Advances in orodispersible films for drug delivery

Abstract

The magnitude of variants of ODF technology and the advantages over conventional dosage forms promise more applications and more marketed products with ODFs in the near future. Therefore, the authorities have to publish a monograph for ODFs as soon as possible to standardize characterization methods and quality specifications.

Orodispersible dosage forms: biopharmaceutical improvements and regulatory requirements

“…However, the experimental set-up 277 cannot be considered an accurate model of the physiological condition in the buccal cavity [65]. For 278 example, the medium volume generally used is significantly larger (up to 0.5 L) than the few millilitres of 279 saliva present in the buccal cavity.…”

“…For 278 example, the medium volume generally used is significantly larger (up to 0.5 L) than the few millilitres of 279 saliva present in the buccal cavity. Hence, several strategies were proposed to evaluate the ODx 280 disintegration in static or dynamic conditions (e.g.¸ shaking or swirling) [65], or using small volumes (from 2 281 to 25 mL) in Petri dish instead of the common vessels and sample holders as supports [66]. [61,62,[65][66][67][68][69].…”

“…Hence, several strategies were proposed to evaluate the ODx 280 disintegration in static or dynamic conditions (e.g.¸ shaking or swirling) [65], or using small volumes (from 2 281 to 25 mL) in Petri dish instead of the common vessels and sample holders as supports [66]. [61,62,[65][66][67][68][69]. In this context, it is noteworthy that pH 6.0 phosphate buffer solution is proposed as 290 dissolution medium as it is already reported for medicated chewing gums by the Ph.…”

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“…The films have much lower elasticity than those obtained by the pouring method, therefore, the extrusion methods are more often used for producing fast-dissolving buccal or oral films. [34][35][36] …”

“…In addition, modern methods of treating periodontal inflammatory diseases require the emphasis on local delivery of antimicrobial agents using controlled release systems of active pharmaceutical ingredients. [16,34,35,39] Dental films on a polymeric basis meet such requirements. While applying dental films, the polymeric base is gradually dissolved under the influence of saliva, and there is prolonged release and diffusion of the active pharmaceutical ingredient to the tissue of the mucous membrane of the oral cavity and paradontium.…”