title: Stability study of oral pediatric idebenone suspensions.
abstract: Adapted forms for administration to infants are limited. The proposed study was performed to propose oral liquid formulations of idebenone in Ora-Plus and either Ora-Sweet or Ora-Sweet SF, Ora-Blend, Ora-Blend SF and Inorpha. Each formulation was stored in 30 ml amber glass bottle at 5 or 25 °C for 90 days. Idebenone contents in these suspensions, determined by a stability-indicating high-performance liquid chromatography method, remained stable at least 90 days in Inorpha when stored at the two temperatures. In Ora-Blend, the stability was estimated at 14 days and in other suspensions at 20 days at the two temperatures. After 90 days storage, the pH of Ora-Plus and Ora-Sweet or Ora-Sweet SF changed between -0.10 and -0.25 units. For others suspensions, the pH changes were not significant (< -0.09 unit). No change was observed in color, odor or visual microbiology. To conclude, we recommended the use of idebenone in Inorpha vehicle stable for at least 90 days at 25 °C.
authors: a Service Pharmacie , Hôpital Jean Verdier - APHP, Hôpitaux Universitaires de Paris-Seine-Saint-Denis , Bondy , France.
authors: Joël
authors: J
authors: Schlatter
authors: a Service Pharmacie , Hôpital Jean Verdier - APHP, Hôpitaux Universitaires de Paris-Seine-Saint-Denis , Bondy , France.
authors: Elodie
authors: E
authors: Bourguignon
authors: a Service Pharmacie , Hôpital Jean Verdier - APHP, Hôpitaux Universitaires de Paris-Seine-Saint-Denis , Bondy , France.
authors: Elyes
authors: E
authors: Majoul
authors: a Service Pharmacie , Hôpital Jean Verdier - APHP, Hôpitaux Universitaires de Paris-Seine-Saint-Denis , Bondy , France.
authors: Sofiane
authors: S
authors: Kabiche
authors: a Service Pharmacie , Hôpital Jean Verdier - APHP, Hôpitaux Universitaires de Paris-Seine-Saint-Denis , Bondy , France.
authors: Issa-Bella
authors: IB
authors: Balde
authors: a Service Pharmacie , Hôpital Jean Verdier - APHP, Hôpitaux Universitaires de Paris-Seine-Saint-Denis , Bondy , France.
authors: Salvatore
authors: S
authors: Cisternino
authors: a Service Pharmacie , Hôpital Jean Verdier - APHP, Hôpitaux Universitaires de Paris-Seine-Saint-Denis , Bondy , France.
authors: Jean-Eudes
authors: JE
authors: Fontan
mesh_terms: D000284:Administration, Oral; D000975:Antioxidants / Q000008:administration & dosage / Q000737:chemistry*; D002648:Child; D004339:Drug Compounding; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D014677:Pharmaceutical Vehicles / Q000737:chemistry*; D013535:Suspensions; D014451:Ubiquinone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry
chemical_list: D000975:Antioxidants; D014677:Pharmaceutical Vehicles; D013535:Suspensions; D014451:Ubiquinone; C036619:idebenone
keywords: Idebenone; pediatric oral suspensions; stability study