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Search results for azelaic root_codes_JECFA\ EVALUATION in JECFA EVALUATION (approximate match)
Status:
Possibly Marketed Outside US
First approved in 1992
Source:
21 CFR 331
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Adipic acid has been incorporated into controlled-release formulation matrix tablets to obtain a pH-independent release for both weakly basic and weakly acidic drugs. It has also been incorporated into the polymeric coating of hydrophilic monolithic systems to modulate the intragel pH, resulting in zero-order release of hydrophilic drugs. The disintegration at intestinal pH of the enteric polymer shellac has been reported to improve when adipic acid was used as a pore-forming agent without affecting release in the acidic media. Adipic acid is used to make bisobrin an antifibrinolytic.
Status:
Possibly Marketed Outside US
First approved in 1990
Source:
21 CFR 358A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Palmitic acid is a saturated fatty acid, the principal constituent of refined palm oil, present in the diet and synthesized endogenously. Palmitic acid is able to activate the orphan G protein-coupled receptor GPR40. Palmitic acid was also a weak ligand of peroxisome proliferator-activated receptor gamma. Palmitic acid is a ligand of lipid chaperones - the fatty acid-binding proteins (FABPs). Dietary palm oil and palmitic acid may play a role in the development of obesity, type 2 diabetes mellitus, cardiovascular diseases and cancer.
Status:
Possibly Marketed Outside US
Source:
NDA022276
(1988)
Source URL:
First approved in 1988
Source:
NDA022276
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 1987
Source:
21 CFR 349
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
CTI-01 (ethyl pyruvate) is an investigational anti-inflammatory agent for the treatment of critical inflammatory conditions. CTI-01 was developed by Critical Therapeutics as a stable prodrug of pyruvate, a potent antioxidant, and a free radical scavenger. The drug showed an anti-inflammatory and tissue protection activity in animal models of pancreatitis, ischemia-reperfusion injury, sepsis, renal injury, and endotoxemia. CTI-01 was investigated in phase 2 clinical trials on patients undergoing cardiac surgery with cardiopulmonary bypass, but despite positive results in animal models, administration of EP does not appear to confer any benefit to cardiac surgical patients undergoing cardiopulmonary bypass. Besides clinical applications, ethyl pyruvate is long used as an additive to pharmaceutical preparations and foods, including candy, beverages, and baked goods. It is generally recognized as safe by the FDA.
Status:
Possibly Marketed Outside US
First approved in 1981
Source:
ANDA204937
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
There is no information related to the biological and pharmacological application of levulinic acid. But is known, that levulinic acid was recognized by the US Department of Energy as one of the top biobased platform chemicals of the future. It is a versatile building block with a clear value proposition in chemicals. Levulinic acid can successfully address many performance-related issues attributed to petroleum-based chemicals and materials.
Status:
Possibly Marketed Outside US
Source:
OHUI Wrinkle Science wrinkle repair eye by LG Household and Healthcare, Inc.
(2010)
Source URL:
First approved in 1968
Source:
NDA204017
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Capric acid (decanoic acid) is a medium-chain fatty acid found in saturated fats (cow butter, and plant oils like coconut oil). Capric acid is a major constituent of the MCT ketogenic diet, providing about 40% of the medium chain fat within the diet. The acid is discussed to have positive effect on seizure control through direct AMPA receptor inhibition and on mitochondrial diseases through the binding to PPARgamma. It readily crosses the blood-brain barrier, probably by a combination of diffusion and saturable carrier-mediated transport via a medium-chain fatty acid transporter.
Status:
Possibly Marketed Outside US
Source:
NDA012750
(1966)
Source URL:
First approved in 1952
Source:
NDA008697
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
A. W. Van Hoffman was the first to isolate sorbic acid from the berries of the mountain ash tree in the year 1859. The antimicrobial (preservative) properties of sorbic acid were recognized in the 1940's. In the late 1940's and 1950's it became commercially available. Sorbic acid and its potassium salt are now used in many countries in the production of sweet white wines. In the United States, BATF permits the use of sorbic acid and potassium sorbate to preserve wine. The maximum concentration of sorbic acid allowed in finished wine is 300 mg/L, (300 ppm). The antimicrobial action of sorbic acid is primarily against yeasts and molds. It's action against bacteria appears to be selective. The soluble sorbates are preferred when it is desired to use the preservative in liquid form, or when aqueous systems are to be preserved. Sodium sorbate in solid form is unstable and very rapidly undergoes oxidation on exposure to atmospheric oxygen. It is therefore not produced on the industrial scale. Aqueous solutions of sodium sorbate remain stable for some time. Calcium sorbate is used in the manufacture of fungistatic wrappers because it is highly stable to oxidation, but this use is very limited. Sorbic acid and sorbates can be directly added into the product. The products can be dipped or sprayed with aqueous solutions of sorbates. Dusting of food with dry sorbic acid is also possible but less recommended because sorbic acid irritates the skin and mucous membranes. Sorbic acid and particularly calcium sorbate can be used as active substances in fungistatic wrappers. A general survey of the numerous uses of sorbic acid in the food sector will be given. Some fields of application will be discussed that are either unimportant or not permitted in the U.K.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 1950
Source:
NDA208090
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Ammonium myristate is passage-delaying substance. It was used as a substance for influencing gastrointestinal passage. The addition of ammonium myristate caused a delay of about 1.5 h in the transit time of the absorbing part of the gastrointestinal tract. The addition of ammonium myristate improves the availability of nitrofurantoin from a slow releasing dosage form - an average increase is 23.8% of the total amount of nitrofurantoin excreted in the urine compared to the values obtained from the reference dosage form without the additional substance. The kinetics of renal elimination of nitrofurantoin is characterized by the longer duration of urinary excretion.
Status:
Possibly Marketed Outside US
First approved in 1942
Source:
21 CFR 356
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Malic acid is a tart-tasting organic dicarboxylic acid that contributes to the taste of many sour or tart foods such as apples. Sodium Malate is the sodium salt of Malic Acid. Malic Acid and Sodium Malate can be found in a wide range of cosmetics and personal care products. Sodium Malate functions as a skin conditioning agent-humectant. As a food additive, Sodium Malate has the E number E350. Sodium Malate has demonstrated protective effect on cisplatin-induced toxicity in mice. Sodium malate could become a useful agent for the reduction of CDDP-induced toxicity, particularly nephrotoxicity and hepatotoxicity.
Status:
Other
Class:
MIXTURE