Sprinkle formulations—A review of commercially available products

Lee, Han Sol; Lee, Su Hwan; Kim, Myeong Gyu; Kim, Ki Taek; Cho, Cheong-Weon; Kim, Dae Duk; Lee, Jae Young

doi:10.1016/j.ajps.2019.05.003

Cited by 27 publications

(25 citation statements)

References 17 publications

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“…Multiparticulate (MP) dosage forms, such as sprinkles, pellets and granules, comprise multiple units (typically below 2.5 mm [3]). These were introduced in the 1940 s and now more than 65 products are available in the US for paediatric populations [4]. MPs can be coated to provide the desired release profile or to achieve taste masking [5], which is known to improve patient compliance.…”

Section: Introductionmentioning

confidence: 99%

“…The capsule/sachet may be opened to allow the MPs to be dosed to the patient directly onto the tongue [11], or given on a spoon [12]. MPs are often mixed with soft food, with applesauce being the most widespread vehicle used, to aid administration [4]. However, this requires additional testing to confirm chemical compatibility with the product and the suitability of vehicle in the target population [13] as well as the global availability of the vehicle being used.…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Introductionmentioning

confidence: 99%

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 beads may be coated to mask the unpleasant taste of the active substance (8). The coating of multiparticulate formulations also provides the opportunity to modify the release kinetics of the active substance.…”

Section: Introductionmentioning

confidence: 99%

Comparison of Different Liquid and Semisolid Vehicles Selected for Oral Administration of Pellets and Minitablets with Diazepam: In Vitro Investigation

2020

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The acceptability and palatability of a dosage form are extremely important to improve patient compliance. Mixing oral solid dosage forms with food carriers is often necessary to ease swallowing and provide the taste-masking effect. The present research investigated how a liquid or semisolid carrier influences the disintegration time and drug dissolution rate of pellets and minitablets with diazepam. The disintegration of pellets and minitablets in liquid carriers (water, milk and apple juice) was determined using a texture analyser. Dissolution tests were performed for the dosage forms dispersed in gel vehicles (2% carmellose and 0.5% carbomer gels) or applesauce. The disintegration of minitablets in water and apple juice was fast (1 min), but it slowed to 3 and 5 min in milk and gel vehicles, respectively. The pellets disintegrated in liquid carriers within 3 min. The drug dissolution rate in 0.1 M HCl depended on the gel viscosity in this medium. The preserved high viscosity of a carmellose gel inhibited the dissolution of diazepam. On the other hand, the viscosity of the carbomer gel decreased rapidly, and in effect, the dissolution rate of diazepam from the incorporated pellets or minitablets was comparable to the dissolution from loose pellets or minitablets.

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“…Multiparticulate (MP) dosage forms, such as sprinkles, pellets and granules, comprise multiple of units (typically below 2.5 mm [3]). These were introduced in the 1940s and now more than 65 products are available in the US for paediatric populations [4]. MPs can be coated to provide the desired release profile or to achieve taste masking [5], which is known to improve patient compliance.…”

Section: Introductionmentioning

confidence: 99%

“…The capsule/sachet may be opened to allow the MPs to be dosed to the patient directly onto the tongue [11], or given on a spoon [12]. MPs are often mixed with soft food, with applesauce being the most widespread vehicle used, to aid administration [4]. However, this requires additional testing to confirm chemical compatibility with the product and the suitability of vehicle in the target population [13] as well as global availability of the vehicle being used.…”

Section: Introductionmentioning

confidence: 99%

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

Hofmanová¹,

Bennett²,

Coupe³

et al. 2020

Preprint

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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 optimized with a ‘standard’ paediatric device which can better harness the flexible dosing potential of MPs. We evaluated a novel oral syringe (SympfinyTM) 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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Sprinkle formulations—A review of commercially available products

Cited by 27 publications

References 17 publications

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

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

Comparison of Different Liquid and Semisolid Vehicles Selected for Oral Administration of Pellets and Minitablets with Diazepam: In Vitro Investigation

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

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