Adapalene powder

Adapalene powder is a retinoic acid compound with a stable chemical structure. It is not easy to decompose in air and light, and the product has good stability. The quality meets USP, EP, and BP standards.
It is white or off-white powder at room temperature and is insoluble in water or ethanol.
Adapalene mainly binds to RARβ and RARγ. This product is suitable for the treatment of common acne such as acne, papules, and pustules.
Animal experiments have found that adapalene has a comedolytic effect and a local anti-inflammatory effect. Its anti-inflammatory activity may be related to its interference with the metabolism of arachidonic acid.

Adapalene vs tretinoin
Like retinoic acid, adapalene binds to specific retinoic acid nuclear receptors. Unlike retinoic acid, adapalene does not bind to cytoplasmic receptors that bind to proteins.

Pharmacokinetics show that the transdermal absorption rate of adapalene is very low. Adapalene is metabolized in animals mainly through oxygen-demethylation, hydroxylation and conjugation reactions, and is mainly excreted through bile.

COA

Test Items	Standard	Test Results
Assay	98.0~ 102.0% (On dried basis)	99.8%
Characteristics	White to off white powder	Complies
Identification	IR Complies	Complies
Solubility	Practically insoluble in water and ethanol,sparingly soluble in tetrahydrofuran	Complies
Solution of appearance	Solution clear Colour ≤BY6	Complies
Heavy metals	≤20ppm	Complies
Loss on drying	≤0.5%	0.09%
Sulphated ash	≤0.1%	0.07%
Related substances	A Impurity A ≤0.3% D Impurity D ≤0.2% C Impurity C ≤0.15% Unknow impurity ≤0.1% Total impurities ≤0.5%	0.03% ND ND 0.01% 0.04%
Residual solvent	Tetrahydrofuran ≤720ppm Acetic acid ≤5000ppm Methanol ≤3000ppm Dichloromethane ≤600ppm N,N-dimethyl formamide ≤880ppm	490ppm ND ND ND ND
Conclusion	Complies with EP7.0 standard.

Adapalene powder

1. Adapalene can effectively inhibit excessive oil secretion.
2. It has been shown to have anti-inflammatory properties in in vivo and in vitro inflammatory models. Standard anti-inflammatory analysis indicates that adapalene is superior to retinoic acid.
3. Human clinical trial studies have shown that adapalene can relieve inflammatory reactions of acne (such as pustules and papules). Adapalene applied to acne-affected areas can relieve inflammatory reactions mediated by cell reactions.
Skin medication tests have shown that adapalene can treat acne and has the activity of regulating cell differentiation and proliferation. Its mechanism of action is to reduce the formation of microacne by normal differentiation of hair follicle epithelial cells.
4. In vitro, by inhibiting glutamine convertase, it has an inhibitory effect on the keratinization process and can regulate cell differentiation.

Adapalene powder factory

Adapalene powder

1. Adapalene powder is the raw material of Adapalene gel and adapalene cream.

Adapalene is dermatological drugs and external preparations of the third-generation retinoic acid. It is the first choice for the treatment of mild to moderate acne with good tolerance and safety.

Reference

[1].Cunliffe WJ, Caputo R, Dreno B, Förström L, Heenen M, Orfanos CE, Privat Y, Robledo Aguilar A, Meynadier J, Alirezai M, Jablonska S, Shalita A, Weiss JS, Chalker DK, Ellis CN, Greenspan A, Katz HI, Kantor I, Millikan LE, Swinehart JM, Swinyer L, Whitmore C, Czernielewski J, Verschoore M. Clinical efficacy and safety comparison of adapalene gel and tretinoin gel in the treatment of acne vulgaris: Europe and U.S. multicenter trials. J Am Acad Dermatol. 1997 Jun;36(6 Pt 2):S126-34.

[2].Grosshans E, Marks R, Mascaro JM, Torras H, Meynadier J, Alirezai M, Finlay AY, Soto P, Poncet M, Verschoore M, Clucas A: Evaluation of clinical efficacy and safety of adapalene 0.1% gel versus tretinoin 0.025% gel in the treatment of acne vulgaris, with particular reference to the onset of action and impact on quality of life. Br J Dermatol. 1998 Oct;139 Suppl 52:26-33. doi: 10.1046/j.1365-2133.1998.1390s2026.x

Adapalene powder