NICHD和美国食品药品管理局研究归纳的BCS分类(2014年)

NICHD和美国食品药品管理局研究归纳的BCS分类(2014年)

Inter-Agency Agreement Between the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the U.S.

Food and Drug Administration (FDA)

Final Report

The objective of this Interagency Agreement (IAA) was to develop formulation approaches that will provide optimal approaches for pediatric drug delivery. The availability of publically available oral pediatric drug delivery approaches would have the corollary benefit of reducing the unregulated extemporaneous compounding of pediatric dosage forms, using dosage forms designed for adult patient populations, which have been responsible for numerous adverse events in the pediatric patient population. An ideal pediatric dosage form is an orally dissolvable solid; tasteless; in an appropriate dose amount that would be appropriate for pediatric patients, ranging from infant to adolescent; contain minimal amounts of safe excipients; stable in light, humidity and heat; and have the necessary release and stability characteristics, as applicable.

As part of this IAA, a list of about 400 best-selling, commercially available, drug products was compiled. These drug products are available in a wide verity of dosage forms, e.g., tablets, capsules, injections, solutions, suspensions, etc., many of which are also suitable for administration to pediatric patients. However, a large number of these drugs are currently not approved for use in the pediatric patients. Excluding these, and a few combination drug products (i.e., those containing more than one drug), reduced the list to 222 drugs, that has information on pediatric use as part of the approved product label. For these 222 drugs, information of the approved dosage forms and their suitability in pediatric patients was determined using the information available on the FDA (Drugs@FDA) and NIH (DailyMed) websites. 184 out of these 222 drugs are available in one or more orally administered dosage from (tablet, capsule, solution, syrup, elixir, suspension, granules, etc.), with many drugs being available in more than one oral dosage from. A further analysis show tablets to be the most popular dosage form with 154 of these drugs being available as tablet for oral administration (A review of the approved product labeling for these drugs showed a significant variation the pediatric use labeling among these 222 drugs. The minimum age for which these drugs were approved ranged from neonates to 16 years old, while, in some cases, different dosage forms had different minimum age or sometime only select dosage forms were approved for use in the pediatric patient population above a certain minimum age. A list of approved dosage forms, with respective minimum age for pediatric use, for these 222 drugs and the permanent link to prescribing information (Dailymed) is present in Appendix I. An MS Excel file of the list is also enclosed with this report.

The list in Appendix I include drugs that may be administered orally as tablet, capsule, solution, suspension, etc., or via other route of administration, such as, parenteral, topical, ophthalmic, nasal, etc. Some of these dosage forms, e.g., parenteral, capsules, etc. may be difficult to administer to pediatric patients, especially those that are very young. The oral dosage forms that

NICHD和美国食品药品管理局研究归纳的BCS分类(2014年)

are most suitable for pediatric patients include chewable tablet, ODT, solution, syrup, suspension and elixir dosage forms. Topical, nasal and ophthalmic dosage forms may also be suitable for use in pediatric patients to treat certain medical conditions. However, only 138 out of these 222 drugs are available in one of these pediatric friendly dosage forms. The availability of these dosage forms for individual drugs has also been identified in Appendix I.

Table 1). Many of these drugs, that are available as tablets, are also available other oral dosage forms, e.g., capsule, solution, syrup, elixir, suspension, chewable tablet, orally disintegrating tablet (ODT), etc (Figure 1).

A review of the approved product labeling for these drugs showed a significant variation the pediatric use labeling among these 222 drugs. The minimum age for which these drugs were approved ranged from neonates to 16 years old, while, in some cases, different dosage forms had different minimum age or sometime only select dosage forms were approved for use in the pediatric patient population above a certain minimum age. A list of approved dosage forms, with respective minimum age for pediatric use, for these 222 drugs and the permanent link to prescribing information (Dailymed) is present in Appendix I. An MS Excel file of the list is also enclosed with this report.

The list in Appendix I include drugs that may be administered orally as tablet, capsule, solution, suspension, etc., or via other route of administration, such as, parenteral, topical, ophthalmic, nasal, etc. Some of these dosage forms, e.g., parenteral, capsules, etc. may be difficult to administer to pediatric patients, especially those that are very young. The oral dosage forms that are most suitable for pediatric patients include chewable tablet, ODT, solution, syrup, suspension and elixir dosage forms. Topical, nasal and ophthalmic dosage forms may also be suitable for use in pediatric patients to treat certain medical conditions. However, only 138 out of these 222 drugs are available in one of these pediatric friendly dosage forms. The availability of these dosage forms for individual drugs has also been identified in Appendix I.

Table 1. Available dosage forms for 222 drugs that have pediatric use information as part of product labeling

Dosage Form Number of Drugs

Tablet (Oral) 154

Injection 78

Capsule (Oral) 65

Solution/Syrup (Oral) 54

Suspension (Oral) 47