Dosage uniformity problems which occur due to technological errors in extemporaneously prepared suppositories in hospitals and pharmacies

Éva Kalmár, Jason Richard Lasher, Thomas Dean Tarry, Andrea Myers, G. Szakonyi, G. Dombi, Gabriella Baki, Kenneth S. Alexander

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)338-342
Number of pages5
JournalSaudi Pharmaceutical Journal
Volume22
Issue number4
DOIs
Publication statusPublished - 2014

Fingerprint

Suppositories
Pharmacies
Pharmacists
Rectal Administration
Hungary
Pharmaceutical Preparations
Research Design
High Pressure Liquid Chromatography
Pediatrics

Keywords

  • Cerimetric titration
  • Clinical pharmacy practice
  • HPLC
  • Quality control
  • Rectal administration

ASJC Scopus subject areas

  • Pharmaceutical Science
  • Pharmacology

Cite this

Dosage uniformity problems which occur due to technological errors in extemporaneously prepared suppositories in hospitals and pharmacies. / Kalmár, Éva; Lasher, Jason Richard; Tarry, Thomas Dean; Myers, Andrea; Szakonyi, G.; Dombi, G.; Baki, Gabriella; Alexander, Kenneth S.

In: Saudi Pharmaceutical Journal, Vol. 22, No. 4, 2014, p. 338-342.

Research output: Contribution to journalArticle

Kalmár, Éva ; Lasher, Jason Richard ; Tarry, Thomas Dean ; Myers, Andrea ; Szakonyi, G. ; Dombi, G. ; Baki, Gabriella ; Alexander, Kenneth S. / Dosage uniformity problems which occur due to technological errors in extemporaneously prepared suppositories in hospitals and pharmacies. In: Saudi Pharmaceutical Journal. 2014 ; Vol. 22, No. 4. pp. 338-342.
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