Methodologies for assessing the acceptability of oral formulations among children and older adults: a systematic review

Ranmal, Sejal R.; O’Brien, Fiona; Lopez, Felipe L.; Ruiz, Fabrice; Orlu, Mine; Tuleu, Catherine; Walsh, Jennifer; Liu, Feng

doi:10.1016/j.drudis.2018.01.038

Cited by 48 publications

(51 citation statements)

References 90 publications

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“…age, ability, disease type and state) [9]. Ideally, evaluation of palatability and acceptability must consider all product factors holistically [6,40]. In this regard, human panels continue to be the gold standard to assess palatability [41].…”

Section: The Link Between Physical Properties Of Excipients and Palatmentioning

confidence: 99%

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Co-Processed Excipients for Dispersible Tablets—Part 2: Patient Acceptability

et al. 2018

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Palatability and patient acceptability are critical attributes of dispersible tablet formulation. Co-processed excipients could provide improved organoleptic profile due to rational choice of excipients and manufacturing techniques. The aim of this study was to identify the most suitable co-processed excipient to use within directly compressible dispersible tablet formulations. Nine excipients, selected based on successful manufacturability, were investigated in a randomised, preference and acceptability testing in 24 healthy adult volunteers. Excipients were classified in order of preference as follows (from most preferred): SmartEx QD100 > F-Melt Type C > F-Melt Type M > MicroceLac > Ludiflash > CombiLac > Pharmaburst 500 > Avicel HFE-102 > Avicel PH-102. Broad differences were identified in terms of acceptability, with SmartEx QD100 being 'very acceptable', F-Melt Type C, F-Melt Type M and MicroceLac being 'acceptable', Ludiflash, CombiLac and Pharmaburst 500 being 'neutral' and Avicel products being 'very unacceptable' based on ratings using five-point hedonic scales. Organoleptic differences were ascribed to different composition and physical properties of excipients, resulting in dissimilar taste and mouth-feel. Excipients with particle size in water larger than 200-250 μm were considered poorly acceptable, which supports the use of this value as a threshold for maximum particle size of dispersible formulation. The most promising co-processed excipients for directly compressible dispersible tablets were successfully identified.

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Section: The Link Between Physical Properties Of Excipients and Palatmentioning

confidence: 99%

“…Patient acceptability of a medicinal product is paramount in paediatric formulations [5,6]. Patient acceptability has been defined as the 'ability and willingness of a patient to use the medicine as intended', and it is influenced by a number of parameters such as palatability, swallowability, appearance and mode of administration [7].…”

Section: Introductionmentioning

confidence: 99%

Co-Processed Excipients for Dispersible Tablets—Part 2: Patient Acceptability

et al. 2018

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“…Medicine acceptability in a pediatric population can be defined as "the overall ability and willingness of the patient to use and its caregiver to administer the medicine as intended" [2]. Although there are several publications relating to the acceptability attributes of medicines in pediatric populations [2,9,12,13], with taste/overall palatability appearing to be the most extensively studied area, there is a lack of standard methodology or criteria that define what can be considered acceptable to children and their caregivers [9,[13][14][15][16][17][18]. In addition, most acceptability studies for product registration are not published, and, in the cases of those that are, there is often very little information detailing the development and validation of the acceptability tools used by the studies' authors.…”

Section: Introductionmentioning

confidence: 99%

Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures

Turner-Bowker

Haack

Krohe

et al. 2020

J Patient Rep Outcomes

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Background Evolving regulatory guidelines recommend routine assessment of the acceptability of pediatric oral medicines throughout clinical development processes. However, such assessment is problematic owing to a lack of standard methods or criteria that define acceptability for children and their caregivers. This research aimed to identify the attributes of acceptability for targeted oral formulation types that are important to children, and to develop content-valid patient- and caregiver-reported outcome acceptability measures for use in the context of clinical drug development. Methods A concept-focused literature review and two advisory panel meetings involving researchers, clinicians, and measurement scientists were conducted to identify acceptability attributes that may be relevant to children taking targeted oral medicine formulations. The Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQs), including patient (P-OMAQ-P) and caregiver (P-OMAQ-C) versions, were drafted to assess these attributes. Qualitative concept elicitation (CE) and cognitive debriefing (CD) patient and caregiver interviews were conducted to confirm key acceptability attribute concepts for measurement and to evaluate patient and caregiver ability to understand and respond to the questions. Results A full-text review of 40 articles identified 24 acceptability attributes that were categorized into 10 overarching domains and organized into a preliminary conceptual model. Feedback from the advisory panel refined the preliminary model. In total, 14 attributes were reported during the CE phase of the interviews (n = 23 pediatric patients, n = 13 caregivers); six attributes were included in the final model. The draft P-OMAQ was refined over four waves of CD interviews (n = 31 pediatric patients, n = 48 caregivers). The final version of the P-OMAQ-P is a 12-item questionnaire designed for young people aged 8–17 years. The P-OMAQ-C is a 19-item questionnaire designed for adult caregivers of young people aged 6 months to 17 years. There are two versions of each questionnaire: one with a 24-h recall period and one with a 7-day recall period. All items are answered on a 5-point numerical rating scale. Conclusions This research supports the content validity of the patient and caregiver versions of the P-OMAQ. Both questionnaires appropriately assess the acceptability of oral medicine formulations from the perspective of pediatric patients and their caregivers.

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“…Regulatory agencies in Europe and the United States [1,16] recommend confirming acceptability of a product in the target population, yet, without a clear guideline on the methodology to be used. In current practice, various methods and measures are used to assess acceptability of medicines [17]. When children are used as subjects, the assessment tool should be simple and easy for the children/caregivers to understand.…”

Section: Introductionmentioning

confidence: 99%

“…In addition, the proportion of participants able to swallow a dose has been recently used as a simple measure of patient acceptability in various placebo studies [14,[21][22][23]. A combination of tools can minimise the bias of using a single method to report acceptability [17].…”

Section: Introductionmentioning

confidence: 99%

A Novel Oral Syringe for Dosing and Administration of Multiparticulate Formulations: Acceptability Study in Preschool and School Children

et al. 2020

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The popularity of multiparticulate formulations (MPs) as a paediatric dosage form continues to increase. MPs comprise of multiple small units that are easy-to-swallow. Currently, MPs are commonly manufactured into unit doses that are either swallowed whole or opened prior to administration. While this is an acceptable approach, dosing is envisioned to be optimised with a “standard” paediatric device which can better harness the flexible dosing potential of MPs. We evaluated a novel oral syringe (SympfinyTM, HS Design, Morristown, NJ, USA) that is being developed as a tool to dispense and administer MPs to children. Forty children, 4–12 years old, received 0.5, 1.2, and 2.0 mL doses of placebo MPs using the oral syringe with spring water or a drink of choice to complete sample intake. Acceptability was recorded as those able to completely swallow the dose and participants also rated dose acceptability on a 5-point scale. The ability to completely swallow the dose decreased as dose volume increased; the smallest dose was completely swallowed by 87.5% (35/40) children, and 69.4% (27/39) of children confirmed their willingness to take the sample as a daily medicine. Larger doses, 1.2 and 2.0 mL, gave values of 55% and 57.5% for the doses completely swallowed and 58.8% and 51.72% for willingness to take the sample as a daily medicine, respectively. Use of a drink of choice showed no increase in swallowability as compared with water. The novel oral syringe being developed is an appropriate device for dispensing doses flexibly and administering neutral tasting MPs directly to the mouth in the lower dose range without the need for a co-administration vehicle in children aged 4–12 years.

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Methodologies for assessing the acceptability of oral formulations among children and older adults: a systematic review

Cited by 48 publications

References 90 publications

Co-Processed Excipients for Dispersible Tablets—Part 2: Patient Acceptability

Co-Processed Excipients for Dispersible Tablets—Part 2: Patient Acceptability

Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures

A Novel Oral Syringe for Dosing and Administration of Multiparticulate Formulations: Acceptability Study in Preschool and School Children

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