Combination Nasal Spray Ryaltris® Disrupts the Rhinitis Market: How Were the Impurity Challenges of Olopatadine and Mometasone Overcome?

On November 10th, the compound nasal spray containing Olopatadine Hydrochloride and Mometasone Furoate (brand name: Ryaltris®), jointly developed by Grand Pharmaceutical Group‘s subsidiary Jiuyue Pharmaceutical and Glenmark, was officially approved for marketing by the National Medical Products Administration (NMPA). This marks Ryaltris® as the first innovative compound nasal spray for allergic rhinitis in China.

Ryaltris® is a novel combination nasal spray containing an antihistamine (Olopatadine) and a corticosteroid (Mometasone Furoate). It is indicated for the symptomatic treatment of moderate-to-severe seasonal allergic rhinitis in adults and children aged 6 years and older, as well as for moderate-to-severe perennial allergic rhinitis in adults and adolescents aged 12 years and older. Prior to its approval in China, Ryaltris® had already been approved and launched in several countries and regions, including the United States, Australia, Russia, and South Korea.

Current mainstream rhinitis treatments primarily include glucocorticoids and antihistamines, such as budesonide, fluticasone propionate, loratadine, and cetirizine. The 2022 Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitisindicate that the combination of a nasal antihistamine and a nasal glucocorticoid offers superior efficacy for treating moderate-to-severe patients. However, no relevant compound nasal spray had been approved in China until now.

Mometasone Furoate is a nasal glucocorticoid with potent anti-inflammatory effects. As one of the active components in Ryaltris®, it primarily works by reducing inflammatory responses in the nasal passages to alleviate symptoms like nasal congestion and rhinorrhea.

Olopatadine is an antihistamine with multiple mechanisms of action. It not only acts as a histamine H1 receptor antagonist but also inhibits the release of allergic mediators (such as histamine and tryptase) from mast cells. It also demonstrates inhibitory effects on symptoms of allergic asthma.

This compound formulation provides a new treatment option for patients with moderate-to-severe allergic rhinitis, breaking the previous market dominance of monotherapy products.

The study of Active Pharmaceutical Ingredient (API) impurities is a critical step in ensuring drug safety and efficacy. For compound formulations, impurity profiling is even more complex, requiring simultaneous attention to the impurities of both active components and potential interaction products between them.

SZEB specializing in drug impurity reference standards, professionally supplies Olopatadine impurity reference standards and Mometasone impurity reference standards, supporting pharmaceutical companies in drug research, development, and regulatory submissions. Find more details about these impurities on our official website: www.ex-biotech.cn .