A Systematic Literature Review on the Assessment of Palatability and Swallowability in the Development of Oral Dosage Forms for Pediatric Patients

Squires, Liza A.; Lombardi, Donald P.; Sjostedt, Philip; Thompson, Charles A.

doi:10.1177/2168479013500288

Cited by 17 publications

(19 citation statements)

References 32 publications

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“…A significant difference was found between those characters (p<0.05). The results indicated that the most important factor was taste with the findings aligning with the published literature [ 20 , 21 , 35 ]. These results reflected the previous study, which identified disintegration time and taste as the two most important factors according to patient opinion, with flavour and size also being important [ 9 ]…”

Section: Resultssupporting

confidence: 87%

“…Overall, in phase 1 and 2, the majority of respondents (90%) recommended that taste and disintegration time were the most important properties respectively in order to develop and design ODTs formulations. Similarly, various studies stated that taste was an important factor in influencing medication adherence and acceptability in paediatric population [ 20 , 21 ].…”

Section: Resultsmentioning

confidence: 99%

“…Acceptability and adherence of medication in paediatric patients is potentially affected by characteristics (i.e. taste, flavour, size, shape and colour) of dosage forms [ 20 , 30 ]. Consequently, the next set of investigations were focused on assessing the healthcare professionals views and their preferences on different attributes of ODTs such as colour, taste, shape, flavour and disintegration time.…”

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Current opinions and recommendations of paediatric healthcare professionals – The importance of tablets: Emerging orally disintegrating versus traditional tablets

et al. 2018

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The appropriate prescribing of paediatric dosage forms is paramount in providing the desired therapeutic effect alongside successful medication adherence with the paediatric population. Often it is the opinion of the healthcare practitioner that dictates which type of dosage form would be most appropriate for the paediatric patient, with liquids being both the most commonly available and most commonly used. Orally disintegrating tablets (ODTs) are an emerging dosage form which provide many benefits over traditional dosage forms for paediatric patients, such as rapid disintegration within the oral cavity, and the reduction in the risk of choking. However the opinion and professional use of healthcare practitioners regarding ODT’s is not known. This study was designed to assess the opinions of several types of healthcare professionals (n = 41) regarding ODTs, using a survey across two hospital sites. Results reaffirmed the popularity of liquids for prescribing in paediatrics, with 58.0% of participants preferring this dosage form. ODTs emerged as the second most popular dosage form (30.0%), with healthcare practitioners indicating an increasing popularity amongst patients in the hospital setting, belief with 63.0% of practitioners agreeing that many liquid formulations could be substituted with a suitable ODT. The desired properties of an ideal ODT were also identified by healthcare practitioners preferring a small, fast disintegrating tablet (90.2% and 95.1% respectively), with the taste, disintegration time and flavour being the three most important attributes identified (29.5%, 28.7% and 21.7% respectively). This study provided a pragmatic approach in assessing healthcare professional’s opinions on ODTs, highlighting the ideas and thoughts of practitioners who are on the frontline of paediatric prescribing and treatment and gave an indication to their preference for ODT properties.

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Section: Resultssupporting

confidence: 87%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Current opinions and recommendations of paediatric healthcare professionals – The importance of tablets: Emerging orally disintegrating versus traditional tablets

et al. 2018

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“…Different study designs and outcome measures are used in current practice due to the lack of standardised methodology 18 . Visual Analogue Scales (VAS), Likert-type scales and hedonic scales have been often employed to evaluate specific sample attributes and/or overall acceptability 19 , 20 . In addition, the proportion of participants able to (safely and completely) swallow a pre-defined dose has been recently used as a simple measure of patient acceptability in various studies 4 – 6 , 9 .…”

Section: Introductionmentioning

confidence: 99%

Acceptability of placebo multiparticulate formulations in children and adults

Lopez

Mistry

Batchelor

et al. 2018

Sci Rep

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Patient acceptability is an important consideration in the design of medicines for children. The aim of this study was to investigate acceptability of multiparticulates in healthy children and adults. A randomised, single-blind acceptability testing was performed involving 71 children (4–12 years) and 61 adults (18–37 years). Each participant received three 500 mg samples of microcrystalline cellulose pellets administered on a medicine spoon with water at 5–10 minutes intervals. Acceptability was measured based on voluntary intake of the samples, facial expressions, ratings on hedonic scales and reported willingness to take multiparticulates everyday as a medicine. Multiparticulates were voluntarily swallowed by 92% of children and 100% of adults. However, palatability issues were identified, with emphasis on textural aspects. Grittiness perception received negative ratings on hedonic scales by 60% of children and 51% of adults. Researcher observations revealed that 72% of children and 42% of adults displayed negative facial expressions towards the samples. Children reported their willingness to take multiparticulates as a medicine in 30% of the cases, compared to 74% in adults. This study demonstrates that multiparticulates may be a suitable formulation platform for children and adults, although palatability concerns have been highlighted. Additional work is required to define acceptability criteria and to standardise methodologies.

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“…When children are used as subjects, the assessment tool should be simple and easy for the children/caregivers to understand. For instance, simple Likert-type scales and hedonic scales have been often employed to evaluate specific sample attributes and/or overall acceptability of medicines in paediatric populations [18,19] as they are appropriate to use from the age of four years [20]. 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].…”

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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A Systematic Literature Review on the Assessment of Palatability and Swallowability in the Development of Oral Dosage Forms for Pediatric Patients

Cited by 17 publications

References 32 publications

Current opinions and recommendations of paediatric healthcare professionals – The importance of tablets: Emerging orally disintegrating versus traditional tablets

Current opinions and recommendations of paediatric healthcare professionals – The importance of tablets: Emerging orally disintegrating versus traditional tablets

Acceptability of placebo multiparticulate formulations in children and adults

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

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