FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
COMPLETE SPECIFICATION (See Section 10)
A PROCESS OF PREPARING ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
M/S. ALEMBIC LIMITED, ALEMBIC ROAD, VADODARA - 390 003, GUJARAT, an Indian Company incorporated under the Companies Act. 1956.
The following specification particularly describes and ascertains the nature of this invention, and the manner in which it is to be performed.



This invention relates to a process of preparing Roxithromycin and Ambroxol Hydrochloride Oral Suspension composition.
More particularly this invention relates to pharmaceutcal compositions comprising in combination, Roxithromycin an antibiotic, and Ambroxol Hydrochloride a mucolytic in association with a pharmaceutical carrier or excipient for use in combating bacterial infections of the respiratory tract.
Simultaneous administration of Roxithromycin an antibiotic and Ambroxol Hydrochloride increases the bronchopulmonary antibiotic concentrations. The levels of antibiotic activity which can be obtained with this new combination, permit successful treatment in severe, acute clinical cases. Even after acute stage of disease has passed, when the dosage of antibiotics is relatively low, sufficiently high levels of antibiotic activity can be maintained in the bronchopulmonary region, so that relapses are extremely rare.
The invention lies in preparation of a liquid oral suspension of Roxithromycin and Ambroxol Hydrochloride in a Stabilised formulation. The advantage is that being a ready to use oral liquid suspension, it can be administered to all patients.

According to this invention the process of preparing Roxithromycin and Ambroxol Hydrochloride Oral Suspension liquid composition comprises the following steps :
a. Transfer Purified Water to a suitable steam jacketed s.s. manufacturing tank.
Add Sucrose (0.00 - 80.0 % w/v) with continuous stirring and heat the content
with stirring till Sucrose is completely dissolved. Boil the syrup for 10 minutes.
b. Dissolve Sodium Methyl Hydroxybenzoate (0.001 - 0.35% w/v)), Sodium
Propyl Hydroxybenzoate (0.001 - 0.035 % w/v) and Saccharin Sodium (0.05 -
5.0) in hot Purified Water in a suitable s.s. vessel. Transfer the solution to the
main manufacturing tank while passing it through #80 s.s. sieve and stir to mix.
Rinse the container with Purified Water and add the rinsings to the bulk. Stir to
mix.
c. Filter the hot syrup bulk of step no.l through "Filter Press" using Purified
Siliceous Earth as filter aid. Cool the filtered syrup to ambient temperature.
d. Transfer a portion of the filtered syrup of step 3 (about 300.000 ml) to another
suitable s.s vessel.
e. Transfer Roxithromycin of #200 to the s.s vessel (Step 4) with continuous
stirring. Stir to obtain a uniform homogenous slurry free from lumps and
transfer to the manufacturing tank.
f. Transfer Guargum (0.01 - 5.0 % w/v) and Carboxymethyl Cellulose Sodium
(0.00 - 5.0 % w/v) to Glycerin (1.0 - 15% w/v). Mix properly and make a
slurry. Add Purified water and stir till a smooth gel is formed and transfer to
the manufacturing tank.
g. Heat Polyoxyl 40 Hydrogenated castor oil (1.0 - 20.0 % w/v). Add Ambroxol
Hydrochloride. Mix properly till Ambroxol Hydrochloride dissolves completely
and transfer to the manufacturing tank.
h. Take 100 ml of hot purifed water and add Carbomer 974 P (0.001 - 5.0) slowly with continuous stirring till if forms homogenous slurry. And transfer this to step no 9.
i. Add Disodium Edetate (0.001 - 5.0 % w/v) to hot purified water and stir to dissolve, rinse the container with sufficient quantity of purified water and add to the manufacturing tank.

j. Transfer Monoammonium Glycyrrhizinate (0.05 - 2.0 % w/v) to purified water and rinse the container with sufficient quantity of purified water and add to the manufcturing tank.
k. Mix and homogenise properly the entire contents in the manufacturing tank till a homogenous suspension is obtained.
1. Transfer Peppermint flavour (0.001 - 5.0 % w/v) and Banana flavour (0.001 -5.0 % w/v) to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of Purified water and add to the manufacturing tank.
m. Dissolve Sunset yellow FCF (0.001 - 5.0% w/v) in Purified water and transfer to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of water and transfer to the manufacturing tank and stir well.
n. Transfer Simethicone 30% to the manufacturing tank and stir well.
o. Mix well for 30 minutes and check the pH. Adjust the pH to between 8.7 to 9.0 by using Tromethamine solution (0 - 20.0 % w/v). Stir well and check the pH again. Ensure that the pH is between 8.7 to 9.0.
p. Make up the volume to 1000 ml with Purified Water and mix.

The invention will be clear with the help of the following examples :
ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL
SUSPENSION EXAMPLE -1
Batch size: 1000 ml

Sr. No. Ingredients Quantity in g
1 Roxithromycin 10.30
2 Ambroxol Hydrochloride 06.18
3 Glycerin 50.00
4 Polyoxyl-40 Hydrogenated Castor Oil 30.00
5 Sorbitol 70% 05.00
6 Polysorbate 60 1.5
7 Polyethylene Glycol 400 30.00
8 Poloxamer F68 2.00
9 Sodium Methyl Hydroxybenzoate 2.3
10 Sodium Propyl Hydroxybenzoate 0.22
11 Colloidal Silicon Dioxide 2.00
12 Monoammonium Glycyrrhizinate 5.00
13 Disodium Edetate 0.5
14 Xanthan Gum 0.5
15 Carbomer 974 P 0.5
16 Sucrose 700.00
17 Sunset Yellow FCF 0.04
18 Banana Flavour 3.00 ml
19 Purified Water q.s.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-1
Manufacturing Process :
1. Transfer Purified Water to a suitable steam jacketed s.s. manufacturing tank.
Add Sucrose with continuous stirring and heat the content with stirring till
Sucrose is completely dissolved. Boil the syrup for 10 minutes.
Sucrose : 700.0 g
Purified Water : 350.000 ml
2. Dissolve Sodium Methyl Hydroxybenzoate and Sodium Propyl
Hydroxybenzoate in hot Purified Water in a suitable s.s. vessel. Transfer the
solution to the main manufacturing tank while passing it through #80 s.s. sieve
and stir to mix. Rinse the container with Purified Water and add the rinsings to
the bulk. Stir to mix.
Sodium Methyl Hydroxybenzoate : 2.3 g
Sodium Propyl Hydroxybenzoate : 0.22 g
Purified water 15.00 ml
3. Filter the hot syrup bulk of step no 1 through "Filter Press" using Purified Siliceous Earth as filter aid. Cool the syrup to ambient temperature.
4. Transfer a portion of the above syrup bulk (about 300.000 ml ) to another suitable s.s vessel.
5. Transfer Polysorbate 60 to a suitable s.s. container. Add warm Purified Water, stir and transfer to the syrup (Step 4) while filtering through #80 s.s. sieve and mix. Rinse the container with sufficient quantity of Purified Water and add it to the s.s. vessel. Stir to mix well.
Polysorbate 60 : 1.500 g
Purified Water : 10.000 ml
6. Transfer Roxithromycin of #200 to the s.s vessel (Step 4) with continuous
stirring. Stir to obtain a uniform homogenous slurry free from lumps.
Roxithromycin ; 10.30 g
7. Transfer Colloidal Silicon Dioxide to the s.s. vessel (Step 4) with continuous
stirring. Stir well to achieve homogenous dispersion. Transfer the resulting
uniform slurry to the main manufacturing tank with continuous stirring. Stir to
mix.Colloidal Silicon Dioxide : 2.000 g

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-1
Manufacturing Process:
8. Transfer Xanthan Gum to Glycerin and Sorbitol. Mix properly and make a
slurry.
Glycerin 50.0 g
Sorbitol : 5.00 g
Xanthan Gum : 0.50 g
9. Heat Polyoxyl 40 hydrogenated castor oil and add Ambroxol Hydrochloride,
Polyethylene glycol 400 and Poloxamer F68. Mix properly till Ambroxol
Hydrochloride dissolves completely and add to step no. 8.
Poloxyl 40 hydrogenated castor oil : 30.0 g
Ambroxol Hydrochloride : 6.18 g
Polyethylene Glycol 400 : 30.0 g
Poloxamer F68 : 2.0 g
10. Take 30 ml of hot purifed water and add Carbomer 974 P slowly with
continuous stirring till it forms homogenous slurry and transfer this to the
manufacturing tank.
Carbomer 974 P : 0.5 g
Purified Water : 30.0 ml
11. Transfer Monoammonium Glycyrrhizinate to purified water and rinse the
container with sufficient quantity of purified water and add to the manufcturing
tank.
Monoammonium Glycyrrhizinate : 5.0 g
Purified water 30.0 ml
12. Add Disodium Edetate to hot purified water and stir to dissolve, rinse the
container with sufficient quantity of purified water and add to the
manufacturing tank.
Disodium Edetate : 0.5 g
Purified water : 25.00 ml
13. Mix and homogenise properly the entire contents in the manufacturing tank till
a homogenous suspension is obtained.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-l
Manufacturing Process:
14. Transfer banana flavour to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of Purified water and add to the manufacturing tank.
Banana Flavour : 3.00 ml
Purified water : 5.00 ml
15.Dissolve Sunset yellow FCF in Purified water and transfer to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of water and transfer it to the manufacturing tank and stir well.
Sunset Yellow FCF : 0.04 g
Purified water : 15.0 ml
16. Make up the volume to 1000 ml with Purified Water and mix.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL
SUSPENSION
EXAMPLE - 2
Batch size: 1000 ml

Sr. No. Ingredients Quantity in g
1 Roxithromycin 10.30
2 Ambroxol Hydrochloride 6.18
3 Glycerin 100.00
4 Polyoxyl-40 Castor Oil 30.00
5 Polysorbate 80 1.5
6 Polyethylene Glycol 400 20.00
7 Sodium Methyl Hydroxybenzoate 2.3
8 Sodium Propyl Hydroxybenzoate 0.22
9 Colloidal Silicon Dioxide 3.5
10 Saccharin Sodium 1.0
11 Disodium Edetate 0.5
12 Xanthan Gum 4.0
13 Guargum 3.0
14 Magnesium Aluminium Silicate 1.0
15 Sucrose 650.00
16 Sunset Yellow FCF 0.04
17 Peppermint Flavour 1.0 ml
18 Pineapple Flavour 1.0 ml
19 Purified Water q.s.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-2 Manufacturing Process :
1. Transfer Purified Water to a suitable steam jacketed s.s. manufacturing tank.
Add Sucrose with continuous stirring and heat the content with stirring till
Sucrose is completely dissolved- Boil the syrup for 10 minutes.
Sucrose : 650.0 g
Purified Water : 350.000 ml
2. Dissolve Sodium Methyl Hydroxybenzoate, Sodium Propyl Hydroxybenzoate
and Saccharin Sodium in hot Purified Water in a suitable s.s. vessel. Transfer
the solution to the main manufacturing tank while passing it through #80 s.s.
sieve and stir to mix. Rinse the container with Purified Water and add the
rinsings to the bulk. Stir to mix.
, Sodium Methyl Hydroxybenzoate : 2.3 g
Sodium Propyl Hydroxybenzoate 0.22 g
Saccharin Sodium : 1.0 g
Purified water : 15.00 ml
3. Filter the hot syrup bulk of step no. 1 through "Filter Press" using Purified Siliceous Earth as filter aid. Cool the syrup to ambient temperature.
4. Transfer a portion of the above syrup bulk (about 300.000 ml ) to another suitable s.s vessel.
5. Transfer Polysorbate 80 to a suitable s.s. container. Add warm Purified Water, stir and transfer to the syrup (Step 4) while filtering through #80 s.s. sieve and mix. Rinse the container with sufficient quantity of Purified Water and add it to the s.s. vessel. Stir to mix well and transfer to the manufacturing tank.
Polysorbate 80 : 1.500 g
Purified Water : 10.000 ml
6. Transfer Roxithromycin of #200 to the s.s vessel (Step 4) with continuous
stirring. Stir to obtain a uniform homogenous slurry free from lumps and
transfer to the manufacturing tank.
Roxithromycin : 10.3 0 g
7. Transfer Colloidal Silicon Dioxide to the s.s. vessel (Step 4) with continuous
stirring. Stir well to achieve homogenous dispersion. Transfer the resulting
uniform slurry to the main manufacturing tank with continuous stirring. Stir to
mix.Colloidal Silicon Dioxide : 3.50 g

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-2
Manufacturing Process:
8. Transfer Xanthan Gum and Guargum to Glycerin. Mix properly and make a
slurry. Add Purified water and stir till a smooth gel is formed and transfer to
the manufacturing tank.
Glycerin : 100.00 g
Xanthan Gum : 4.0 g
Guargum 3.0 g
Purified water 50.0 ml
9. Heat Polyoxyl 40 castor oil. Add Ambroxol Hydrochloride and Polyethylene
glycol 400. Mix properly till Ambroxol Hydrochloride dissolves completely
and transfer to the manufacturing tank.
Poloxyl 40 castor oil 30.0 g
Ambroxol Hydrochloride : 6.18 g
Polyethylene Glycol 400 : 20.0 g
10. Add Disodium Edetate to hot purified water and stir to dissolve, rinse the
container with sufficient quantity of purified water and add to the
manufacturing tank.
Disodium Edetate 0.5 g
Purified water ; 25.00 ml
11. Transfer Magnesium Aluminium Silicate under stirring to hot Purified water
(60°C) and stir till a smooth slurry is formed. Keep the slurry for hydration
upto 4 hours then transfer to the manufacturing tank.
Magnesium Aluminium Silicate : 1.0 g
Purified water : 75.0 ml
12. Mix and homogenise properly the entire contents in the manufacturing tank till a homogenous suspension is obtained.
13. Transfer Peppermint flavour and Pineapple flavour to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of Purified water and add to the manufacturing tank.
Peppermint flavour : 1.00 ml
Pineapple flavour : 1.00 ml
Purified water : 5.00 ml

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-2
Manufacturing Process :
14. Dissolve Sunset yellow FCF in Purified water and transfer to the
manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the
container with sufficient quantity of water and transfer it to the manufacturing
tank and stir well.
Sunset Yellow FCF : 0.04 g
Purified water : 15.0 ml
15. Make up the volume to 1000 ml with Purified Water and mix.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL
SUSPENSION EXAMPLE - 3
Batch size: 1000 ml

Sr. No. Ingredients Quantity in g
1 Roxithromycin 10.30
2 Ambroxol Hydrochloride 6.18
3 Polyoxyl-35 Castor Oil 40.00
4 Sorbitol 70% 30.0
5 Polysorbate 60 1.5
6 Propylene Glycol 30.0
7 Diethylene Glycol Monoethyl Ether 30.0
8 Colloidal Silicon Dioxide 3.00
9 Saccharin Sodium 1.0
10 Sodium Benzoate 3.00
11 Disodium Edetate 0.5
12 Xanthan Gum 0.8
13 Carbomer 934 P 1.0
14 Sucrose 500.00
15 Liquid Glucose 100.00
16 Sunset Yellow FCF 0.04
17 Mango Flavour 1.5 ml
18 Vanilla .0.5 ml
19 Purified Water q.s.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-3 Manufacturing Process:
1. Transfer Purified Water to a suitable steam jacketed s.s. manufacturing tank.
Add Sucrose with continuous stirring and heat the content with stirring till
Sucrose is completely dissolved. Boil the syrup for 10 minutes.
Sucrose : 500.0 g
Purified Water : 250.000 ml
2. Dissolve Sodium Benzoate and Saccharin Sodium in hot Purified Water in a
suitable s.s. vessel. Transfer the solution to the main manufacturing tank while
passing it through #80 s.s. sieve and stir to mix. Rinse the container with
Purified Water and add the rinsings to the bulk. Stir to mix.

Sodium Benzoate Saccharin Sodium Purified water

3-0 g 1.0 g 20.00 ml

3. Filter the hot syrup bulk of step no.l through "Filter Press" using Purified
Siliceous Earth as filter aid. To the hot filtered syrup transfer liuqid Glucose
and stir well. Cool the mixture to ambient temperature.
Liquid Glucose : 100.0 g
4. Transfer a portion of the mixture of step 3 (about 300.000.ml ) to another suitable s.s vessel.
5. Transfer Polysorbate 60 to a suitable s.s. container. Add warm Purified Water, stir and transfer to the syrup (Step 4) while filtering through #80 s.s. sieve and mix. Rinse the container with sufficient quantity of Purified Water and add it to the s.s. vessel. Stir to mix well and transfer to the manufacturing tank.
Polysorbate 60 : 1.500 g
Purified Water 10.000 ml
6. Transfer Roxithromycin of #200 to the s.s vessel (Step 4) with continuous
stirring. Stir to obtain a uniform homogenous slurry free from lumps and
transfer to the manufacturing tank.
Roxithromycin : 10.30 g
7. Transfer Colloidal Silicon Dioxide to the s.s. vessel (Step 4) with continuous
stirring. Stir well to achieve homogenous dispersion. Transfer the resulting
uniform slurry to the main manufacturing tank with continuous stirring. Stir to
mix.Colloidal Silicon Dioxide : 3.00 g

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-3
Manufacturing Process:
8. Transfer Xanthan Gum to Sorbitol 70%. Mix properly and make a slurry. Add
Purified water and stir till a smooth gel is formed and transfer to the
manufacturing tank.
Sorbitol 70% : 30.00 g
Xanthan Gum : 0.8 g
Purified water 50.0 ml
9. Heat Polyoxyl 35 castor oil. Add Ambroxol Hydrochloride, Propylene Glycol
and Diethylene Glycol Monoethyl Ether. Mix properly till Ambroxol
Hydrochloride dissolves completely and transfer to the manufacturing tank.
Poloxyl 35 castor oil : 40.0 g
Ambroxol Hydrochloride : 6.18 g
Propylene Glycol : 30.0 g
Diethylene Glycol Monoethyl Ether : 30.0 g
10. Take 100 ml of hot purifed water and add Carbomer 934 P slowly with
continuous stirring till it forms homogenous slurry and transfer it to the
manufacturing tank.
Carbomer 934 P : 1.0 g
Purified Water : 30.0 ml
11. Add Disodium Edetate to hot purified water and stir to dissolve, rinse the
container with sufficient quantity of purified water and add to the
manufacturing tank.
Disodium Edetate : 0.5 g
Purified water : 25.00 ml
12. Mix and homogenise properly the entire contents in the manufacturing tank till a homogenous suspension is obtained.
13. Transfer Mango flavour and Vanilla flavour to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of Purified water and add to the manufacturing tank.
Mango flavour 1.5 ml
Vanilla flavour 0.5 ml
Purified water : 5.00 ml

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-3
Manufacturing Process :
14. Dissolve Sunset yellow FCF in Purified water and transfer to the
manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the
container with sufficient quantity of water and transfer to the manufacturing
tank and stir well.
Sunset Yellow FCF : 0.04 g
Purified water : 15.0 ml
15. Make up the volume to 1000 ml with Purified Water and mix.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL
SUSPENSION
EXAMPLE - 4
Batch size: 1000 ml

Sr. No. Ingredients Quantity in g
1 Roxithromycin 10.30
2 Ambroxol Hydrochloride 6.18
3 Sorbitol 70% 10.00
4 Polysorbate 80 1.5
5 Diethylene Glycolmonoethyl ether 30.00
6 Polyethylene glycol 400 30.00
7 Colloidal Silicon Dioxide 3.00
8 Monoammonium Glycyrrhizinate 4.5
9 Sodium Benzoate 3.00
10 Disodium Edetate 0.5
11 Guargum 0.8
12 Carbomer 974 P 0.6
13 Sucrose 550.00
14 Sunset Yellow FCF 0.04
15 Mango Flavour 2.00 ml
16 Banana Flavour 1.00 ml
17 Purified Water q.s.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-4 Manufacturing Process :
1. Transfer Purified Water to a suitable steam jacketed s.s. manufacturing tank.
Add Sucrose with continuous stirring and heat the content with stirring till
Sucrose is completely dissolved. Boil the syrup for 10 minutes.
Sucrose 550.0 g
Purified Water : 250.000 ml
2. Dissolve Sodium Benzoate in hot Purified Water in a suitable s.s. vessel.
Transfer the solution to the main manufacturing tank while passing it through
#80 s.s. sieve and stir to mix. Rinse the container with Purified Water and add
the rinsings to the bulk. Stir to mix.
Sodium Benzoate 3.0 g
Purified water : 20.00 ml
3. Filter the hot syrup bulk of step no.l through "Filter Press" using Purified Siliceous Earth as filter aid. Cool the mixture to ambient temperature.
4. Transfer a portion of the filtered syrup of step 3 (about 300.000 ml ) to another suitable s.s vessel.
5. Transfer Polysorbate 80 to a suitable s.s. container. Add warm Purified Water, stir and transfer to the syrup (Step 4) while filtering through #80 s.s. sieve and mix. Rinse the container with sufficient quantity of Purified Water and add it to the s.s. vessel. Stir to mix well and transfer to the manufacturing tank.
Polysorbate 80 1.500 g
Purified Water 10.000 ml
6. Transfer Roxithromycin of #200 to the s.s vessel (Step 4) with continuous
stirring. Stir to obtain a uniform homogenous slurry free from lumps and
transfer to the manufacturing tank.
Roxithromycin 10.30 g
7. Transfer Colloidal Silicon Dioxide to the s.s. vessel (Step 4) with continuous
stirring. Stir well to achieve homogenous dispersion. Transfer the resulting
uniform slurry to the main manufacturing tank with continuous stirring. Stir to
mix.
Colloidal Silicon Dioxide : 3.00 g

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-4
Manufacturing Process :
8. Transfer Guargum to Sorbitol 70%. Mix properly and make a slurry. Add Purified water and stir till a smooth gel is formed and transfer to the manufacturing tank.
Sorbitol 70% : 10.00 g
Guargum : 0.8 g
Purified water : 50.0 ml
9. Heat a mixture of Polyethylene glycol 400 and Diethylene glycol monoethyl ether. Add Ambroxol Hydrochloride. Mix properly till Ambroxol Hydrochloride dissolves completely and transfer to the manufacturing tank.
Polyethylene glycol 400 : 30.0 g
Diethylene Glycol Monoethyl Ether : 30.0 g
Ambroxol Hydrochloride : 6.18 g
10. Take 100 ml of hot purifed water and add Carbomer 974 P slowly with
continuous stirring till it forms homogenous slurry and transfer it to the
manufacturing tank.
Carbomer 974 P 0.6 g
Purified Water : 30.0 ml
11. Add Disodium Edetate to hot purified water and stir to dissolve, rinse the
container with sufficient quantity of purified water and add to the
manufacturing tank.
Disodium Edetate : 0.5 g
Purified water : 25.00 ml
12. Transfer Monoammonium Glycyrrhizinate to purified water and rinse the
container with sufficient quantity of purified water and add to the manufcturing
tank.
Monoammonium Glycyrrhizinate : 4.5 g
Purified water : 30.0 ml
13.Mix and homogenise properly the entire contents in the manufacturing tank till a homogenous suspension is obtained.

i
ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-4
Manufacturing Process :
14.Transfer Mango flavour and Banana flavour to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of Purified water and add to the manufacturing tank.
Mango flavour : 2.0 ml
Banana flavour 1.0 ml
Purified water : 5.00 ml
15.Dissolve Sunset yellow FCF in Purified water and transfer to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of water and transfer to the manufacturing tank and stir well.
Sunset Yellow FCF ; 0.04 g
Purified water 15.0 ml
16. Make up the volume to 1000 ml with Purified Water and mix.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL
SUSPENSION
EXAMPLE - 5
Batch size: 1000 ml

Sr. No. Ingredients Quantity in g
1 Roxithromycin 10.30
2 Ambroxol Hydrochloride 6.18
3 Glycerin 30.00
4 Polyoxyl 40 Hydrogenated castor oil 40.00
5 Sorbitol 70% 8.00
6 Polysorbate 60 1.5
7 Saccharin Sodium 2.5
8 Sodium Benzoate 3.0
9 Disodium Edetate 0.50
10 Guargum 0.70
11 Methyl Hydroxyethyl Cellulose 3.50
12 Magnesium Aluminium Silicate 0.5
13 Sucrose 600.00
14 Sunset Yellow FCF 0.04
15 Raspberry Flavour 0.7 ml
16 Peppermint Flavour 0.8 ml
17 Purified Water q.s.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-5 Manufacturing Process :
1. Transfer Purified Water to a suitable steam jacketed s.s. manufacturing tank.
Add Sucrose with continuous stirring and heat the content with stirring till
Sucrose is completely dissolved. Boil the syrup for 10 minutes.
Sucrose 600.0 g
Purified Water : 300.00 ml
2. Dissolve Sodium Benzoate and Saccharin Sodium hot Purified Water in a
suitable s.s. vessel. Transfer the solution to the main manufacturing tank while
passing it through #80 s.s. sieve and stir to mix. Rinse the container with
Purified Water and add the rinsings to the bulk. Stir to mix.
Sodium Benzoate : 3.0 g
Saccharin Sodium : 2.5 g
Purified water 25.00 ml
3. Filter the hot syrup bulk of step no.l through "Filter Press" using Purified Siliceous Earth as filter aid. Cool the mixture to ambient temperature.
4. Transfer a portion of the filtered syrup of step 3 (about 300.000 ml ) to another suitable s.s vessel.
5. Transfer Polysorbate 60 to a suitable s.s. container. Add warm Purified Water, stir and transfer to the syrup (Step 4) while filtering through #80 s.s. sieve and mix. Rinse the container with sufficient quantity of Purified Water and add it to the s.s. vessel. Stir to mix well and transfer to the manufacturing tank.
Polysorbate 60 1.500 g
Purified Water 10.000 ml
6. Transfer Roxithromycin of #200 to the s.s vessel (Step 4) with continuous
stirring. Stir to obtain a uniform homogenous slurry free from lumps and
transfer to the manufacturing tank.
Roxithromycin : 10.30 g

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-5
Manufacturing Process :
7. Transfer Guargum to a mixture of Glycerin and Sorbitol 70%. Mix properly
and make a slurry. Add Purified water and stir till a smooth gel is formed and
transfer to the manufacturing tank.
Glycerin : 30.0 g
Sorbitol 70% 8.00 g
Guargum : 0.7 g
Purified water : 50.0 ml
8. Heat Polyoxyl 40 Hydrogenated castor oil. Add Ambroxol Hydrochloride. Mix
properly till Ambroxol Hydrochloride dissolves completely and transfer to the
manufacturing tank.
Polyoxyl 40 Hydrogenated castor oil : 40.0 g
Ambroxol Hydrochloride : 6.18 g
9. Take 100 ml of hot purified water and add Methyl Hydroxy Ethyl Cellulose
slowly with continuous stirring till it forms homogenous slurry and transfer this
to the manufacturing tank.
Methyl Hydroxy Ethyl Cellulose : 3.5 g
Purified Water 30.0 ml
10. Transfer Magnesium Aluminium Silicate under stirring to hot Purified water
(60°C) and stir till a smooth slurry is formed. Keep the slurry for hydration
upto 4 hours then transfer to the manufacturing tank.
Magnesium Aluminium Silicate : 0.5 g
Purified water 40.0 ml
11. Add Disodium Edetate to hot purified water and stir to dissolve, rinse the
container with sufficient quantity of purified water and add to the
manufacturing tank.
Disodium Edetate 0.5 g
Purified water : 25.00 ml
12. Mix and homogenise properly the entire contents in the manufacturing tank till
a homogenous suspension is obtained.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-5 Manufacturing Process :
13.Transfer Raspberry flavour and Peppermint flavour to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of Purified water and add to the manufacturing tank.
Raspberry flavour : 0.7 ml
Peppermint flavour : 0.8 ml
Purified water : 5.00 ml
14. Dissolve Sunset yellow FCF in Purified water and transfer to the
manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the
container with sufficient quantity of water and transfer to the manufacturing
tank and stir well.
Sunset Yellow FCF : 0.04 g
Purified water : 15.0 ml
15. Make up the volume to 1000 ml with Purified Water and mix.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL
SUSPENSION
EXAMPLE - 6
Batch size: 1000 ml

Sr. No. Ingredients Quantity in g
1 Roxithromycin 10.30
2 Ambroxol Hydrochloride 6.18
3 Glycerin 40.00
4 Polyoxyl 35 castor oil 25.00
5 Polyoxyl 40 Hydrogenated castor oil 25.00
6 Sorbitol 70% 7.00
7 Sodium Methyl Hydroxybenzoate 2.3
8 Sodium Propyl Hydroxybenzoate 0.22
9 Monoammomium Glycyrrhizinate 3.00
10 Disodium Edetate 1.0
11 Guargum 1.2
12 Carbomer 974 P 1.0
13 Sucrose 250.00
14 Liquid Glycose 350.00
15 Sunset Yellow FCF 0.04
16 Pinepple Flavour 0.8 ml
17 Vanilla Flavour 0.8 ml
18 Purified Water q.s.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-6 Manufacturing Process:
1. Transfer Purified Water to a suitable steam jacketed s.s. manufacturing tank.
Add Sucrose with continuous stirring and heat the content with stirring till
Sucrose is completely dissolved. Boil the syrup for 10 minutes.
Sucrose : 250.0 g
Purified Water : 125.00 ml
2. Dissolve Sodium Methyl Hydroxybenzoate and Sodium Propyl
Hydroxybenzoate in hot Purified Water in a suitable s.s. vessel. Transfer the
solution to the main manufacturing tank while passing it through #80 s.s. sieve
and stir to mix. Rinse the container with Purified Water and add the rinsings to
the bulk. Stir to mix.
Sodium Methyl Hydroxybenzoate : 2.3 g
Sodium Propyl Hydroxybenzoate : 0.22 g
Purified water 15.00 ml
3. Filter the hot syrup bulk of step no.l through "Filter Press" using Purified
Siliceous Earth as filter aid. To the hot filtered syrup transfer Huqid Glucose
and stir well. Cool the mixture to ambient temperature.
Liquid Glucose 350.0 g
4. Transfer a portion of the mixture of step 3 (about 300.000 ml ) to another suitable s.s vessel.
5. Transfer Roxithromycin of #200 to the s.s vessel (Step 4) with continuous stirring. Stir to obtain a uniform homogenous slurry free from lumps and transfer to the manufacturing tank.

Roxithromycin

10.30 g

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-6;
Manufacturing Process :
6. Transfer Guargum to a mixture of Glycerin and Sorbitol 70%. Mix properly
and make a slurry. Add Purified water and stir till a smooth gel is formed and
transfer to the manufacturing tank.
Glycerin : 40.0 g
Sorbitol 70% : 7.0 g
Guargum : 1.2 g
Purified water : 50.0 ml
7. Heat a mixture of Polyoxyl 35 castor oil and Polyoxyl 40 Hydrogenated castor
oil. Add Ambroxol Hydrochloride. Mix properly till Ambroxol Hydrochloride
dissolves completely and transfer to the manufacturing tank.
Polyoxyl 35 castor oil : 25.0 g
Polyoxyl 40 Hydrogenated castor oil : 25.0 g
Ambroxol Hydrochloride : 6.18 g
8. Take 100 ml of hot purifed water and add Carbomer 974 P slowly with
continuous stirring till it forms homogenous slurry and transfer it to
manufacturing tank.
Carbomer 974 P : 1.0 g
Purified Water 50.0 ml
9. Add Disodium Edetate to hot purified water and stir to dissolve, rinse the
container with sufficient quantity of purified water and add to the
manufacturing tank.
Disodium Edetate : 1.0 g
Purified water : 50.00 ml
10. Transfer Monoammonium Glycyrrhizinate to purified water and rinse the
container with sufficient quantity of purified water and add to the manufcturing
tank.
Monoammonium Glycyrrhizinate : 3.0 g
Purified water : 30.0 ml
1 l.Mix and homogenise properly the entire contents in the manufacturing tank till a homogenous suspension is obtained.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-6
Manufacturing Process :
12. Transfer Pineapple flavour and Vanilla flavour to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of Purified water and add to the manufacturing tank.
Pineapple flavour : 0.8 ml
Vanilla flavour : 0.8ml
Purified water 5.00 ml
13.Dissolve Sunset yellow FCF in Purified water and transfer to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of water and transfer to the manufacturing tank and stir well.
Sunset Yellow FCF : 0.04 g
Purified water 15.0 ml
14. Make up the volume to 1000 ml with Purified Water and mix.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL
SUSPENSION
EXAMPLE - 7
Batch size: 1000 ml

Sr. No. Ingredients Quantity in g
1 Roxithromycin 10.30
2 Ambroxol Hydrochloride 6.18
3 Glycerin 30.00
4 Polyoxyl 40 Hydrogenated castor oil 50.00
5 Saccharin Sodium 1.0
6 Sodium Methyl Hydroxybenzoate 2.3
7 Sodium Propyl Hydroxybenzoate 0.22
8 Monoammomium Glycyrrhizinate 5.00
9 Disodium Edetate 2.0
10 Xanthan Gum 1.2
11 Tromethamine 10.0
12 Sucrose 600.00
13 Sunset Yellow FCF 0.04
14 Pinepple Flavour 5.0 ml
15 Peppermint Flavour 5.0 ml
16 Banana Flavour 1.2 ml
17 Purified Water q.s.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-7 Manufacturing Process :
1. Transfer Purified Water to a suitable steam jacketed s.s. manufacturing tank.
Add Sucrose with continuous stirring and heat the content with stirring till.
Sucrose is completely dissolved. Boil the syrup for 10 minutes.
Sucrose : 600.0 g
Purified Water 300.00 ml
2. Dissolve Sodium Methyl Hydroxybenzoate, Sodium Propyl Hydroxybenzoate
and Saccharin Sodium in hot Purified Water in a suitable s.s. vessel. Transfer
the solution to the main manufacturing tank while passing it through #80 s.s.
sieve and stir to mix. Rinse the container with Purified Water and add the
rinsings to the bulk. Stir to mix.

Sodium Methyl Hydroxybenzoate Sodium Propyl Hydroxybenzoate Saccharin Sodium Purified water

2.3 g 0-22 g 1-0 g 25.00 ml

3. Filter the hot syrup bulk of step no.l' through "Filter Press" using Purified Siliceous Earth as filter aid. Cool the filtered syrup to ambient temperature.
4. Transfer a portion of the filtered syrup of step 3 (about 300.000 ml) to another suitable s.s vessel.
5. Transfer Roxithromycin of #200 to the s.s vessel (Step 4) with continuous stirring. Stir to obtain a uniform homogenous slurry free from lumps and transfer to the manufacturing tank.
Roxithromycin : 10.30 g

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-7
Manufacturing Process:
6. Transfer Xanthan Gum to Glycerin. Mix properly and make a slurry. Add
Purified water and stir till a smooth gel is formed and transfer to the
manufacturing tank.
Glycerin 30.0 g
Xanthan Gum : 1.2 g
Purified water 50.0 ml
7. Heat Polyoxyl 40 Hydrogenated castor oil. Add Ambroxol Hydrochloride. Mix
properly till Ambroxol Hydrochloride dissolves completely and transfer to the
manufacturing tank.
Polyoxyl 40 Hydrogenated castor oil : 50.0 g
Ambroxol Hydrochloride : 6.18 g
8. Add Disodium Edetate to hot purified water and stir to dissolve, rinse the
container with sufficient quantity of purified water and add to the
manufacturing tank.
Disodium Edetate : 2.0 g
Purified water : 50.00 ml
9. Transfer Monoammonium Glycyrrhizinate to purified water and rinse the
container with sufficient quantity of purified water and add to the manufcturing
tank.
Monoammonium Glycyrrhizinate : 5.0 g
Purified water : 30.0 ml
10. Mix and homogenise properly the entire contents in the manufacturing tank till
a homogenous suspension is obtained.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-7
Manufacturing Process :
11. Transfer Pineapple flavour, Peppermint flavour and Banana flavour to the
manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the
container with sufficient quantity of Purified water and add to the
manufacturing tank.
Pineapple flavour 5.0 ml
Peppermint flavour 5.0 ml
Banana flavour 1.2 ml
Purified water 5.00 ml
12. Dissolve Sunset yellow FCF in Purified water and transfer to the
manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the
container with sufficient quantity of water and transfer to the manufacturing
tank and stir well.
Sunset Yellow FCF : 0.04 g
Purified water ; 15.0 ml
13.Mix well for 30 minutes and check the pH. Adjust the pH to between 8.7 to 9.0 by using Tromethamine solution. Stir well and check the pH again. Ensure that the pH is between 8.7 to 9.0.
Tromethamine 10.0 g
Purified water 100.0 ml
14. Make up the volume to 1000 ml with Purified Water and mix.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL
SUSPENSION
EXAMPLE - 8
Batch size: 1000 ml

Sr. No. Ingredients Quantity in g
1 Roxithromycin 10.30
2 Ambroxol Hydrochloride 6,18
3 Glycerin 20.00
4 Polyoxyl 40 Hydrogenated castor oil 50.00
5 Saccharin Sodium 1.0
6 Sodium Methyl Hydroxybenzoate 2.3
7 Sodium Propyl Hydroxybenzoate 0.22
8 Monoammomium Glycyrrhizinate 1.00
9 Disodium Edetate 2.0
10 Guargum 1.4
11 Carbomer 974 P 2.0
12 Carboxymethyl Cellulose Sodium 0.6
13 Tromethamine 10.0
14 Simethicone 30% 1.0 ml
15 Sucrose 534.00
16 Sunset Yellow FCF 0.04
17 Peppermint Flavour 5.0 ml
18 Banana Flavour 5.0 ml
19 Purified Water . q.s.

* ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-8 Manufacturing Process :
1. Transfer Purified Water to a suitable steam jacketed s.s. manufacturing tank.
Add Sucrose with continuous stirring and heat the content with stirring till
Sucrose is completely dissolved. Boil the syrup for 10 minutes.
Sucrose 534.0 g
Purified Water 260.00 ml
2. Dissolve Sodium Methyl Hydroxybenzoate, Sodium Propyl Hydroxybenzoate
and Saccharin Sodium in hot Purified Water in a suitable s.s. vessel. Transfer
the solution to the main manufacturing tank while passing it through #80 s.s.
sieve and stir to mix. Rinse the container with Purified Water and add the
rinsings to the bulk. Stir to mix.
Sodium Methyl Hydroxybenzoate : 2.3 g
Sodium Propyl Hydroxybenzoate : 0.22 g
Saccharin Sodium : 1.0 g
Purified water : 25.00 ml
3. Filter the hot syrup bulk of step no.l through "Filter Press" using Purified Siliceous Earth as filter aid. Cool the filtered syrup to ambient temperature.
4. Transfer a portion of the filtered syrup of step 3 (about 300.000 ml) to another suitable s.s vessel.
5. Transfer Roxithromycin of #200 to the s.s vessel (Step 4) with continuous stirring. Stir to obtain a uniform homogenous slurry free from lumps and transfer to the manufacturing tank.
Roxithromycin : 10.30 g

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-8
Manufacturing Process:
6. Transfer Guargum and Carboxymethyl Cellulose Sodium to Glycerin. Mix properly and make a slurry. Add Purified water and stir till a smooth gel is formed and transfer to the manufacturing tank.

Glycerin 20.0 g
Carboxymethyl Cellulose Sodium 0.6 g
Guargum 1-4 g
Purified water 50.0 ml
7. Heat Polyoxyl 40 Hydrogenated castor oil. Add Ambroxol Hydrochloride. Mix
properly till Ambroxol Hydrochloride dissolves completely and transfer to the
manufacturing tank.
Polyoxyl 40 Hydrogenated castor oil : 50.0 g
Ambroxol Hydrochloride : 6.18 g
8. Take 100 ml of hot purifed water and add Carbomer 974 P slowly with
continuous stirring till it forms homogenous slurry and transfer it to
manufacturing tank.
Carbomer 974 P : 2.0 g
Purified Water : 50.0 ml
9. Add Disodium Edetate to hot purified water and stir to dissolve, rinse the
container with sufficient quantity of purified water and add to the
manufacturing tank.
Disodium Edetate : 2.0 g
Purified water : 50.00 ml
10.Transfer Monoammonium Glycyrrhizinate to purified water and rinse the container with sufficient quantity of purified water and add to the manufcturing tank.
Monoammonium Glycyrrhizinate : 1.0 g
Purified water : 30.0 ml
11. Mix and homogenise properly the entire contents in the manufacturing tank till a homogenous suspension is obtained.

ROXITHROMYCIN AND AMBROXOL HYDROCHLORIDE ORAL SUSPENSION
Example-8
Manufacturing Process :
12. Transfer Peppermint flavour and Banana flavour to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of Purified water and add to the manufacturing tank.
Peppermint flavour 5.0 ml
Banana flavour : 5.0 ml
Purified water 5.00 ml
13.Dissolve Sunset yellow FCF in Purified water and transfer to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of water and transfer to the manufacturing tank and stir well.
Sunset Yellow FCF 0.04 g
Purified water : 15.0 ml
14. Transfer Simethicone 30% to the manufacturing tank and stir well.
Simethicone 30% 1.0 ml
15. Mix well for 30 minutes and check the pH. Adjust the pH to between 8.7 to 9.0
by using Tromethamine solution. Stir well and check the pH again. Ensure that
the pH is between 8.7 to 9.0.
Tromethamine : 10.0 g
Purified water : 100.0 ml
16. Make up the volume to 1000 ml with Purified Water and mix.

We claim :
1) The process of preparing stable Roxithromycin and Ambroxol Hydrochloride oral suspension liquid composition comprises the following steps :
a. Transfer Purified "Water to a suitable steam jacketed s.s. manufacturing tank.
Add Sucrose (0.00 - 80.0 % w/v) with continuous stirring and heat the content
with stirring till Sucrose is completely dissolved. Boil the syrup for 10 minutes.
b. Dissolve Sodium Methyl Hydroxybenzoate (0.001 - 0.35% w/v)), Sodium
Propyl Hydroxybenzoate (0.001 - 0.035 % w/v) and Saccharin Sodium (0.05 -
5.0) in hot Purified Water in a suitable s.s. vessel. Transfer the solution to the
main manufacturing tank while passing it through #80 s.s. sieve and stir to mix.
Rinse the container with Purified Water and add the rinsings to the bulk. Stir to
mix.
c. Filter the hot syrup bulk of step no. 1 through "Filter Press" using Purified
Siliceous Earth as filter aid. Cool the filtered syrup to ambient temperature.
d. Transfer a portion of the filtered syrup of step 3 (about 300.000 ml) to another
suitable s.s vessel.
e. Transfer Roxithromycin of #200 to the s.s vessel (Step 4) with continuous
stirring. Stir to obtain a uniform homogenous slurry free from lumps and
transfer to the manufacturing tank.
f. Transfer Guargum (0.01 - 5.0 % w/v) and Carboxymethyl Cellulose Sodium
(0.00 - 5.0 % w/v) to Glycerin (1.0 - 15% w/v). Mix properly and make a
slurry. Add Purified water and stir till a smooth gel is formed and transfer to
the manufacturing tank.
g. Heat Polyoxyl 40 Hydrogenated castor oil (1.0 - 20.0 % w/v). Add Ambroxol
Hydrochloride. Mix properly till Ambroxol Hydrochloride dissolves completely
and transfer to the manufacturing tank.
h. Take 100 ml of hot purifed water and add Carbotner 974 P (0.001 - 5.0) slowly with continuous stirring till if forms homogenous slurry. And transfer this to step no 9.
i. Add Disodium Edetate (0.001 - 5.0 % w/v) to hot purified water and stir to dissolve, rinse the container with sufficient quantity of purified water and add to the manufacturing tank.

j. Transfer Monoammonium Glycyrrhizinate (0.05 - 2.0 % w/v) to purified water and rinse the container with sufficient quantity of purified water and add to the manufacturing tank.
k. Mix and homogenise properly the entire contents in the manufacturing tank till a homogenous suspension is obtained.
1. Transfer Peppermint flavour (0.001 - 5.0 % w/v) and Banana flavour (0.001 -5.0 % w/v) to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of Purified water and add to the manufacturing tank.
m. Dissolve Sunset yellow FCF (0.001 - 5.0% w/v) in Purified water and transfer to the manufacturing tank while filtering through 80# s.s. sieve and mix. Rinse the container with sufficient quantity of water and transfer to the manufacturing tank and stir well.
n. Transfer Simethicone 30% to the manufacturing tank and stir well.
o. Mix well for 30 minutes and check the pH. Adjust the pH to between 8.7 to 9.0 by using Tromethamine solution (0 - 20.0 % w/v). Stir well and check the pH again. Ensure that the pH is between 8.7 to 9.0.
p. Make up the volume to 1000 ml with Purified Water and mix.
2) A process as claimed in claim 1, where the sieving in step (e) is carried out by using #200 s.s. sieve.
3) A process as claimed in claim 1, wherein the sieving in steps (b), (I), (m) is carried out by using # 80 s.s. sieve.
4) A process as claimed in claim I, wherein the said liquid composition of step (p) is subjected to sampling and analysis for approval.
5) A process as claimed in claim 1,2,3 and 4 wherein the said liquid composition after approval is filled in suitable containers preferably amber glass bottles under continuous moerate stirring and sealed, preferably with pilfer proof aluminium cap with EP wad.
6) A process as claimed in any of the preceding claims wherein the said manufacturing tank is a steam jacketed stainless steel (S.S) manufacturing tank.

7) A process as claimed in any of the preceding claims wherein the said other vessels and/or containers used are made of stainless steel.
8) A process is claimed in any of the preceding claims wherein the said vessels and/or containers are rinsed with purified waer and rinsing is added and mixed to the bulk in the manufacturing tank.
9) A process of preparing Roxithromycin and Ambroxol Hydrochloride liquid
composition, substantially as herein described and illustrated in the examples.
Dated this 12th day of June, 2001.