Synonyms
Sodium cromoglycate, Disodium cromoglycate
Molecular Formula
C23H14Na2O11
Smiles
C1=CC2=C(C(=C1)OCC(COC3=CC=CC4=C3C(=O)C=C(O4)C(=O)[O-])O)C(=O)C=C(O2)C(=O)[O-].[Na+].[Na+]
General Description
Cromolyn sodium is a mast cell stabilizer derived from khellin, a natural extract from the eastern Mediterranean herb Ammi visnaga. First introduced as an inhaled treatment for asthma in 1969, it is available in multiple formulations including inhalation solution, nasal spray, ophthalmic solution, and oral concentrate. It is a white to off-white powder freely soluble in water, formulated as a sterile solution for various routes of administration.
Mechanism of Action
Cromolyn sodium inhibits the degranulation of sensitized mast cells following antigen exposure, preventing release of histamine, leukotrienes, and slow-reacting substance of anaphylaxis. It has no intrinsic vasoconstrictor, antihistamine, or anti-inflammatory activity.
Application
Cromolyn sodium is FDA-approved for prophylaxis of mild to moderate bronchial asthma, allergic rhinitis, systemic mastocytosis, and treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis. It is not effective for acute attacks and must be used prophylactically at regular intervals.
Wang YJ, et al. investigated the anti-inflammatory effects of cromolyn, a mast cell stabilizer currently being evaluated in clinical trials for Alzheimer's disease, on human HMC3 microglial cells. Following activation by the inflammatory cytokine TNF-α, cromolyn treatment dramatically reduced the secretion of a broad spectrum of pro-inflammatory mediators, including cytokines (IL-1β, IL-6, IL-8, IFN-γ) and chemokines (CXCL10, CCL2, CCL3, CCL4). A fluorinated analog of cromolyn produced similar effects. These findings demonstrate that cromolyn directly modulates microglial inflammatory responses, providing mechanistic insight into its potential therapeutic role in neurodegenerative disorders by dampening the neuroinflammation associated with disease progression.
Fig. 1 Cromolyn and F-cromolyn inhibit secretion of pro-inflammatory cytokines by HMC3 microglia cell line induced by TNF-α. (Wang YJ, et al., 2021)
References
- Wang YJ, et al. Ashton-Rickardt PG, Elmaleh DR. Cromolyn inhibits the secretion of inflammatory cytokines by human microglia (HMC3). Sci Rep. 2021;11(1):8054.
Does Cromolyn Sodium require protection from moisture during storage?
Yes, it is hygroscopic. It must be stored in tightly sealed containers in a dry environment to prevent moisture absorption, which can affect its physical properties.
What is the recommended storage temperature for Cromolyn Sodium?
Store at controlled room temperature, between 15°C and 30°C. It is stable under normal conditions but should be protected from excessive heat and humidity.
Is Cromolyn Sodium stable in nebulized solutions for extended periods?
Reconstituted solutions have limited stability. We recommend using them promptly after preparation. For bulk API, the solid form is stable when stored as recommended.
How is the particle size of Cromolyn Sodium controlled for inhalation use?
We offer micronized grades with tight particle size distribution, verified by laser diffraction, ensuring optimal deposition and therapeutic efficacy for inhalation products.