Acceptance of uncoated mini-tablets in young children: results from a prospective exploratory cross-over study

Spomer, Natalie; Klingmann, Viviane; Stoltenberg, Ines; Lerch, Christian; Meißner, Thomas; Breitkreutz, Jörg

doi:10.1136/archdischild-2011-300958

Cited by 144 publications

(84 citation statements)

References 4 publications

(3 reference statements)

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“…Studies that investigated the use of mini-tablets (tablets ≤3 mm) found that mini-tablets were a potential dosage form suitable for 2-6 year olds (based on placebo tablets 3 mm in diameter) [71]. Additionally Spomer and co-workers found that very young children (6-12 months) were fully capable of swallowing mini-tablets of 2 mm diameter, often accepting them in preference to sweet liquid formulations [72].…”

Section: Oral Solid Dosage Forms -Conventional Tablets and Capsulesmentioning

confidence: 99%

Formulations for children: problems and solutions

Batchelor

Marriott

2015

Brit J Clinical Pharma

145

107

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Paediatric formulation design is complex as there is a need to understand the developmental physiological changes that occur during childhood and their impact on the absorption of drugs. Paediatric dose adjustments are usually based on achieving pharmacokinetic or pharmacodynamic profiles equivalent to those achieved in adult populations. However, differences in the way in which children handle adult products or the use of bespoke paediatric formulations can result in unexpected pharmacokinetic drug profiles with altered clinical efficacy. Differences in drug formulations need to be understood by healthcare professionals involved in the prescribing, administration or dispensing of drugs to children such that appropriate advice is given to ensure that therapeutic outcomes are achieved. This issue is not confined to oral medicines but is applicable for all routes of administration encountered in paediatric therapy.

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Section: Oral Solid Dosage Forms -Conventional Tablets and Capsulesmentioning

confidence: 99%

Formulations for children: problems and solutions

Batchelor

Marriott

2015

Brit J Clinical Pharma

145

107

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“…The age limit was further decreased in an exploratory study which demonstrated that children aged 6 to 12 months were capable of swallowing uncoated, drug-free, 2-mm mini-tablets and accepted them better than sweet liquid formulations. 120,121 For infants aged ,2 years, a new promising development is the orally disintegrating mini-tablet, which combines mini-tablets and fast-dissolving dosage forms. 111 A complementary research area is the development of pediatric dosing devices, which facilitate the accurate and consistent administration of oral pediatric formulations.…”

Section: Novel Oral Pediatric Formulationsmentioning

confidence: 99%

Pediatric Drug Formulations: A Review of Challenges and Progress

et al. 2014

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Children differ from adults in many aspects of pharmacotherapy, including capabilities for drug administration, medicine-related toxicity, and taste preferences. It is essential that pediatric medicines are formulated to best suit a child' s age, size, physiologic condition, and treatment requirements. To ensure adequate treatment of all children, different routes of administration, dosage forms, and strengths may be required. Many existing formulations are not suitable for children, which often leads to off-label and unlicensed use of adult medicines. New regulations, additional funding opportunities, and innovative collaborative research initiatives have resulted in some recent progress in the development of pediatric formulations. These advances include a paradigm shift toward oral solid formulations and a focus on novel preparations, including flexible, dispersible, and multiparticulate oral solid dosage forms. Such developments have enabled greater dose flexibility, easier administration, and better acceptance of drug formulations in children. However, new pediatric formulations address only a small part of all therapeutic needs in children; moreover, they are not always available. Five key issues need to be addressed to stimulate the further development of better medicines for children: (1) the continued prioritization of unmet formulation needs, particularly drug delivery in neonates and treatment gaps in pediatric cancers and childhood diseases in developing countries; (2) a better use of existing data to facilitate pediatric formulation development; (3) innovative technologies in adults that can be used to develop new pediatric formulations; (4) clinical feedback and practice-based evidence on the impact of novel formulations; and (5) improved access to new pediatric formulations. Pediatrics

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“…[13,29] In this regard, some alternatives have been proposed to replace traditional tablets, such as multiparticulates (granules, pellets), dispersible formulations, orodispersible films, mini-tablets (disintegrable, uncoated, and coated) and chewable tablets. [30][31][32][33] These products are not found in all countries and there are significant problems due to the lack of pediatric formulations available in the market. Health professionals often have solved this difficulty.…”

Section: Introductionmentioning

confidence: 99%

Quality Assessment in the Extemporaneous Pediatric Preparation of Powder Papers Containing Crushed Tablets of Spironolactone or Amiodarone

Carrillo¹,

Herrera²

2017

WJPR

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To elaborate the pediatric medicines the specifics of this population must be considered. Powder papers as extemporaneous formulations may be an option to provide dosing flexibility. The main objective of this research was to evaluate the quality of powder papers in its manual preparation stages and during the 60 days of storage. The results shown that a smaller than expected mass of tablets was distributed for the 40 papers at each formulation. The precision in the distribution performed by the crushed and pulverized tablet preparatory assistant reflected relative standard deviations ranging from 9 to 15%. On the start day, the uniformity of mass showed an inaccuracy reflected in several values outside the expected range, for all formulations. The accuracy of the tablets powder mass during storage at 60 days showed a ±10% of difference respect basal mass for papers with spironolactone 6,25 mg and the 15 and 75 mg amiodarone hydrochloride papers. For 10 mg of amiodarone hydrochloride formulation, random errors occurred outside the expected ranges at two sampling times. Powder adherence percentage was between the 10 and 20%. In conclusion, the preparation of four formulations in powder paper showed some errors which resulted in a significant loss of dose. A standardized operating procedure for the preparation of powder papers should be available taking into account the risk points of the manufacturing processes. It is advisable to enable the galenical section in hospital pharmacies and to have legislation regulating extemporaneous formulations in Costa Rica.

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Acceptance of uncoated mini-tablets in young children: results from a prospective exploratory cross-over study

Abstract: Uncoated mini-tablets seem to be a very promising alternative to liquid formulations and could be used at an earlier age in paediatric drug therapy than previously anticipated.

Cited by 144 publications

References 4 publications

Formulations for children: problems and solutions

Formulations for children: problems and solutions

Pediatric Drug Formulations: A Review of Challenges and Progress

Quality Assessment in the Extemporaneous Pediatric Preparation of Powder Papers Containing Crushed Tablets of Spironolactone or Amiodarone

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