| Identification | Back Directory | [Name]
POLYDIMETHYLSILOXANE | [CAS]
8050-81-5 | [Synonyms]
phazyMe
Q 7-2587
HSDB 3906
SiMiticone
ANTIFOAM A
ANTIFOAM AF
DCantifoamA
Sab SiMplex
SilfoaM SE 2
Aligest Plus
Dow AntifoaM A
ANTIFOAM A(TM)
SILICONE FLUID
ANTIFOAM AF(TM)
Simethicone,Usp
DIMETHYL SILICONE
VISCOSITY STANDARD
POLYMETHYLSILOXANE
Simethicone (50 g)
POLYDIMETHYLSILOXAN
ANTIFOAM A EMULSION
ANTIFOAM B EMULSION
ANTIFOAM B SILICONE
ANTIFOAM C EMULSION
SILICONE OIL DC 200
ANTIFOAM EMULSION RD
DIMETHICONE COPOLYOL
Sentry SiMethicone GS
Dow Corning AntifoaM A
SIMETHICONE USP LIQUID
Mylicon Infant's Drops
ANTIFOAM A CONCENTRATE
POLYDIMETHYLSILOXANE GUM
POLYDIMETHYLSILOXANE 311
DOW CORNING 1500 ANTIFOAM
DOW CORNING 1510 ANTIFOAM
POLYDIMETHYLSILOXANE 1'850
POLYDIMETHYLSILOXANE 3'320
POLYDIMETHYLSILOXANE 7'100
SIMETHICONE 30%,50% & 100%
Sentry SiMethicone EMulsion
POLYDIMETHYLSILOXANE 71'000
POLYDIMETHYLSILOXANE 89'800
POLYDIMETHYLSILOXANE 47'500
SILICONE ANTI-FOAM EMULSION
POLYDIMETHYLSILOXANE 25'800
POLYDIMETHYLSILOXANE 16'000
DOW CORNING 1520EU ANTIFOAM
POLYDIMETHYLSILOXANE 173'000
POLYDIMETHYLSILOXANE 158'000
POLYDIMETHYLSILOXANE 303'000
POLYDIMETHYLSILOXANE 197'000
ANTIFOAM B(R) SILICONE EMULSION
DOW CORNING ANTIFOAM RD EMULSION
EIGHT-ARM POLY(DIMETHYL SILOXANE)
DOW CORNING ANTIFOAM MSA COMPOUND
DOW CORNING DB-310 ANTIFOAM EMULSION
SILCOREL(R) ADP1000 ANTIFOAM COMPOUND
REDUCED VOLATILITY POLYDIMETHYLSILOXANE
DOW CORNING DB-110A EU ANTIFOAM EMULSION
POLY(DIMETHYLSILOXANE), METHYL TERMINATED
EXTREME LOW VOLATILITY POLYDIMETHYLSILOXANE
DOW CORNING 346 EMULSION SINGLE RELEASE AGENT
Viscosity standard, Specpure, nominally 9.5cSt @ 40° and 2.8cSt @ 100°
α-(Trimethylsilyl)-ω-methylpoly[oxy(dimethylsilylene)] mixture with silicon dioxide | [Molecular Formula]
(C2H6OSi)n | [MDL Number]
MFCD00084411 | [MOL File]
8050-81-5.mol |
| Chemical Properties | Back Directory | [Appearance]
Viscous, greyish-white, opalescent liquid. | [density ]
1 g/mL at 20 °C
| [vapor pressure ]
5 mm Hg ( 20 °C)
| [refractive index ]
n20/D 1.406
| [Fp ]
>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 | [LogP]
3.404 (est) | [EPA Substance Registry System]
Simethicone (8050-81-5) |
| Hazard Information | Back Directory | [Usage]
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 | [Usage]
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. | [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. | [Chemical Properties]
Viscous, greyish-white, opalescent liquid. | [Originator]
Mylicon,Stuart,U.S.,1960 | [Uses]
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 | [Uses]
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. | [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. | [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 | [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. |
|
|