Clocortolone Pivalate is a synthetic fluorinated corticosteroid and pharmaceutical active ingredient used primarily in topical dermatological formulations. It belongs to the glucocorticoid class and is valued for its anti-inflammatory, antipruritic and vasoconstrictive properties.
Clocortolone Pivalate is chemically related to the corticosteroid clocortolone and is formulated as the pivalate ester to provide suitable physicochemical properties for topical pharmaceutical preparations. It is commonly incorporated into creams and other semisolid dermatological dosage forms intended for application to the skin.
The API has the molecular formula C₂₇H₃₆ClFO₅ and a molecular weight of 495.03 g/mol. Its CAS number is 34097-16-0.
Clocortolone Pivalate is primarily used as an active ingredient in topical dermatological products. Its corticosteroid activity makes it suitable for pharmaceutical formulations intended to reduce local skin inflammation, itching and associated symptoms.
It may be used in formulations developed for conditions involving:
The final therapeutic indication depends on the finished pharmaceutical formulation, concentration, dosage form and applicable regulatory approval.
Clocortolone Pivalate offers several characteristics relevant to pharmaceutical formulation and API development:
Clocortolone Pivalate belongs to the glucocorticoid class of corticosteroids. Following topical application, corticosteroid activity helps regulate inflammatory responses in the skin.
The active corticosteroid interacts with intracellular glucocorticoid receptors, leading to changes in gene expression associated with inflammatory mediators. This results in suppression of several components of the inflammatory response.
Its pharmacological effects include:
Because Clocortolone Pivalate is intended primarily for topical use, its pharmaceutical development focuses on achieving appropriate activity at the site of application while maintaining suitable formulation characteristics.
Clocortolone Pivalate is a synthetic corticosteroid ester containing chlorine and fluorine atoms within its steroid structure.
The API is identified by:
Chemical Name:
9-Chloro-6α-fluoro-11β,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-pivalate
Molecular Formula:
C₂₇H₃₆ClFO₅
Molecular Weight:
495.03 g/mol
CAS Number:
34097-16-0
Physical Form:
Crystalline solid
Appearance:
White to almost-white crystalline powder
Water Solubility:
Practically insoluble in water
These physicochemical characteristics are important when developing topical formulations because the API must be appropriately incorporated into the selected pharmaceutical vehicle.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR absorption conforms to reference; HPLC retention time corresponds to reference standard |
| Assay (HPLC) | 98.0% – 102.0% on dried basis |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| Water Content | NMT 1.0% by loss on drying |