Clobetasol Propionate

Clobetasol Propionate

Cat Number
API25122467
CAS Number
25122-46-7

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CAS Number
25122-46-7
EINECS
246-634-3
Storage
Store at room temperature
Synonyms
Clobetasol 17-propionate; Clobex; Dermovate; Temovate; Embeline; Cormax
Molecular Formula
C25H32ClFO5
Molecular Weight
466.97
Smiles
CCC(=O)OC1(C(C)CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC12C)C(=O)CCl
Appearance
White to off-white crystalline powder
Melting Point
190-197℃
Boiling Point
569.0±50.0℃ (Predicted)
Relative Density
1.28
General Description
Clobetasol propionate is a super-high-potency topical corticosteroid reserved for severe, recalcitrant dermatoses. This agent is one of the most potent steroids in clinical use and is intended for short-term application due to its significant systemic absorption risk.
Mechanism of Action
Clobetasol propionate binds with high affinity to glucocorticoid receptors in cutaneous cells, initiating a cascade of anti-inflammatory gene modulation. It potently inhibits phospholipase A2, reducing arachidonic acid release and subsequent prostaglandin and leukotriene synthesis. The drug also suppresses cytokine production (IL-1, IL-2, IL-6, TNF-alpha), decreases Langerhans cell antigen presentation, and induces vasoconstriction, collectively achieving rapid resolution of inflammation.
Application
This steroid is indicated for moderate to severe plaque psoriasis, atopic dermatitis, lichen planus, discoid lupus erythematosus, and other steroid-responsive conditions unresponsive to less potent agents.

Using dermal open‑flow microperfusion, the kinetics of clobetasol‑17‑propionate (CP‑17) from Dermovate® cream were measured in lesional and non‑lesional psoriatic skin of 12 patients. Mixed‑effects modeling showed that skin condition (lesional vs. non‑lesional), treatment duration, and probe depth influenced penetration. CP‑17 penetrated more slowly into lesional skin, but repeated daily dosing normalized penetration, and no drug accumulation occurred in the dermis. The thickened psoriatic stratum corneum likely acts as a trap, slowing penetration. These time‑ and depth‑resolved data provide insight into topical corticosteroid behavior in diseased skin.

Fig. 1 The membrane-free dOFM probe within the dermis is continuously perfused and delivers interstitial fluid for further analysis. (Bodenlenz M, <i>et al</i>., 2016) Fig. 1 The membrane-free dOFM probe within the dermis is continuously perfused and delivers interstitial fluid for further analysis. (Bodenlenz M, et al., 2016)

References

  1. Bodenlenz M, et al. Kinetics of Clobetasol-17-Propionate in Psoriatic Lesional and Non-Lesional Skin Assessed by Dermal Open Flow Microperfusion with Time and Space Resolution. Pharm Res. 2016;33(9):2229-2238.

Clobetasol propionate (CP) was loaded into lecithin/chitosan nanoparticles (~250 nm, positive surface charge) and incorporated into a chitosan gel (final CP 0.005%). In the carrageenan‑induced paw edema test in rats, this nanoparticle‑in‑gel formulation produced significantly higher edema inhibition than a commercial cream (CP 0.05%) and a sodium deoxycholate gel (CP 0.05%), despite containing ten‑fold less drug. No significant skin barrier disruption or histological changes were observed. The nanoformulation markedly improves the risk‑benefit ratio for topical CP.

Fig. 2 Histology of the rat skin samples. (Şenyiğit T, <i>et al</i>., 2016) Fig. 2 Histology of the rat skin samples. (Şenyiğit T, et al., 2016)

References

  1. Şenyiğit T, et al. In Vivo Assessment of Clobetasol Propionate-Loaded Lecithin-Chitosan Nanoparticles for Skin Delivery. Int J Mol Sci. 2016;18(1):32.

Does Clobetasol Propionate require protection from light and moisture?

Yes, it is sensitive to both light and moisture. Store in original, tightly sealed, light-resistant containers with desiccant to prevent degradation.

What is the recommended storage temperature for Clobetasol Propionate?

Store at controlled room temperature (15-25°C). Avoid excessive heat above 30°C, which can accelerate hydrolysis of the propionate ester and oxidation of the corticosteroid ring.

Is Clobetasol Propionate stable in topical cream and ointment formulations?

Yes, it shows good stability in common topical bases. We provide compatibility data for various emollients, preservatives, and antioxidants (e.g., butylated hydroxytoluene).

How is the impurity clobetasol (free alcohol) monitored during stability?

This primary hydrolysis product is specifically quantified using a stability-indicating HPLC method, ensuring it remains within pharmacopoeial limits for topical use.
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