Paracetamol Solution
The solution contains Paracetamol 120 mg per 5 mL. This oral solution features Carbopol® 971P NF polymer which is used as a
rheology modifier in the formulation.
Number Ingredients % w/w
Part A: Carbopol polymer dispersion phase
®
1. Carbopol® 971P NF polymer 0.30
2. Deionized water 25.00
Part B (sugar syrup phase):
3. Sucrose 30.00
4. Methyl paraben 0.20
5. Propyl paraben 0.02
6. Sodium saccharine 0.25
7. Disodium EDTA 0.05
8. Deionized water 25.00
Part C (neutralization):
9. Sodium hydroxide solution (10% w/w) q.s. to ~pH 5.00
Part D (drug phase):
10. Paracetamol, USP 2.40
11. Propylene Glycol 25.00
Part E:
12. Mixed Fruit Flavor 0.25
13. FD&C Red Number 40 (1% w/v Solution) 0.50
14. Deionized water q.s. to 100.00
TOTAL: 100.00
Lab batch size – 1,000 mL
Process:
1. P
art A (Carbopol® polymer dispersion phase): Add deionized water in a vessel equipped with dispersing type or propeller type
impeller. Dissolve disodium EDTA and sodium saccharine in this water. Disperse Carbopol® 971P NF into the water by submerging
the impeller until it is very close to the bottom of the vessel. Angle the impeller to generate a vortex that is 1 to 1½ impeller diameters.
Slowly sift the polymer through a stainless steel 20 mesh screen into the vortex of the rapidly agitating liquid (about 800-1500 rpm).
Increase the agitation as the viscosity of the dispersion increases to maintain a vortex. After all of the dry polymer has been
introduced, reduce the agitation to 400-600 rpm and reposition the mixer to vertical position to avoid or minimize air entrapment.
Continue the agitation for about 45 minutes, or until a lump-free dispersion is attained.
2. P
art B (sugar syrup phase): Dissolve methyl paraben and propyl paraben in deionized water that has been heated to 95°C.
Add sucrose and maintain the temperature at 75°C to dissolve the sugar. Filter the sugar solution through a 100-mesh nylon filter
while hot. Add the sorbitol solution and mix well. Cool the syrup to room temperature.
3. Add the Carbopol polymer dispersion phase (Part A) to the cooled syrup phase (Part B) and mix for 15 minutes.
4. P
art C: Neutralize the above mixture with the 10% sodium hydroxide solution to pH 5.0 and mix for 30 minutes using a U or paddle
shaped low-shear mixer.
5. P
art D (drug phase): Dissolve the paracetamol in propylene glycol while stirring continuously.
6. A
dd Part D to Part C and mix for 15 minutes.
7. P
art E: Add the color and flavor and continue mixing for 15 minutes using U or paddle shaped low-shear mixer. Add water to the
specified batch size. Continue mixing for at least 30 minutes until uniform pH and viscosity is achieved.
Paracetamol Solution
Product Properties Stability
Stable for a minimum of 3 month when stored under the following
Appearance: Clear, red viscous solution
ICH conditions:
pH: 5.00 Long term (25 ± 2°C / 60 ± 5% relative humidity)
Viscosity (cP)* : 370 • *Brookfield RVT @25°C, 20 rpm, Spindle
Accelerated (40 ± 2°C / 75 ± 5% relative humidity)
#3, measured at 24 hours
Design of mixing elements:
Propeller or dissolver for Paddle or U-shaped low-shear
dispersing Carbopol® polymers. impeller for neutralization.
Summary:
Carbopol® polymers have demonstrated to be useful and highly efficient as rheology modifiers and suspension stabilizer
making them a first choice when formulating liquid oral suspensions.
The Lubrizol Life Science Health website www.lubrizol.com/Health provides additional information:
• Bulletin 04 - Dispersion Techniques; Bulletin 07 - Flow and Suspension Properties;
Bulletin 22 - Oral Suspensions
• Dispersion and neutralization videos from video gallery
• Technical Data Sheets, Test Procedures, Certificates, and other Formulations
Please contact your Lubrizol representative to get samples, quotations or
further technical assistance.
9911 Brecksville Road
Cleveland, OH 44141-3201 USA Lubrizol.com/Health
The information contained herein is believed to be reliable, but no representations, guarantees or warranties of any kind are made as to its accuracy, suitability for particular applications or the results to
be obtained. The information often is based on laboratory work with small-scale equipment and does not necessarily indicate end-product performance or reproducibility. Formulations presented may not
have been tested for stability and should be used only as a suggested starting point. Because of the variations in methods, conditions and equipment used commercially in processing these materials, no
warranties or guarantees are made as to the suitability of the products for the applications disclosed. Full-scale testing and end-product performance are the responsibility of the user. Lubrizol Advanced
Materials, Inc., shall not be liable for and the customer assumes all risk and liability for any use or handling of any material beyond Lubrizol Advanced Materials, Inc.’s direct control. The SELLER MAKES NO
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considered as permission, recommendation nor as an inducement to practice any patented invention without permission of the patent owner. Lubrizol Advanced Materials, Inc., is a wholly owned subsidiary
of The Lubrizol Corporation.
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Edition: March 2020 • Previous Edition: June 2011 20-124
