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Novel Lozenges Formulation

Abstract: ABSTRACT: This present invention relates to a troche composition which imparts a favorable oral sensation. Further the invention relates to novel the torche formulation which contains Hexylresorcenol and Benzalkonium chloride. The conventional troches impart coarse and powdery feelings, and thus are not favorably accepted by patients. In view of this situation, extensive studies were undertaken to develop troches which are not coarse or powdery, but give a favorable feeling when administered.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
02 July 2015
Publication Number
30/2017
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
Parent Application

Applicants

STABICON LIFE SCIENCES PVT. LTD.
PLOT NO. 28, BOMMASANDRA INDUSTRIAL AREA, 4TH PHASE, JIGANI HOBLI, ANEKAL TALUK, BANGALORE - 560 100,

Inventors

1. VIJAY KUMAR RANKA
PLOT NO. 28, BOMMASANDRA INDUSTRIAL AREA, 4TH PHASE, JIGANI HOBLI, ANEKAL TALUK, BANGALORE - 560 100,
2. MONOHAR URANKAR
PLOT NO. 28, BOMMASANDRA INDUSTRIAL AREA, 4TH PHASE, JIGANI HOBLI, ANEKAL TALUK, BANGALORE - 560 100,
3. GULAB HUSIEN SOUDAGAR
PLOT NO. 28, BOMMASANDRA INDUSTRIAL AREA, 4TH PHASE, JIGANI HOBLI, ANEKAL TALUK, BANGALORE - 560 100,

Specification

DETAILED DESCRIPTION OF THE INVENTION

Hexylresorcinol is an organic compound with local anaesthetic, antiseptic and anthelmintic properties

Hexylresorcenol is a white to off-white powder, freely soluble in ether and acetone; very slightly soluble in water.

Benzalkonium chloride is an organic salt called a quaternary ammonium compound.

Benzalkonium chloride solution is a topical antiseptic. It works by preventing infection. It is a clear, colourless or slightly yellowish liquid, miscible with water and with alcohol. It froths copiously when shaken.

The present invention relates to a taste masked Hexylresorcenol and Benzalkonium chloride formulation in the form of compressed lozenges (troche composition) which imparts a favorable oral sensation. An attempt was made to formulate and evaluate lozenges of Hexylresorcenol and Benzalkonium chloride using different sugars, flavours & colours for optimization.

The pharmaceutical compositions according to the present invention are in the form of compressed lozenges containing sugar (Saccharose, Fructose, or other crystallizable sugars) or without sugar, based on polyalcohols (Sorbitol, Xylitol, Mannitol, Isomalt, Maltitol and the like) in combination with artificial sweeteners(Aspartame, Sucralose, Saccharin, Neotame, Acesulfame K, Cyclamate).

According to the present invention, the process for preparation of said lozenges comprises the following steps:

a) Granulating Hexylresorcenol and Benzalkonium chloride and Mannitol/Glucose powder with binder.
b) Dry the wet mass till required LoD is achieved.
c) Mill the dried granules using suitable mesh.
d) Lubricate the dried sifted granules with remaining materials.
e) Compress the lubricated granules at high hardness using suitable punch set.
The prepared lozenges were evaluated for various parameters like thickness, Hardness, &

CLAIMS:
1. A Novel Solid oral lozenges pharmaceutical compositions comprises Hexylresorcinol and Benzalkonium Chloride.
2. A novel solid oral lozenges of claim 1, comprises of Sweetner, Binding agent, Colours and Flavours.
3. A novel solid oral lozenges of claim 2, wherein sugar is selected from Sugar
(Sucrose, Glucose, Dextrose, Fructose), Sugar Alcohols
(Sorbitol, Xylitol, Mannitol, Maltitol, Erythritol, Isomalt, Lactitol, Glycerol) or Artificial
Sweeteners (Aspartame, Sucralose, Saccharin, Neotame, Acesulfame K, Cyclamate).
4. A novel solid oral lozenges of claim 3, wherein binding agent is Ethyl cellulose/Polyvinyl pyrrolidone/ Methacrylic Acid Copolymers/ Hypromellose.
5. A novel solid oral lozenges of claim 4, wherein contain suitable Colours and Flavours.
6. A novel solid oral lozenges of claim 5, is in the form of compressed tablet.

Documents

Application Documents

# Name Date
1 3371-CHE-2015 FORM-28.pdf 2016-09-02
1 3371-CHE-2015 FORM-3 02-07-2015.pdf 2015-07-02
2 3371-CHE-2015 FORM-28 02-07-2015.pdf 2015-07-02
2 3371-CHE-2015-Claims-010716.pdf 2016-07-28
3 3371-CHE-2015-Correspondence-010716.pdf 2016-07-28
3 3371-CHE-2015 FORM-2 02-07-2015.pdf 2015-07-02
4 3371-CHE-2015-Description(Complete)-010716.pdf 2016-07-28
4 3371-CHE-2015 FORM-1 02-07-2015.pdf 2015-07-02
5 3371-CHE-2015 DESCRIPTION (PROVISIONAL) 02-07-2015.pdf 2015-07-02
5 3371-CHE-2015-Form 2(Title Page)-010716.pdf 2016-07-28
6 3371-CHE-2015 CORRESPONDENCE OTHERS 02-07-2015.pdf 2015-07-02
7 3371-CHE-2015 DESCRIPTION (PROVISIONAL) 02-07-2015.pdf 2015-07-02
7 3371-CHE-2015-Form 2(Title Page)-010716.pdf 2016-07-28
8 3371-CHE-2015 FORM-1 02-07-2015.pdf 2015-07-02
8 3371-CHE-2015-Description(Complete)-010716.pdf 2016-07-28
9 3371-CHE-2015 FORM-2 02-07-2015.pdf 2015-07-02
9 3371-CHE-2015-Correspondence-010716.pdf 2016-07-28
10 3371-CHE-2015-Claims-010716.pdf 2016-07-28
10 3371-CHE-2015 FORM-28 02-07-2015.pdf 2015-07-02
11 3371-CHE-2015 FORM-3 02-07-2015.pdf 2015-07-02
11 3371-CHE-2015 FORM-28.pdf 2016-09-02