Pharma industry trends in Preservative-Free Drug Delivery

Tholey, Germany: – Spray dosage specialist URSATEC GmbH is playing a leading role in meeting increasing demand from pharma and cosmetics industries for preservative-free drug delivery systems.

URSATEC has been a pioneer in this field since 1993, when it was founded in southwestern Germany based on its innovative propellant-free dosage system suitable for preservative-free contents. Over more than three decades since, the company has sold around two billion units worldwide and established itself as a market leader in preservative-free solutions for the global healthcare industry.

Early warnings

Pharma and cosmetics industry awareness of the need for preservative-free delivery systems dates from early in the millennium, with publication by the Laryngo-Rhino-Otol journal of an influential study of nasal sprays showing that “Formulations without conservations are less cytotoxic”, concluding that preserved nasal sprays were becoming obsolescent and should be replaced by preservative-free alternatives, also urging manufacturers to pay greater attention to galenic properties and dosage of the active ingredients (Verse, Klöcker; 2003).

The following year, German Health Authorities issued a recommendation that “Preservatives should be avoided wherever possible.” By 2006, the In-Pharmatechnologist online journal was noting that the US Food and Drug Administration (FDA) had urged the pharma industry to develop preservative free nasal sprays.

More recently, there has been pressure from the ophthalmic sector, with increased linking of preservatives in eye dropper solutions with issues such as induced irritation and inflammation, especially in patients with dry eye syndrome.

Driving change

Over recent years, the pharma industry has seen a significant shift towards preservative-free drug delivery systems, driven by patient safety concerns, regulatory pressures, and technological advancements.

Four key trends have now emerged that are driving change:

The most influential of these is the increasing focus of regulatory bodies on the potential adverse effects of preservatives on patient safety, leading to stricter guidelines and a push for preservative-free formulations in which pharma and cosmetic companies are actively encouraged to innovate and adopt preservative-free delivery systems.

This would not be possible unless better alternatives were available but this is no longer the case. URSATEC has been a leading force in driving forward technology advances in delivery systems, with innovations in drug delivery devices. Significant milestones have included:

• COMOD® (1994): a pioneering system for keeping liquid dosage forms sterile without need for preservatives
• 3K® Nasal Spray (1998): A dosage system for the preservative-free application of nasal formulations that is also applicable to other pharmaceutical products and in medical devices
• COMFORT® Dermal Spray (2008): A non-propellant dosage system for the preservative-free 360-degree application of dermal pharmaceutical and cosmetic suspensions and emulsions as well as medical devices
• SOFTBREEZER® (2019): A novel system for the inhalation of preservative-free aqueous solutions

A cleaner and more connected world

Advancing technology is a second key factor behind increased pharma ad cosmetic industry uptake of preservative-free delivery. A third factor is the general imperative for greater sustainability in all things in which ‘Less is more’. This includes use of preservatives that not only complicate recycling but also stand in the way of greater use of reusable drug delivery devices.

Adding value

URSATEC also sees “preservative-free” as creating added value for its white label customers in both pharmaceutical and cosmetics industries, by enhancing market appeal, regulatory compliance, brand value and sustainability.

Dr. Andreas Bilstein, Managing Director for Marketing and Sales and Finished Product Development, explains: “We have dedicated ourselves to the establishment of the technical requirements and the required level of specialization that are needed to realize preservative-free products.”

“When Preservative Free Matters is more than just a slogan for us. It defines the focus of our actions and the commitment we bring to our product and service portfolio. Preservative-free is not a niche product in our overall portfolio, but our core business. This results in a high level of technical expertise and many years of experience in the field, from which our customers can benefit.”

“The possibility of formulating without any preserving ingredients, even those that do not have to be declared, will also revolutionize the cosmetics industry,” Dr. Bilstein adds.

About URSATEC

Founded in 1993 and based at Tholey in southwest Germany, URSATEC GmbH is an innovative development and sales organization that specializes in spray dosage systems for preservative-free solutions. The company’s mission is to support the global healthcare industry in providing purer products by developing and distributing dosing systems and safe, effective, as well as well-tolerated finished products designed for preservative-free delivery.

URSATEC offers a comprehensive suite of services providing preservative-free solutions to four principal sectors: Pharmaceuticals, Medical Devices, Cosmetics, and Food Supplements. It’s ONE Source® portfolio of services include product development, raw material and procurement, source management, dosage systems tailored for various applications including nasal, oral, dermal, and otological uses, sterilization and aseptic filling processes, laboratory testing and validation, and regulatory support.

All URSATEC white-label offerings are based on its proprietary technologies for preservative-free dose delivery. In addition, URSATEC solutions can be applied to inhalation and breathing aids, food supplement dispensers, cosmetic ointments and gels, lip and eyelid relief, intimate care sprays, and pharmaceutical dosage of drugs such as xylometazoline, oxymetazoline, and corticosteroids.

For further information, see https://www.ursatec.com/en/