FORM 2
THE PATENT ACT 1970
(39 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. TITLE OF THE INVENTION
A PHARMACEUTICAL TOPICAL DRUG APPLICATOR
2. APPLICANT (S)
(a) NAME: LINCOLN PHARMACEUTICALS LIMITED
(b) NATIONALITY: an Indian Company
(c) ADDRESS: Nirav complex,
Opp Navrang High School, Naranpura, Ahmedabad-380014. Gujarat State, India.
3. PREMABLE TO THE DESCRIPTION

PROVISIONAL
The following specification describes the invention.

COMPLETE
The following specification particularly describes the invention and the manner in which it is to be performed.

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The present invention relates to a pharmaceutical topical drug applicator.
The main object of the present invention is to offer novel, refreshing proposal for the topical treatment of disorders. In the present invention an applicator for pharmaceutical topical drug is prepared.
The state of prior art:
Most pharmaceutical formulations are available in the form of tablets, capsules and liquids. Health care professionals prescribed particular drug, strength and dosing intervals. When a doctor diagnosis a diseased condition and prescribes a topical treatment such as a cream, ointment, lotion, liquid, etc, precision dosing is more difficult.
Generally creams, gel and ointments are packaged in a tube or jar so it is difficult for patient to determine exact dose. However it may be prescribed that how many times one should apply that particular formulation but its amount is very difficult to prescribe. As a result of that it would be too little dose or too much. If to little dose is applied it will not treat disease condition within proper time and if too much dose is applied it might cause side effect.
Another problem associated is that when a topical formulation is dispensed from a tube for the application the patient or caregiver taking the formulation in their hand and applying it to the affected area. In such situation some of the
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amount can absorbed into the skin of person who is applying the formulation on the affected area. This can be avoided by wearing a glove during application. Another problem of the hand application is that drug can be absorbed to an area that is not intended to be so it may cause toxicity or produce undesirable side effects. Many people find gloves are uncomfortable and allergic.
Many patients do not concentrate on cleanliness and sanitization of their hands prior to application of topical drug formulation which can lead to spread of microbes.
It has also been known to deliver therapeutic agents transdermally by applying to the skin of a patient an adhesive patch containing a therapeutic agent. Such patches have typically further included a rate-moderating membrane, an adhesive, a liner and a backing material. The adhesive has often required special formulation to ensure compatibility with the other components of such patches and this type of formulation has often increased the cost of such patches. Furthermore, not all therapeutic agents are suitable for inclusion in such patches for many reasons, such as stability, absorption, etc.
US 6,723,337 relates to a transdermal drug delivery system for anti-Inflammatory analgesic agent comprising diclofenac diethylammonium salt, wherein a backing film (1), a matrix layer (2) containing active ingredients, a

release liner (3) which is removed before application onto the skin are laminated therein. How ever some time patient feels uneasy and shy to use this type of patch.
To overcome disadvantages of topical pharmaceutical formulations discussed above, there is a need of device for topical anti-inflammatory drug.
Detail Description of Invention
The main object of the present invention is to prepare a pharmaceutical topical drug applicator.
Brief Description of the Drawings
Figure 1: It is showing arrangement of ball (1) and socket (2).
Figure 2: It shows front face of cylindrical plastic housing of container (3) on
which socket (2) is fitted.
Figure 3: It shows side face of cylindrical plastic housing of container (3) on
which socket (2) is fitted. In this it is clearly shown that plastic cylindrical housing
container has concavity on one side.
Figure 4: It shows partial section view of the embodiment shown in FIG. 3.
The drug delivery system of comprises a cylindrical plastic container with ball and socket type configuration fit into handy container.
The housing of the container (3) is capable of storing pharmaceutical formulation comprising a drug incorporated with a pharmaceutically acceptable carrier suitable for topical application onto the skin.
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The middle of the cylindrical container is sunken i.e. it is having concavity. Because of this concavity the pharmaceutical formulation which comes at the top of the container at the time of the application doesn't go back quickly even if it is tilted and it provides uniform and equal spreading of the pharmaceutical antiinflammatory formulation.
On the top of the cylindrical container (3) a socket (2) is located in to which a ball (1) is fitted. The socket (2) is at 30° angle of the cylindrical container (3). The ball (1) rolls over the area of the skin at the time of application.
When this applicator is used for the application of topical antiinflammatory drug containing Diclofenac Diethylammonium 1.16% W/W equivalent to Diclofenac Na 1% W/W. Oleum (alpha -linolenic acid) 3% W/W. Menthol 5% W/W and Methyl Salicylate 10% W/W it gives following results.

Sr. No. Time for Applying Wt. Of drugformulation afterspreading on skin in mg
1 10 times 350-370
2 20 times 680-700
3 30 times 1050-1055
4 40 times 1395-1400
5 50 times 1745-1760
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The results of the above test show that the applicator provides good homogeneity, consistency, and spreadability of the anti-inflammatory drug.
This applicator can be uses for managing the area of pain, easy to use, rapid penetration so quick in action, no need to wash hands after application, optimum product consistency i.e. easy spreading, devoid of sweating after application.
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We claim:
1. A pharmaceutical topical drug applicator comprises cylindrical plastic housing of container (3) on top of it socket (2) is located in to which a roll on ball (1) is fitted.
2. A pharmaceutical topical drug applicator as claim in claim 1 wherein the plastic housing of container (3) is having concavity on the one side.
3. A pharmaceutical topical drug applicator as claim in claim 1 wherein socket (2) is at the 30° angle of the applicator.
4. A pharmaceutical topical drug applicator herein describes with foregoing description and drawings.
Dated this 2nd day of September 2006.


ABSTRACT
The present invention discloses a pharmaceutical topical drug applicator which comprises cylindrical plastic housing of container on top of it socket is located in to which a roll on ball is fitted. Plastic housing of container (3) is having concavity on the one side. This applicator can be uses for managing the area of pain, easy to use, rapid penetration so quick in action, no need to wash hands after application, optimum product consistency i.e. easy spreading, devoid of sweating after application.