Yes, Azelaic acid occurs in cereals.
Azelaic acid is manufactured by epoxidation of vegetable oleic acid, followed by oxidation of the epoxide. It then must be purified and micro-milled to become our pharmaceutical and mic-cosmetic version of Azelaic acid.
Azelaic Acid has proven in studies to be effective for the Treatments of acne, rosacea, stimulating hair growth, skin lightening, treating "liver" spots.
If you are creating a pharmaceutical for use in treating acne the U.S. Food & Drug Administration (FDA) has approved a 20% concentration of Azelaic acid; for treatment of rosacea the FDA specifies a 15% concentration - both these must be used by people with a doctor's prescription. For use in cosmetic products you must use a less than 15% concentration which then is not regulated by FDA regulations.
No, Azelaic acid also works superior on Acne ectopia (hidradenitis suppurativa). Realize if you are creating a pharmaceutical product it should contain 20% concentration to be in line with FDA regulations, for cosmetic products you can use any concentration up to 14% and studies have shown it will still be effective against various types of acne breakouts. Obviously the effectiveness will depend upon the concentration of Azelaic acid in the product.
You would need 5-14% Azelaic acid for a cosmetic product and 15% for a pharmaceutical product to conform with FDA regulations. Again with a cosmetic product the higher the concentration the better the product will perform.
Tests have shown results using from 10% - 14% has produced the best results. There is no FDA guideline for using the product other than you must use a less than 15% concentration.
Tests have shown results using from 3% - 10% has produced the best results. There is no FDA guideline for using the product other than you must use a less than 15% concentration.
Azelaic acid exhibits poor solubility in water but using 1,2-glycols or glycerin as the solvent will greatly improve the solubility of Azelaic acid.
This Azelaic acid solution can be thickened to a fully transparent gel with the following:
- Hydroxypropylcellulose (HPC).
- Carbomers (anhydrous systems only).
The alkali salts of Azelaic acid are reasonably soluble in water, but a co-solvent such as e.g. 2- methyl-1,3-propanediol is recommended.
The toxicological profile of Azelaic acid is excellent:
- LD50-value (oral/rat) is >5000 mg/kg body weight,
- In pure form mild skin & eye irritancy, that disappears upon dilution,
- No CMR properties.
The toxicological profile of Azelaic acid is excellent:
- LD50-value (oral/rat) is >5000 mg/kg body weight,
- In pure form mild skin & eye irritancy, that disappears upon dilution,
- No CMR properties.
Pharmaceutical acid must be greater than 99% pure.
The pharmaceutical grade has a typical purity of 99.7- 99.9%, which is today the highest available purity at the market. The remaining substances are dicarboxyl acids such as pelargonic acid, suberic acid and related products.
The U.S. Food & Drug Administration (FDA) does not control the ingredients used in cosmetics other than prohibiting certain ingredients. Azelaic Acid is not prohibited and may be used in cosmetics or personal care items up to a concentration of 14%. Anything over that concentration is considered a drug and subject to FDA controls and uses. According to EU Commission Regulation 1223/209 of April 26, 2015 azelaic acid can be used without restriction. In several Asian countries Azelaic acid is mentioned in Annex II, but it is highly likely that it will be shifted to Annex III shortly.
No, but Azelaic acid works specifically on particular organisms such as Propionibacterium acnes and Staphylococcus epidermides
No, its activity is limited to opportunistic organisms such as P.acnes & S.epidermides.
Azelaic acid inhibits 5-a-reductase, an a-blocker, and delays the formation of dihydrotestosterone from testosterone.
Yes! That is best done using betaine (trimethylglycine).
