Extemporaneous Indomethacin Oral Suspension Prepared from Injectable Ampules for Therapy in Premature Infants and Pediatric Patients.

Indomethacin is used for off-label prescription for the treatment of patent ductus arteriosus in premature infants. In Argentina, indomethacin is only available as a suppository, dermic cream, injectable ampules, and delayed-release capsules. Aiming to improve pediatric treatment and minimize the risk associated with improper dosage, this work focused on the development of an extemporaneous 0.2% indomethacin oral suspension, starting from the commercially injectable formulation. Two 150-mL batches of suspension were prepared using Generally Recognized as Safe excipients. The suspensions were stored for 17 days at room temperature. Physical stability, morphological analysis of suspended particles, sedimentation volume, easy re-suspension, and dynamic viscosity were studied. The indomethacin content, dissolution studies, and microbiological attributes of nonsterile pharmaceutical products were also evaluated. After 17 days of storage, the suspension was easily re-dispersed after 15 seconds of the hand-shaking technique. There were no detectable changes in color, odor, and/or flavor. The suspension showed minimal changes in pH, viscosity, shape, and mean size of the suspended indomethacin particles. The content uniformity and drug dissolution remained within the acceptable range during storage. This oral liquid suspension is an interesting alternative to be prepared by hospital pharmacy services for optimizing the pediatric treatment of patent ductus arteriosus.