title: Suspensions as a Valuable Alternative to Extemporaneously Compounded Capsules.
abstract: The objective of this study was to determine the variation in content of 74 different active pharmaceutical ingredients (APIs) and compare it with what is known in the literature for the content uniformity of extemporaneous prepared capsules. Active pharmaceutical ingredients quantification was performed by high-performance liquid chromatography, via a stability-indicating method. Samples for all active pharmaceutical ingredients were taken throughout a 90-day period and the content was determined. In total, 5,190 different samples were analyzed for 74 different active pharmaceutical ingredients at room (15°C to 25°C) or controlled refrigerated temperature (2°C to 8°C). Each of these datasets was analyzed according to the United States Pharmacopeia Content Uniformity monograph, corrected for the sample number. The mean acceptance values were well within specifications. In addition, all suspensions complied with the criteria defined by the British Pharmacopoeia monograph for Content Uniformity of Liquid Dispersions for both room and controlled refrigerated temperature. In previous studies, it was found that a routine weight variation check is often not sufficient for quality assurance of extemporaneous prepared capsules. Compounded oral liquids show little variation in content for 74 different active pharmaceutical ingredients; therefore, compounded oral liquids are a suitable alternative when compounding individualized medications for patients.
authors.affiliation: Fagron BV, Rotterdam, The Netherlands. eli.dijkers@fagron.com.
authors.forename: Eli
authors.initials: E
authors.lastname: Dijkers
authors.affiliation: Fagron BV, Rotterdam, The Netherlands.
authors.forename: Valerie
authors.initials: V
authors.lastname: Nanhekhan
authors.affiliation: Fagron BV, Rotterdam, The Netherlands.
authors.forename: Astrid
authors.initials: A
authors.lastname: Thorissen
authors.affiliation: Ortofarma-Quality Control Laboratories, Brazil.
authors.forename: Hudson
authors.initials: H
authors.lastname: Polonini
mesh_terms: D000284:Administration, Oral; D002214:Capsules; D002851:Chromatography, High Pressure Liquid; D004339:Drug Compounding; D004355:Drug Stability; D004356:Drug Storage; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry*; D019999:Pharmaceutical Solutions; D013696:Temperature; D013997:Time Factors
chemical_list: D002214:Capsules; D004364:Pharmaceutical Preparations; D019999:Pharmaceutical Solutions