Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
2006-09-12
2006-09-12
Low, Christopher S. F. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C514S782000, C514S785000, C514S946000, C514S947000, C514S054000
Reexamination Certificate
active
07105571
ABSTRACT:
The invention provides methods and compositions for treating erectile dysfunction. The methods include the step of placing within the fossa navicularis of the patient an effective erection-inducing amount of a vasoactive prostaglandin composition of a semi-solid consistency. The composition comprises a vasoactive prostaglandin, a penetration enhancer, a shear-thinning polysaccharide, a lipophilic compound, and an acidic buffer system. The penetration enhancer is an alkyl-2-(N-substituted amino)-alkanoate ester, a (N-substituted amino)-alkanol alkanoate, or a mixture of these enhancers. The lipophilic compound may be an aliphatic C1to C8alcohol, aliphatic C2to C30ester, an aliphatic C8to C30ester, or a mixture of these. The composition includes a buffer system providing a buffered pH value for said composition in the range of about 3 to about 7.4.
REFERENCES:
patent: 2818855 (1958-01-01), Miller et al.
patent: 4127118 (1978-11-01), Latorre
patent: 4254145 (1981-03-01), Birnbaum
patent: 4311707 (1982-01-01), Birnbaum et al.
patent: 4801587 (1989-01-01), Voss et al.
patent: 4980378 (1990-12-01), Wong et al.
patent: 5242391 (1993-09-01), Place et al.
patent: 5256652 (1993-10-01), El-Rashidy
patent: 5380760 (1995-01-01), Wendel et al.
patent: 5708031 (1998-01-01), Scott
patent: 5820587 (1998-10-01), Place
patent: 5843961 (1998-12-01), Kock et al.
patent: 5942545 (1999-08-01), Samour et al.
patent: 6046244 (2000-04-01), Buyuktimkin et al.
patent: 6102849 (2000-08-01), Hakac
patent: 6323241 (2001-11-01), Yeager et al.
patent: 6414028 (2002-07-01), Buyuktimkin et al.
patent: 6693135 (2004-02-01), Yeager et al.
patent: 2005/0004226 (2005-01-01), Lu et al.
patent: 2005/0009918 (2005-01-01), Wen et al.
patent: 0 357 581 (1990-03-01), None
patent: 0 552 405 (1993-07-01), None
patent: 1 367 550 (1974-09-01), None
patent: WO 91/16021 (1991-10-01), None
patent: WO 99/22714 (1999-05-01), None
patent: WO 99/65303 (1999-12-01), None
patent: WO 00/33825 (2000-06-01), None
patent: WO 00/69469 (2000-11-01), None
patent: WO 01/35998 (2001-05-01), None
patent: WO 01/51053 (2001-07-01), None
patent: WO 01/74279 (2001-10-01), None
patent: WO 03/070281 (2003-08-01), None
Smith, A., “Options for Viagra Failures,”Pharmaceutical Science and Technology Today, 1(5): 188-189 (Aug. 1998).
Padma-Nathan, Harin, “A New Era in the Treatment of Erectile Dysfunction,”American Journal of Cardiology, 84(5B): 18N-23N (Sep. 9, 1999).
Perimenis, P., et al., “Switching from Long-term Treatment with Self-injections to Oral Sildenafil in Diabetic Patients with Severe Erectile Dysfunction,”European Urology, 41(4): 387-391 (Apr. 2002).
Heaton, J.P., et al., “Intracavernosal Alprostadil is Effective for the Treatment of Erectile Dysfunction in Diabetic Men,”International Journal of Impotence Research, 13(6): 317-321 (Dec. 2001).
Costabile, Raymond A., et al., “Efficacy and Safety of Transurethral Alprostadil in Patients with Erectile Dysfunction Following Radical Prostatectomy,”Journal of Urology, 160(4): 1325-1328 (Oct. 1998).
Emilien, G., “Alprox-ID NexMed Inc.,”Current Opinion in Central and Peripheral Nervous System Investigational Drugs, 2(3): 311-320 (2000).
Droller, M.J. et al., Impotence. Consensus Development Conference Statement, National institutes of HealthJAMA270(1):83-90 (1993).
Murray, F.T. et al., Evaluation and Treatment of Erectile Dysfunction,Amer. J. Medical Sci.309:99-109 (1995).
O'Keefe, M. et al., Assessment and Treatment of Impotence,Medical Clinics of North America79:415-434 (1995).
Vickers, M.A. et al., Diagnosis and Treatment of Psychogenic Erectile Dysfunction in a Urological Setting: Outcomes of 18 Consecutive Patients,J. Urology149:1258-1261 (1993).
Padma-Nathan, H., et al., Treatment of Men with Erectile Dysfunction with Transurethral Alprostadil,N. Eng. J. Med., 336:1-7 (1997), (see especially Fig. 1).
Peterson, C.A., et al., Erectile Response to Transurethral Alprostadil, Prazosin and Aprostadil-Prazosin Combinations,J. Urol., 159:1523-1528 (1998).
Porst, H., Transurethral Alprostadil with MUSE™ (medicated urethral system for erection) vs. intracavernous Alprostadil-a comparative study in 103 patients with erectile dysfunction,Int. J. Impot. Res., 9:187-192 (1997).
Benson, G., (see editorial comment),J. Urol., 159:1527-1528 (1998).
Büyüktimkin, et al., Chemical Means of Transdermal Drug Permeation Enhancement inTransdermal and Topica Drug Delivery Systems, Ghozh T.K., Pfister W.R., Yum S.I. (Eds.), Interpharm Press Inc., Buffalo Groves, IL. (1997).
Pudney J., and Anderson, D.J., Immunobiology of the human penile urethra,Amer. J. path., 147:155-165 (1995).
Holestein, A.F., et al., Different epithelia in the distal human male uretha,Cell Tiss. Res.264:23-32 (1991).
Durso, D.F., Introduction, pp. 1-1 to 1-3 in Davidson, R. L. editor,Handbook of Water-Soluble Gums&Resins, McGraw-Hill, Inc., N.Y. (1980).
Seaman, J.K., Guar Gum, pp. 6-1 to 6-19 in Davidson, R. L. editor,Handbook of Water-Soluble Gums&Resins, McGraw-Hill, Inc., N.Y. (1980).
Seaman, J.K., Locust Guar Gum, pp. 14-1 to 14-16 in Davidson, R. L. editor,Handbook of Water-Soluble Gums&Resins, McGraw-Hill, Inc., N.Y. (1980).
Williams C. et al., Efficacy and safety of Transurethral alprostadil therapy in men with erectile dysfunction,Brit. J. Urol., 81:889-894 (1998).
Physician's Desk Reference, 51stEd., pp. 2575-2576 (1997).
The Merck Index, 12thEd., Merck & Co., N.J., pp. 1352-1354 (1996).
Martindale The Extra Pharmacopoeia, 28thEd., London, The Pharamaceutical Press, p. 1353 (1982).
Kunelius, P., et al., Intracavernous self-injection of Prostaglandin E1 in the treatment of erectile Dysfunction,International J. of Impot. Res., 11:21-24 (1999).
Zecchi Orlandini, S., et al., Ultrastructure of Human Male Urethra,Archives of Andrology, 23:51-59 (1989).
Ishii, N., et al., Studies on Male Sexual Impotence Report II,The Japanese J. of Urol., 77(9):954-961 (1986).
Hedlund H., et al., Contraction and Relaxation induced by some Porstanoids in Isolated Human Penile Erectile Tissue and Cavernous Artery,J. of Urol., 154:1245-1250 (1986).
Gerber, G.S., et al., Phamacological Erection Program Using Prostaglandin E1,J. of Urol., 146:786-789 (1991.
Malloy, T.R., et al., Pharmacologic Treatment of Impotence,Urologic Clinics of North America, 14(2):297-305.
Wolfson, B., et al., Intralurethral Prostaglandin E-2 Cream: A possible Alternative Treatment for Erectile Dysfunction,Urology, 42(1):73-75.
Catanazarite, V.A., et al., Prostaglandins: Mundane and Visionary Applications,Contemporary OB/GYNpp. 21-41(Oct. 1987).
Remington: Practice of the Science and Pharmacy, 19thEdition Mack Publishing company A.R. Gennaro (Ed.,) pp. 410-412.
Chattarij, S.C., et al., Penetration Enhancer Classification inPercutaneous Penetration Enhancers, E.W. Smith, H.I. Maibach (Eds.) CRC, Press, Inc. pp. 5-20 (1995).
Büyüktimkin, et al., Alkyl N, N-Disubstituted-Amino Acetates inPercutaneous Penetration Enhancers, E.W. Smith, H.I. Maibach (Eds.) CRC, Press, Inc. pp. 91-102 (1995).
Tiefer, L., et al., Impotence: NIH Consensus Statement, 10(4):1-31 (1993).
Büyüktimkin Nadir
Büyüktimkin Servet
Yeager James L.
Jagoe Donna
Low Christopher S. F.
Mirick O'Connell DeMallie & Lougee LLP
NexMed (Holdings) , Inc.
Zimmerman Roger P.
LandOfFree
Prostaglandin compositions and methods of treatment for male... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Prostaglandin compositions and methods of treatment for male..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Prostaglandin compositions and methods of treatment for male... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3559678