1.Aviptadil (Senatek).
Keijzers GB1. Curr Opin Investig Drugs. 2001 Apr;2(4):545-9.
Aviptadil is an injectable formulation of vasoactive intestinal polypeptide (VIP) in combination with the adrenergic drug phentolamine. Aviptadil in combination with phentolamine and sexual stimulation, is expected to provide a new and effective alternative for erectile dysfunction (ED) patients that is essentially free of the troublesome side effects and cumbersome delivery methods which limit the use of other pharmacologic preparations. Aviptadil can be delivered using Senetek's novel and patented autoinjector (Reliaject), which renders the self-injection process exceptionally easy, unobtrusive to perform and helps ensure accurate, safe delivery of the medication [306380]. In July 1997, Senetek filed a PLA with the Danish Medicines Authority [253591] and its third PLA in Ireland for the treatment of moderate-to-severe, organic-based ED [255084]. In September 1997, Senetek filed PLAs seeking approval to market aviptadil in Switzerland, South Africa and New Zealand 1263505]; by April 2000, it had been approved in New Zealand [361039].
2.It's there in three colours for all to see!
Wyllie MG1. BJU Int. 2008 Nov;102(9):1175-6. doi: 10.1111/j.1464-410X.2008.08126.x.
3.Analytics of the therapeutic peptide aviptadil by sheathless CE-MS and comparison with nanoRP-HPLC-MS.
Gross PC1, Burkart SC, Müller R. J Pharm Biomed Anal. 2014 Jan;88:477-82. doi: 10.1016/j.jpba.2013.09.024. Epub 2013 Oct 5.
Purification and quality control of therapeutic peptides is often performed by one single method, RP-HPLC. As usage of an orthogonal technique is highly advisable for quality assurance, capillary electrophoresis (CE) employing a coated capillary coupled via a sheathless interface to a mass spectrometer was applied in parallel. The basic therapeutic peptide aviptadil served as a model substance to study the impurity profiles revealing 15 detectable impurities using CE-MS, two were detected by an appropriate nanoRP-HPLC-MS method. None of the impurities detected by CE were observed in LC and vice versa. The LOD in CE-MS was determined in the base peak electropherogram at ∼1fmol, a value 2500 times smaller than the LOD found in nanoRP-HPLC-MS (3pmol). In nanoRP-HPLC-MS only 0.2% of the extrapolated CE-MS signal for a 25ng aviptadil load was observed. We conclude that both, the LOD as well as the impurity profile of aviptadil, as analyzed by nanoRP-HPLC are influenced by both, the ligand-derivatized silica matrix and the flow-rate.
4.The anatomy of drug development: Invicorp, a product before its time.
Wyllie MG1. BJU Int. 2010 Sep;106(5):723-4. doi: 10.1111/j.1464-410X.2010.09603.x.
