FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003
COMPLETE SPECIFICATION
(See Section 10 and Rule 13)
A TOPICAL COMPOSITION FOR TREATING PENILE ERECTILE DYSFUNCTION
ASolution Pharmaceuticals Pvt. Ltd.
with their office at:
11- A Mittal Chambers, Nariman Point
Mumbai, India 400021.
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED

FIELD OF THE INVENTION
The present invention relates to topical compositions for treating penile erectile dysfunctions (ED). More particularly, it relates to a composition for the topical administration to the penis, which is effective for the treatment of penile erectile dysfunctions, thereby avoiding drug traveling through other parts of the body, which in turn eliminates phosphodiesterase type 5 (PDE5) productions in the penis to help retain sexually aroused erection of penis.
BACKGROUND OF THE INVENTION
Impotence is generally described as the inability to develop or sustain an erection sufficient for coitus. Many men are afflicted with a degree of impotence resulting from psychological and physiological conditions. Causes of impotence are numerous. One cause could be atonic due to paralysis of the motor nerves (nervi erigentes) without any evidence of lesion to the central nervous system. Another cause could be paretic, a result of a lesion in the central nervous system, particularly the spinal cord. Yet another cause could be psychic and dependent on a mental complex or instability. The cause could also be some othertlisorder, e.g., injury to nerves in the perineal region whereby the sensory portion of the erection reflex is blocked.
For example, in US patent application no. 4801587, describes an ointment for relieving impotence. The ointment generally consists of a primary agent, a carrier, and a base, and is applied directly to the penis. The primary agent is a vasodilator, when this primary agent enters the corpora cavernosa within the penis; it causes dilation of the corpora, resulting in an erection.

In addition to psychological causes, specific physiological disorders may be the cause of penile erectile dysfunction or male impotence like pelvic vascular disease, diabetes mellitus, neurodegenerative disorders, side effects of medication, pelvic surgery, and trauma.
One solution used for treating impotency involves implants that, in essence, are internal prostheses. However, implants often involve surgery, are generally expensive and not always effective.
The other solution for treating male impotence is the use of drugs. Since penile erection involves vasodilation of the arteries of the penis, vasodilation agents can often treat the pathophysiologic basis of impotence.
PRIOR ART:
Past and ongoing clinical and experimental research efforts to develop new and better drugs, as well as delivery routes for such drugs, have been the subject of several literature articles and the issued patents include, for example, the following United States Patents enlisted below.
U.S. Pat. No. 4,801,587 discloses the use of an ointment containing a vasodilator or alpha blocker in combination with a carrier agent for topical or intra-urethral administration to relieve impotency in men by improving localized circulation. Also proposed is the surgical removal of a portion of the fibrous sheath surrounding the corpora cavernosum in order to facilitate the penetration of a vasodilator-containing ointment into the corpora cavernosum. Vasodilators suggested for use include papaverine, hydralazine, sodium

nitroprusside, phenoxybenzamine and phentolamine; with papaverine as the most preferred. However, no information regarding the actual efficacy of the treatments is provided nor the nature of the response to such treatments.
U.S. Pat. No. 5,256,652 describes a topical non-invasive composition consisting of a vasodilator, pharmacologically acceptable enhancer to facilitate absorption of the vasodilator as well as a vasoconstrictor with a topical carrier for the vasodilator in order to enhance penile erection in men. Vasodilators aid with the increase in blood flow thereby providing erection, while the maintenance of penis erection may be further enhanced by restricting the blood flow from the penis with slow acting vasoconstrictors. The method for making the composition has also been provided.
U.S. Pat. No. 5,336,678 describes the use of the vasodilator minoxidil for the preparation of a topically administered medicament useful for the treatment of erectile impotence.
U.S. Pat. No. 5,583,144 describes a method for treating erectile impotence comprising of topically administered composition consisting of piperoxan in combination with a pharmaceutically acceptable carrier.
U.S. Pat. No. 5,482,039 describes a method for diagnosing vasculogenic erectile dysfunction and methods of treatment. The method involves transurethral administration of a vasodilating agent to induce an erection,
U.S. Pat. No. 5,451,609 describes an anti-impotence composition as well as a method for the treatment of impotence, whereby deacetyl moxisylyte or one of its non-toxic salts is administered in a ready to use aqueous solution by injection per intracavernosal route.

U.S. Pat. No. 5,242,391 describes method of treatment for erectile dysfunction by transurethral administration of a therapeutically effective agent One type of medication involves application of the therapeutic agent as a coating on a penile insert configured to prevent complete insertion and to facilitate removal. Another type of medication describes using the therapeutic agent contained in a gel, cream, ointment or suppository for example which may be deposited in the urethra from a specially designed inserter.
U.S. Pat. No. 5,145,852 describes a vasoactive medicine, particularly at least one alpha blocker and a phosphodiasterase inhibitor representing a total of 5 to 20% by weight of the papaverine, that is applicable in particular to the treatment of impotence in men.
U.S. Pat. No. 5,399,581 describes method and compositions for treatment of sexual impotence in the form of an oral drug consisting of a non-selective alpha 1 -alpha2 adrenergic blocking drug, such as dibenzyline, with that of a particular type of beta adrenergic blocking agent which also possesses vasodilator activity, such as labetalol, celiprolol, or carvedilol.
U.S. Pat. No. 5,270,323 describes a method comprising of administering an erectile impotence relieving amount of a compound selected from the group consisting of U.K. 52,046, Amlodipine, Doxazosin and the pharmaceutically acceptable acid addition salts thereof.
U.S. Pat. No. 5,236,904 describes methods and compositions for inducing penile erections, sufficient for vaginal penetration, in a human male suffering from impotence.

U.S. Pat. No. 4,127,118 describes a method of alleviating and treating male impotence by effecting and enhancing an erection by injecting into the penis an appropriate vasodilator, a sympathomimetic amine, or an adrenergic blocking agent.
U.S. Pat. No. 5,565,466 describes improved methods for modulating the human sexual response by administering a vasodilator, via transmucosal, transdermal, intranasal or rectal routes that avoids the "first-pass" effect. Vasodilation agent is selected from the group consisting of phentolamine mesylate, phentolamine hydrochloride, phenoxybenzamine, yohimbine, nitroglycerin, thymoxamine, nicotinyl alcohol, imipramine, verapamil, isoxsuprine, naftidrofuryl, tolazoline, and papaverine
U.S. Pat. No. 5,492,911 describes use of linsidomine and its pharmacologically compatible salts for the treatment of erectile dysfunctions. The most suitable administration forms are both parenteral and topical formulations such as, for example, lotions, creams, solutions, gels, sprays, elastic liquid plasters, transdermal systems or coatings for condoms.
U.S. Pat. No. 5,594,032 describes the treatment of erectile dysfunction by administering to a patient, inducible Nitric Oxide Synthase (iNOS) agents, including penile iNOS, inducers of penile iNOS, iNOS cDNA, or penile smooth muscle cells transformed with iNOS cDNA.
U.S. Pat. No. 5,488,059 describes A method to induce or enhance an erection or treat erectile dysfunction through the administration of a pyridylguanidine compound, preferably, N-cyano-N'( 1,1 -dimethyl propyl)-N"-3-pyridinyl guanidine, in low doses to

the penis. Administration can be by injection into the corpus cavernosum of the penis or transdermal application.
U.S. Pat. No. 5,439,938 describes methods and devices for regulating penile erection and urethral function. Inhibitors of nitric oxide synthase and precursors of nitric oxide are applied to relax or contract the muscles of the corpus cavernosum and the urethra.
Currently available Erectile Dysfunction (ED) drugs in market include Sildenafil Citrate, Tadalafil, Vardanafil, and combinations thereof. These are supplied as Oral Solid Dose (OSD) drugs. When a person takes an ED drug as OSD through mouth, e.g., sildenafil citrate tablet or capsule, it flows through the body, but what matters in the treatment of erectile dysfunction is its presence in the penis where it interacts with the PDE5 enzyme* in the penis. Its act of eliminating PDE5 helps build cyclic gucmosine monophosphate (produced by nitric oxide), and smoothens the arteries in the penis. The drawback of OSD treatment is that the person has to anticipate coitus and take the drug in advance for it to act.
Further, because the drug flows through the body to get to the penis, there are side effects on other organs, e.g., pulmonary dilation. There is therefore a need to administer the drug directly at the penis whereby potential side effects on other organs of the body are minimized and the drug could be administered without advance anticipation but a short time before the coitus.
Further, as known in the prior art, the penis can be either erect or limp depending whether it gets more or less blood from arteries. This will depend on blood pressure in

the arteries. When veins in the penis contract, the blood pressure in the arteries will fall to maintain the balance.
The ED drugs only work on the smooth muscle in the penis and not on the entire penis because the penis contains two cigar-shaped structures, called corpora cavernosa (also known in singular as corpus cavernosum) that it uses to become erect. Arteries bring blood into these two tubes, and veins carry blood away from them.
It has been found that the average male has four to eight spontaneous erections every night while he sleeps. They usually occur during the REM stage, when dreaming is most common. When a doctor wants to know whether a patient's difficulty achieving an erection is due to physiological or mental reasons, one way to find out is to fit the patient's penis with a sensor and see whether the patient's dream erections are working properly. If not, the problem is probably physiological.
For erection, the brain sends signals to non-adrenergic non-cholinergic (NANC) cells in the artery. The NANC cells release nitric oxide (NO). Nitric oxide acts as a signaling molecule and stimulates an enzyme called guanylate cyclase in nearby cells. The guanylate cyclase converts a chemical called Guanosine Triphosphate (GTP) into cGMP. cGMP causes muscles in the walls of the arteries to relax. This relaxation increases blood flow. Meanwhile, PDE is decomposing the cGMP and turning it back into GTP. There is a cycle guanylate cyclase turns GTP into cGMP, and PDE turns cGMP into GTP. Nitric oxide is the one that turns this cycle on. The cycle starts because cGMP is produced when the brain sends messages down the nerve fibers in the artery, which generate nitric oxide and keeps the cycle going. When the brain stops sending the

signal, all of the cGMP goes away because PDE is deactivating the cGMP. This way the brain can turn valves on and off whenever it wants to.
When the brain gets sexually aroused, it sends a signal to the penis. Nerve cells in the penis' corpora cavernosa start producing nitric oxide, which leads to the creation of cGMP. The cGMP causes arteries in the corpora cavernosa to dilate, causing increased blood flow into the penis. The extra blood flowing causes the penis to inflate like a balloon and erection occurs. However, one of the most common reasons for ED, especially in older men, is that the arteries in the penis arent dilating enough when the brain sends the signal. The man is aroused and the nerves in the penis are producing nitric oxide, but the amount of cGMP produced isn't enough to maintain an erection.
There are at least three ways for a ED drug to increase blood flow to the penis:
(1) Increase the amount of nitric oxide produced in the penis.
(2) Increase the amount of cGMP produced in the penis in response to the nitric oxide.
(3) Eliminate the PDE in the penis so that the cGMP builds up instead of getting decomposed by the PDE.
One commonly used ED drug is Sildenafil (Viagra) which is an inhibitor of cGMP-specific phosphodiesterase type 5 and enhances the vasodilatory effects of cGMP in the corpus cavernosum and hence is used to treat erectile dysfunction. Note that PDE inhibitors have also been identified as new potential therapeutics in areas such as pulmonary arterial hypertension, coronary heart disease, dementia, depression, and

schizophrenia.The way that Viagra goes about solving the ED problem is described below.
Sildenafil (Viagra) uses Method No. 3 identified above. Sildenafil eliminates the PDE that is decomposing the cGMP, so cGMP builds up in the penis and has a greater effect on the artery walls. The greater the amount of cGMP, the greater the blood flow; the greater the blood flow, the greater the degree of the erection. Sildenafil uses this technique because of a unique behavior of PDE in the human body. The human body has at least 11 different kinds of PDE that it produces, but only one of them, PDE5, is found primarily in the penis. Therefore, selectively blocking PDE5 would directly impact penile dysfunction. With the PDE5 blocked, cGMP could build up in the penis and increase the blood flow there without affecting other parts of the body.
PDE5 is an enzyme that accepts cGMP and breaks it down. ED curative drugs are the chemicals (like Sildenafil citrate) that fit into PDE5 enzyme and disable the enzyme. When a man takes an ED cure drug as OSD„ e.g. sildenafil citrate, the drug flows throughout his body, but it affects only the PDE5 enzyme in the penis. The drug stays in the bloodstream for about four hours, and is then washed out of the blood by the liver and kidneys.
When taken orally by a man, sildenafil citrate enters his entire bloodstream, flows throughout the body and attaches to the PDE5 enzyme in the penis, disabling most of the enzyme. When the man becomes sexually aroused, the brain sends the normal message to nerve cells in his penis, which produce nitric oxide as usual. The nitric oxide creates cGMP, which starts relaxing the arteries in his penis. Since the PDE5 has been disabled,

the cGMP in the penis does not break down. Instead, cGMP builds up and lets the arteries in the penis dilate further. The penis inflates with blood and the man gets a full erection. As discussed above, in order to disable PDE5 in the penis, the drug has to travel through the body from the mouth to the penis when the drug is taken orally. During the passage of the drug through the body, the drug interacts with and affects other organs of the body that may result in side effects. Such interactions with man's organs other than penis and potential side effects from the interactions can be minimized or avoided by simply making the drug available at the site of interest, which is the penis. The at-site availability of the drug to penis can be achieved by using meter dose spray pump, or by using autopsray or gel, or cream formulated by using any ED drug like sildenafil citrate.
Thus, the present invention proposes a topical composition to overcome the above listed limitatiqps.
OBJECTS OF THE INVENTION
The primary object of the present invention is to treat penile erectile dysfunction by the use of non-invasive methodology, in particular the topical administration to the target area.
Another primary object of the invention is to provide a drug composition to use in the non-invasive methodology to treat penile erectile dysfunction, which is applied topically at thgrtarget area.

Another object of the invention is to provide a safe, easy to use as well as handle and an effective drug composition, which acts on the target area in a short time, thereby eliminating the need to consume the drug in well in advance.
Another object of the invention is to provide multivariate delivery methods to treat penile erectile dysfunction, which can be used with the suggested innovative drug composition or. with existing ED drug compositions or in general, combination drugs, to keep the erection of the penis for a desired time.
Yet another object of the invention is to provide a composition for treating penile erectile dysfunction, such that when administered by the non-invasive delivery methods directly to the target area, eliminates the process of the drug traveling through other parts of the body which in turn eliminates phosphodiesterase type 5 (PDE5) production in the penis to help retain sexually aroused erection of penis.
SUMMARY OF THE INVENTION
Before the present invention is described, it is to be understood that present invention is not limited to particular methodologies and materials described, as these may vary as per the person skilled in the art. It is also to be understood that the terminology used in the description is for the purpose of describing the particular embodiments only, and is not intended to limit the scope of the present invention.
The present invention relates to compositions and methods for treating penile erectile dysfunctions, such as male erectile impotence, by delivering the drug directly to the penis. Further present invention discloses the topical compositions and method for

applying the topical composition to the penis, effective for the treatment of penile erectile dysfunctions. Also the composition of the present invention is applied non-invasively thus avoiding the drug traveling through other parts of the body which in turn eliminates phosphodiesterase type 5 (PDE5) production in the penis to help retain sexually aroused erection of penis,
According to the one embodiment of the present invention, an ED drug is provided at a target site of penis to overcome erectile dysfunction. The ED drug is provided to the penis by a meter dose spray, pressurized auto spray, transdermal spray patch, or as micro-emulsion gel. This local administration minimizes the side effects otherwise caused when the drug is administrated OSD.
Such a delivery of the ED drug provides maximum effect in a short time thereby making it easier to use by an individual. In local application, the drug is delivered when a person is sexually aroused. Because it is delivered at the penis, it becomes bioavailable at the site in a relatively short period. The local application makes the treatment easier than taking OSD because the person does not have to anticipate coitus and take the drug in advance for it4o act.
In the present invention, delivering the ED drug to the penis as sustain release or time release alleviates the side effects of the drug. Thus, the present invention displays the ease of the use as well as the increase in user safety by not delivering the drug as OSD thereby avoiding traveling of the drug through the body and its interaction with organs not associated with erectile dysfunction. This makes the present invention safe to use as well as easy to handle.

According to the present invention, the different types of delivery systems mentioned above can be used with existing ED drugs or combination drugs to keep the erection of the penis for a desired time. The present invention also enables the wearing of a condom after spraying or applying the ED drug to the penis.
DETAILED DESCRIPTION
Before the present invention is described, it is to be understood that this invention is not limited to particular methodologies and materials described, as these may vary as per the person skilled in the art. It is also to be understood that the terminology used in the description is for the purpose of describing the particular embodiments only, and is not intended to limit the scope of the present invention.
Before the present invention is described, it is to be understood that unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Further, it is to be understood that the present invention is not limited to the methodologies and materials similar, equivalent to those described herein can be used in the practice, or testing of the present invention, the preferred methods and materials are described, as these may vary within the specification indicated. Unless stated to the contrary, any use of the words such as "including," "containing," "comprising," "having" and the like, means "including without limitation" and shall not be construed to limit any general statement that it follows to the specific or similar items or matters immediately following it. Embodiments of the invention are not mutually exclusive, but may be implemented in various combinations. The described embodiments of the invention and

the disclosed examples are given for the purpose of illustration rather than limitation of the invention as set forth the appended claims. Further, the terms disclosed embodiments are merely exemplary methods of the invention, which may be embodied in various forms.
The present invention relates to a topical composition and methods of applying the said composition for treating penile erectile dysfunctions, such as male erectile impotence. Further, the present invention describes the topical compositions and various non-invasive methods effective for the treatment of penile erectile dysfunctions, such that the active drug of the composition is delivered directly at the targeted area. This helps to eliminate the PDE5 production in the penis, and helps to retain sexually aroused erection of penis, and further avoiding drug traveling through parts of the body other than the penis.
Further, the present invention describes that envisage topical dosage forms of ED drugs can minimize the side effects of oral administration, and provide relatively a consistent drug level at the application site for prolonged periods. Topical delivery vehicles such as creams, gels, sprays, etc. can improve patient compliance due to reduced dosing frequency. The natural barrier for topical delivery is skin, which makes the drug delivery difficult. To improve absorption, the affinity of the drug for the skin is critical. For this purpose, topical dosage forms like metered dose film-forming sprays and micro emulsion gelsjre used.

According to one of the embodiment of the present invention, the metered dose topical spray is a topical solution (Topical Aerosol) made up of a volatile and nonvolatile vehicle comprising the ED drug dissolved as single-phase solution.
In another embodiment of the present invention, metered dose topical sprays form a transparent adherent film so that active ingredient is released in sustained and controlled manner, and film remains in contact with the skin for prolonged pharmacological action.
In yet another embodiment, a metered dose topical spray formulation is formulated with or without the use of propellant to be sprayed on penis. The metered dose topical spray (MDTS) formulations offer advantages of lower skin irritation, greater ease of use, increased dosage flexibility and a simple manufacturing method. A consistent drug level at the penis for required periods is achieved through topical delivery vehicles and can treat the erectile dysfunction with compliance due to required dosing frequency.
In another embodiment, a formulation of the ED drugs is delivered as micro emulsion that is thermodynamically stable and macroscopically isotropic, clear dispersion of two immiscible liquids such as oil and water solubilized and stabilized by surfactant and co-surfactant molecules. Micro emulsions offer several advantages such as better reservoir for poorly soluble drugs, ease of preparation, thermodynamic stability, enhanced drug solubility, controlled release, protection against enzymatic hydrolysis and permeation enhancement ability. In certain embodiments, the micro emulsions provide superior efficacy compared to conventional topical formulations. A composition for topical administration to penis for treating penile erectile dysfunction comprising of*

(a) one or more pharmaceutically active drug ingredient for treating an erectile dysfunction;
(b) One or more solvents;
(c) One or more transdermal permeation enhancers, and
(d) Polymers viz. PVP, HPMC, Methacrylates.
The composition of the present invention, wherein one or more pharmaceutically active drug ingredients are selected from the group consisting of PDE5 Inhibitor (particularly Sildenafil Citrate, Tadalafil, Verdanafil, Avanafil, salts of Sildenafil Citrate, salts of Tadalafil, salts of Verdanafil, salts of Avanafil, Phentolamine, Alprostadil, Steroids, Alpha blocker viz. Phentolamine and its salt form; Vasodilator viz. Alprostadil.
The composition of the present invention wherein one or more solvents are selected from the group consisting of DMSO (10%), Acetone (10-15%), Ethanol (to make up to 100%), acetone, isopropyl alcohol, methylene chloride, methyl-ethyl-ketone, absolute alcohol, ethyl acetate, and trichloro-mono-fluoro-methane.
The composition of the present invention wherein one or more permeation enhancers are selected from the group consisting of lipophilic solvents, surfactants, menthol, fatty acid esters and polyhydric alcohols. Sulphoxides and similar chemicals for e.g. Dimethyl sulphoxides (DMSO), Azones, Alcohols like benzyl alcohol, ethyl alcohol, Polyhydric alcohols including Polyethylene glycols like PEG 400, Propylene glycol, Pyrrolidones like N-methyl-2-pyrolidone, fatty acids and long-chain fatty acids, like oleic acid, Oleyl alcohol, lauric acid, myristic acid, capric acid, isopropyl myristate,

Essential oil, terpenes and terpenoids, like essential oils of eucalyptus, chenopodium and ylang-ylang, Sesquiterpenes; Oxazolidinones such as 4-decyloxazolidin-2-one or urea or combinations thereof.
Further, Nitric Oxide donors like, but not limited to, L-arginine, N-Hydroxy L arginine, Glyceyl trinitrate, Nitroglycerine, S-Nitroso-N-Acetyl Penicillamine, Isoamylnitrite, DiethylaminoNONOate, ProliNO, etc.are also used as one or more permeation enhancers.
The composition further comprises of a film forming polymer, a plasticizer, solubilizer, and humectant.
The film forming polymer is selected from the group consisting of Plastoid B, Eudragit polymers and copolymers, poly vinyl acetate, cellulose acetate, polyvinyl alcohol, povidone, povidone vinyl acetate, hydroxypropyl methyl cellulose, hydroxy ethyl cellulose and methyl cellulose.
The plasticizer is selected from the group consisting of citrate esters, dimethyl isosorbide, castor oil, propylene glycol and polyethylene glycol.
The solubilizer is selected from the group consisting of acrylate and methacrylate ester polymers and copolymers, surfactants, polyhydric alcohols, Vitamin E, Vitamin E TPGS and labrasol.
The humectant is selected from the group consisting of propylene glycol, butylene glycol, polyethylene glycols, glycerol, sorbitol and polyvinylpyrrolidone.

A method of applying composition of the present invention topically to a penis includes a pressurized spray dispenser, micro-emulsion form, Metered Dose Topical Spray (MDTS), wherein MDTS is delivered using a spray container containing the composition of the present invention.
Another embodiment of the present invention describes use of gels or creams, micro-emulsion gels, transdermal spray patch as method for applying the composition of the present invention topically to the targeted area.
Thus, the present invention uses multiple methods for applying the said drug at the targeted site i.e. penis thereby minimizing the side effects of erectile dysfunction drugs experienced when administered orally.
BEST MODE OR EXAMPLES FOR WORKING OF THE INVENTION
The present invention is described in the examples given below; further, these are provided only to illustrate the invention and therefore should not be construed to limit the scope of the invention.
Example 1- Film forming Metered dose topical sprays (MDTS):
The MDTS formulations are developed in the form of a liquid composition of an ED drug and a polymeric solvent system containing at least one penetration enhancer. Drug is dissolved in the solvent system comprising alcohol (e.g. ethanol) and/or a co-solvent (e.g. Acetone) in required proportions (9:1; 8:2; 7:3; 6:4; 5:5, 4:6, 3:7,2:8, 1:9.), permeation enhancer (like menthol or any other enhancers), film forming polymer (e.g., Eudragit) and plasticizer (e.g., Propylene Glycol). A simple pressurized spray is provided

for applying MDTS with the use of propellants. The commercially available Spray containers are used for delivering the accurate amount of drug from container. Example 2- Micro emulsion and Micro emulsion based gels
Micro emulsion formulations are prepared by using oils in which the drug is either solubilized or emulsified in various oils, surfactants and co-surfactants in weight ratios of 9:1, 8:2, 7:3, 6:4, 5:5, 4:6, 5:5, 4:6, 3:7, 2:8 and 1:9 and diluted drop wise with water, under moderate agitation until turbid. The o/w type optimized micro emulsion is then incorporated in hydrated Poloxamer (0.1 to 30 % w/w) to form hydrogel and thickened micro emulsion. Example 3- Micro emulsion Spray
A micro emulsion medicinal spray of one or more ED drugs (selected from Sildenafil Citrate, Tadalafil, Vardanafil, Avanafil, Phentolamine, Alprostadil and combinations thereof or any other combination with steroids) is applied topically on
penis. This medicinal application on penis comprises a volatile vehicle and one or more
film-forming polymers. When sprayed on perns, the composition forms a stable,
breathable film from which the drug is trans dermally available.
Preferably, the composition comprises from about 0.1 % to 30% (weight) of one
or more medicaments, from about 0.1 % to 15 % (weight) film-forming polymer, from
about 0.1 % to 20 % (weight) solubilizer, from about 0.1 % to 12 % (weight) permeation
enhancer, from about 1.0 % to 15 % (weight) plasticizer, and a vehicle. A meter dose
spray dispenser or simple pressurized spray dispenser containing the topical composition
is used to deliver the micro emulsion spray.

Example 4- Use of Penetration enhancer
An antibacterial ED composition for topical administration comprising of about 0.5 to about 10 weight percent of an ED drug;
one to about 30 weight percent of a water-insoluble polymeric composition;
0.5 to about 40 weight percent of a plasticizer which can plasticizes the polymeric composition; and
50 to about 95 weight percent of a solvent in which said polymeric composition and plasticizer are dissolved.
Upon topical application of above ED composition, the solvent will evaporate or penetrate the skin and leaves a thin protective film of polymeric composition that retains the ED compound against the skin.
While considerable emphasis has been placed herein on the specific elements of the preferred embodiment, it will be appreciated that many alterations can be made and that many modifications can be made in preferred embodiment without departing from the principles of the invention. These and other changes in the preferred embodiments of the invention will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.

We Claim,
1. A topical composition for treating penile erectile dysfunction wherein the composition
is applied directly at the targeted area comprising of:
(a) at least one pharmaceutically active drug ingredient for treating an erectile dysfunction;
(b) at least one solvent or solvents;
(c) at least one transdermal permeation enhancers, and
(d) at least one polymer or polymers.

2. The topical composition of claim 1, wherein at least one pharmaceutically active drug ingredient is selected from the group consisting of PDE5 Inhibitor, Sildenafil Citrate, Tadalafil, Verdanafil, Avanafil, salts of Sildenafil, salts of Tadalafil, salts of Verdanafil, salts of Avanafil; Alpha blocker, Phentolamine, Phentolamine and its salt form, Alprostadil, Steroids,; Vasodilator, Alprostadil or combinations thereof.
3. The topical composition of claim 1, wherein at least one or more solvents are selected from the group consisting of sulphoxides, DMSO, ketone solvents, acetate solvents, acetone, alcoholic solvents, ethanol, aldehyde solvents, halogenated solvents and compounds, hydrophenolic solvents, fatty acids, fatty alcohols, esters, ethers, hydrocarbons, isopropyl alcohol, methylene chloride, methyl-ethyl-ketone, absolute alcohol, ethyl acetate, and trichloro-mono-fluoro-methane or any combinations thereof.

4. The topical composition of claim 1, wherein at least one or more permeation enhancers are selected from the group consisting of lipophilic solvents, surfactants, menthol, fatty acid esters, polyhydric alcohols, Sulphoxides , Dimethyl sulphoxides (DMSO), Azones, Alcohols like benzyl alcohol, ethyl alcohol, Polyhydric alcohols, Polyethylene glycols, Propyleneglycol, Pyrrolidones, N-methyl-2-pyrolidone; Naturally occurring or semisynthetic or synthetic phosphatidyl choline compounds and mixtures thereof, Cholesterol, fatty acids and long-chain fatty acids, oleic acid, Oleyl alcohol, lauric acid, myristic acid, capric acid, isopropyl myristate, palmitate,Oils, linseed oil, cottonseed oils, sesame oils, castor oils, coconut oils, palm kernel oils; Essential oil, terpenes and terpenoids oils , essential oils of eucalyptus, essential oils of chenopodium , essential oils of ylang-ylang, Sesquiterpenes; Oxazolidiones, 4-decyloxazolidin-2-one, urea or combinations thereof.
5. The topical composition of claim 1, wherein the said composition further comprises of a film forming"polymer, a plasticizer, solubilizer, and humectant.
6 The topical composition of claim 1, wherein the said film forming polymer is selected from the group consisting of Plastoid B, Methylacrylate, methacrylic acid polymers and copolymers, Eudragit polymers and copolymers, polyvinyl acetate, cellulose, cellulose acetate derivatives, polyvinyl alcohol, povidone, povidone vinyl acetate, hydroxypropyl methyl cellulose, hydroxy ethyl cellulose, methylcellulose or combinations thereof.
7. The topical composition of claim 1, wherein the said plasticizer is selected from the group consisting of citrate esters, dimethyl isosorbide, castor oil, propylene glycol and polyethylene glycol or combinations thereof.

8. The topical composition of claim 1, wherein the said solubilizer is selected from the group of acrylate, methacrylate ester polymers and copolymers, surfactants, polyhydric alcohols, Vitamin E, Vitamin E TPGS, labrasol, Oils, linseed oils, cottonseed oils, sesame oils, castor oils, coconut oils, palm kernel oil, Essential oil, terpenes and terpenoids, essential oils of eucalyptus, essential oils of chenopodium , essential oils of ylang-ylang or combinations thereof.
9. The topical composition of claim 1, wherein the said humectant is selected from the group consisting of propylene glycol, butylene glycol, polyethylene glycols, glycerol, sorbitol, polyvinyl-pyrrolidone or combinations thereof.
10. The topical composition of claim 1, wherein the said composition is applied to the
target area using various non-invasive methods including colloidal, micro-emulsion based
topical sprays; micro emulsion based topical gels, other colloidal based topical
formulations, Metered Dose Topical Spray (MDTS) etc.