Address: Aptar Radolfzell GmbH, Oeschlestrasse 54-56, 78315 Radolfzell, Germany
Tel: +49 7732 801 0
Fax: +49 7732 801 226

Aptar Pharma

Aptar Pharma is a world leader in pharmaceutical dispensing systems and packaging solutions, setting standards for the drug delivery sector for decades and continuing to break new ground in innovative healthcare technologies. More than 350 drug products marketed globally use Aptar Pharma delivery devices.

As a trusted partner of the pharmaceutical community, Aptar Pharma provides specialized products and services that enable its clients to offer superior drug delivery routes and drug delivery solutions.

Respected for its proven regulatory expertise, Aptar simplifies and accelerates its partners’ path through approval and compliance processes. The company embraces reliable and caring values, recognizing healthcare trends, to continuously improve the innovation, convenience and safety of its products.

Aptar Pharma products & services

Aptar Pharma’s products cover the whole spectrum of drug delivery routes, including nasal, pulmonary, dermal/transdermal, eye care and injectables. Within those sectors, Aptar Pharma has developed a wide portfolio of drug delivery solutions.

Standalone solutions

These include a number of industry-leading stand-alone products:

Advanced Preservative Free (APF): based on tip-seal/filter technology, avoiding chemical additives to prevent contamination of container content.

Airless Dispensing: market-proven airless piston technology ensures better protection, safe dispensing and convenient application of your formulation.

Bag On Valve (BOV): cost effective and environmentally safe technology that provides full protection of the content, ease of use and high convenience.

BDS: gold standard bi-dose system for disposable use, delivering two nasal shots for therapies where a very precise amount of active drug formulation that exceeds 100μl is required.

Classic Technology Platform: local and systemic drug delivery system allowing for administration of Rx and OTC products via nasal, oral, dermal, and other routes.

CPS Technology Platform: highly versatile spray pump designed for multi-dose delivery of preserved or non-preserved drug formulations via nasal route.

DF30 Technology: gold-standard metering valve platform has been the industry gold standard for more than 20 years, continually optimized, to powers several blockbuster prescription drug products marketed worldwide.

Latitude®: innovative side-actuated nasal spray device designed to help improve patient convenience.

Ophthalmic Squeeze Dispenser: new multidose dispenser for preservative-free ophthalmic solutions.

Prohaler®: novel high performance pre-metered multidose DPI designed for optimal patient compliance, using unique breath-triggered dose-opening function.

SimpliSqueeze®: patented advanced packaging solution for liquid formulations that uses rolling valve technology for precise and safe dispensing.

Twister®: versatile and affordable dry powder inhaler.

UDS: unit-dose systems for disposable use, applicable to therapies where a small and very precise amount of active drug formulation is required in a single nasal shot.

VP3 Technology Platform: multidose spray pump that remains industry gold standard after more than 30 years and is most widely used in the world for local and systemic pharmaceutical applications, powering numerous blockbuster prescription drug products.

VP6: versatile pump system, designed to provide a reliable system fitting individual needs while offering good performance even with viscous formulations.

VP7 Technology Platform: spray pump specifically designed for Rx nasal prescription drug products.

e-Lockout: it is the first and only fully integrated electronic nasal drug delivery device with time-interval properties approved by a U.S. or European regulatory authority.

e-Dose Counter for MDIs: The integrated spray sensing solution designed to be easy-to-use and reliable, contributing to patient compliance.

Component solutions

In addition, Aptar Pharma offers a number of component solutions that can enhance overall drug delivery devices:

Cartridge Components: a wide range of cartridge plungers designed to offer optimal contact conditions and precise mechanical performance during assembly and injection.

Child Resistant Feature: a new, simple and intuitive solution complying with newly established standards to ensure child-resistance and senior friendliness for nasal sprays while not interfering with basic function or spray performance.

Diagnostic Stoppers: designed specifically to meet customers' primary packaging requirements for liquids and powders.

Elastomeric Valves: proprietary normally closed valve designed to solve fluid management challenges.

Landmark® Dose Indicator: patented mechanical dose indicator for all metering valves.

Large Volume Parenteral Stoppers: LVP closures for vials and infusion bags that provide high chemical inertness and self-sealing as well as low permeability and resistance to coring.

Lyophilization Stoppers: designed to remain stable on the vial during transfer and sublimation in freeze drying, ensuring high chemical inertness, recovery of the reconstituted drug product and protection of lyocake.

Needle Shields: Aptar is one of the world’s leading supplier of elastomeric needle shields, with patented high-performance latex-free needle rigid shield formulations used by all major glass system manufacturers and leading pharmaceutical companies worldwide.

Plungers: comprehensive range of elastomeric plungers, compatible with the pre-filled syringes offered by the world’s top glass system manufacturers.

Small Volume Parenteral Stoppers: Aptar’s SVP stoppers designed for blowback and non-blowback vials are used in more than 70 countries, providing optimal protection and drug delivery.

Tip Caps: Recognized as the global leader in pre-filled syringe components, Aptar tip caps combine effective permeability and chemical inertness.

Services

Aptar Pharma’s service offering covers five complementary fields:

Customized Development: managing projects from early concept through to proven feasibility and fully functional prototype, harnessing understanding of latest evolutions of the drug delivery market including latest standards, regulatory requirements and best practices, coupled with Aptar’s portfolio of proprietary solutions and advanced capabilities.

Laboratory Services: Selection and testing of primary packaging components, containers and systems as well as drug delivery devices, using expert teams in analytical development labs that are FDA-registered, together with physical labs that measure actual performance.

Regulatory Support: expert teams based in the EU and USA, dedicated to helping customers with regulatory questions and support regulatory submissions/

Elastomer Development: Ensuring the quality and the compatibility of primary packaging components that are in contact with the drug product to protect stability and the performance of the drug product. This includes reliable sourcing of carefully selected ingredients and the development and state-of-the-art manufacturing of the most suitable and purest formulations dedicated to pharma use, using dedicated research centers.

Technical Support: recommendations to help customers optimize the whole delivery package, including elastomeric formulation, primary packaging components and formulation development for pMDIs and DPIs.

Technologies

With more than 600 international patents granted, Aptar Pharma’s active protection of IP rights reinforces its own customers' technology lead.

Significant Aptar Pharma technologies include:

Airless Dispensing Solutions: airless piston technology ensures best protection, safe dispensing and convenient application of sensitive formulations, conferring a significant range of user benefits including accurate, precise and clean dispensing, suitability for wide range of viscosities, no backflow of air into container, superior evacuation rate, full 360° functionality and standard top filling process.

Bag on Valve: Aptar Pharma's Bag On Valve (BOV) technology serves a wide range of pharma applications with major benefits such as 360° use, no pumping, better preservation and ultimate protection of content and better environmental protection). BOV systems, meticulously developed over a number of years, are widely accepted by major multinational companies.

Nasal spray systems: Aptar Pharma’s unitdose system (UDS) is the gold standard disposable systems for powder and liquid formulations. UDS are applicable for therapies where a small and very precise amount of active drug formulation is required in a single nasal shot. Some of these therapies delivered intra-nasally require high deposition in targeted areas of the nasal cavity. The nose-to-brain pathway which may allow therapeutic compounds to enter the CNS requires the targeting of the upper part of the nasal cavity or “the olfactory region”. Other nasal spray systems include the highly versatile CPS spray pump, designed for the multi-dose delivery of preserved or non-preserved drug formulations and the Nasal Spray Classic Technology Platform. Other Aptar nasal spray systems include the Latitude® side-actuated device or VP3, VP6 and VP7 Technology Platforms.

Mutlidose Preservative Free Systems: include Advanced Preservative Free, Advanced Preservative Free Plus, Cartridge Pump System (CPS) and Aptar Pharma’s Ophthalmic Squeeze Dispenser.

The proven and unrivalled microbiological safety of the Ophthalmic Squeeze Dispenser (OSD), combined with a precise and reproducible drop ejection allows pharmaceutical customers worldwide to enter into discussions with regulatory agencies such as the FDA. Aptar Pharma's Ophthalmic Squeeze Dispenser provides a unique competitive advantage by addressing the worldwide trend towards patient-friendly, cost-effective and preservative-free multidose dispensers.

Smart metering and dosing systems: Aptar Pharma has patented a number of solutions to ensure correct dosing. These include the e-Dose Counter for MDIs, the electronic e-Lockout smart solutions for spray devices and the Landmark® patented mechanical dose indicator for metering valves.

History and organization

Aptar Pharma is part of the Aptargroup, which is also active in the Beauty & Home and Food/Beverages industries. The group was formed in 1993 with the Ing. Erich Pfeiffer GmbH and Valois SAS of France as its foundation members.

Aptar Pharma traces its history back to 1947, when Erich Pfeiffer set up his company in Germany. In 2016, Aptar Pharma significantly expanded its Airless Products offerings with the integration of the Mega Airless Pharma portfolio into its range.

With a strong focus on leveraging innovation to provide patient-focused solutions, Aptar Pharma allocates 5% of annual revenues to R&D. In 2016, Aptar Pharma recorded global sales worth more than USD 741m.

The group has nine manufacturing sites in Argentina, China, France, Germany, India, Switzerland and the U.S.A., producing more than 6 billion systems each year for the pharmaceutical industry market worldwide.

Quality, Regulatory and Standards

Aptar Pharma’s products and processes are quality compliant with key International Standards: ISO 9001:2008 (Quality Management), ISO 13485:2012 AC: 2012 (Medical Devices) and ISO 15378:2011 (Quality Management/GMP).

Aptar Pharma also holds Drug Master Files for numerous product lines.

Contact

To learn more about Aptar Pharma products and services and how they can assist your business, please contact the supplier.



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