Diclofenac sodium

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Cat Number

API0231517

CAS Number

15307-79-6

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CAS Number

15307-79-6

EINECS

239-346-4

Storage

Store at room temperature

Synonyms

Diclofenac sodium salt; Sodium diclofenac; Solaraze; Neriodin; Prophenatin; Voltaren; Diclophenac sodium

Molecular Formula

C14H10Cl2NNaO2

Molecular Weight

318.13

Smiles

C1=CC=C(C(=C1)CC(=O)[O-])NC2=C(C=CC=C2Cl)Cl.[Na+]

Appearance

White to off-white powder

Melting Point

288-290℃

Boiling Point

412℃

General Description

Diclofenac sodium is a potent nonsteroidal anti-inflammatory drug (NSAID) of the phenylacetic acid class, available in a wide variety of formulations including oral, topical, ophthalmic, and parenteral preparations. It is one of the most commonly prescribed NSAIDs globally, characterized by its balanced inhibition of cyclooxygenase enzymes and favorable analgesic properties. The molecule exhibits high protein binding and extensive tissue penetration.

Mechanism of Action

It exerts its effects through non-selective, reversible inhibition of both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), thereby reducing the synthesis of prostaglandins and thromboxane. The drug demonstrates preferential distribution to inflamed tissues, where it achieves higher concentrations than in plasma. This results in potent anti-inflammatory, analgesic, and antipyretic effects with a predictable dose-response relationship.

Application

Its applications span the management of acute and chronic pain, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute musculoskeletal injuries. The topical formulation is widely used for localized pain relief, such as in actinic keratosis treatment, while the ophthalmic solution is indicated for postoperative inflammation following cataract surgery. Due to cardiovascular and gastrointestinal risk profiles, it is used at the lowest effective dose for the shortest duration.

A randomized controlled trial compared diclofenac sodium plus occlusal splint versus vitamin D supplementation plus occlusal splint in 40 patients with myofascial pain and vitamin D deficiency. Both groups showed significant and comparable improvements in mouth opening and visual analog scale pain scores at 1, 4, and 12 weeks. The changes in primary outcomes were homogeneous between groups, indicating equivalent efficacy. The authors conclude that vitamin D supplementation offers anti‑inflammatory and analgesic effects comparable to NSAIDs for managing myofascial pain associated with vitamin D deficiency, suggesting it as an alternative treatment option.

Fig. 1 CONSORT Flow Diagram. (Kahraman NH, Tunç SK, 2025)

References

Kahraman NH, Tunç SK. Comparative evaluation of the effects of diclofenac sodium and vitamin D supplementation on symptoms in individuals with myofascial pain and vitamin D deficiency: a randomized controlled clinical trial. BMC Oral Health. 2025; 25(1):1383.

Hydrogels of sodium alginate co‑polymerized with 2‑acrylamido‑2‑methyl propane sulphonic acid (AMPS) were fabricated via free radical polymerization for sustained diclofenac sodium delivery. The hydrogels showed pH‑independent swelling due to AMPS, with higher drug release at pH 7.4 than at pH 1.2. Sol‑gel analysis indicated increased gel fraction with higher concentrations of sodium alginate, AMPS, and cross‑linker. These naturally derived polymer hydrogels represent a potential sustained release platform for diclofenac sodium, offering controlled drug delivery over extended periods.

Fig. 2 FTIR spectra of (A) DS, (B) SA, (C) AMPS, (D) unloaded SA-co-poly(AMPS) hydrogeI (E) loaded SA-co-poly(AMPS) hydrogel. (Suhail M, et al., 2021)

References

Suhail M, et al. Fabrication and Characterization of Diclofenac Sodium Loaded Hydrogels of Sodium Alginate as Sustained Release Carrier. Gels. 2021; 7(1):10.

Does Diclofenac Sodium require protection from light during storage?

Yes, it is photosensitive. Exposure to light can cause discoloration and degradation. Store in light-resistant, well-closed containers.

What is the recommended storage temperature for Diclofenac Sodium?

Store at controlled room temperature, between 15°C and 30°C. Avoid excessive heat and humidity, which can cause caking and accelerate degradation.

Is Diclofenac Sodium hygroscopic, and how is this managed during storage?

It exhibits moderate hygroscopicity. We package it in moisture-barrier bags with desiccant to prevent moisture absorption and maintain free-flowing properties.

How is the impurity profile of Diclofenac Sodium monitored for topical and parenteral formulations?

We use a stability-indicating HPLC method to monitor related substances, including the known impurity 1-(2,6-dichlorophenyl)indolin-2-one, ensuring compliance with pharmacopoeial limits.