Acceptability of orodispersible films for delivery of medicines to infants and preschool children

Abstract

Orodispersible films (ODFs) possess potential to facilitate oral drug delivery to children; however, documentation of their acceptability in this age group is lacking. This study is the first to explore the initial perceptions, acceptability and ease of use of ODFs for infants and preschool children, and their caregivers through observed administration of the type of dosage form. Placebo ODFs were administered to children stratified into aged 6 to 12 months, 1 year, 2 years, 3 years, 4 years and 5 years old and into those with an acute illness or long-term stable condition in hospital setting. Acceptability of the dosage form and end-user views were assessed by (a) direct observation of administration, (b) questionnaires to caregivers and nurses, and (c) age-adapted questionnaires for children aged 3 years and over. The majority of children (78%) aged 3 years and over gave the ODF a positive rating both on verbal and non-verbal scales. Despite little prior experience, 78% of caregivers expressed positive opinion about ODFs before administration. After the ODFs were taken, 79% of infant caregivers and 86% caregivers of preschool children positively rated their child’s acceptance of the ODF. The intraclass correlation coefficient value was 0.92 showing good agreement between ratings of caregivers and nurses. ODFs showed a high degree of acceptability among young children and their caregivers. If drug loading permits, pharmaceutical companies should consider developing pediatric medicines in this format. The methodology described here is useful in assessing the acceptability of active ODF preparations and other dosage forms to children.

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].…”

“…Moreover, ODFs break down into soft particles upon disintegration, thus preventing the patient from experiencing potential discomfort due to the gritty nature of multiparticulates, or orodispersible tablets (ODTs). The addition of sweeteners, flavors, and the application of taste-masking technologies can considerably improve the palatability of ODFs, making medicine administration less imposing, particularly to children [2,6]. Finally, the tendency of ODFs to stick to the mucosa immediately upon placement can facilitate their application to uncooperative patients and patients who due to their illness are unable to take medication.…”

“…patient acceptability of ODFs is provided in several studies. Different ODF formulations were assessed in vivo with regards to swallowability, palatability, presence of residues in the mouth, grittiness, taste-masking, mouth freshening, size, thickness, solubility, disintegration time, and ease of administration [6,[20][21][22]. The 'gummy' nature of disintegrating ODFs as a potentially disadvantage contributing to their mouthfeel and possibly to their acceptability was reviewed by Krampe et al [2].…”

“…Characteristics such as ease of transportability and handling, thinness and flexibility, dose flexibility, and the possibility of taking them with no or just little water make oromucosal films suitable drug-delivery systems for patient populations with special needs [2,5]. In particular, patients (older) affected by dysphagia [2], infants and young children [6] and uncooperative [7] or nauseated/vomiting patients [8] may benefit from the patient-centric nature of these dosage forms. The rapid disintegration and/or the mucoadhesive properties of oromucosal films ensure that the formulation cannot be easily spat out [9].…”

Disintegration Properties and Drug Release Profiles of Sodium Alginate Films Modified with Additives

“…Therefore, the FD is an excellent tool by which drugs can be delivered to local disease sites in the oral cavity [1,2]. FDs can simplify drug administration and may be useful for patients who have difficulty swallowing conventional oral dosage forms [3][4][5].…”