Primary packaging considerations in developing medicines for children: oral liquid and powder for constitution.
The packaging presentation of oral liquid pediatric medicines is a critical step in maintaining chemical and physical stability, compliance, adherence, and proper handling by the target patient population, guardians, caregivers, and health-care professionals. The common packaging presentations for commercial oral liquid pediatric drug products are glass bottle, plastic bottle, sachet, and stick pack configurations. The type of pack presentation selected is driven by the quality target product profile (QTPP) that is designed around the physicochemical properties of the drug substance and the desired drug product suitability for the target population. The QTPP defines the intended use of the drug product, drug product quality criteria, dose strength, dosage form, container closure system, storage conditions, stability criteria, dosing device, shelf life, and attributes affecting the pharmacokinetic characteristics. Oral liquid pediatric formulations are typically prepared from a powder that is constituted at the time of use as a suspension or a solution for single or multiple use depending on the stability of the constituted formulation. Active ingredients with high aqueous solubility can be developed as a powder for oral solution and presented in a bottle for multiple use product and a stick pack, packet, or sachet for single-use product. Active ingredients with low aqueous solubility can be developed as a powder for oral suspension and presented in a bottle for multiple use product and a stick pack or sachet for single-use product. A secondary package may be used in cases where the primary pack failed to provide adequate protection against light degradation. This work will help formulation scientists select the most appropriate pack presentation in the early stages of pediatric clinical development.
Injectable/Sterile COE, Global Formulation Development, Product Development, Platform Technologies and Science, Collegeville, Pennsylvania, 19426.
Gossett A
GA
Campbell
Erick
E
Vallejo
D000284:Administration, Oral; D000293:Adolescent; D055598:Chemical Phenomena; D002626:Chemistry, Pharmaceutical; D002648:Child; D002675:Child, Preschool; D004339:Drug Compounding; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D015507:Drugs, Investigational / Q000008:administration & dosage / Q000737:chemistry*; D006801:Humans; D007223:Infant; D010372:Pediatrics / Q000379:methods*; D019999:Pharmaceutical Solutions; D010601:Pharmacology, Clinical / Q000379:methods*; D011208:Powders; D012995:Solubility; D013535:Suspensions; D017749:Total Quality Management
D015507:Drugs, Investigational; D019999:Pharmaceutical Solutions; D011208:Powders; D013535:Suspensions
chemical stability; degradation products; moisture sorption; pediatric; physical stability; physicochemical properties; solubility