POLYDIMETHYLSILOXANE
- CAS NO.:8050-81-5
- Empirical Formula: (C2H6OSi)n
- Molecular Weight: 0
- MDL number: MFCD00134211
- EINECS: 201-245-8
- SAFETY DATA SHEET (SDS)
- Update Date: 2024-04-22 18:05:02
What is POLYDIMETHYLSILOXANE?
Absorption
Simethicone is not systemically absorbed and so these data are not readily available.
Toxicity
Data regarding overdoses with simethicone are rare due to the fact that it is not systemically absorbed.. In the case of an overdose stop the drug and initiate symptomatic and supportive care.
Chemical properties
Viscous, greyish-white, opalescent liquid.
Chemical properties
The PhEur 6.0 and USP 32 describe simethicone as a mixture of
fully methylated linear siloxane polymers containing repeating units
of the formula [–(CH3)2SiO–]n, stabilized with trimethylsiloxy endblocking
units of the formula [(CH3)3 SiO–], and silicon dioxide. It
contains not less than 90.5% and not more than 99.0% of the
polydimethylsiloxane [–(CH3)2SiO–]n, and not less than 4.0% and not more than 7.0% of silicon dioxide. The PhEur 6.0 additionally
states that the degree of polymerization is between 20–400.
Simethicone occurs as a translucent, gray-colored, viscous fluid.
It has a molecular weight of 14 000–21 000.
Originator
Mylicon,Stuart,U.S.,1960
The Uses of POLYDIMETHYLSILOXANE
Simethicone is an oral anti-foaming agent used to reduce bloating, discomfort and pain caused by excess gas in the stomach or intestinal tract. Simethicone is a mixture of polydimethylsiloxane and hydrated silica gel.
The Uses of POLYDIMETHYLSILOXANE
Antifoam A Concentrate has been used as a component of Luria Bertani culture medium for growth of BL21 (DE3) E. coli cells transformed with the plasmids. It has also been used as a constituent in the preparation of aerosol generation fluid.
The Uses of POLYDIMETHYLSILOXANE
Simethicone Emulsion USP is a water dilutable, non-ionic emulsion containing 30% Simethicone USP by weight. Highly stable over a broad pH range. Simethicones are used as anti foam agents in the manufacture of drugs. Their use in Pharmaceuticals is to comb
Indications
Simethicone is indicated for the treatment of bloating, pressure, and cramps caused by gas. Simethicone is also used as part of bowel preparation for colonoscopies.
Background
Simethicone is a silicon based surfactant that decreases the surface tension of gastrointestinal gas bubbles to facilitate their elimination. It has a favourable safety profile as it is not systemically absorbed.
Simethicone has been in use since the 1940s but was granted FDA approval in 1952.
Production Methods
Silicon dioxide is initially rendered hydrophobic in one of a variety of proprietary processes specific to a particular manufacturer. It is then slowly mixed with the silicone fluids in a formulation. After mixing, the simethicone is milled to ensure uniformity.
Manufacturing Process
In a 5 liter three-necked flask, fitted with a reflux condenser, agitator and
thermometer, were placed 1,393 g (9.41 mold) of redistilled (CH3)2Si(OEt)2
and 1,110 g (9.41 mols) of (CH3)3SiOEt. To this solution was added 254 g (14.11 mols) of water containing 7.5 g of NaOH (approximately 1 NaOH per
100 silicon atoms). This insured the formation of only straight chain polymers.
The mixture was heated to 40°C and the temperature continued to rise for
nearly an hour. After adding 50 cc (20% excess) more water, the mixture was
refluxed for two hours and then allowed to stand overnight.
Alcohol was then distilled off, until the temperature reached 100°C. 1,706.6 g
of distillate was collected. (Theory 1,430 g.) This alcohol was poured into four
times its volume of water and an insoluble oil separated (457 g). The
insoluble fraction was added back to the copolymer residue from the
distillation and 555 cc of 20% hydrochloric acid was added. The acid mixture
was refluxed for two hours, and the silicon oils were carefully washed with
distilled water until neutral. The yield was 1,420 g. (Theory 1,409 g.)
brand name
Gas-X (Novartis); Mylanta Gas Relief (Johnson & Johnson-Merck Consumer); Mylicon Infant’s Drops (Johnson & Johnson-Merck Consumer); Sentry Simethicone (Witco); Sentry Simethicone Emulsion (Witco).
Therapeutic Function
Antiflatulent
General Description
Antifoam A Concentrate is an extremely effective foam suppressor for aqueous and non-aqueous systems. It is 100% active silicone polymer. No emulsifiers are present. Antifoam A Concentrate is typically effective at 1-100 ppm. Antifoam A Concentrate should be diluted with 3-10 parts of propylene glycol (aqueous) or vegetable oil (nonaqueous) with slow mixing. The product will be stable in the pH range of 5 to 9. Antifoam A Concentrate can be added directly to a fermentation medium, but it is not recommended that it be pumped to a fermenter on an as-needed basis.
Pharmaceutical Applications
The main use of simethicone as an excipient is as an antifoaming
agent in pharmaceutical manufacturing processes, for which
1–50 ppm is used.
Therapeutically, simethicone is included in a number of oral
pharmaceutical formulations as an antiflatulent, although its
therapeutic benefit is questionable. It is also included in antacid
products such as tablets or capsules. In some types of surgical or
gastroscopic procedures where gas is used to inflate the body cavity,
a defoaming preparation containing simethicone may be used in the
area to control foaming of the fluids.
When simethicone is used in aqueous formulations, it should be
emulsified to ensure compatibility with the aqueous system and
components.
In the USA, up to 10 ppm of simethicone may be used in food
products.
Pharmacokinetics
Simethicone decreases the surface tension of gas bubbles in the gastrointestinal tract, facilitating their expulsion. It has a short duration of action as it is generally given as needed, and a wide therapeutic index as it is not systemically absorbed.
Safety
Simethicone is used in cosmetics, foods, and oral and topical
pharmaceutical formulations, and is generally regarded as a
relatively nontoxic and nonirritant material when used as an
excipient. Direct contact with the eye may cause irritation.
Therapeutically, oral doses of 125–250mg of simethicone, three
or four times daily, have been given as an antiflatulent. Doses of
20–40 mg of simethicone have been given with feeds to relieve colic
in infants.
LD50 (dog, IV): 0.9 g/kg
Metabolism
Simethicone is not systemically absorbed and so it is not metabolised by the body.
storage
Simethicone is generally regarded as a stable material when stored
in the original unopened container. A shelf-life of 18 months from
the date of manufacture is typical. However, some simethicone
products have a tendency for the silicon dioxide to settle slightly and
containers of simethicone should therefore be shaken thoroughly to
ensure uniformity of contents before sampling or use. Simethicone
should be stored in a cool, dry, location away from oxidizing
materials.
Simethicone can be sterilized by dry heating or autoclaving. With
dry heating, a minimum of 4 hours at 160℃ is required.
Incompatibilities
Simethicone as supplied is not generally compatible with aqueous systems and will float like an oil on a formulation unless it is first emulsified. It should not be used in formulations or processing conditions that are very acidic (below pH 3) or highly alkaline (above pH 10), since these conditions may have some tendency to break the polydimethylsiloxane polymer. Simethicone cannot normally be mixed with polar solvents of any kind because it is very minimally soluble. Simethicone is incompatible with oxidizing agents.
Regulatory Status
GRAS listed. Included in the FDA Inactive Ingredients Database (oral emulsions, powders, solutions, suspensions, tablets; and rectal and topical preparations). Included in nonparenteral medicines licensed in the UK.
Properties of POLYDIMETHYLSILOXANE
Density | 1 g/mL at 20 °C |
vapor pressure | 5 mm Hg ( 20 °C) |
refractive index | n |
Flash point: | >101°C |
storage temp. | room temp |
solubility | Practically insoluble in water, very slightly soluble or practically insoluble in anhydrous ethanol, practically insoluble in methanol, partly miscible with ethyl acetate, with methylene chloride, with methyl ethyl ketone and with toluene. |
form | emulsion |
color | Colorless |
EPA Substance Registry System | Simethicone (8050-81-5) |
Safety information for POLYDIMETHYLSILOXANE
Signal word | Warning |
Pictogram(s) |
Exclamation Mark Irritant GHS07 |
GHS Hazard Statements |
H319:Serious eye damage/eye irritation H335:Specific target organ toxicity, single exposure;Respiratory tract irritation |
Precautionary Statement Codes |
P261:Avoid breathing dust/fume/gas/mist/vapours/spray. P305+P351+P338:IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continuerinsing. |
Computed Descriptors for POLYDIMETHYLSILOXANE
Abamectin manufacturer
Nitika Pharmaceutical Specialities Pvt Ltd
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