Dexamethasone Sodium Phosphate

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Cat Number

API0232552

CAS Number

2392-39-4

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CAS Number

2392-39-4

EINECS

219-243-0

Synonyms

Dexamethasone 21-phosphate disodium salt, Dalalone, Dexadreson

Molecular Formula

C22H28FNa2O8P

Molecular Weight

516.4

Smiles

C[C@@H]1C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@@]4([C@]3([C@H](C[C@@]2([C@]1(C(=O)COP(=O)([O-])[O-])O)C)O)F)C.[Na+].[Na+]

Appearance

White to off-white powder

Melting Point

233-235℃

Boiling Point

669.6℃

General Description

Dexamethasone sodium phosphate is the water-soluble inorganic ester salt of dexamethasone, a synthetic glucocorticoid with potent anti-inflammatory and immunosuppressive properties. This formulation produces a rapid response even when injected intramuscularly, distinguishing it from less soluble corticosteroid preparations.

Mechanism of Action

Dexamethasone exerts its effects by binding to cytoplasmic glucocorticoid receptors and modulating gene expression, resulting in profound anti-inflammatory and immunosuppressive actions. It inhibits NF-kB activation, reduces cytokine production, and suppresses leukocyte accumulation at inflammatory sites. Following injection, the phosphate ester is rapidly hydrolyzed to active dexamethasone.

Application

Dexamethasone sodium phosphate is indicated for a wide range of endocrine, rheumatic, collagen, dermatologic, allergic, ophthalmic, and neoplastic disorders when oral therapy is not feasible. It is also employed for cerebral edema associated with brain tumors, acute exacerbations of multiple sclerosis, and diagnostic testing of adrenocortical hyperfunction. In oncology, it is frequently used as a supportive care agent, including antiemetic therapy and management of lymphoid malignancies.

Papangkorn K, et al. evaluated a novel noninvasive ocular delivery system for dexamethasone sodium phosphate (DSP-Visulex) in a rabbit model of experimental uveitis. Following uveitis induction, animals received either no treatment or one of several DSP-Visulex regimens differing in drug concentration (4%, 8%, or 15%), application time, and treatment frequency. Untreated controls developed persistent panuveitis with significant inflammation in the vitreous, choroid, and retina. All DSP-Visulex treatments reduced inflammation, with higher-dose regimens (8% and 15%) demonstrating more rapid and complete resolution and achieving near-normal posterior segment histology. The 4% regimen showed more limited efficacy, primarily affecting anterior and intermediate uveitis. All treatments were well tolerated throughout the 29-day study.

Fig. 1 Vitreous scores of various treatment groups tested in the experimental uveitis rabbit model. (Papangkorn K, et al., 2017)

References

Papangkorn K, et al. Noninvasive Ocular Drug Delivery System of Dexamethasone Sodium Phosphate in the Treatment of Experimental Uveitis Rabbit. J Ocul Pharmacol Ther. 2017;33(10):753-762.

Radnovich R, et al. evaluated the safety and efficacy of repeat epidural injections of SP-102, a novel gel formulation containing 10 mg dexamethasone sodium phosphate, in patients with lumbosacral radiculopathy. Following initial injection, hypothalamic-pituitary-adrenal (HPA) axis suppression resolved rapidly, with all subjects achieving a normal cortisol response by day 3. Repeat injection produced similar effects on glucose levels and white blood cell counts, with no evidence of cumulative HPA suppression. Pain scores decreased after each injection and remained low throughout the 28-day follow-up period, with preliminary evidence suggesting an enhanced analgesic effect after repeat dosing.

Fig. 2 Pharmacodynamic assessments of single and repeat doses of SP-102. (Radnovich R, et al, 2021)

References

Radnovich R, et al. Repeat Epidural Injections of SP-102 (Dexamethasone Sodium Phosphate Injectable Gel) in Subjects with Lumbosacral Radiculopathy. J Pain Res. 2021;14:1231-1239.

Is Dexamethasone Sodium Phosphate prone to hydrolysis of the phosphate ester?

Yes, the phosphate ester can hydrolyze, releasing dexamethasone. Storage at controlled room temperature and protection from moisture are essential to minimize this degradation.

Does Dexamethasone Sodium Phosphate require cold chain shipping?

No, it is stable at ambient temperatures. However, we avoid extreme heat and use standard thermal protection during summer months to ensure product integrity.

What is the recommended storage condition for Dexamethasone Sodium Phosphate in high-humidity environments?

It is hygroscopic. In tropical climates, it should be stored in an air-conditioned warehouse and only opened in low-humidity areas to prevent moisture absorption and caking.

How is the inorganic phosphate content monitored as a degradation marker?

We use ion chromatography to quantify free phosphate, which serves as a direct indicator of ester hydrolysis during stability studies, ensuring levels remain within specifications.