24/06/2005 - Controller General of Patents, Designs, and Trade Marks

(12) PATENT APPLICATION PUBLICATION
(19) INDIA (21) Application No: 1202/MUM/2001 A
(22) Date of filing of Application : 21/12/2001 (43) Publication Date:
24/06/2005
Post Dated to 30/05/2002
(54) Title of the invention:
(51) International Classification:
A 61 K 9/72, A 61 K 45/00, A 61 P 37/08
(31) Priority Document No. : NIL
(32) Priority Date :
(33) Name of priority country :
(86)
A PROCESS OF PREPARING LORATADINE NASAL SPRAY
SOLUTION.
NIL
NIL
International Application : NIL
No. and Filing Date :
NIL
(87) International :
Publication No.
NIL
(61) Patent of addition to
Application No. : NIL
Filed on N.A.
(62)
Divisional to
Application No. : NIL
Filed on : N.A.
(71)
(72)
Name of the Applicant:
ALEMBIC LIMITED
Address of the Applicant:
ALEMBIC ROAD,
VADODARA – 390 003,
GUJARAT, INDIA.
Name of the Inventors:
1. BHATTACHARYA SAMPAD
2. LAGU KIRAN
Filed U/S 5(2) before the
Patents (Amendment)
Ordinance,2004 : NO
(57) Abstract : The process of preparing loratadine nasal spray solution comprises the following steps:
i) adding loratidine 0.4% to 0.5% w/v in sufficient quantity of purified water under stirring to make
a slurry and adding Hydrochloric acid 1M solution for dissolving and forming a clear solution of
loratadine;
ii) adding Glycerin 0.5% to 10% w/v, Propylene glycol 0.1% to 50% w/v and Polyoxyl-35 castor oil
0.1% to 50% w/v to the clear solution of loratadine and stirring to form a homogenous solution;
iii) dissolving Disodium edetate 0.025% to 0.3% w/v in purified water and adding Phenyl ethyl
alcohol 0.1% to 0.3% w/v and 50% Benzalkonium chloride solution 0.001% to 0.04% w/v and
stirring to form solution and mixing the said solution to the homogenous solution of the above
step (ii);
iv) preparing a 5% w/v solution of Sodium Hydroxide in purified water;
v) adjusting the pH of homogenous solution of the above step (iii) in the range of 4 to 7 by using
Sodium Hydroxide solution of the above step (iv);
vi) making up the desired volume by adding desired quantity of purified water and stirring;
vii) filtering the solution of the above step (vi) and filtering it in the containers as per requirement.
( Figure: NIL )
Total Pages : 13.
The Patent Office Journal 24.06.2005 17769