Prednisolone Acetate

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Cat Number

API52211

CAS Number

52-21-1

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Product Detail Description Scientific Support Customer Q&A

CAS Number

52-21-1

EINECS

200-134-1

Storage

Store at room temperature

Synonyms

Prednisolone 21-acetate; Omnipred; Econopred; Pricortin; Meticortelone acetate; Pred Mild

Molecular Formula

C23H30O6

Molecular Weight

402.5

Smiles

CC(=O)OCC(=O)[C@]1(CC[C@@H]2[C@@]1(C[C@@H]([C@H]3[C@H]2CCC4=CC(=O)C=C[C@]34C)O)C)O

Appearance

White to off-white powder

Melting Point

240-244℃

Boiling Point

579.8℃ at 760 mmHg

General Description

Prednisolone acetate is a potent glucocorticoid ester commonly suspended in ophthalmic solutions for topical ocular use. It represents the acetate form of prednisolone, offering enhanced corneal penetration compared to the parent alcohol. The drug is available in multiple concentrations for the management of inflammatory eye conditions.

Mechanism of Action

Once absorbed into ocular tissues, prednisolone acetate is hydrolyzed to active prednisolone, which binds to cytoplasmic glucocorticoid receptors. The receptor-ligand complex translocates to the nucleus, suppressing transcription of pro-inflammatory cytokines, adhesion molecules, and enzymes such as phospholipase A2. This broad anti-inflammatory action reduces vascular permeability, leukocyte migration, and fibroblast activity without directly killing pathogens.

Application

This agent is indicated for steroid-responsive inflammatory disorders of the palpebral and bulbar conjunctiva, cornea, and anterior segment, including uveitis, allergic conjunctivitis, and post-surgical inflammation. It is also used for chemical burns and herpes zoster ophthalmicus (with antiviral coverage).

In a phase 3B randomized double‑masked trial (80 children aged 0–3 years undergoing cataract surgery), difluprednate 0.05% four times daily was compared with prednisolone acetate 1% four times daily for 14 days, then tapered. Adverse events were similar, including two cases of increased intraocular pressure per group. At day 14, complete anterior chamber cell clearance occurred in 78.9% of difluprednate‑treated patients versus 77.5% of prednisolone‑treated patients. However, on days 1 and 8, nearly twice as many difluprednate patients had a global inflammation score indicating no inflammation. The authors conclude that difluprednate has similar safety and efficacy to prednisolone acetate, with possibly faster resolution of inflammation.

Fig. 1 Change in mean IOP (mm Hg) following difluprednate and prednisolone treatment after cataract surgery. (Wilson ME, et al., 2016)

References

Wilson ME, et al. Difluprednate versus prednisolone acetate for inflammation following cataract surgery in pediatric patients: a randomized safety and efficacy study. Eye (Lond). 2016;30(9):1187-1194.

Does Prednisolone Acetate require protection from light during long-term storage?

Yes, it is photosensitive. Prolonged UV exposure can cause photodegradation and discoloration. Store in light-resistant containers, preferably amber glass.

What is the recommended storage temperature for Prednisolone Acetate?

Store at controlled room temperature (15-25°C). Avoid excessive heat above 30°C, which can accelerate hydrolysis of the acetate ester to prednisolone free alcohol.

Is Prednisolone Acetate susceptible to moisture-induced degradation?

It is slightly hygroscopic. Under high humidity, it may absorb moisture and hydrolyze. Store in tightly sealed containers with desiccant for long-term stability.

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

This primary hydrolysis product is specifically quantified using a stability-indicating HPLC method, ensuring it remains below pharmacopoeial (USP/EP) limits.