Budesonide

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Cat Number

API0232260

CAS Number

51333-22-3

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Product Detail Description Scientific Support Customer Q&A

CAS Number

51333-22-3

EINECS

257-139-7

Storage

Store at room temperature

Synonyms

Rhinocort; Entocort; Preferid; Rhinocort Aqua; Entocort EC; Uceris; Pulmicort Respules

Molecular Formula

C25H34O6

Molecular Weight

430.5

Smiles

CCCC1O[C@@H]2C[C@H]3[C@@H]4CCC5=CC(=O)C=C[C@@]5([C@H]4[C@H](C[C@@]3([C@@]2(O1)C(=O)CO)C)O)C

Appearance

White to off-white powder

Melting Point

194-199°C

Boiling Point

599.7±50.0°C at 760 mmHg (Predicted)

Relative Density

1.27±0.1 (Predicted)

General Description

Budesonide is a synthetic glucocorticoid with a 16α,17α-acetal group and a 22R,22S epimeric mixture, belonging to the class of non-halogenated corticosteroids. Its chemical structure is 11β,21-dihydroxy-16α,17α-[(1,2-butanediyl)bis(oxy)]pregna-1,4-diene-3,20-dione. Budesonide is a white to off-white powder, practically insoluble in water but soluble in organic solvents.

Mechanism of Action

Budesonide binds to the cytoplasmic glucocorticoid receptor, and the receptor-ligand complex translocates to the nucleus, modulating gene expression. It suppresses the production of pro-inflammatory cytokines, inhibits phospholipase A2 and cyclooxygenase, and reduces leukocyte migration. The drug has a high first-pass metabolism, reducing systemic side effects.

Application

Budesonide is indicated for the treatment of asthma (as an inhalation aerosol), inflammatory bowel disease (Crohn's disease and ulcerative colitis), and for the management of allergic rhinitis and nasal polyps. It is also used for the treatment of eosinophilic esophagitis and for the prevention of rejection in organ transplantation.

Post‑hoc analyses of the KRONOS study in COPD patients with blood eosinophils 100–300 cells/mm³ showed that fixed‑dose triple therapy (budesonide/glycopyrronium/formoterol) improved lung function and reduced moderate/severe exacerbations compared to dual therapy, even in patients without recent exacerbations or with moderate disease. The findings suggest that clinicians may consider stepping up to triple therapy in symptomatic patients with eosinophils >100 cells/mm³.

Fig. 1 Lung function difference versus BGFa, b: EOS subgroups by exacerbation history or COPD severity, mITT population. (Muro S, et al., 2024)

References

Muro S, et al. Benefits of budesonide/glycopyrronium/formoterol fumarate dihydrate on lung function and exacerbations of COPD: a post-hoc analysis of the KRONOS study by blood eosinophil level and exacerbation history. Respir Res. 2024;25(1):297.

Does Budesonide require protection from light and moisture during storage?

Yes, it is sensitive to both light and moisture. Light causes photodegradation and moisture promotes hydrolysis of the acetal group. Store in light-resistant, tightly sealed containers with desiccant.

What is the recommended storage temperature for Budesonide?

Store at controlled room temperature (15-25°C). Avoid excessive heat above 30°C, which accelerates oxidation and degradation of the corticosteroid ring.

Is Budesonide stable in inhalation suspension and oral formulations?

Yes, when formulated with preservatives and protected from light.

How is the impurity budesonide 22R/22S epimer (a process-related impurity) monitored?

This epimeric impurity is quantified using a stability-indicating chiral HPLC method, ensuring the ratio remains within pharmacopoeial limits.