, Katarzyna

doi:10.3390/ma14174872

Cited by 25 publications

(25 citation statements)

References 59 publications

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“…It should be emphasised that the most important feature of all excipients used in film technology is their inertness on the mucous membrane, non-toxicity and non-irritation after application. The production of films is carried out by using the following methods: solvent casting, hot-melt extrusion and electrospinning [ 12 , 13 , 14 ].…”

Section: Introductionmentioning

confidence: 99%

Orodispersible Films with Rupatadine Fumarate Enclosed in Ethylcellulose Microparticles as Drug Delivery Platform with Taste-Masking Effect

et al. 2022

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Orally disintegrating (orodispersible) films provide a versatile tool for drug administration, especially in the pediatric and geriatric population, since they reduce the risk of choking and do not necessitate drinking water during application. By considering their direct contact with the taste buds, palatability is an influential aspect related to patient compliance. The microparticles based on taste-masking polymers containing drugs enclosed inside effectively mask the unpleasant taste of medicines. Ethylcellulose is a hydrophobic polymer widely used as a taste-masking material. Rupatadine fumarate, a second-generation antihistamine drug, is characterised by an intense bitter taste; therefore, it is crucial to achieve a tolerable taste whilst developing orodispersible formulations with its content. The objective of this study was to develop orally disintegrating films with rupatadine fumarate in the form of ethylcellulose-based microparticles obtained from aqueous dispersions of ethylcellulose—Surelease® or Aquacoat® ECD. It was a technological challenge to achieve homogenous drug content per dosage unit and sufficient mechanical properties for film operating due to the necessity to suspend the microparticles in the casting solution. Although the process of obtaining films consisted of several steps (mixing, pouring, drying), the particles were homogeneously dispersed, and each film of the desired size contained the proper dose of the drug. The taste-masking effect was also maintained. This parameter was confirmed by three independent methods: in vivo by healthy volunteers, an electronic tongue and a dissolution test. The applied taste-evaluation techniques showed that the films containing Aquacoat® ECD microparticles have the highest degree of bitter taste reduction, which confirms the results obtained in our previous studies.

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Section: Introductionmentioning

confidence: 99%

Orodispersible Films with Rupatadine Fumarate Enclosed in Ethylcellulose Microparticles as Drug Delivery Platform with Taste-Masking Effect

et al. 2022

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“…Impact of film components on recovery of live AAV during the film-forming process. The formulation previously optimized for use with a recombinant adenovirus 24 was highly viscous (4000 cp) 29 . While this is acceptable for administration by the oral and nasal route, it is physiologically incompatible with intravenous administration, the manner by which many AAV-based and other vectors are currently administered [30][31][32] .…”

Section: Resultsmentioning

confidence: 99%

Thermostability and in vivo performance of AAV9 in a film matrix

Doan

Bajrovic

et al. 2022

Commun Med

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Background Adeno-associated virus (AAV) vectors are stored and shipped frozen which poses logistic and economic barriers for global access to these therapeutics. To address this issue, we developed a method to stabilize AAV serotype 9 (AAV9) in a film matrix that can be stored at ambient temperature and administered by systemic injection. Methods AAV9 expressing the luciferase transgene was mixed with formulations, poured into molds and films dried under aseptic conditions. Films were packaged in individual particle-free bags with foil overlays and stored at various temperatures under controlled humidity. Recovery of AAV9 from films was determined by serial dilution of rehydrated film in media and infection of HeLa RC32 cells. Luciferase expression was compared to that of films rehydrated immediately after drying. Biodistribution of vector was determined by in vivo imaging and quantitative real-time PCR. Residual moisture in films was determined by Karl Fischer titration. Results AAV9 embedded within a film matrix and stored at 4 °C for 5 months retained 100% of initial titer. High and low viscosity formulations maintained 90 and 85% of initial titer after 6 months at 25 °C respectively. AAV was not detected after 4 months in a Standard Control Formulation under the same conditions. Biodistribution and transgene expression of AAV stored in film at 25 or 4 °C were as robust as vector stored at −80 °C in a Standard Control Formulation. Conclusions These results suggest that storage of AAV in a film matrix facilitates easy transport of vector to remote sites without compromising in vivo performance.

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“…MDXs are freely soluble in water and slightly soluble to almost insoluble in alcohol [ 21 ]. MDX characteristics and classification are based on the parameter known as dextrose equivalence (DE).…”

Section: Orodispersible Films Based On Maltodextrinmentioning

confidence: 99%

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

et al. 2022

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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.

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“Success Depends on Your Backbone”—About the Use of Polymers as Essential Materials Forming Orodispersible Films

Cited by 25 publications

References 59 publications

Orodispersible Films with Rupatadine Fumarate Enclosed in Ethylcellulose Microparticles as Drug Delivery Platform with Taste-Masking Effect

Orodispersible Films with Rupatadine Fumarate Enclosed in Ethylcellulose Microparticles as Drug Delivery Platform with Taste-Masking Effect

Thermostability and in vivo performance of AAV9 in a film matrix

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

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