title: Dosage uniformity problems which occur due to technological errors in extemporaneously prepared suppositories in hospitals and pharmacies.
abstract: The availability of suppositories in Hungary, especially in clinical pharmacy practice, is usually provided by extemporaneous preparations. Due to the known advantages of rectal drug administration, its benefits are frequently utilized in pediatrics. However, errors during the extemporaneous manufacturing process can lead to non-homogenous drug distribution within the dosage units. To determine the root cause of these errors and provide corrective actions, we studied suppository samples prepared with exactly known errors using both cerimetric titration and HPLC technique. Our results show that the most frequent technological error occurs when the pharmacist fails to use the correct displacement factor in the calculations which could lead to a 4.6% increase/decrease in the assay in individual dosage units. The second most important source of error can occur when the molding excess is calculated solely for the suppository base. This can further dilute the final suppository drug concentration causing the assay to be as low as 80%. As a conclusion we emphasize that the application of predetermined displacement factors in calculations for the formulation of suppositories is highly important, which enables the pharmacist to produce a final product containing exactly the determined dose of an active substance despite the different densities of the components.
authors.affiliation: Institute of Pharmaceutical Analysis, Faculty of Pharmacy, University of Szeged, Szeged, Hungary.
authors.forename: Eva
authors.initials: E
authors.lastname: Kalmár
authors.affiliation: College of Pharmacy and Pharmaceutical Sciences, University of Toledo, Toledo, OH, USA.
authors.forename: Jason Richard
authors.initials: JR
authors.lastname: Lasher
authors.affiliation: College of Pharmacy and Pharmaceutical Sciences, University of Toledo, Toledo, OH, USA.
authors.forename: Thomas Dean
authors.initials: TD
authors.lastname: Tarry
authors.affiliation: College of Pharmacy and Pharmaceutical Sciences, University of Toledo, Toledo, OH, USA.
authors.forename: Andrea
authors.initials: A
authors.lastname: Myers
authors.affiliation: Institute of Pharmaceutical Analysis, Faculty of Pharmacy, University of Szeged, Szeged, Hungary.
authors.forename: Gerda
authors.initials: G
authors.lastname: Szakonyi
authors.affiliation: Institute of Pharmaceutical Analysis, Faculty of Pharmacy, University of Szeged, Szeged, Hungary.
authors.forename: György
authors.initials: G
authors.lastname: Dombi
authors.affiliation: College of Pharmacy and Pharmaceutical Sciences, University of Toledo, Toledo, OH, USA.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Baki
authors.affiliation: College of Pharmacy and Pharmaceutical Sciences, University of Toledo, Toledo, OH, USA.
authors.forename: Kenneth S
authors.initials: KS
authors.lastname: Alexander
keywords: Cerimetric titration; Clinical pharmacy practice; HPLC; Quality control; Rectal administration