Claims:CLAIMS

We claim,
1. A medicated vaginal douche kit comprising,
a) Povidone Iodine solution in an concentrate bottle,
b) An Applicator,
c) A squeeze bottle,
d) Instructions which comprise storage information for the composition, dosing information and instructions regarding how to administer the composition.

2. The medicated vaginal douche kit as claimed in claim 1 wherein the concentration of Povidone Iodine solution is selected from 1 to 20 % w/v.

3. The medicated vaginal douche kit as claimed in claim 1 wherein the applicator is anatomically shaped, made up of rigid material such as polystyrene, silicone, hard plastic, high density polyethylene or medical grade PVC.

4. The medicated vaginal douche kit as claimed in claim 1 wherein the squeeze bottle is 100-200 ml bottle, made up of material such as polystyrene, silicone, plastic, low density polyethylene or medical grade PVC.

5. The medicated vaginal douche kit as claimed in claim 1 wherein the method of application comprises
i. Pouring 15 ml of Povidone-Iodine vaginal solution into the squeezable douche bottle up to the first line,
ii. Adding lukewarm water up to the water fill line,
iii. Attaching nozzle to douche bottle and mixing by shaking, holding bottle straight until ready to use,
iv. Inserting nozzle about three inches into the vagina, holding douche bottle so as to provide proper flow of contents, squeezing douche bottle on both sides,
v. Rinsing out the douche bottle and nozzle and letting them drain dry.

6. The medicated vaginal douche kit as claimed in claim 1 for treating bacterial, viral, fungal, protozoal and yeast infection, any specific or unspecific vaginitis, all mixed infection including chlamydia, mycoplasma, herpes, Candida albicans (Monilia), Trichomonas vaginalis and pre-operative disinfection of the vagina.

Dated this 03rd February, 2021
, Description:Form 2
The Patent Act 1970
(39 of 1970)
&
The Patent Rules, 2003
COMPLETE SPECIFICATION
(see section 10 and rule 13)
1. TITLE OF THE INVENTION

MEDICATED VAGINAL DOUCHE KIT
2. APPLICANT(S)

(a) NAME: WESTCOAST PAHRMACEUTICLS WORKS LTD

(b) NATIONALITY: INDIAN

(c) ADDRESS: MELDI ESTATE, NEAR PRASANG PARTY PLOT, OPP. SOLA BHAGWAT, SAYONA CITY ROAD, GOTA, AHMEDABAD-382481, GUJARAT, (INDIA).
3. PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention and the manner in which it is to be performed.

MEDICATED VAGINAL DOUCHE KIT

FIELD OF THE INVENTION
This present invention relates to medicated vaginal douche kit comprising Povidone Iodine solution providing complete broad spectrum microbicidal activity against all pathogenic organisms which commonly cause vaginal infection.

BACKGROUND OF THE INVENTION
Povidone-iodine is a complex of molecular iodine with polyvinyl pyrrolidone. Povidone iodine powder contains approximately 85% povidone, 10% I and 5% iodide. A 10% solution of this powder contains 1% free, available iodine. Povidone-iodine is called iodophore which means povidone acts as a carrier of iodine. Iodine is considered as the active moiety that mediates microbicidal actions.

Povidone iodine is a kind of iodine disinfectant which directly cause in vivo protein denaturation, precipitation of bacteria, and further resulting in the death of pathogenic microorganisms. Therefore, it is effective in disinfection and sterilization. It can kill viruses, bacteria, spores, fungi, and protozoa with low toxicity to human. Povidone-iodine aqueous solution has strong pharmacological activity against Staphylococcus aureus, Neisseria gonorrhoeae, Pseudomonas aeruginosa, syphilis, hepatitis B virus, HIV, and Trichomonas vaginalis.

Povidone iodine can kill common gram-positive cocci, enterobacteria, gram-negative bacilli, spores, viruses, spirochetes, anaerobes, vibrio and other pathogenic bacteria. And there are few drug resistance reactions and the bacteria killing effect is better. But povidone-iodine has the same general laws as other chemical disinfectants. Within a certain range, as the effective iodine content increases and the action time extends, its bactericidal effect increases. However, after the effective iodine of the iodine-containing disinfectant reaches a certain concentration, its bactericidal effect is limited. In particular, even if the concentration of the iodophor disinfectant increases, its ability to kill bacterial spores is not significantly enhanced. Povidone-iodine has a wide range of uses. It is often used for disinfection of surgical sites, skin and mucous membranes.

Povidone iodine gel is a gynecological topical semi-mobile colloidal agent made by povidone iodine and hydrophilic matrix. It is a system for maintaining its sustained release. Owing to the continuous release of free iodine, it can enable the skin and mucous membranes to maintain a certain effective concentration of iodine for killing bacteria. It is mainly used for gynecological vaginal infection. It exerted its effect through being miscible with vaginal secretions and further killing the inside pathogenic microorganisms, and thus blocking the spread of sexually transmitted diseases and invasion, as well as treating other infected vaginal diseases caused by other kinds of bacteria. The prior art discloses various preparations of povidone iodine, including tablets, oral liquids, gels, ointments and suppositories.

CN102552104A discloses a gel for treating vaginitis consisting of povidone iodine, potassium iodate, glycerol, hydroxypropyl methylcellulose and purified water.

USOO5545401A discloses a virucidal, spermicidal vaginal gel consisting essentially of water, Povidone and iodine wherein the weight ratio of povidone to iodine is at least 15 to 1 and wherein the povidone contains between 1 and 25 percent povidone having a molecular weight at least as low as 20 kd, said gel having a viscosity such that a conical body drawn from said gel does not visibly slump for a period of about one minute at 37 degrees celsius.

CN102335120 discloses a povidone iodine effervescent suppository comprising povidone iodine, sodium hydrogencarbonate, tartaric acid, S-40, polyethylene glycol 6000.

CN111150712A discloses an effervescent tablet containing povidone iodine, an acidic reagent selected from sodium benzoate, L-cysteine and citric acid an alkaline reagent selected from sodium bicarbonate, A kind of potassium hydrogen phosphate, polyethylene glycol 4000 and other excipients.

CN105920650A discloses a gynecological medical sponge which is prepared from the following raw materials: povidone iodine, sodium carboxymethyl cellulose, polyvinyl alcohol, glycerol glycidol Ether, water soluble biopolysaccharide, povidone and water.

CN1528341A discloses a povidone iodine foam preparation for gynecological inflammation made up by combining two medicines with four macromolecular compounds, and its composition contains (wt%) pharmacodynamic component povidone iodine 0.2-10, borneol 0.01-10, film-forming agent ketopyrrolidine polymer 0.5-10, emulfier fatty alcoholpolyoxyethylene ether 5-10, sodium ether carboxylate 0.5-10 and acidity regulating agent sodium citrate 0.1-2.

US2014134246A1 discloses a rapid dissolve vaginal tablet compositions in the form of rapid dissolve microgranules wherein said pharmaceutical composition rapidly disintegrates upon insertion into the vaginal cavity of a patient or subject forming a viscous drug-containing suspension that rapidly, widely spreads coating the vaginal mucosa.

US5244096A discloses a prophylactic kit for use in connection with sexual intercourse and related intimate contacts between partners, which comprises: a sealed enclosure, and therein: a condom; a first container holding a quantity of a first liquid solution of povidone- iodine; a second container holding a quantity of a second liquid solution of a microbicidal agent taken from a group consisting of povidone- iodine, chlorhexidine gluconate and sodium propionate; wherein said first solution is formulated for topical applications, and said second solution is formulated for use as a mouthwash; and written indications and instructions for use of the kit before and after said sexual intercourse and related intimate contacts.

KR101235370B1 discloses a cleaning composition for vaginitis symptom relief comprising 200 to 450 parts by weight of glucose, 3 to 20 parts by weight of a calcium salt, and 3 to 20 parts by weight of a ginseng extract as an active ingredient per 100 parts by weight of sodium chloride. A vaginal cleaning kit comprising the composition and a vaginal washer.

EP0338589A2 discloses a prophylactic kit for use in connection with sexual intercourse and related intimate contacts to prevent transmission of infectious diseases from one partner to another which comprises a sealed enclosure containing: a plurality of individually packaged germicidal solutions; a condom; and at least one solution applicator.

US4925033A discloses a prophylactic kit for use in connection with sexual intercourse and related intimate contacts between partners, which comprises: a sealed enclosure, and therein: a condom; a first container holding a quantity of a first liquid solution of povidone- iodine; a second container holding a quantity of a second liquid solution of povidone- iodine; wherein said first solution is formulated for topical applications, and said second solution is formulated for use as a mouthwash; and written indications and instructions for use of the kit before and after said sexual intercourse and related intimate contacts.

WO2019147937A1 discloses a kit for treating vaginal dryness. The kit comprises a hand held applicator and a dispenser or receptacle storing a vaginal care composition.

US2018280672A1 discloses a vaginal detoxing kit comprises a vaginal insert apparatus and a hollow tube.

CA2577350A1 discloses a kit comprising one or more vaginal applicators and a pharmaceutical vaginal cream composition comprising a conjugated estrogen in an amount sufficient for treating a menopausal condition in a female in need thereof.

US2006154375A1 discloses a self-triage kit for evaluating vaginal discharge comprising an absorbent member having a constant diameter; an applicator at least partially enclosing the absorbent member and a pH indicator contacted with fluid collected from the lower portion of the user's vagina.

Under normal circumstances, the vagina often contains a certain amount of "beneficial bacteria" such as "Lactobacillus, Bifidobacterium, and Eubacteria". In the dynamic process of maintaining normal vaginal micro-ecological balance, Lactobacillus, Bifidobacterium and Bacillus. These three types of beneficial bacteria account for more than 60% of the total bacteria in the vagina, which can effectively inhibit the development and reproduction of harmful bacteria, and play a controlling role in regulating the balance of the vaginal flora. As the absolute dominant flora in vaginal flora, Lactobacillus can resist the colonization and overgrowth of endogenous and exogenous pathogens, maintain the balance of normal vaginal flora and prevent vaginitis, and also affect urinary tract infection and sexuality. The prevention and treatment of communicable diseases also play an important role.

At present, the traditional treatment methods after the onset of gynecological diseases in the market are the extensive use of broad-spectrum antibacterial drugs. This method, while resisting harmful bacteria, also eliminates the beneficial bacteria, and seriously destroys the "bacterial balance" of the vagina. The function of vaginal self-protection has been greatly reduced, and various "harmful bacteria" have taken over and multiplied, resulting in repeated infections and repeated attacks of various gynecological diseases.

In order to solve the problem of repeated infection the present invention provides a medicated vaginal douche kit comprising Povidone Iodine solution, an applicator and a squeeze bottle for self-application and better patient compliance.

OBJECTIVE OF THE INVENTION
The main objective of the present invention provides a medicated vaginal douche kit comprising Povidone Iodine solution providing complete broad spectrum microbicidal activity against all pathogenic organisms which commonly cause vaginal infection.

Another objective of the present invention provides a medicated vaginal douche kit comprising Povidone Iodine solution in a concentrate bottle, applicator and a squeeze bottle.

Another objective of the present invention provides a medicated vaginal douche kit comprising Povidone Iodine solution to provide higher patient compliance, better cleansing action as compared to other solid and semisolid vaginal dosage forms and ease of administration

Another objective of the present invention provides a medicated vaginal douche kit comprising Povidone Iodine solution maintaining microbicidal activity in the presence of blood, pus and vaginal secretions.

Another objective of the present invention provides a medicated vaginal douche kit for treating bacterial, viral, fungal, protozoal and yeast infection, any specific or unspecific vaginitis, all mixed infection including chlamydia, mycoplasma, herpes, Candida albicans (Monilia), Trichomonas vaginalis and pre-operative disinfection of the vagina.

SUMMARY OF THE INVENTION
The main aspect of the present invention provides a medicated vaginal douche kit possessing Povidone Iodine solution providing complete broad spectrum microbicidal activity against all pathogenic organisms which commonly cause vaginal infection.

Another aspect of the present invention provides a medicated vaginal douche kit comprising Povidone Iodine solution in a concentrate bottle, applicator and a squeeze bottle.

Another aspect of the present invention provides a medicated vaginal douche kit for treating bacterial, viral, fungal, protozoal and yeast infection, any specific or unspecific vaginitis, all mixed infection including chlamydia, mycoplasma, herpes, Candida albicans (Monilia), Trichomonas vaginalis and pre-operative disinfection of the vagina.

BRIEF DESCRIPTION OF THE DRAWING
Figure 1: Povidone Iodine solution in a concentrate bottle, an Applicator and a squeeze bottle
Figure 2: Method of preparation and application of the Povidone Iodine solution; A Pouring Povidone-Iodine vaginal solution into the squeezable douche bottle; B Adding lukewarm water up to the water fill line; C Inserting nozzle about three inches into the vagina, holding douche bottle so as to provide proper flow of contents

DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to medicated vaginal douche kit containing Povidone Iodine solution for treating vaginal infections.

Vaginal infections can cause vaginal discharge, discomfort, and vaginal odor. However, these symptoms do not necessarily indicate an infection. Instead, they may result from other conditions that affect the vagina. For example, chemicals or other materials (such as hygiene products, bubble bath, laundry detergents, contraceptive foams and jellies) can irritate the vagina and cause a discharge and discomfort. The inflammation that results is called noninfectious (inflammatory) vaginitis. A vaginal discharge may be caused by a disorder that affects other reproductive organs, rather than the vagina. For example, a discharge can result from certain sexually transmitted diseases such as chlamydial infection or gonorrhea. The bacteria that cause these diseases can spread from the vagina to the cervix (the lower, narrow part of the uterus that opens into the vagina) and the uterus, causing pelvic inflammatory disease. Genital herpes, which can cause blisters on the vulva (the area around the opening of the vagina), in the vagina, and on the cervix, can also cause a vaginal discharge.

Vaginal infections may be caused by bacteria, yeast, and other microorganisms. Certain conditions make infection more likely: Reduced acidity (increased pH) in the vagina: When acidity in the vagina is reduced, the number of protective bacteria (lactobacilli) that normally live in the vagina decreases, and the number of bacteria that can cause infection increases, sometimes resulting in bacterial vaginosis, Tissue damage: If tissues in the pelvis are damaged, the body’s natural defenses are weakened. Damage can result from tumors, surgery, radiation therapy, or structural abnormalities such as birth defects or fistulas. Fistulas are abnormal connections between organs, which may, for example, allow the intestine’s contents (which include bacteria) to enter the vagina, Irritation: Irritation of vaginal tissues can lead to cracks or sores, which provide access to the bloodstream for bacteria and yeast.

Vaginal infections with bacterial vaginosis, candidiasis and trichomoniasis are a global health problem for women. Vaginitis is the inflammation and infection of vagina. Bacterial vaginosis, candidiasis and trichomoniasis are responsible for majority of vaginal infections in women of reproductive age.

Candida vaginitis (CV) is one of the most frequent infections in women of reproductive age. Approximately 75 % of adult women will have at least one episode of vaginitis by candida during their life time. Unfortunately, about 40 – 50 % of women who had a first episode is likely to present a recurrence and 5 % may present a form of “recurring” characterized by at least three or more episodes of infection per year

Trichomonal vaginitis (TV) is the most common sexually transmitted disease. It is caused by a parasitic protozoan T. vaginalis. Globally, TV affects approximately 57–180 million people, with the majority living in developing countries. However, in most cases TV is asymptomatic. In women, TV affects more frequently between 20 and 40 years old and is quite rare before puberty and postmenopausal age. The symptoms of TV are mainly characterized by vaginal discharge with gray or greenish-yellow fluid rather frothy, foul-smelling, intense itching, edema cervix redness, the sensation of itching, dyspareunia and postcoital bleeding, pelvic pain and urinary symptoms.

Bacterial vaginosis (BV) is the most common cause of abnormal vaginal discharge among women of reproductive age. The prevalence of BV is about 30 % in women of reproductive age. BV is characterized by raised vaginal pH and milky discharge in which normal vaginal flora (Lactobacilli) is replaced by a mixed flora of aerobic, anaerobic and microaerophilic species. Anaerobic organisms like Gardnerella vaginalis, Prevotella spp., Mycoplasma hominis, Mobiluncus spp. colonize vagina predominantly in BV.

Aerobic vaginitis has been identified for a smaller proportion of women whose microbiota (lactobacilli) is dominated by facultative anaerobic or aerobic bacteria especially S. aureus, group B streptococci, E.coli and Klebsiella spp.

Vaginal infections are associated with a significant risk of morbidity in women. If untreated they can lead to pelvic inflammatory disease (PID), which can cause long-term sequelae, such as tubal infertility, ectopic pregnancy, reproductive dysfunction and adverse pregnancy outcomes (e.g., preterm labor and delivery and low birth weight). Cervical dysplasia, increased risk of postoperative infection, HIV and Herpes simplex virus (HSV)-1 acquisition and transmission are also resulted from vaginal infections. Moreover, BV propagates viral replication and vaginal shedding of the HIV and HSV-2.

Main embodiment of the present invention provides a medicated vaginal douche kit containing Povidone Iodine solution providing complete broad spectrum microbicidal activity against all pathogenic organisms which commonly cause vaginal infection.

Numerous dosage forms or large number of intra-vaginal delivery systems are available in form of tablets, suppositories, creams, gel, ointment, ring, powder and films. These are the formulations which are designed to dissolve in the vaginal cavity and discharge the active components over an extended period of time. These suppositories are mainly intended for localized effects primarily as contraceptives, antiseptics and anti-fungal. Binders, disintegrant and additional excipients are obtainable in vaginal tablets. Itraconazole, clotrimazole and prostaglandins are some drugs that are directed as vaginal tablets. Absorption of drug from a vaginal formulation is decreased by the presence of aqua-phobic and release impeding materials. Highly aqua-phobic drugs might not be appropriate for vaginal tablets. Polystyrene sulfonate (PSS) is developed in the form of vaginal tablet as it shows highly or superior anti-microbial activity in contradiction of HIV and HSV. Presence of diffusion enhancers like surfactants and bile salts can considerably enrich the absorption of drugs in vagina.

The manufacturing process of vaginal bioadhesive controlled release matrix tablets consist of the preparation of a matrix mixture comprising the pharmaceutically acceptable excipients. The release mechanism is based on drug diffusion through the swollen polymers and progressive erosion /dissolution of the gel matrix. The controlled-release properties of the vaginal tablets may be modified by the presence in the dosage form of soluble and insoluble fillers and by their weight ratio.

Vaginal films are polymeric drug delivery systems shaped as thin sheets, usually ranging from 220 to 240 micrometer in thickness. These systems are often square (approximately 5cm X 5cm), colourless and soft, presenting a homogenous surface. Vaginal films are produced with polymers such as polyacrylates, polyethylene glycol, polyvinyl alcohol and cellulose derivatives. A bioadhesive hot-melt extruded film is used for topical and mucosal adhesion applications.

Another preferred embodiment of the present invention provides a medicated vaginal douche kit comprising Povidone Iodine solution in a concentrate bottle, applicator and a squeeze bottle and instructions which comprise storage information for the composition, dosing information and instructions regarding how to administer the composition.

As per one embodiment, the present invention provides Povidone Iodine solution wherein the concentration of Povidone Iodine is selected from 1 to 20 % w/v.

Pessaries are solid, single dose preparations. They have various shapes, usually ovoid, with a volume and consistency suitable for insertion in to the vagina. They contain one or more active substances dispersed or dissolved in a suitable bases that may be soluble or dispersible in water or may melt at body temperature. Vaginal suppositories or Pessaries weigh about 3-5gm and are molded in globular or oviform shape or compressed on a tablet press into conical shapes. Pessaries are a type of suppository intended for vaginal use.

Creams, gels and foams are used for current distribution of contraceptives and anti-bacterial drugs. These dosage forms are very difficult and hard to apply and uncomfortable when they leak or spread into the cloth. Due to non-uniform distribution and leakage creams and gels might not deliver an exact dose. Desired properties of gels and creams are conventional and viable in vaginal administrations. The prerequisite for gels, foams and creams used in vaginal formulations should be tranquil to use, non-toxic and non-irritating to the mucous membrane.

The vaginal ring is a torous or circular shaped device which is made up of silicone elastomers which owing to its elastomeric properties exert a slight tension on vaginal walls. The factors governing the release rate from the ring are its design, solubility of drug in the elastomers and the molecular weight of the drug. They are 5.5 cm in diameter with a circular cross section diameter of 4-9 mm, where drugs are homogeneously dispersed. Drugs at the surface of the ring release faster than the drug in the inner layer. The key challenge behind the development of this type of device is finding the optimum dose that will deliver the least amount of drug necessary to ensure protection

The advantages of Povidone Iodine Vaginal Douche of present invention as compared to the other available conventional dosage forms creams, ointment, suppositories, gel, tablet is as below:
1. Less messy and comfortable as compared to the creams, ointments, gel, suppositories, tablet, rings and powder.
2. Better Cleansing action as compared to other solid and semisolid vaginal dosage forms
3. Easy to use and administer with the help of applicator squeeze bottle
4. No itching, burning or swelling
5. Higher Patient Compliance

Also the conventional dosage forms known in the prior are very difficult and hard to apply. To overcome these problems of the prior art the present invention provides a medicated vaginal douche kit comprising Povidone Iodine solution in a concentrate bottle, applicator and a squeeze bottle and instructions for administering the Povidone Iodine solution.

As per another embodiment, the present invention provides vaginal douche kit wherein the Applicator is anatomically shaped as represented in figure 1 which helps in ease of administration of the Povidone Iodine solution.

As per another embodiment, the present invention provides the applicator made up of rigid material such as polystyrene, silicone, hard plastic, hard plastic, high density polyethylene or medical grade PVC.

As per another preferred embodiment the applicator is anatomically shaped made up of hard plastic or medical grade PVC which is firm enough to maintain integrity of the applicator when it is inserted into the vagina.

As per another embodiment, the present invention provides vaginal douche kit wherein the squeeze bottle may be of the capacity of 100-200 ml bottle made up of material such as polystyrene, silicone, plastic, low density polyethylene or medical grade PVC.

As per another preferred embodiment, the present invention provides the method of application of the medicated vaginal douche comprising steps
i. Pouring 15 ml of Povidone-Iodine vaginal solution into the squeezable douche bottle up to the first line,
ii. Adding lukewarm water up to the water fill line,
iii. Attaching nozzle to douche bottle and mixing by shaking, holding bottle straight until ready to use,
iv. Inserting nozzle about three inches into the vagina, holding douche bottle so as to provide proper flow of contents, squeezing douche bottle on both sides,
v. Rinsing out the douche bottle and nozzle and letting them drain dry.

Another preferred embodiment of the present invention provides a medicated vaginal douche kit for treating bacterial, viral, fungal, protozoal and yeast infection, any specific or unspecific vaginitis, all mixed infection including chlamydia, mycoplasma, herpes, Candida albicans (Monilia), Trichomonas vaginalis and pre-operative disinfection of the vagina.