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When Preservative-Free Matters: Now is the Time to Start

URSATEC sheds light on a megatrend that already has transformed the European market for nasal sprays—the elimination of preservatives.

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Released By Ursatec

In this article, URSATEC sheds light on a megatrend that already has transformed the European market for nasal sprays—the elimination of preservatives. This article outlines the added value, medical advantages, and hands-on solutions, that may be particularly interesting for the future of the North American nasal market, the leading global market for nasal sprays.

As a company serving the healthcare industry, URSATEC is guided by the vision of preservative-free products in different market segments: medicinal products, medical devices, food supplements, and cosmetics. This article will shed some light on the technical prerequisites of manufacturing preservative-free products and provides guidance on why the time for change has come.


 
PRESERVATIVES AND THEIR INFLUENCE ON HUMAN PHYSIOLOGY

Preservatives are widespread and known for their once groundbreaking properties of enabling formulations to withstand microbiological contamination by air germs and bacterial ingress during manufacturing or by the end user. Especially formulations with high water activity and no preserving properties of the APIs or excipients themselves will automatically be contaminated over time, which is potentially health-threatening and changes the product specifications. This is exactly where the career of preservatives started. Benzalkonium chloride, as an example, is an integrated part of most OTC nasal sprays, which is known to intensify the Rhinitis Medicamentosa (RM) induced by the overuse of decongesting nasal sprays.

Moreover, there are preservatives that can have a repressive influence on the sensitive ciliated epithelium of the nasal mucosa, which has detrimental consequences on the cilial function of the epithelium, which safeguards the removal of allergens or infectious particles like viruses and bacteria. Considering how many people suffer from chronic sinus pathologies—in the U.S. an estimated number of 50 million people—the problems revolving around preservatives in nasal sprays affect a huge target group which reflects a steadily growing market. Before the pandemic episode, this corresponds to an 8.4 billion U.S. dollar market, which is estimated to grow up to 19.5 billion U.S. dollars in 2028 (Statista 2022).

But nasal pathologies are not the only indications that are sensitive to the problem. The devastating effect of preservatives on the human microbiome plays an important role in overthinking the standard use of preservatives. The naturally well-balanced and very diverse microbiome of the human body contributes vastly to the human physiology of health and its impairments are known to trigger pathologies. The impairment of the skin microbiome, which is often characterized by a decreased diversity of species plays an essential role in developing atopic dermatitis and acne, which negatively spotlights preservatives also in a cosmetic context. In this product class, preservatives are utilized on a regular basis and personal care products have widespread, daily use, which affects the customers that display hypersensitivity against preservatives (e.g., 6 % of Europeans).

STARTING POINTS FOR PRESERVATIVE-FREE DEVELOPMENTS

Both the knowledge of adverse effects on human physiology and true alternatives grew over the last few years and this is where the success story of preservative-free products was born. One common theme and point of attack in the striving for preservative-free products is primary packaging. If the packaging embeds a sophisticated sealing concept that prevents microorganisms from the surrounding air to intrude into the container, the interior of the primary packaging will constitute a completely sterile environment, where no growth will occur. If this primary packaging is filled with a sterilized formulation in a clean room, all pieces of the puzzle are aligned and a preservative-free product with a long shelf life has been conceptualized.

Designing, manufacturing, and selling these preservative-free products all over the world has been the unique selling point of URSATEC, leading to a dedication to the topic for three decades now. And with the growing global awareness of the importance of microbiome-friendly products propagated by healthcare professionals and authorities, a good consumer education, and a general emphasis on the less-is-more philosophy, the preservative-free theme could not be more timely. In the European market, preservative-free nasal sprays already displaced many preserved predecessor products, setting a new standard in the industry. Also, the U.S. Food and Drug Administration (FDA) has urged the pharma industry to develop preservative-free nasal sprays.

PRESERVATIVE-FREE PRIMARY PACKAGING FOR DIFFERENT APPLICATIONS

All URSATEC primary packaging solutions embed the technology that is required to enable a preservative-free product to stay microbiological safe over time. This technology consists of three safety barriers: a microbiological tight closing valve, an air purifying filter, and oligodynamic surfaces.


Figure 1: The triple protection technology of the 3k Pump®. The name 3K follows its function: three germ barriers guarantee protection against contamination. First, there are oligodynamic surfaces that act on microorganisms in exposed pump heads. Second, a microbiological tight closing valve secures the system against contamination. And third, an air-purifying filter is used to filter the air for a controlled air intake. If the formulation is oxygen sensitive, an airless inner bag is used (COMFORT series) that successively inflates on pump actuation.

Apart from this common feature, different applicators guarantee a wide product range for targeting the nose, the mouth/throat, the ear, and the skin. Some formulations may require an airless system in order to avoid reactivity with oxygen, which is feasible with the URSATEC systems as well as the delivery of semi-solid formulations. But as we learned before, the primary packaging is only one step on the way to a preservative-free product. As important as the pre-sterilized packaging is the sterilized formulation. For most liquid formulations this can be performed by a sterile filter. Other formulations may require a dedicated heating process in order to eliminate the microorganisms before the aseptic filling process in the clean room class A can be performed.

For a preservative-free product, a highly sophisticated supply chain compliant with the quality standards of the pharmaceutical industry needs to be qualified. Since linking the process steps together one by one is a hard and time-consuming task, URSATEC offers to step in from the very beginning. Customers will get access to a qualified supply chain, facilities, and regulatory know-how, all bundled in a single point of contact. Projects of every scope profit from the customized solutions over each step of the product’s life cycle.


Figure 2: Manufacturing a preservative-free product comes along with dedicated requirements of the supply chain and it takes a straightforward network of primary packaging manufacturers, sterilization sites, sterile fillers, and regulatory support to successfully bring a product onto the market. The URSATEC One Source philosophy covers every step on the way.

WHITE LABEL PRODUCTS

Looking back on a long history of consumer experience with preservative-free nasal sprays, the trends, and requirements in the field lead to the development of several finished products that are available for licensing. The different products inherit individual features that fit both the target group and the philosophy of pure, natural care and microbiome-friendly formulations. Especially the infant segment will profit from well-tolerated isotonic sea salt nasal spray without preservatives. Using preservatives in these products actually negates the function of supporting the physiological cilial function of the epithelium and should be prevented whenever possible.
 
Moreover, the theme of microbiological friendliness is reflected in URSATEC’s finished products as well. Some natural ingredients, such as short-chain fatty acids (SCFAs) and their role in our immune system, can help to support the nasal microbiome and maintain a healthy balance of bacteria positively impacting the protection against allergic inflammation in the lung.

Since the preservative-free philosophy is not limited to the world of medicinal products and medical devices, developments of innovative cosmetic products and food supplements also profit from short ingredient lists without preserving agents and are ready for licensing.


Figure 3: Relying on years of applied experience in the development of our unique dosage systems, primary packaging materials, and developing preservative-free formulations, URSATEC introduces to the health community safe, tolerable and at the same time highly effective products with proven efficacy. These three pillars are the key of our success in the market-ready ‘’white label’’ world.

SUMMARY

Preservatives look back to a long-lasting use in product development throughout any product class, enabling the preservation of formulations. Since the mode of action for preservation is eliminating microorganisms, the process of preservation is a double-edged sword. The awareness of the microbiome throughout the whole human body and its contribution to a healthy life in many aspects requires the industry to perform some rethinking. Although processing a preservative-free product throughout its sophisticated manufacturing cycle means some significant effort, it is without alternatives to keep up with time. With the increasing prevalence of respiratory diseases and allergies, OTC nasal sprays will continue their growth over the coming years and will inevitably be under the burning glass of regulatory authorities and the eyes of the end users.

ABOUT THE COMPANY

URSATEC was founded in 1993 to accomplish one mission: the establishment of preservative-free applications based on its proprietary packaging systems in different application areas, primarily the nasal, dermal, buccal, and otological fields. Having sold almost 2 billion units within the last 30 years, URSATEC systems are widely established. URSATEC is consistently expanding its business and offers a full development service, dosage systems, primary packaging materials, and filling services for OTC and Rx applications to the healthcare industry, and also stands for sophisticated cosmetic products and food supplements that completely lack preserving ingredients.

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