U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

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Showing 11 - 20 of 24 results

Status:
First approved in 1984
Source:
NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE by OMP, INC.
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)



Butylated hydroxytoluene, commonly known as BHT, is an organic compound that is used in the food, cosmetic, and pharmaceutical industry as an antioxidant. BHT is a substituted derivative of phenol. BHT helps to prevent the formation of free radicals and oxidation. When used in food products, it delays oxidative rancidity of fats and oils, and prevents loss of activity of oil-soluble vitamins. It may be found in pharmaceutical gels, creams and liquid or gelatin capsules, tablets and other pharmaceutical dosage forms. The ability of oral BHT to lead to cancer is a controversial topic, but most food industries have replaced it with butylated hydroxyanisole (BHA). BHT was first used as an antioxidant food additive in 1954. BHT does have other commercial uses, as in animal feeds and in the manufacture of synthetic rubber and plastics, where it also acts as an antioxidant. The U.S. Food and Drug Administration has deemed that BHT is safe enough when used in limited concentrations. It currently permits its use in concentrations of about 0.01% to 0.02% in most foods. As an emulsion stabilizer in shortening, it may be used in a somewhat higher concentration, 200 parts per million.
Tocophersolan (Vedrop, tocofersolan) or d-alpha-Tocopheryl Polyethylene Glycol 1000 Succinate (TPGS) is a watersoluble derivative of the natural active (d-alpha) isomer of vitamin E. The active constituent of the medicinal product is essentially vitamin E (alpha tocopherol). Chronic congenital or hereditary cholestasis is a clinical condition where vitamin E deficiency results from an impaired bile secretion. Decreased intestinal absorption observed in chronic congenital or hereditary cholestatic patients is due to decreased bile secretion and the resulting decrease in intestinal cellular absorption. As a result, fatsoluble vitamins (i.e. vit. E) are not absorbed properly and deficiency can occur. Tocophersolan (Vedrop) is used to treat or prevent vitamin E deficiency (low vitamin E levels). It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut. Tocophersolan (Tocofersolan) can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet. This can increase vitamin E levels in the blood and help to prevent neurological deterioration (problems in the nervous system) due to vitamin E deficiency. No treatment-related findings were reported, as all clinical observations and findings at autopsy were similar in treatment and control groups. In many of the studies, the LD50 was not determined as tocofersolan was well tolerated.
Propyl Gallate is the n-propyl ester of gallic acid (3,4,5-trihydroxybenzoic acid). It is soluble in ethanol, ethyl ether, oil, lard, and aqueous solutions of polyethylene glycol (PEG) ethers of cetyl alcohol, but only slightly soluble in water. Propyl Gallate currently is used as an antioxidant in a reported 167 cosmetic products at maximum concentrations of 0.1%. Propyl Gallate is a generally recognized as safe (GRAS) antioxidant to protect fats, oils, and fat-containing food from rancidity that results from the formation of peroxides. The biological activity of Propyl Gallate is consistent with its free-radical scavenging ability, with effects that include antimicrobial activity, enzyme inhibition, inhibition of biosynthetic processes, inhibition of the formation of nitrosamines, anesthesia, inhibition of neuromuscular response to chemicals, ionizing/ultraviolet (UV) radiation protection, chemoprotection, antimutagenesis, anticarcinogenesis and antitumorigenesis, antiteratogenesis, and anticariogenesis. Propyl gallate has being shown to be a hepatoprotector in vitro and in vivo.
mixture
Status:
Possibly Marketed Outside US
First approved in 1941
Source:
Morphine Sulfate by Bryant Ranch Prepack
Source URL:

Class:
MIXTURE

structurally diverse
Status:
Possibly Marketed Outside US
Source:
NCT01426750: Phase 4 Interventional Completed Malnutrition
(2002)
Source URL:

Class:
STRUCTURALLY DIVERSE

Conditions:

Phopsholipon is a well-established lipoid brand characterizes natural and hydrogenated lecithin fractions and phospholipids from soybean, rapeseed (canola) or sunflower for pharmaceutical oral or topical applications and for use in cosmetics, as well in emulsions; liposomal formulations; as natural oil replenishing agents in shampoos and bath additives. Applications: preparation of mixed micelles, liposomes and micro emulsions. Solubilizer for parenteral administration forms; emulsifier for pharmacy, dermatology and cosmetics; phosphatidylcholine source for drugs and dietetics.
Ascorbic acid (vitamin C) is a water-soluble vitamin. It occurs as a white or slightly yellow crystal or powder with a slight acidic taste. Ascorbic acid is an electron donor, and this property accounts for all its known functions. As an electron donor, ascorbic acid is a potent water-soluble antioxidant in humans. Ascorbic acid acts as an antioxidant under physiologic conditions exhibiting a cross over role as a pro-oxidant in pathological conditions. Oxidized ascorbic acid (dehydroascorbic acid (DHA) directly inhibits IkappaBalpha kinase beta (IKKbeta) and IKKalpha enzymatic activity in vitro, whereas ascorbic acid did not have this effect. These findings define a function for vitamin C in signal transduction other than as an antioxidant and mechanistically illuminate how vitamin C down-modulates NF-kappaB signaling. Vitamin C is recommended for the prevention and treatment of scurvy. Its parenteral administration is desirable for patients with an acute deficiency or for those whose absorption of orally ingested ascorbic acid (vitamin c) is uncertain. Symptoms of mild deficiency may include faulty bone and tooth development, gingivitis, bleeding gums, and loosened teeth. Febrile states, chronic illness, and infection (pneumonia, whooping cough, tuberculosis, diphtheria, sinusitis, rheumatic fever, etc.) increase the need for ascorbic acid (vitamin c). Hemovascular disorders, burns, delayed fracture and wound healing are indications for an increase in the daily intake.
Status:
First marketed in 1921
Source:
Elixir of Iron Lactate N.F.
Source URL:

Class (Stereo):
CHEMICAL (RACEMIC)



Sodium lactate is primarily indicated as a source of bicarbonate for prevention or control of mild to moderate metabolic acidosis in patients with restricted oral intake whose oxidative processes are not seriously impaired. Sodium Lactate is most commonly associated with an E number of “E325” Sodium Lactate blends are commonly used in meat and poultry products to extend shelf life and increase food safety. They have a broad antimicrobial action and are effective at inhibiting most spoilage and pathogenic bacteria. In addition sodium lactate is used in cosmetics as a humectant, providing moisture.
Status:
US Previously Marketed
Source:
Exsiccated Sodium Sulphite U.S.P.
(1921)
Source URL:
First marketed in 1921
Source:
Exsiccated Sodium Sulphite U.S.P.
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)


Sulfites are compounds that contain the sulfite ion. The sulfite ion is the conjugate base of bisulfite. Although its acid is elusive, its salts are widely used. Sulfite is used in the photography industry to protect developing solutions from oxidation, in the pulp and paper industry, in water treatment as an oxygen scavenger agent, as a desulfurizing and dechlorinating agent in the leather industry and as a bleaching agent in textile industry. Sodium sulfite is a component in many pharmaceuticals, which is effective to maintain the potency and stability of drugs. It is added to a number of drug preparations as an antioxidant and antimicrobial agent. Sulfite is used as a food preservative. Topical, oral or parenteral exposure to sulphites has been reported to induce a range of adverse clinical effects in sensitive individuals, ranging from dermatitis, urticaria, flushing, hypotension, abdominal pain and diarrhoea to life-threatening anaphylactic and asthmatic reactions. Exposure to the sulphites arises mainly from the consumption of foods and drinks that contain these additives; however, exposure may also occur through the use of pharmaceutical products, as well as in occupational settings. Sulfite is accepted for use as a food additive in Europe. Sodium sulfite is generally recognized as safe by FDA. It is included in FDA Inactive Ingredients Database (epidural, IM, IV, and SC injections; inhalation solution; ophthalmic solutions; oral syrups and suspensions; otic solutions; topical creams and emulsions). Included in nonparenteral medicines licensed in the UK.
Status:
Possibly Marketed Outside US

Class (Stereo):
CHEMICAL (ABSOLUTE)

Conditions:

Erythorbic acid, an epimer of L-ascorbic acid, is used in the United States as a food additive. It was studied, that erythorbic acid enhanced of iron absorption and could play a major role in enhancing iron bioavailability from mixed diets that include foods preserved with erythorbic acid. In addition, was investigated if the erythorbic acid could influence on the metabolism of vitamin C in young women, and obtained results showed, that prolonged ingestion of erythorbic acid had no effect on vitamin C uptake or clearance from the body.
Status:
Possibly Marketed Outside US

Class (Stereo):
CHEMICAL (ACHIRAL)

METABISULFITE ION is a food additive, also known as E-224. It is used as the preservative in processed fruit products including dried fruits, juices, and wine.

Showing 11 - 20 of 24 results