Formulation of medicines for children

Abstract

The development of age‐adapted dosage forms and taste‐masking of bitter‐tasting drugs administered orally for children, are formidable challenges for formulation scientists. Childhood is a period of maturation requiring knowledge of developmental pharmacology to establish dose but the ability of the child to manage different dosage forms and devices also changes. Paediatric formulations must allow accurate administration of the dose to children of widely varying age and weight. Whilst the oral route will be preferred for long term use and the intravenous route for the acutely ill, many of the dosage forms designed for adults, such as oro‐dispersible tablets, buccal gels and transdermal patches, would also benefit children if they contained an appropriate paediatric dose. The age at which children can swallow conventional tablets is of great importance for their safety. Liquid medicines are usually recommended for infants and younger dhildren so the ability to mask unpleasant taste with sweeteners and flavours is crucial. More sophisticated formulations such as granules and oro‐dispersible tablets may be required but there will be limitations on choice and concentration of excipients. There are many gaps in our knowledge about paediatric formulations and many challenges for the industry if suitable preparations are to be available for all ranges. A CHMP points to consider document is soon to be released. More research and clinical feedback are important because a formulation with poor acceptability may affect compliance, prescribing practice and ultimately commercial viability.

Opinion of Bulgarian Pharmacists on Drug Delivery Systems, Orodispersible and Pediatric Dosage Forms

“…The participation of the medicine representatives in the process is crucialthey are in the most of cases the primary source of information for the most innovative dosage forms and help to the pharmacists to enhance their knowledge. 4.A significant part of the pharmacists think that the future role of the pharmacists will be in development of new drug delivery forms and 78.8% of the respondents think that new therapeutic approaches would be created. A significant part of the pharmacists conclude that with the development of new drug delivery forms the need for more pharmaceutical consultations about their use will become greater.…”

Melt-in-Mouth Multi-particulate System for the Treatment of ADHD: A Convenient Platform for Pediatric Use

“…Melt-in-mouth products are meant for oral cavity and may dissolve on the tongue in the presence of small amount of saliva or liquid. They are easy to administer and provides accuracy of dose (4). Since each individual unit of multi-particulate contains predetermined quantity of drug, the drug dose can be easily adjusted by measuring a specific amount/number of the pellets, depending on the patient's body weight.…”

“…The oral route of administration is the preferred one for children (4). Although tablets are generally easier and cheaper to develop, manufacture, transport, store and dispense than liquid medicines, the pediatric population often shows problems in swallowing the medications due to size, shape, unpleasant smell and taste (5).…”

Polymorphism: an evaluation of the potential risk to the quality of drug products from the Farmácia Popular Rede Própria

“…This predominance of solid drug formulations reflects the greater chemical stability of solid state compared with liquid state formulations (Nunn et al, 2005;Lee et al, 2011). Moreover, the development, manufacture, transportation, storage and supply of solid state formulations are simpler and less expensive in comparison to liquid state formulations (Nunn et al, 2005).…”