title: Stability of extemporaneous pediatric oral liquids compounded from tablets and drug substance: case of propranolol and theophylline.
abstract: The stability of theophylline (T) and propranolol hydrochloride (P) in extemporaneously compounded oral suspensions (25 mg/mL or 50 mg/mL for T and 2 mg/mL or 5 mg/mL for P) were studied. Suspension with P and T were prepared with bulk substance or tablets using three different suspending vehicles: Ora-Sweet (M1), modified Ora-Sweet (M2) and simple syrup with glycerol and sorbitol (M3). Each suspension was stored for 35 days in a dark place at 25 degrees C and 4 degrees C. The results demonstrated that the prepared suspensions with P either from tablets or from a substance were stable in all three studied vehicles (more than 95% of initial concentration remaining). However, it is recommended that storage at 4 degrees C of suspensions prepared with M2 should be avoided because of crystallization of the buffer substances. Extemporaneous suspensions with T in an appropriate pediatric concentrations of the drug were not obtained because the problem of fast crystallization of T was not eliminated.
authors.affiliation: Department of Pharmaceutical Technology, Medical University of Bialystok, 2C Mickiewicza St., 15-222 Białystok, Poland. monikam@umb.edu.pl
authors.forename: Monika
authors.initials: M
authors.lastname: Muśko
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Sznitowska
mesh_terms: D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D004355:Drug Stability; D005990:Glycerol / Q000737:chemistry; D006801:Humans; D014677:Pharmaceutical Vehicles / Q000737:chemistry; D011433:Propranolol / Q000008:administration & dosage / Q000737:chemistry*; D012995:Solubility; D013012:Sorbitol / Q000737:chemistry; D013535:Suspensions; D013549:Sweetening Agents / Q000737:chemistry; D013607:Tablets; D013649:Taste; D013678:Technology, Pharmaceutical / Q000379:methods; D013696:Temperature; D013806:Theophylline / Q000008:administration & dosage / Q000737:chemistry*; D013997:Time Factors
chemical_list: D014677:Pharmaceutical Vehicles; D013535:Suspensions; D013549:Sweetening Agents; D013607:Tablets; D013012:Sorbitol; D011433:Propranolol; D013806:Theophylline; D005990:Glycerol