Therefore, a medicinal product containing xylometazoline HCl and iota-carrageenan for the proposed indication and route of administration is advantageous and reasonable from a scientific and a medicinal point of view. Therefore, a nasal spray which combines decongestant and antiviral properties is benefitial for patients when compared to conventional xylometazoline HCl products. The above described indications frequently involve viral infections which worsen the course of the underlying disesase. Additionally, iota-carrageenan can reduce the reproduction and spreading of respiratory viruses. Furthermore, it facilitates drainage of the secretion during sinusitis and can be used as an adjuvant treatment of mucosal swelling due to otitis media.

The intranasal (i.n.) topical application provides reliable and fast relief from the symptoms of nasal congestion and facilitates breathing during common cold/flu-like illnesses and allergic rhinitis.

The rationale for merging xylometazoline HCl with iota-carrageenan into one product is based on the intent to combine their properties, namely the decongestant efficacy provided by xylometazoline HCl and the effectiveness to reduce viral infection accomplished by iota-carrageenan. 26 Carrageenan is contained in medical device nasal sprays that have been approved and marketed in the EU for 10 years for the supportive treatment of common cold/flu-like illnesses caused by viruses. 23 – 25 The pooled analysis of two studies conducted in 153 children and 203 adults revealed that patients infected with any respiratory virus who were intranasally treated with iota-carrageenan showed a 1.9-day faster recovery from common cold symptoms than placebo-treated patients in the intention-to-treat population. 22 Furthermore, we demonstrated the broad antiviral efficacy of an iota-carrageenan containing nasal spray against common cold viruses in several randomized, double-blind, parallel-group, placebo-controlled clinical trials. 18 – 20 We already published that iota-carrageenan is a potent inhibitor of major (intercellular adhesion molecule 1 receptor) and minor group (low-density lipoprotein receptor) human rhinovirus (hRV) 21 and influenza virus A replication. The antiviral effectiveness varies with the type of polymer as well as the virus and the host cells, 7 – 17 as reviewed previously. As a result, infection of cells is inhibited. 6 The antiviral mechanism of carrageenan is based on the interference with viral attachment: carrageenan forms a barrier on the mucosal surface, thereby preventing the interaction between virus and cellular surface. They differ in the degree of sulfation, solubility and gelling properties. 5 Three main forms of carrageenans are commercially used: iota-, kappa- and lambda-carrageenan. Since then a large number of preparations containing xylometazoline HCl have been approved and marketed in several European countries.Ĭarrageenan is a high-molecular-weight sulfated polymer derived from red seaweed (Rhodophyceae) that has been extensively used in food, cosmetic and pharmaceutical industries, and is generally recognized as safe (GRAS) by the US Food and Drug Administration (FDA), as reviewed by Cohen and Ito. 3, 4 Xylometazoline HCl has been used in the EU in the treatment of nasal congestion caused by rhinitis/sinusitis since 1959. 2 The efficacy of xylometazoline HCl as a topical nasal decongestant is well proven. Xylometazoline HCl action is characterized by a fast onset with an effect obtained after 5–10 minutes and lasting for 6–8 hours. It causes vasoconstriction in the nasal submucosa, which is manifested as a collapse of the venous sinusoids.

Xylometazoline HCl is applied topically to relieve nasal congestion associated with acute or chronic rhinitis, common cold, sinusitis, hay fever or other allergies. Xylometazoline hydrochloride (HCl) (2-4,5-dihydro-1 H-imidazole HCl) is a well-established nasal decongestant that belongs to the pharmacotherapeutic group of sympathomimetic drugs and acts selectively on α-adrenergic receptors (alpha-adrenergic agonist).

Iota carrageenan sigma