FORM 2 THE PATENTS ACT, 1970
(39 of 1970)
(COMPLETE SPECIFICATION
[see section 10]


1.
2.

A process of preparing SMOKER HEALTH TOOTHPASTE (BOWMAN'S BIRK INHIBITOR)
(a) 401/501, Ashwamegh Complex Near Mithakhali Under Bridge, Navrangpura, Ahemedabad. Gujarat (India).
(b) Private Limited Company.

The following specification particularly describes the nature of the invention and the manner in which it is to be performed:



Nabros
Pharma Pvt. Ltd.

401, Ashwamegh Complex, Nr. Mithakhali Underbridge, Navrangpura, Ahmedabad-380 009. (India) Phone: (O) 6405299, 6447591 Fax: (O) 91-79-6407399, E-mail :nabros-pharma@nabros-pharma.com Factory: National Highway No. 8, Kheda - 387 411. Phone: 02694-222387
Title of the invention:
A process for complexation and entrapment of Bowman's Birk Inhibitor and cleanser in gel based tooth paste
Bowman's birk inhibitor (BBI) is a known mucosal nourishing and anti carcinogenic agent The compound is also effectively used for removal of static charge from mucosal surface. The compound is lipophilic in nature and has very high contact angle leading to poor uptake of BBI by oral mucosal cells. It results in to non effectiveness BBI for its role in preventing cancer of buccal cavity. Hence, longer contact time (retention time) with the mucosal surface and presence of suitable penetration enhancing agent for optimum uptake of BBI in mucosal cells are vital to render BBI effective for preventing oral cancers.
The present process involves invention relating to entrapment of BBI with muco-adhesive agents along with absorption promoting agents. The muco-adhesive agent/s embedded BBI is than uniformly distributed with oral mucosal uptake promoting agent, cleanser and solubiliser/foaming agent in a gel matrix constituted by specialized silica The gel based tooth paste described in the invention may be prepared by molecular distribution of emulsified BBI in muco-adhesive agent followed by uniform distribution in gel based cleanser containing matrix.


Nabros
Pharma Pvt. Ltd.
401, Ashwamegh Complex, Nr. Mithakhali Underbridge, Navrangpura, Ahmedabad-380 009. (India) Phone: (O) 6405299, 6447591 Fax: (O) 91-79-6407399, E-mail: nabros-pharma@nabros-pharma.com Factory: National Highway No. 8, Kheda - 387 411. Phone: 02694-222387 The main advantages of the invention are
1. Chroric smokers or tobacco chewers in form of paa paranasal a, Alcohol /
vodka consumers or inserts with lime will lead to inactivation, malfunctioning
or killing of the buccal and gum mucosal cells. Smokers Health tooth paste
containing BBI/PC will help in regeneration of the mucosal cells.
2. Smokers tooth paste is formulated with aid of muco-adhesive agent, which facilitates more retention time of BBI with mucosal cells and Smokers Health tooth paste will further help in accomplishing extended action the above said benefit.
3. Smokers Health tooth paste consists of natural mucosal uptake promoting agent (PC), which upon dilution with salivary fluid or hydrophilic or water containing liquid or water leads to emulsification. The emulsified globules of BBI has very high surface area as compared to natural form which also aids better buccal mucosal uptake and serves the above said benefit claimed in 1.
4. The Smokers Health tooth paste contains a specific size range of abrasive silica along with wetting agent and acts as an efficient, effective cleanser. The cleanser also serves a very good wetting agent for PC-carbomer complex and aid in the distribution results in to aided advantage to claim 3.
5. The presence of menthol and bubble gum taste in the Smokers Health tooth paste aids the smokers to overcome the smoking or tobacco chewing cessation. The mucous-adhesive properly of carbomer will further extend the effectiveness by retention in the mouth along with feel of freshness.


Nabros
Pharma Pvt. Ltd.

401, Ashwamegh Complex, Nr. Mithakhali Underbridge, Navrangpura, Ahmedabad-380 009 (India) Phone: (O) 6405299, 6447591 Fax: (O) 91-79-6407399, E-mail: nabros-pharma@nabros-pharma.com Factory: National Highway No. 8, Kheda - 387 411. Phone: 02694-222387 Composition of the present invention
Example 1:
Smokers Health tooth paste prepared by gelling and mlling process:

S.No. Ingredients Weight in G/ 50 ml tooth paste
1. Bowman's birk inhibitor 1.00
2. Muco-adhesive agent1 2.50
3. Matrix former2 8.0
4. Abrasive3 5.0
5. 6. Humectants/sweetener/mouth feelers4 Low calorie sweetener5 33.75 0.10
7. Suitable preservative/s 0.15
8. Permitted colors 0.075
9. Foaming agent/s6 2.0
10. Flavor/s 0.60
11. Purified water Q.S. up to 50 ml
1 Muco-adhesive agents such as cellulose derivatives, carbomer derivatives, naturally occurring synthetic and semi synthetic gums.
2 Matrix former such as silica, inorganic salts
3 Abrasives such as precipitated chalk, silicon dioxide, inorganic and organic salts
4 Humectants such as polyols-glycerol, sorbitol, xylitol, manritol
5 Low calorie sweetner like Aspartame, achharine,cyclamates etc.
6 Foaming agents such as sodium and potassium salts of higher fatty acid esters


Nabros
Pharma Pvt. Ltd.
401, Ashwamegh Complex, Nr. Mithakhali Underbridge, Navrangpura, Ahmedabad-380 009. (India) Phone: (0) 6405299, 6447591 Fax: (0) 91-79-6407399, E-mail: nabros-pharma@nabros-pharma.com Factory: National Highway No. 8, Kheda - 387 411. Phone: 02694-222387
Manufacturing procedure for the present invention:
Example 1:
Smokers Health tooth paste prepared by gelling and milling process:
1. In a planetary mixer, accurately weighed humectants along with purified water were added and mixed for 30 minutes.
2. Low calorie sweetener, color, muco-adhesive agent, preservative and foaming agents were added in solution of step no.l under constant stirring till uniform dispersion was obtained.
3. The resultant mixture was stirred up to 60 minutes.
4. Matrix former and abrasive were added one after another gradually with constant stirring in planetary mixer. The resultant paste was stirred for 30 minutes in order to obtain smooth uniform gel devoid of lumps.
5. Bowman's birk inhibitor and flavors were mixed together for 10 minutes using stirrer till gel like semi solid consistency is obtained.
6. Step no.5 seni solid mass was added to step no.4 gel and mixed for 30 minutes in planetary mixer.
7. The resultant gel of step no.6 was milled through triple roller mill and mixed in a planetary mixer for 30 minutes.
8. Gel was filled in a lami tube at a target weight of 55 G±2G and heat sealed.
9. The tube was packed in mono carton followed by shipper box.

Nabros
Pharma Pvt. Ltd.
401, Ashwamegh Complex, Nr. Mithakhali Underbridge, Navrangpura, Ahmedabad-380 009. (India)
Phone: (0) 6405299, 6447591 Fax: (0) 91-79-6407399, E-mail: nabros-pharma@nabros-pharma.com
Factory: National Highway No. 8, Kheda - 387 411. Phone: 02694-222387

What we claim:
1. The process described for Smokers Health tooth paste releases the BBI and
gets emulsified with the salivary secretion. The emulsified BBI has relatively
larger surface area and promotes regeneration of mucosal cells of gums and
buccal cavity by the process of gel as described,
2. A dosage form as defined in claim 1, wherein Bowman's birk inhibitor is
emulsified and pre complexed with muco-adhesive agent will adhere or
carried or hydrate buccal mucosa or combinati on of above said mechanisms
extends the effectiveness of claim 1.
3. A dosage form as defined in claim 2 consists of matrix former and abrasive aid
in the optimal distribution of BBI and further enhances the effectiveness of
claim 2.
4. A benefit as defined in claim 3, gets facilitated by applying or brushing or
combination of these processes in buccal cavity specifically above and beneath
gums, exactly on teethes.
5. A dosage form as defined in claim 2 consists of humectants or combination of
wide variety of phanmcetiicatty acceptable hunectaiis could lead to moisten
or prevent dry mouth or combination of the said mechanisms, may prevent,
protect further cell death or inactivaaon or both.
6. A dosage form defined in claim 4, after application expected to release
menthol and flavor, which may retain for extended period of time due to
mucosal adhesive property of carbomer derivative as defined in claim 2.
Further the cleanser aid could result in better distribution in to rarely
accessible area may aid to freshness after application of the dosage form as
defined in claim 4.


Nabros
Pharma Pvt. Ltd.

401, Ashwamegh Complex, Nr. Mithakhali Underbridge, Navrangpura, Ahmedabad-380 009. (India) Phone: (0) 6405299, 6447591 Fax: (0) 91-79-6407399, E-mail: nabros-pharma@nabros-pharma.com Factory: National Highway No. 8, Kheda - 387 411. Phone: 02694-222387
7. Smokers Health complexed and gelled tooth paste as described in claim 5, the manufacturing of which comprises emufsification, comp/exation and embedment of silica with or without pharmaceuti cally acceptable anti oxidants or preservatives or colorants or humectants or combinations of the said excipients with addition of an appropriate amount of Bowman's birk inhibitor.