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The Gold Standard of Preservative Free Nasal and Topical Sprays

 

Preservative free system qualified with microbiological tests

Advanced Preservative-Free System makes any preservatives obsolete

Preservatives in nasal formulations, such as Benzalkonium Chloride (BAC), can have a negative impact on the ciliated tissue in the nasal cavity. The APF is a leading preservative free nasal pump spray solution, that eliminates the need for preservatives in liquid formulations.

With the APF and APFPlus systems a filter membrane prevents the ingress of any microbiological contamination with venting air. Combined with the purely mechanical Tip-Seal technology present across the entire APF family of products, including the recyclable APF  Futurity™ line, eliminates the need for preservatives or additives such as silver ions or surface coating.

The microbial integrity of Aptar Pharma‘s patented Tip-Seal technology has been qualified by microbial challenging tests and has passed relevant worst-case simulation.

APFPlus adds dermal, oral and eye care solutions to the preservative-free offering

The advanced preservative free plus (APFPlus) pump system expands the versatility of the original APF nasal spray applications to dermal, oral and eye-care products, enabling a wide range of preservative-free brand portfolios. Variable spray characteristics of APFPlus specifically support products in different application fields, such as analgesics, cough and cold, dermal drug delivery, eye care and wound care. With the APFPlus formulations varying in their viscosity from liquid aqueous solutions and suspensions to higher viscous formats can be applied.

APF  Futurity™ Recyclable Nasal Spray Device

 

An Asian woman with long, dark hair sits in a modern living room, holding the APF Futurity™ recyclable nasal spray by Aptar Pharma close to her nose. She is wearing a grey checkered coat and is in the process of using the spray.

Aptar_APF_futurity_Nasal_Spray_Pump_by_Aptar_Pharma_logo_withTM.jpg

 

Aptar Pharma’s latest APF  Futurity™ nasal spray pump is its first highly recyclable nasal spray system. While maintaining all of the performance and function of the standard APF multidose nasal spray, APF  Futurity™ adds enhanced recyclability to the product line.

The metal-free, polyolefin only construction means the APF  Futurity™ device can be placed directly into current recycling streams without any separation work for easy recyclability. APF  Futurity™ advantages include:

  • Designated “Highly Recyclable”, rated “AA” by cyclos-HTP
  • The first metal free nasal spray pump
  • Made from polyolefin only with no recycling disruptors
  • APF  Futurity™ can be directly recycled as a unit
  • APF  Futurity™ delivers drug formulation precisely and consistently
  • Preservative free multidose nasal spray delivery with Tip Seal technology
  • Provides circular material options for use of renewable feedstocks & mass balance approach

Learn More About APF Futurity™

This image shows a variety of nasal, eye, and dermal care products from leading brands using Aptar Pharma's APF Advanced Preservative Free (APF) and APF Plus system. The bottles feature different shapes and colors, with some displaying a 360-degree rotation symbol, indicating a view of the full product.

APF – Advanced Preservative Free

The APF system provides precise and consistent multidose nasal spray drug delivery and eliminates the need for preservatives and additives in the formulation. As the high-quality leader of preservative free multi-dose solutions, Aptar Pharma provides a comprehensive data package for the APF nasal spray pump which is designed to support pharmaceutical customers in meeting regulatory demands. Our APF system is part of many major nasal spray product launches in highly regulated markets.

APFPlus – Advanced Preservative FreePlus

Our APFPlus system brings the same level of quality, precision, and reliability as our original APF nasal spray systems, but expands the applications to dermal, oral and eye-care products through the ability to support preservative free liquid suspensions and solutions of a wider range of viscosities.

Device support services for APF range from concept to commercialization

Aptar Pharma provides comprehensive support services that support our APF product lines in partnership with customers. Our objective is to apply our decades of multidose nasal spray development experience, including formulation and analytical development services, to support our customers’ needs and get their products to market faster and more efficiently. We help customers with selection of the right solution, create and optimize formulations to harmonize the best way with the APF spray pump, and develop/validate analytical tests that can confirm its compliance to specifications. We also provide in-person support to seamlessly integrate assembly and filling operations to your manufacturing lines. Our long-term relationships with partners for industrial filling worldwide are an asset customers can trust. Finally, our outstanding regulatory know-how and close cooperation with our customers, smooth the way to market for new or repositioned APF-based product.

APF and APFPlus Advantages

 

  • Microbiological Integrity

  • Stable Formulation

  • Sterile Product

  • 360° Usage

  • A woman with dark hair styled is sitting on a couch, using her right hand to hold a white nasal Aptar Pharma’s nasal spray pump near her nose. She is wearing a black top.

    Aptar Pharma‘s leading preservative free multidose technology provides proven microbiological integrity

    Aptar Pharma’s patented Tip-Seal technology has been qualified by “microbial challenge tests” and has passed relevant worst-case simulation. Our comprehensive data package for the APF and APFPlus solutions platform is designed to support pharmaceutical customers in meeting regulatory demands.

  • A woman with dark hair styled is sitting on a couch, using her right hand to hold a white nasal Aptar Pharma’s nasal spray pump near her nose. She is wearing a black top.

    TipSeal closure and metal-free fluid path ensure stable formulations

    The mechanical TipSeal closure prevents any ingress of air or backflow of liquid after actuation of the pump. This avoids crystallization leading to clogging of the tip or contamination of the formulation through ingress of bacteria. The metal-free fluid path makes sure sensitive formulations don’t oxidate through iron-based metals.

  • A woman with dark hair styled is sitting on a couch, using her right hand to hold a white nasal Aptar Pharma’s nasal spray pump near her nose. She is wearing a black top.

    Sterile product validated to ISO11137 upon request

    For sterility needs of pharma-products we offer either gamma-irradiated or sterile APF products, including packaging proved for gamma-irradiation and storage stability. Our irradiation process is validated according to ISO11137.

  • A woman with dark hair styled is sitting on a couch, using her right hand to hold a white nasal Aptar Pharma’s nasal spray pump near her nose. She is wearing a black top.

    The unvented solution for comfortable usage at 360°

    Topical administration is often needed at any angle. APF and APF+ are provided as 360° sprays that enable fully flexible use through an inner pouch that gradually collapses instead of having an inflow of venting air. So the dip tube is immersed in the formulation enabling spraying at any angle.

Product Details

 

Dose volumes of 50µl, 90µl and 140µl per actuation with other volumes available upon request. This provides maximal flexibility to use with formulations of diverse concentrations, and to adapt dosing accordingly.

Our APF pumps are valued because of their superior and fast priming, reaching the wanted dose volume quickly. Re-priming is not needed as the dose volume stays stable over time.

APF pump sprays produce a soft gentle mist. The topical spray is characterized by its round and even spray pattern, providing a long and stable fully developed phase of spray.

The materials used for Aptar Pharma’s APF, APFPlus and APF  Futurity™ pumps are compliant with the regulatory requirements of the U.S. and EU Food Contact regulations and the U.S. and European Pharmacopoeias with regard to formulation contact requirements.

The APF pumps that are US-DMF and HC-DMF supported and can contribute to faster and smoother drug product approvals by applicable regulatory authorities.

Solve Your Preservative-Free Product Challenge Now

You can trust the leading expertise of Aptar Pharma in preservative-free multidose dispensing technologies for nasal, ophthalmic, topical and oral applications and rely our knowledgeable end-to-end support from development to commercialization of your products.

We Have a Broad Range of Value Added Services to Accelerate and Derisk
Your Drug Product Development.

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