​​Breaking Dosage Form Barriers: Escitalopram Oxalate Drops Approval Opens New Chapter in Depression Treatment​

On August 25,the Escitalopram Oxalate Drops of Guangzhou Yipinhong Pharmaceutical Co., Ltd successfully obtained the drug registration certificate issued by the National Medical Products Administration (NMPA), deemed to have passed the consistency evaluation. As the first domestic generic version, it fills a domestic gap for this dosage form.

This Escitalopram Drops, with a specification of 15ml:300mg (calculated as C₂₀H₂₁FN₂O), is indicated for the treatment of depression and panic disorder with or without agoraphobia.

Selective serotonin reuptake inhibitors (SSRIs), represented by escitalopram, are first-line therapeutic agents for clinically treating major depressive disorder. Escitalopram is the S-enantiomer of citalopram. It works by inhibiting the reuptake of serotonin (5-HT) by neurons in the central nervous system, thereby enhancing serotonergic activity and improving symptoms of depression and anxiety.

Escitalopram Oxalate was jointly developed by H. Lundbeck A/S and Allergan. It received approval from the U.S. FDA in 2002 and was approved for marketing in China in 2006.

Compared to traditional tablets, capsules, and other dosage forms, the drop formulation offers advantages such as flexible dose adjustment and ease of swallowing, significantly enhancing medication convenience and safety for special populations and carving out a differentiated niche in the market. Developing the drop formulation is far from a simple conversion of dosage form; it involves addressing challenges such as stability of active ingredients, control of bioavailability, and impurity profile management.

During production and storage, escitalopram may generate various process-related impurities and oxidative degradation products. Some impurities may affect efficacy and pose safety risks. In generic drug consistency evaluations and innovative dosage form development, impurity studies serve as the cornerstone for ensuring drug safety and efficacy.

SZEB supplies escitalopram impurity reference standards, providing critical support to pharmaceutical companies in overcoming technical bottlenecks and empowering drug innovation and quality manufacturing.