Key acceptability attributes of orodispersible films

Abstract

The features rendering orodispersible films (ODFs) patient-centric formulations are widely discussed in the scientific literature. However there is a lack of research studies exploring ODF characteristics with a potential impact on end-user acceptability. The aim of this study was to identify the key ODF characteristics affecting end-user acceptability by developing in vitro test methods for the prediction of ODFs acceptability and correlate these formulation characteristics with the data obtained from a human panel study. Four drug-free single-polymer films were prepared by solvent casting. Solutions of poly(vinyl) alcohol (PVOH) 39 KDa (P1), PVOH 197 KDa (P2), carboxymethylcellulose (CMC) 395 KDa (C1), and CMC 725 KDa (C2) were prepared. Texture analysis and Dynamic Mechanical Analysis (DMA) were used to assess film tack. Petri dish and drop methods were used to assess disintegration time. A human panel of 24 healthy young adults was employed to identify end-user acceptability criteria of the four study film samples. Texture analysis data of ODF tack were not found to be in agreement with the in vivo perceived stickiness in the mouth. However, measurement of the area under the adhesive force curve obtained by DMA correlated with in vivo perceived stickiness data for all samples. The disintegration times obtained by drop method were more comparable to human panel data than the petri dish method. Hence DMA and drop methods proved to be promising methodologies for the prediction of the end-user acceptability. The type and molecular weight of the film-forming polymer had a strong influence on stickiness perception, whereas only polymeric molecular weight influenced perceived disintegration time. The human panel study showed that Participant Reported Outcomes (PROs) for the perceived stickiness in the mouth and disintegration time of test films received significantly different scores between samples, and thus were identified as the key attributes with the potential to affect the end-user acceptability. ODF stickiness and disintegration time should therefore be evaluated at an early stage of the drug product design.

Oromucosal films: from patient centricity to production by printing techniques

“…The impact that a medicinal product design can have on patient acceptability requires assessment, and novel methodologies are being proposed and tested [4,6]. The number of scientific publications on the assessment of patient acceptability for medicinal products and dosage forms is rapidly increasing [6,16,17].…”

“…The patient-centric design of ODFs was found to contribute to the high acceptability observed in infants and preschool children, and their carers [6]. Patient acceptability of ODFs was found to be influenced by individual formulation attributes such as ODF perceived stickiness and disintegration time [16] and by non-formulation-related parameters such as the alteration of the intended use, the subdivision of the dose intake, the use of drink or food to facilitate administration, or the use of restraint [17].…”

Towards Printed Pediatric Medicines in Hospital Pharmacies: Comparison of 2D and 3D-Printed Orodispersible Warfarin Films with Conventional Oral Powders in Unit Dose Sachets

“…Both dosage forms are shown to be suitable for infants aged 6–23 months and preschool children aged 2–6 years [12,13,14]. ODFs are thin, rapidly dissolving or disintegrating polymer films that are administered directly into the mouth where they stick to the tongue or palatal [9,15]. The administration does not require water intake, making it a good alternative for patients with fluid restrictions or patients that are unable to swallow conventional tablets [9].…”

The Popularization of Orodispersible Tablets in the Pharmaceutical Market

“…This kind of tablets dispenses the use of water being designed to disintegrate instantly in the mouth by simple contact with saliva. This convenience leads to a higher treatment adherence and to better clinical results (8)(9)(10)(11)(12). The value of this technic includes convenient administration in every day situations in which it is difficult to get water, for example when the patient is traveling or when he is in a work that can not be interrupt.…”