Physicochemical stability study of a new Trimix formulation for treatment of erectile dysfunction.
Currently, severe erectile dysfunction can be treated by intracavernous injections of solutions containing three active ingredients: prostaglandin E1 (PGE1), papaverine and urapidil. Very few data exist on this mixture where phentolamine has been replaced by Urapidil because Phentolamine is not used for this indication in France. The aim of our study was to assess the stability of this formulation and to extend its expiration to permit preparation of batches. Three batches of the preparation containing 15μg/mL PGE1, 15mg/mL of papaverine and 2mg/mL urapidil were made aseptically and then packed in polypropylene syringes stored at 4°C. The physico-chemical stability has been tested as follows: HPLC stability-indicating method, visual observation, measurement of pH and osmolarity. We found that the limiting factor was PGE1 and we exceeded the threshold of 10% loss after 55 days. Replacement of Urapidil by Phentolamine seems to have a slight detrimental effect on stability. Nevertheless, these results allow us to consider the advance preparation of this formulation and provide quality treatment to these patients by avoiding too frequent visits to the hospital.
Service de pharmacie, hôpital Henri-Mondor, 51, avenue du Maréchal-de-Lattre-de-Tassigny, 94010 Créteil cedex, France. Electronic address: victoire.vieillard@hmn.aphp.fr.
V
V
Vieillard
N
N
Eychenne
A
A
Astier
R
R
Yiou
C
C
Deffaux
M
M
Paul
D000527:Alprostadil / Q000032:analysis* / Q000627:therapeutic use; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004338:Drug Combinations; D004355:Drug Stability; D004356:Drug Storage; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D010208:Papaverine / Q000032:analysis* / Q000627:therapeutic use; D010879:Piperazines / Q000032:analysis* / Q000627:therapeutic use; D013056:Spectrophotometry, Ultraviolet; D013594:Syringes; D014665:Vasodilator Agents / Q000032:analysis* / Q000627:therapeutic use
D004338:Drug Combinations; D010879:Piperazines; D014665:Vasodilator Agents; C015568:urapidil; D010208:Papaverine; D000527:Alprostadil
Chromatograhie; Chromatography; Hospital preparation; Injection intracaverneuse; Intracavernous injection; Préparation hospitalière; Stability; Stabilité; Trimix