الفهرس 
GENERAL INTRODUCTIONOnly 14 pages are availabe for public view
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Abstract
The design and selection of new pharmaceutical dosage forms involves the careful consideration and balancing of the quality of the product against technical challenges and development feasibility. Pediatric dosage forms present particular complexity due to the diverse patient population, patient compliance challenges and safety considerations of this vulnerable population. selecting and designing an appropriate dosage form for the pediatric population is particularly challenging. In addition to those challenges usually encountered when developing adult dosage forms; developing a dosage form for children poses other challenges such as the diversity of the patient population both in terms of size and physiological and biological maturation; specific patient compliance challenges such as swallowing difficulties and low tolerance to unacceptable taste; and specific safety concerns associated with the required excipients.
As with adult patients, the oral route of drug administration is the most commonly used for pediatric patients. This poses the additional challenges of developing dosage forms that are easily swallowed and have acceptable palatability. The difficulty in administering prescribed drugs to young children may be compounded by unpleasant tasting and difficult to swallow preparations. Although the role of palatability and the magnitude of its effect on adherence have not been formally well studied, many healthcare workers and caregivers have observed that children refuse to take certain medications. It is reasonable to assume that when parents have difficulty giving medication to children, adherence may be a problem.
Fewer options are often available for younger children who may prefer liquid preparations. Tablets and capsules, which are usually more palatable, may not be a practical alternative. It has even been suggested that the struggle to give bitter products to infants may influence parents to prefer injectables; furthermore, developmental delay may also complicate the situation. Formal evaluation of taste by children should be an essential part of the evaluative process for new drug products for use in that age group.
Moreover, timing of medication doses may also be important when considering what therapeutic regimen is the most appropriate. The need to administer medications at school or daycare may complicate matters. Although it is preferable to choose medications that allow dosing during the child’s waking hours, there is an increasing need toward improving adherence with evening dosing.
Reasons reported for failure to administer medication regularly to pediatrics include forgetting, discontinuing medication because symptoms have resolved, misunderstanding of instructions, resistance of the child, and apparent ineffectiveness or adverse effects of the medication.
All these problems led to the increased need for developing new pediatric formulations to cope with those challenges and enhancing safety and patient compliance.