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Search results for "JECFA|Functional Classification|Emulsifier" in comments (approximate match)
Status:
US Approved Rx
(2020)
Source:
NDA211281
(2020)
Source URL:
First approved in 1953
Source:
ANDA040621
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Lactitol is a sugar alcohol. This ingredient has been determined to be GRAS for specified uses as a direct food additive and foods containing lactitol are eligible for a health claim related to dental caries. Lactitol is used as an oral powder or solution in the management of hepatic encephalopathy and in case of short-term treatment of occasional constipation. Intestinal flora of large intestine is metabolize lactitol to low-molecular organic acid, which leads to an increase in osmotic pressure in intestine, increase in volume of fecal masses bowel function normalization. This drug might cause abdominal discomfort, especially flatulence and abdominal pain rarely or sometimes abdominal distension. These effects tend to diminish or disappear after a few days of regular intake of the drug. Since 'antacids and neomycin can neutralize ' acidifying effect of lactitol on stool, they should not be co-administered with lactitol in cirrhotic patients with hepatic encephalopathy; however both substances do not alter the 'laxative effect in patients with constipation.
Status:
Possibly Marketed Outside US
Source:
21 CFR 349
(2015)
Source URL:
First approved in 2004
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Sorbitan tristearate (E492) is used as an emulsifier and stabiliser. It is produced by the esterification of sorbitol with commercial stearic acid derived from food fats and oils.It is a mixture of the partial esters of sorbitol and its mono- and dianhydride with edible stearic acid. It is permitted as a food additive in bakery products, toppings and coatings, fat emulsions, milk and cream analogues, beverage whiteners, edible ices, desserts, sugar confectionery including chocolate, emulsified sauces, dietary food supplements, chewing gum and dietetic foods.
Status:
Possibly Marketed Outside US
Source:
PLIAGLIS by Atlas Powder
Source URL:
First approved in 1985
Source:
ANDA088450
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Sorbitan monopalmitate (Span 40) is a nonionic emulsifier, surfactant and food additive. The product of Croda Inc. Span 40 is used in skin care, hair care and decorative cosmetics. It is also used as an effector in compositions capable of facilitating penetration across a biological barrier. Inactive ingredient of some medications it improves transdermal delivery of drugs and is a potential carrier for topical drug delivery. In PLIAGLIS cream (lidocaine and tetracaine) sorbitan monopalmitate is used as an inactive ingredient. Sorbitan monopalmitate is a fatty acid sorbitan ester, yellowish brown wax, slightly soluble in isopropanol, xylene and liquid paraffin, insoluble in water, non-toxic.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(1980)
Source URL:
First approved in 1980
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Sorbitan monostearate (Span 60) is a non-ionic surfactant with emulsifying, dispersing, and wetting properties used as a food additive, additive in mixtures for drug use and in skin care products. It is approved for use by FDA in quantities not exceeding the amount reasonably required to accomplish the intended effect. 0.5-5% of Liposorb® S (sorbitan monostearate) is used for oil-in-water emulsions in combination with a high hydrophilic-lipophilic balance emulsifier to produce smooth lotions and creams in skin and hair care, make-up bases, and mild cleaning products. Sorbitan monostearate based organogels and vesicles (niosomes) formulated to enhance the oral bioavailability were characterized for use as a drug delivery vehicle. In combination with other non-ionic surfactants sorbitan monostearate is patented for use in vaccine formulations as a saponin-containing adjuvant for oil-in-water injectable emulsions. It is fatty acid ester of sorbitan (a sorbitol derivative) and stearic acid sometimes called synthetic wax. Has low hydrophilic-lipophilic balance. Non-toxic.
Status:
Possibly Marketed Outside US
Source:
Vaginne Intimate Hygiene Wash by WOYA BIO-TECHNOLOGY CO.,LTD.
(2022)
Source URL:
First approved in 1973
Source:
ANDA083231
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Sorbitan laurate (Span 20) is a mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible lauric acid. It is an excipient. Sorbitan laurate is a non-ionic surfactant that is widely used as an emulsifier and stabilizer in pharmaceutical formulations, food and cosmetic industries. As a food additive, it is designated with the E number E493. Span 20 finds application in topical preparations. It is soluble in many fatty compositions and solvents and dispersible in water, dilute acids and alkalis. Recommended topical usage levels of 0.5-5%.
Status:
Possibly Marketed Outside US
Source:
21 CFR 334
(2010)
Source URL:
First approved in 1972
Source:
ANDA061621
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Sorbitan monooleate (Span 80) is a partial oleate ester of sorbitol and its mono- and dianhydrides. Sorbitan Monooleate is a nonionic emulsifier and surfactant and used in cosmetics and foods. It is a food additive with the E number E495. Span 80 was suitable as surfactant in the preparation of Poly(divinylbenzene) emulsion-derived (PolyHIPE) solid foam. Anionic nanoparticles based on Span 80 as low-cost, simple and efficient non-viral gene-transfection systems. Sorbitan monooleate is approved by FDA to be used as an emulsifier in polymer dispersions that are used in the clarification of cane or beet sugar juice or liquor in an amount not to exceed 7.5 percent by weight in the final polymer dispersion. The additive is used in an amount not to exceed 0.70 part per million in sugar juice and 1.4 parts per million in sugar liquor.
Status:
US Previously Marketed
Source:
LACRISERT by BAUSCH AND LOMB INC
(1981)
Source URL:
First approved in 1975
Source:
NDA017579
Source URL:
Class:
MIXTURE
Status:
US Previously Marketed
Source:
21 CFR 310.527(a) hair loss prevention polysorbate 60
Source URL:
First approved in 1938
Source:
Belladonna and Opium by Bryant Ranch Prepack
Source URL:
Class:
MIXTURE
Status:
US Previously Marketed
First marketed in 1921
Class:
MIXTURE