Loteprednol Etabonate is a synthetic corticosteroid used primarily in ophthalmic pharmaceutical formulations for the treatment of inflammatory conditions of the eye. It is a glucocorticoid derivative structurally related to prednisolone and is designed as a soft corticosteroid with rapid conversion to inactive metabolites after exerting its therapeutic effect.
Loteprednol Etabonate is commonly used in ophthalmic preparations to manage steroid-responsive ocular inflammation, including inflammation associated with allergic conjunctivitis, postoperative ocular inflammation and certain inflammatory disorders of the eye.
Loteprednol Etabonate is a synthetic corticosteroid with the molecular formula C24H31ClO7 and a molecular weight of approximately 466.95 g/mol. Its CAS Number is 82034-46-6.
The molecule contains a corticosteroid nucleus with a chloromethyl ester modification and an etabonate ester group. These structural characteristics contribute to its topical ophthalmic activity and metabolic profile.
Loteprednol Etabonate acts as a glucocorticoid receptor agonist. After entering target cells, it interacts with intracellular glucocorticoid receptors and influences gene transcription.
This results in suppression of inflammatory mediators and inhibition of multiple components of the inflammatory response, including inflammatory cell migration and production of cytokines and other mediators.
Loteprednol Etabonate is used in ophthalmic formulations for the treatment of steroid-responsive inflammatory conditions of the eye. It is used in products intended to reduce ocular inflammation and associated symptoms.
Depending on the specific formulation and regulatory approval, applications include treatment of postoperative ocular inflammation and allergic or other steroid-responsive ocular conditions.
Loteprednol Etabonate API can be evaluated using validated analytical procedures for identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
Chromatographic and spectroscopic techniques may be used for identity, assay and purity determination. Appropriate control of steroid-related impurities, degradation products and residual solvents should be incorporated into the applicable drug-substance specification.
Acceptance criteria should be based on the applicable manufacturer's drug-substance specification, Certificate of Analysis and relevant pharmacopoeial and regulatory requirements.
Loteprednol Etabonate should be stored in a tightly closed pharmaceutical-grade container under controlled conditions. It should be protected from excessive heat, moisture and direct light.
Specific storage and transportation requirements should follow the applicable manufacturer's approved specification.
Loteprednol Etabonate API may be supplied for qualified pharmaceutical manufacturing, ophthalmic formulation development, analytical and research applications, subject to applicable quality and regulatory requirements.
Loteprednol Etabonate API is available for qualified pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory standards. Customers can request product specifications, Certificate of Analysis, analytical documentation, packaging information and commercial details according to their requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |