FORM 2
THE PATENT ACT, 1970
(39 OF 1970)
AND
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION (See section 10; rule 13)
1 TITLE OF THE INVENTION : Vaginal Applicator
2 APPLICANT(S)
(a) Name: VHB Pharmaceutical Pvt. Ltd.
(b) Nationality: rNDIAN
(c) Address: 40-B/l, Shankar Smruti, Sir Bhalchandra Road, Dadar (E), Mumbai-400 014
3 PREAMBLE TO THE DESCRIPTION
COMPLETE
The following specification
particularly describes the invention
and the manner in which it is to be
performed. :
4 DESCRIPTION (Description shall start from next page)
See the attachment
5 CLAIMS (not applicable for provisional specification. Claims should start with
the preamble - "I/We claim" on separate page)
See the attachment
6 DATE AND SIGNATURE (to be given at the end of last page of specification)
See the attachment
7 ABSTRACT OF THE INVENTION (to be given along with complete specification"
on separate page)
See the attachment
Note-
* Repeat boxes in case of more than one entry
* To be signed by the applicant(s) or by authorized registered patent agent.
* Name of the applicant should be given in full, family name in the beginning.
* Complete address of the applicant should be given stating the postal index no. / code State ad country.
* Strike out the column which is/are not applicable.

Title of invention:
Vaginal Applicator
Field of invention:
This invention relates to a simple device that is used for the application of medicated creams or gels intravaginally.
Background of invention:
Urinary tract infections are very common among females. According to available statistical data/ one among every five women experiences this infection once in their lifetime. Mostly these infections occur due to unhygienic conditions, usage of uncleaned public toilets, infrequent change of sanitary napkins. Microorganisms like E. coli, Chlamydia and Mycoplasma are the known causative agents for urinary tract infections. These infectious diseases can be transferred sexually. They can also cause morbidity, if left untreated.
Some conditions like, Amenorrhoea, Dysfunctional uterus bleeding, Dysmenorrhea and certain menopausal symptoms require hormonal treatments, which are prefered to be administered directly at the site of action i.e. uterus. The application of such drugs are inconvient or uncomfortable to the pateints. Moreover proper sanitation for prevention of reoccurance is necessary. Treatnent of infectious diseases require proper care and hygienic practices. Hence certain sanitory methods are provided for easy application of medicines and effective treatment of such diseases or disorders.
A vaginal applicator can be used to apply intravaginally. The vaginal applicators presently used, are single use and are disposible. But these applicators does not deliver drugs effeciently or completely. Hence an applicator which can deliver

drug with less retention and has provision for applying the drug in the surrounding uterine wall is required.
Description:
This invention is a simple vaginal applicator, which is used for application of semisolid medicaments intravaginally. The applicator provides easy drug application with more patient compliance. The vagina is normally inhabited by numerous microorganisms. Due to unhygienic conditions and hormonal imbalances, there high chances of a woman suffering from various vaginal diseases or hormonal disorders. Various bacterial infections are caused in the vaginal area as it has most susceptible environmental conditions for their growth. Bacterial vaginosis, vaginal yeast infection, Trichomoniasis and various fungal infections like Candidiasis or thrush are the most prevalent infectious diseases. Chlamydia and gonorrhoea are most common sexually transmitted infections.
Besides these infectious diseases there are many other hormonal products that are supposed to be applied intravaginally like estrogens and progesterone. These hormonal products are basically used to facilitate endometrium growth thereby supporting the implanted embryo and also maintain pregnancy.
These drugs are generally applied directly into the site of actions i.e. uterus. The direct application provides better and faster absorption of the drug, thereby eliminating the first pass effect and other metabolism. This in turn enhances the pharmacokinetics and increases the potency of the drug.
To aid the drug administration into the site of action, a simple device i.e. a vaginal applicator is used. For improvising patient compliance and assisting easy administration of the drug, a smooth, simple device is invented.

This invention has multiple apertures that are aligned in particular angle so as the drug can penetrate at faster rate and can be applied to the surrounding uterine walls too.
The applicator is a single use, disposable applicator as it can be the source of reoccurrence of the infection if reused. This invention provides an easy and better administration of medicaments.

Detail Description of the Invention:
This invention relates to a device, which is used for intravaginal application of medicament. This device is a simple, unique applicator, which contains pre-filled drugs in the form of creams or gels. (Fig: 1)
This invention consists of drug previously filled in it. The applicator has to be inserted in to the vaginal cavity up to a certain level. As the applicator reaches the site of action, the plunger of the device has to be pushed to so as the drug expels out of the applicator to the site of action. As the plunger is pushed, entire drug gets expelled out and the plunger head locks the barrel thereby disabling it for reuse (Fig: 2). This design is especially made to avoid the reuse of the applicator and to maintain hygienic conditions.
The present invention consists of two parts: (As Shown in Fig: 1)
1. Barrel (1,2)
2. Plunger (3, 4, 5)
1. Barrel:
The barrel of the device is a simple, cylindrical shaped hollow tube (2). It made of medical grade plastic. The barrel consists of drug in a gel or a cream formulation. It has curved smooth tip (1), which provides painless introduction of medicaments into the vaginal cavity. The tip of the tube consists of several small apertures (Fig: 3). There is a central aperture, which has big diameter than the several smaller apertures surrounding it. The no. of small apertures range from 2 - 10. This arrangement makes the system relatively zero hold - up device. Thereby, it reduces the wastage percentage and enhances delivery percentage of the drug. The barrel tip is covered with a screw cap, which has to be removed while usage.
2. Plunger:

The plunger is made of three parts (As shown in Fig 1):
a. Plunger head (3)
b. Plunger handle (4)
c. Plunger end (5)
The plunger head is made of silicon and has curved surface, therefore it moves easily and smoothly. This facilitates easy application of drugs with application of less force. Once the plunger is pushed inside the barrel, the silicon plunger head gets stuck inside it, thereby allowing only single usage of the device. The curved surface of the plunger head allows expulsion of the entire contents of the barrel. The plunger head is detachable from the plunger. (Fig: 4, 5) It is fitted to a tip, which is an extension of the plunger handle, The plunger head has a cavity in which the tip of the plunger is fixed. The plunger head loosely fits on it. Hence when the plunger is moved out of the barrel, the plunger head gets detached from it and is stuck inside the barrel, thereby making the device non reusable. At the end of the plunger handle is a wide flat base known as plunger end. The plunger end is circular and has bigger diameter than plunger handle, which is provided for smoothly pushing it. The plunger sealingly seats within the barrel and smoothly displaces the gels or creams.
Precisely, this invention has four detachable components - the cap, the barrel, the plunger, and the silicon plunger head. The applicator can be easily assembled. The filling of applicator can be done easily. The barrel diameter is ranging from 20mm - 30mm, which enables easy and painless insertion into the vaginal cavity. The device has no sharp edges. It has smooth surfaces and curved tips.
The device is made of biocompatible materials which are pharmacologically inert. Additionally, they are sterilizable and nontoxic. The screw cap is removed and the applicator is inserted into the vagina and the plunger is pushed with slight application of force. As the plunger moves into the barrel, the dose expels

out through the apertures at tip of the applicator. As the drug is facilitated to expel through various cavities, the time required to administer the dose decreases, the area in contact with the drug increases. This intum facilitates, increase in absorption rate, and onset of action in quicker. As there are many apertures, the drug retention decreases, this inturn decreases the drug loading dose and reduces drug wastage.
Fig: 1 - represents the vaginal applicator - 1 - tip of the barrel, 2- barrel where
drug is filled, 3 - plunger head, 4- plunger handle, 5 - plunger end.
Fig: 2- represents the vaginal applicator after expulsion of drug .
Fig: 3 - represents the front view of the tip of the barrel - where there is a big
central aperture and several smaller apertures sirrounding it.
Fig: 4 - dettached plunger head.
Fig: 5 - plunger without plunger head - 4- plunger handle, 5- broad plunger end
for easy administration, 6 - elongated tip of plunger handle for fixing into the
cavity of plunge head.

Summary:
This invention is a vaginal applicator, which is used for application of semisolid dosage forms intravaginally. Vaginal applicators are used in order to apply the drug at the site of action directly for faster onset of action. Applying drug directly on the site of action eliminates metabolism of the drug by first pass effect and also lowers the dose requirements. This invention facilitates easy application of medicaments without any inconvience or unhygenie conditions. The applicator has several drug opening at its tip, which enables quicker release of the drug. The drug retention is less in this applicator as it has several apertures for drug explusion.
This invention has four detachable components - the cap, the barrel, the plunger, and the silicon plunger head. The device is made of biocompatible materials which are pharmacologically inert. Additionally, they are sterilizable and nontoxic. The applicator has smooth surfaces as well as curved edges so as the drug is administered painlessly. The applicator has to be inserted into the vaginal cavity upto certain level. Then the plunger is pushed into the barrel, which inturn displaces the drug from it. The drug is uniformly expelled out in all directions. The drug retention in the barrel is negligible. Therefore the drug loading quantity decreases. The plunger sealingly, seats into the barrel. The device is made for single use only. The drug is pre filled in the applicator. This provides to maintain more hygenic conditions.

Objective of the device:
1. The main objective of this invention is to provide easy to use and safe application of intravaginal medicaments.
2. To make an applicator for delivering maximum medicament into the site of application with less amount of drug hold -up.
3. To make an applicator, which provides a visually assesment regarding the delivery of medicament,
4. To make an applicator having greater patient compliences.

We Claim:
1. 'Vaginal Applicator' is a device which consists of :
a screw cap, a barrel, a plunger and a silicon plunger head,
which is used for application of semisolid dosage forms intra vaginally.
2. 'Vaginal Applicator ' of claim 1 wherein said the barrel tip has several apertures for expelling the drug thereby reducing the drug retention in the barrel.
3. 'Vaginal Applicator ' of claim 1 wherein said the plunger sealably seats in the barrel and smoothly displaces the drug when pushed with slight force.
4. 'Vaginal Applicator ' of claim 1 wherein said the plunger head self locks the device after the entire drug is delivered.

5. 'Vaginal Applicator ' of claim 1 wherein said the barrel has smooth surface and curved edges.
6. 'Vaginal Applicator ' of claim 1 wherein said the barrel, the cap and the plunger is made of biocompatible and pharmacologically inert materials.
7. 'Vaginal Applicator ' of claim 1 wherein said the device is sterilizable.
8. 'Vaginal Applicator ' of claim 1 wherein said the barrel is a reservoir for the drugs to be administered.
9. 'Vaginal Applicator ' of claim 1 and claim 8 wherein said the internal diameter of the barrel ranges from 20mm to 30mm.

10. 'Vaginal Applicator ' of claim 1 and claim 2 wherein said the number of cavities in the barrel tip ranges from 2 - 10.
11. 'Vaginal Applicator ' of claim 1, claim 2 and claim 10 wherein said the diameter of centeral aperture is more than the diameter of the adjacent apertures.
12. 'Vaginal Applicator' of claim 1, claim 2 , claim 10 and claim 11 wherein said the centeral aperture has internal threadings for fixing the screw cap.
13. 'Vaginal Applicator ' of claim 1 and claim 3 wherein said the plunger of the device has three components:
the plunger head, plunger handle and plunger end.
14. 'Vaginal Applicator ' of claim 1, claim 3 and claim 12 wherein said the plunger head is detachable and is loosely fitted on the enlongted tip of the plunger handle.
15. 'Vaginal Applicator ' of claim 1, claim 3, claim 12 and claim 13 wherein said the plunger head gets detached from the plunger and gets stuck in the barrel when pulled in reverse direction, thereby making the device non reusable.
16. 'Vaginal Applicator ' of claim 1, claim 3, claim 12 and claim 13 wherein said the plunger head has smooth curved tip, which fits exactly to the inner curve of the barrel tip.
17. 'Vaginal Applicator ' of claim 1, claim 3 and claim 12 wherein said the plunger handle has an extension, which fits into the cavity of plunger head at one end and a broad plunger end at the other end.

18. 'Vaginal Applicator ' of claim 1 and claim 13 wherein said the plunger end may be of various shapes for e.g. circle, square, triangle etc.
19. 'Vaginal Applicator ' of claim 1, claim 13 and claim 18 wherein said the plunger end is of circular shape and has broad surface.
20. 'Vaginal Applicator ' of claim 1, claim 2 wherein said the barrel is of cylindrical shape and has rounded edges at the tip where sereval small apertures are present.