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Analysis of Extemporaneous Alprostadil Formulations

Author(s):  Sarver Jeffrey G, Peng Ning, Lerdkanchanaporn Supaporn, Oravecz-Wilson Katherine, Alexander Kenneth S, Erhardt Paul W

Issue:  Mar/Apr 1999 - Compounding for Men's Health
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Abstract:  Twenty-two extemporaneous alprostadil (PGE1) injection solution samples from five different suppliers and three Caverject ® (Pharmacia & Upjohn, Inc., Bridgewater, NJ) samples from three different lots, all intended for the clinical treatment of erectile dysfunction, were analyzed to determine PGE1 concentration, assess formation of the PGE1 aqueous breakdown product (PGA1), define pH and assess active microbial contamination. High-pressure liquid chromatography (HPLC), pH meter and cell culture techniques were used to conduct the analyses. Of the 22 extemporaneously formulated samples, six showed PGE1 concentrations 10% greater than their listed amounts and seven showed PGA1 weight fractions corresponding to at least 1.5% of the total prostaglandin content. It should be noted that no standard has been published in the United States Pharmacopeia/National Formulary for this preparation as of this date. All samples were within the pH range 4.5 to 6.0. Four samples tested positive for active microbial contamination. In addition, nearly all the extemporaneously formulated samples contained what appeared to be benzyl alcohol, and about one half had at least two other undefined peaks within their HPLC chromatograms. In contrast, all three Caverject samples were within ± 7.5% of their listed PGE1 concentrations while showing PGA1 prostaglandin weight fractions of less than 0.6%, all were within the pH range 4.0 to 4.5 and all tested negative for active microbial contamination. Chromatograms of the Caverject samples also displayed peaks consistent with the presence of benzyl alcohol but did not exhibit additional undefined peaks. The results suggest that significant variations in PGE1 concentration and in PGA1 formation, accompanied by the possibility of microbial contamination, can occur as a result of the extemporaneous formulation and subsequent transfer of this type of product as a premixed solution intended for treating erectile dysfunction.

Related Keywords: alprostadil, PGE1, erectile dysfunction, Caverject, microbial contamination, aqueous breakdown


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