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Search results for "PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION" in comments (approximate match)
Status:
US Approved OTC
Source:
21 CFR 332.10 antiflatulent simethicone
Source URL:
First approved in 1952
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Silicon dioxide (silica) is most commonly found in nature as quartz, as well as in various living organisms. Silicon dioxide one of the most complex and most abundant families of materials, existing both as several minerals and being produced synthetically. In food and pharmaceutical industry silica is a common additive, where it is used primarily as a flow in powdered foods, or to adsorb water in hygroscopic application. In pharmaceutical products, silica aids powder flow when tablets are formed.
Status:
US Approved OTC
Source:
21 CFR 344.12 otic:ear drying aid isopropyl alcohol
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Isopropanolamine (1-Amino-2-propanol) is a colorless to yellowish liquid with an amine-like odor. It is miscible in water. Intermediate used in the production of dyes, lubrification oils, corrosion inhibitor, detergents, cutting fluids.
Status:
US Approved OTC
Source:
21 CFR 346.10(b) anorectal:local anesthetic benzyl alcohol
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Benzyl Alcohol is an aromatic alcohol used in a wide variety of cosmetic formulations as a fragrance component, preservative, solvent, and viscosity-decreasing agent. FDA agency approved benzyl alcohol for the treatment of head lice. The drug acts on head lice by inhibiting them from closing their respiratory spiracles, allowing the vehicle to obstruct the spiracles and causing the lice to asphyxiate.
Status:
US Approved OTC
Source:
21 CFR 331.11(f) antacid glycine (aminoacetic acid)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Glycine (Cly) is a natural amino acid neurotransmitter that acts as a co-agonist at Glutamate [NMDA] receptors in the brain and is an activator of glycine receptors, GLRA1-3, GLRB. The abnormal Gly levels have been implicated in neuropsychiatric disorders. Alterations in Gly levels are implicated in several diseases of the central nervous system. Glycine was studied in phase II of clinical trials in patients with schizophrenia. The results have shown that using of glycine was associated with reduced symptoms with promising effect sizes and a possibility of improvement in cognitive function. Besides, glycine was also studied in clinical trials phase II in children with cystic fibrosis. The clinical, spirometric and inflammatory status of subjects with cystic fibrosis improved after just 8 weeks of glycine intake, suggesting that this amino acid might constitute a novel therapeutic tool for these patients. In addition, Gly was proposed as a biomarker for brain tumor malignancy. Glycine is a component of a nutrients mixture for peripheral administration to well-nourished mildly catabolic adult patients who require only short-term parenteral nutrition.
Status:
US Approved OTC
Source:
21 CFR 346.16(a) anorectal:analgesic, anesthetic, antipruritic camphor
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Camphor is a bicyclic monoterpene ketone found widely in plants, especially cinnamomum camphora. Topically, camphor is used to relieve pain. It has been used to treat warts, cold sores, hemorrhoids, and osteoarthritis. It has also been applied topically as an analgesic and an antipruritic. It has been used as a counterirritant, and to increase local blood flow. Camphor has frequently been used topically to treat respiratory tract diseases involving mucous membrane inflammation. It is sometimes used topically to treat cardiac symptoms. Camphor is also used topically as an eardrop, and for treating minor burns.
In inhalation therapy, camphor is used as an antitussive.
Orally, camphor is used as an expectorant, antiflatulent, and for treating respiratory tract diseases. Today, most camphor is synthetic. It is approved by the FDA as a topical antitussive. Camphor is produced synthetically from the oil of turpentine. It has been used for centuries for its medicinal features, in religious rituals, and in cooking. It is no longer used as pesticide. In 1982, the US Food and Drug Administration restricted commercial products intended for medicinal use to contain <11% camphor.
Status:
Investigational
Source:
NCT02194764: Not Applicable Interventional Completed Healthy Adults
(2014)
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Status:
Investigational
Source:
Oncology. 2005;69(1):19-26.: Phase 3 Human clinical trial Completed Lymphoma, Non-Hodgkin/pathology
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Investigational
Source:
NCT02883751: Not Applicable Interventional Withdrawn Diabetes Mellitus
(2017)
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Investigational
Source:
NCT00608634: Phase 2 Interventional Completed Precancerous Condition
(2004)
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
The monoterpene perillyl alcohol (POH) is a naturally occurring compound derived from citrus fruits, mint, and herbs. It exhibited chemotherapeutic potential against various malignant tumors in preclinical models and was being tested in clinical trials in patients with refractory advanced cancers. POH was formulated in soft gelatine capsules and orally administered to cancer patients several times a day on a continuous basis. However, such clinical trials in humans yielded disappointing results, also because of the large number of capsules that had to be swallowed caused hard-to-tolerate intestinal side effects, causing many patients to withdraw from treatment due to unrelenting nausea, fatigue, and vomiting. The clinical trials in Brazil have explored intranasal POH delivery as an alternative to circumvent the toxic limitations of oral administration. In these trials, patients with recurrent malignant gliomas were given comparatively small doses of POH via simple inhalation through the nose. Results from these studies showed, that this type of long-term, daily chemotherapy was well tolerated and effective. The precise mechanism of action is still undetermined, but it is known, that perillyl alcohol plays an important role in the process of hepatoma cell invasion and migration via decreasing the activity of Notch signaling pathway and increasing E-cadherin expression regulated by Snail. Another possible mechanism is included inhibition of Na/K-ATPase (NKA). The NKA α1 subunit is known to be superexpresses in glioblastoma cells (GBM) and POH acts in signaling cascades associated with NKA can control cell proliferation and/or cellular death.
Status:
Excipient
Source:
1%w/w TOPICAL SHAMPOO
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)