Simethicone is known as an Antifoaming agent, tablet diluent, and water-repellent. This compound is part of the diverse product portfolio offered by Arvin Kala.
The PhEur 6.0 and USP 32 define simethicone as a blend of fully methylated linear siloxane polymers with repeating units of the formula [–(CH3)2SiO–]n, stabilized by trimethylsiloxy end-blocking units of the formula [(CH3)3 SiO–], and silicon dioxide. It comprises 90.5% to 99.0% polydimethylsiloxane [–(CH3)2SiO–]n and 4.0% to 7.0% silicon dioxide. Additionally, the PhEur 6.0 specifies that the degree of polymerization ranges from 20 to 400. Simethicone appears as a translucent, gray, viscous fluid with a molecular weight of 14,000 to 21,000.
The structural formula of this substance is as follows:
The primary application of simethicone as an excipient is its role as an antifoaming agent in pharmaceutical manufacturing processes, typically used in concentrations ranging from 1 to 50 ppm.
Therapeutically, simethicone is incorporated into various oral pharmaceutical formulations as an antiflatulent, although its clinical effectiveness remains debatable.(1,2) It is also a common component in antacid products, including tablets and capsules.(3 to 7) Additionally, in certain surgical or gastroscopic procedures where gas is employed to inflate body cavities, a defoaming preparation containing simethicone may be applied to manage fluid foaming in the area.
When simethicone is utilized in aqueous formulations, it must be emulsified to ensure compatibility with both the aqueous system and its components.
In the United States, simethicone may be used in food products at concentrations of up to 10 ppm.
Simethicone is typically considered stable when kept in its original, unopened container, with a common shelf-life of 18 months from the manufacturing date. However, due to the slight settling of silicon dioxide in some simethicone products, it is recommended to shake the containers well before use to ensure content uniformity. For optimal storage, simethicone should be placed in a cool, dry area, away from oxidizing agents.
Simethicone can be sterilized using either dry heat or autoclaving. For dry heat sterilization, it needs to be heated for at least 4 hours at 160°C.
Simethicone is commonly utilized in cosmetics, foods, and both oral and topical pharmaceutical formulations. It is generally considered to be relatively nontoxic and nonirritating when used as an excipient. However, direct contact with the eyes can cause irritation.
Therapeutically, oral doses of 125 to 250 mg of simethicone are administered three to four times daily as an antiflatulent. For infants, doses of 20 to 40 mg of simethicone are given with feeds to alleviate colic.
Follow standard safety precautions based on the specific situation and amount of material being handled. It is advisable to wear eye protection and gloves. Ensure that simethicone is handled in well-ventilated areas.
Chemical-physical values
| Test Item | Unit | Specification |
|---|---|---|
|
DESCRIPTION |
|
Translucent, gray, viscous fluid. |
|
ASSY |
% |
NLT 90.5 &
NMT 99.0
|
|
Content of silicon dioxide |
% |
NLT 4.0 &
NMT 7.0
|
|
Loss on heating |
% |
NMT 18.0 |
|
Defoaming activity |
Second |
NMT 15
|
|
Acidity |
|
NMT 3.0 |
|
Viscosity |
Cps |
NLT 1500 &
NMT 3000
|
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