All posts by Ciara Jackson

Aptar Pharma is an Outstanding Issue Sponsor in April's ONdrugDel...

In this special Pulmonary & Nasal Drug Delivery issue, experts from Aptar Pharma, Nanopharm and Noble have contributed three interesting articles:

  • Is Now the Time to Shake Up the pMDI Environment?” by Chris Baron, Director Business Development, Rx, EMEA at Aptar Pharma.

This article explores how the use of propellants in pressurised metered dose inhalers has evolved – and how alternative propellants could be a catalyst for greater patient adherence.

  • “Developing an In Vitro Dissolution and Release System for Orally Inhaled Drug Products” by Rob Price, Chief Scientific Officer, Nanopharm Ltd, an Aptar Pharma company.

This article critiques regulatory routes for the development of generic OINDPs, runs through recent announcements and developments of note from regulators, and describes how Nanopharm has pioneered the concept of structural Q3 equivalence.

  • “Be prepared. The Importance of Training and Onboarding Programs for Intranasal Rescue Therapies” by Joe Masci, Executive Director of Business Development Noble International, an Aptar Pharma company.

With a recent resurgence in nasal drug repurposing, this article looks at the importance of training and onboarding for intranasal rescue therapies.

Download all three articles here.

April 20, 2020

Nanopharm to Host Webinar on April 21st Discussing In-Vitro Disso...

Nanopharm Ltd will host an educational webinar entitled “Overcoming the Challenges in Developing an In-Vitro Dissolution and Release System for Orally-Inhaled Drug Products” on Tuesday, April 21, 2020 at 4 pm CET/10 am EST.

Presented by Prof. Rob Price, Chief Scientific Officer at Nanopharm Ltd, an Aptar Pharma company, this event is an opportunity for scientists, regulatory experts and senior managers to learn more about novel advanced analytical approaches for the characterization of orally-inhaled drug products. The webinar will cover the range of dissolution tests available, why they are important to consider, and how Nanopharm’s latest innovation – a new in-vitro release testing system – can help to accelerate and de-risk the development of orally-inhaled drug products.

This webinar is free-to-attend and will be available on-demand after the live presentation.

Register for Nanopharm’s webinar here.

April 8, 2020

Aptar Pharma Partners with Lupin to Launch India’s First Connec...

Aptar Pharma, a global leader in drug delivery systems, services and active packaging solutions, is pleased to announce that it has partnered with Lupin Limited to launch India’s first connected device for metered-dose inhalers (MDI) called ADHERO. This unique add-on smart device is designed to help patients with chronic respiratory diseases track their MDI usage and facilitate improved adherence to their prescribed therapy.

Inhalers are the preferred treatment option for managing the rising incidence of chronic respiratory diseases like asthma and chronic obstructive pulmonary disease (COPD) in India. However, it is estimated that nearly 45 percent of patients do not adhere to their therapy, including the filling and refilling of prescriptions or maintaining the prescribed medication schedule. This inconsistent adherence adversely impacts clinical outcomes and the patient’s quality-of-life. This new device, ADHERO, is designed to improve patient adherence to therapy.

ADHERO is a bluetooth-enabled, reusable smart device that attaches to the top of an MDI. With built-in sensors, the device tracks the patient’s daily medication usage and consumption patterns. Patients can access this information by connecting their ADHERO device to the “MyAdhero” app on their smartphones. The app is also equipped to send reminders, provide contextual health alerts based on factors like Air Quality Index at the patient’s current location and enable visual analytics. Patients can also grant their physician access to their information and medical tracking data through the dashboard portal as well as the app.

Aptar Pharma collaborated with Navia Life Care to develop the digital ecosystem for the MyAdhero App, which includes the Patient App, Care Provider App and the Doctor Portal.

Speaking about the launch, Rajeev Sibal, Lupin’s President India Region Formulations said, “Lupin lays great emphasis on three aspects of respiratory medicine, namely disease awareness, diagnosis and adherence. The launch of ADHERO will be a great help to patients using metered dose inhalers as well as for doctors to track adherence and compliance to therapy, thereby improving clinical outcomes and the quality-of-life of patients.”

Kanwal Tikoo, Aptar Pharma’s President of India & Southeast Asia commented, “We are pleased to have partnered with Lupin Limited on their ADHERO connected device program in India. With the steady rise in cases of asthma and COPD, this is an important step towards helping to improve adherence and health outcomes.”

Added Sai Shankar, Aptar Pharma’s Vice President, Global Digital Healthcare Systems, “Aptar Pharma has been building a portfolio of connected devices within the digital medicines ecosystem. We are focused on integrating services across device development and manufacturing, the digital platform experience and implementation with the healthcare stakeholders. We are excited about the first launch of a connected inhaler program for respiratory diseases in India with Lupin Limited.”

Read full Press Release.

January 28, 2020

Aptar Pharma Featured in ONdrugDelivery’s Ophthalmic Issue Janu...

In this month’s Ophthalmic Drug Delivery issue of ONdrugDelivery magazine, read about how Aptar Pharma is delivering on the growing need for topical preservative-free ophthalmic treatments.  Authored by Matthias Birkhoff, Vice-President Business Development at Aptar Pharma, this article gives an overview of the existing technologies available in ophthalmic drug delivery and describes the progress that has been made in topically-applied medications. Birkhoff asserts that more and more topical applications are required to be provided as preservative-free formulations in multi-dose delivery systems, such as Aptar Pharma’s Ophthalmic Squeeze Dispenser (OSD), the only U.S. FDA-reviewed multi-dose eye dispenser. This article also introduces a new market standard for testing microbial integrity in preservative-free formulations, the TSIT 2.0, which has recently been developed by Aptar Pharma.

Read the full article here.

January 23, 2020

Aptar Pharma’s Nasal Unidose Device Again Approved by US FDA fo...

Aptar Pharma, a global leader in drug delivery systems, services and active packaging solutions, today announced that its patented Unidose Liquid System is the device delivering a new nasal spray approved by the U.S. FDA for another rescue treatment for people with epilepsy aged six and older suffering from acute repetitive seizures. This ready-to-use rescue treatment can be used when and where a seizure cluster occurs thanks to Aptar’s proven, intuitive and convenient Unidose Liquid System.

This approval again demonstrates Aptar’s expertise in developing patient-friendly drug delivery solutions to help pharmaceutical customers address unmet healthcare needs. Aptar offers a broad portfolio of innovative technologies and wide array of services to meet the highest quality standards of the pharmaceutical industry.

This new rescue treatment for seizure activity is an example of a Combination Product submission, and benefited from Aptar Pharma’s services offering, a comprehensive portfolio of stage-specific development packages.

“The launch of our Unidose System for this new U.S. FDA-approved nasal rescue treatment for seizure activity once again demonstrates Aptar Pharma’s ability to help our customers develop and launch complex treatments,” stated Gael Touya, President, Aptar Pharma.  “Our proven nasal systems combined with our lab and analytical service capabilities create substantial value for our customers and help them secure approval. The ultimate end result is that we help expand life-saving treatments with our patient-friendly systems.”

See full Press Release for details.

January 22, 2020

Aptar Opens New Sales Office in Dubai

Aptar celebrated the official opening of its new Aptar Dubai office during an inauguration ceremony, which took place on November 27, 2019 at The Westin Dubai Mina Seyahi Resort, Dubai.

The sales office is shared by all three segments of Aptar – Beauty + Home, Food + Beverage and Pharma.

Delegates from Aptar welcomed more than 30 customers who attended the opening ceremony, which included an Aptar presentation and cocktail event.

Several countries in the Middle East are experiencing robust economic growth currently and the presence of an office in Dubai is an ideal central meeting location for bringing Aptar closer to our customers in the region.

December 19, 2019

Aptar Pharma’s Connected Devices Experts Featured in ONdrugDeli...

Aptar Pharma’s Connected Devices Team is featured in the December Connected Drug Delivery issue of ONdrugDelivery magazine.

The article “The Current State of Play in Connected Devices”, written by Marcus Bates, Joachim Koerner and Jerôme Praquin – Aptar Pharma’s Connected Devices team –  explains what connected device advocates are doing to enable faster implementation and how we can optimize connected technology while reducing costs and improving human factors.

Read the full article here.

December 18, 2019

Aptar Pharma to Highlight Drug Delivery Solutions Portfolio and E...

Aptar Pharma will be a leading exhibitor at Pharmapack 2020, which will take place February 5-6 at Paris Expo, Porte de Versailles, in Paris, France.

Located at booth A68-A70, Hall 7.2, Aptar Pharma will showcase their broad portfolio of drug delivery solutions that help improve and save lives, as well as their latest innovations across nasal, pulmonary, eye care, injectables, dermal drug delivery routes, including:

  • Aptar Pharma’s expanding range of connected drug delivery devices designed to help increase dose adherence and improve patient health outcomes
  • Innovative active packaging solutions from Aptar CSP Technologies, the active packaging specialists, who will showcase a variety of solutions including their award-winning XcelerateTM Development Services
  • Aptar Pharma’s newly expanded services platform, with leading experts from Aptar Pharma’s analytical service companies Nanopharm, Next Breath and Gateway Analytical on hand to discuss how their value-added services can help customers accelerate and derisk their drug development journey.

Also exhibiting alongside Aptar Pharma will be Noble International, a global leader in drug delivery device trainers and patient onboarding, and the latest addition to the Aptar Pharma family.

Aptar Pharma will host three insightful Learning Lab sessions on Wednesday, February 5 at Pharmapack:

  • Rethinking DPI Packaging: New Solutions to Old Challenges (13:50 – 14:20), presented by Badre Hammond, Vice-President, Commercial Operations, Aptar CSP Technologies
  • Accelerating and derisking your drug development journey (14:30–15:00), presented by Dr. Julie D. Suman, President and Founder of Next Breath, an Aptar Pharma company
  • Inhaler Devices and the Environment: Going Green Needn’t Cost the Earth (15:10–15:40), presented by Chris Baron, Director of Business Development, Rx EMEA, Aptar Pharma

More than 410 exhibitors and 5,500 visitors from 75 different countries are expected to attend Pharmapack 2020. Aptar Pharma looks forward to meeting with existing customers and partners from around the world, and welcomes the opportunity to make new connections in the industry to discuss how Aptar Pharma can help transform their ideas into a market opportunities.

Read the full details in our Press Release.

December 16, 2019

Aptar Pharma and Nanopharm Featured in ONdrugDelivery’s Novembe...

Aptar Pharma is featured in the November 2019 edition of ONdrugDelivery magazine, which focuses on Pulmonary & Nasal Drug Delivery.

In this interesting article entitled “A Faster, More Cost-Effective Alternative to Generic Bioequivalence”, Dr. Jag Shur, CEO of Nanopharm, an Aptar Pharma company, explores the challenges companies face in bringing generic respiratory and nasal therapies to market amidst a changing regulatory landscape.  He explains the Aptar Pharma Services range for accelerating and derisking OINDP development, and introduces the CPhI 2019 Award winning SmartTrack as an alternative to bioequivalence studies.

Read the full article here.

 

November 27, 2019

Aptar Pharma Experts to Host Webinar on Analytical Strategies for...

Aptar Pharma will host a live educational webinar entitled “Breathe Easy: Selecting analytical strategies for inhaled drug product development” on Thursday, December 5, 2019 at 3.30 pm GMT/10.30 am ET.

Led by OINDP experts from Next Breath and Nanopharm, both Aptar Pharma companies, this webinar will examine the analytical methods and regulatory frameworks associated with ensuring and establishing bioequivalence. It will question which analytical methods are most relevant to OINDP in vitro bioequivalence studies, as well as explore what supporting evidence can be generated to aid formulation optimization, therefore helping to expedite successful product development and regulatory submission.

This webinar, which is sponsored by Malvern Panalytical and is free to attend, will be co-presented by Dr. Julie D. Suman, Founder & President, Next Breath and Dr. Jag Shur, CEO, Nanopharm.

The webinar will be available on-demand after the live presentation.

Click here to register: https://bit.ly/2O8CIIN.

 

 

November 26, 2019

Aptar Pharma Platinum Sponsor at DDL 2019 to Showcase Expanded Po...

Aptar Pharma is pleased to announce its Platinum Sponsorship of this year’s Drug Delivery to the Lung (DDL) Conference 2019, which takes place from December 11-13 in Edinburgh, Scotland.

Aptar Pharma will exhibit its broad respiratory portfolio and showcase its latest drug delivery innovations and services for respiratory devices at the three-day conference, which is celebrating its 30th anniversary this year.

A worldwide leader in respiratory drug delivery devices for the treatment of asthma and COPD, Aptar Pharma will exhibit at Booth 432 at DDL, where their team of experts will showcase their innovative range of respiratory drug delivery systems and connected devices that help improve adherence and patient health outcomes.

Noble International, a global leader in drug delivery device trainers and patient onboarding and the latest addition to the Aptar Pharma family, will also be on exhibit at Booth 432.

Also exhibiting at Booth 432 will be Aptar CSP Technologies, the active packaging specialists.

Aptar Pharma’s newly expanded Aptar Pharma Services platform will also be highlighted at DDL 2019. Leading experts from Aptar Pharma companies Nanopharm, Next Breath and Gateway Analytical will be on hand at the following Booths to discuss how their value-added services can help customers accelerate and derisk their drug development journey:

Nanopharm will exhibit at Booth 518
Next Breath will exhibit at Booth 516
Gateway Analytical will exhibit at Booth 514.

To further share its expertise in respiratory drug delivery with the scientific community, Aptar Pharma will be presenting five scientific posters, during DDL 2019. Delegates and attendees will have the opportunity to view them during the dedicated poster sessions, which will take place daily at the Conference.

Guillaume Brouet, Vice-President Regulatory, Analytical & Scientific Affairs at Aptar Pharma, commented, “As a leader in inhalation drug delivery systems, we are proud to be a Platinum Sponsor of DDL this year. We look forward to showcasing our expanded Aptar Pharma device, technologies and services offering, which provide complete solutions for customers and further support their respiratory drug development journeys”.

Aptar Pharma is also a sponsor of the special DDL 2019 Dinner celebrating DDL’s 30th Anniversary, which will take place on Thursday, December 12th and to which all delegates and exhibitors are invited.

Download full Press Release here.

November 25, 2019

Aptar Pharma’s Preservative-Free Multidose Dispenser Approved i...

Aptar Pharma is pleased to announce that its innovative, preservative-free multidose Ophthalmic Squeeze Dispenser is the delivery system for Allergan’s REFRESH® RELIEVA™ PF, its new over-the-counter (OTC) preservative-free treatment for eye dryness in the U.S.

This use reconfirms the market-leading position of Aptar Pharma’s Ophthalmic Squeeze Dispenser as the multidose delivery system for ophthalmic agents and formulations without preservatives for prescription and OTC products.

Launched along with REFRESH® RELIEVA™ PF are REFRESH® RELIEVA™ and REFRESH® RELIEVA™ FOR CONTACTS. This new line of artificial tear formulations from Allergan is specifically developed to relieve discomfort due to eye dryness and to prevent further irritation. REFRESH®, a doctor recommended brand for artificial tears, further expands its portfolio by offering the only family of products in the U.S. with carboxymethylcellulose (CMC), hyaluronic acid (HA, an inactive ingredient), glycerin, and Allergan’s HydroCell™ technology. This formulation enables hydration and maintains the volume of cells on the ocular surface.

Preservatives have been known to cause signs and symptoms of irritation, allergy and ocular surface toxicity. Aptar Pharma has been partnering with Allergan across numerous preservative-free product launches.

“Our Ophthalmic Squeeze Dispenser technology has been launched with close to 250 preservative free eye care products worldwide. Its proven unrivalled microbiological safety combined with a diverse technological platform enables our customers to introduce their formulations to market in the purest form and offering outstanding convenience, meeting the needs of consumers and patients,” explained Matthias Birkhoff, VP Business Development, Aptar Pharma. “By offering the first and only FDA-reviewed technology for multidose preservative-free systems, our customers can rely on Aptar Pharma’s comprehensive service package to support their development of eye care products without preservatives.”

Allergan is a leader in eye care, with 70 years of experience and over 125 eye care products launched, among those some of the most innovative products in the industry.

Download Full Press Release here.

 

Photo: Courtesy of Allergan

November 22, 2019

Aptar Pharma’s Nanopharm Wins "Excellence in Pharma" Award for ...

Aptar Pharma announces that Nanopharm has won an Excellence in Pharma Award at the 2019 CPhI Pharma Awards. Nanopharm, an Aptar Pharma company and part of our expanded services offering, won in the Contract Services and Outsourcing category for its recently-launched SmartTrack™ process.

Accepting the award were Dr. Jag Shur, CEO of Nanopharm, and Guillaume Brouet, Vice-President of Analytical, Regulatory and Scientific Affairs at Aptar Pharma.

The award was presented as part of the 16th annual CPhI Pharma Awards dinner, which took place Tuesday, November 5th at the Forum at Messe Frankfurt, Germany.

Established in 2004, the CPhI Pharma Awards are one of the most prestigious recognition’s in the Pharmaceutical industry today, and celebrate the innovation and dedication of companies and individuals who are driving the pharmaceutical industry forward. This year’s awards included 13 categories that span the entire industry’s supply chain.

A specialist in respiratory drug delivery services, Nanopharm is the world’s leading contract provider of orally inhaled and nasal drug product (OINDP) design and formulation development services to customers worldwide. Recognized for their advanced scientific understanding, Nanopharm offers an integrated solution approach via SmartTrack™.

SmartTrack™ is a novel integrated solution providing an alternative bioequivalence (BE) clinical endpoint approach. SmartTrack™ can dramatically decrease program costs, mitigate risk and expedite development from concept to delivery, ensuring that every aspect of a drug product development’s critical path is optimized.

“This award marks a significant milestone for our SmartTrack™ platform, and signifies the R&D endeavor at Nanopharm to develop alternative bioequivalence strategies for OINDPs,” commented Jag Shur, PhD, Chief Executive Officer of Nanopharm. “I would like to thank our employees, clients and partners in this success.”

Aptar Pharma President Gael Touya, who was on hand to present the Excellence in Pharma Drug Delivery Device and Packaging Awards at this year’s event added, “We are delighted that Nanopharm’s SmartTrack™ was recognized by the industry for its innovative approach. This reinforces the Aptar Pharma Services mission to further help customers during their entire product lifecycle of the drug product and deliver them a complete solution.”

Aptar Pharma, along with Nanopharm, are a main exhibitor at CPhI Worldwide 2019, which is taking place in Frankfurt, Germany from November 5 – 7. For several years, Aptar Pharma has had a significant presence at this major event in the pharmaceutical industry attended by over 45,000 Pharma professionals.

Download the press release here.

 

 

November 6, 2019

Aptar Pharma to Showcase Latest Injectables Offerings at PDA PFS,...

Aptar Pharma is pleased to be exhibiting at 2019 PDA Universe of Pre-Filled Syringes and Injection Devices (PDA PFS), taking place October 22-23 in Gothenburg, Sweden.

At Booth No. F72, we will be showcasing our broad PFS product portfolio including the latest developments in our Premium injectables offering: PremiumFill®, PremiumCoat™ and PremiumVision™.

Learn more about our newly expanded Aptar Pharma Service Platform. Meet with experts from Aptar Pharma’s analytical services company, Gateway Analytical, who will be on hand to discuss how their value-added services can help customers accelerate and derisk their drug development journey.

Visitors to our booth can find out how Aptar Pharma is driving for supply chain excellence by increasing production capabilities and capacity worldwide.

A scientific poster entitled “Evaluating the impact of Sterilization Methods on Stopper Performances” – a collaborative study by Aptar Pharma and BD Medical – will also be presented during the poster sessions on both days of PDA PFS 2019.

PDA PFS has been running since 2004 and has become a must-attend event for those working in the biopharmaceutical and parenteral drug delivery and device development fields. This is the first time the event will be held in Gothenburg. Aptar Pharma looks forward to welcoming you there!

For more information on PDA PFS 2019, click here.

October 15, 2019

Aptar Pharma to Highlight Expanded Services Platform at CPhI Worl...

Aptar Pharma is pleased to be an exhibitor once again at CPhI Worldwide 2019, which will take place November 5-7 in Frankfurt, Germany.

At Stand 111D70, Aptar Pharma will showcase its diverse portfolio of drug delivery systems, components and active packaging solutions including their latest innovations across nasal, pulmonary, eye care, injectables and dermal drug delivery routes. These innovations will include:

  • PureHale – a revolutionary, portable and ready-to-use device designed to deliver natural care to upper airways
  • QuickStartTM for Injectables – a sterile, ready-to-use early stage injectable development package now orderable on aptar.com/pharma
  • Nanopharm’s SmartTrackTM – a novel approach to decrease program costs and avoid BE studies in OINDPs

A dedicated Connectivity hub hosting their range of connected drug delivery devices will demonstrate Aptar Pharma’s focus on building a connected devices eco-system for digital medicines.

Aptar Pharma’s newly expanded Aptar Pharma Services platform will be introduced at this year’s CPhI WW.  Offering early stage to commercialization services, Aptar Pharma has over 25 years’ experience supporting regulatory submissions. Leading experts from Aptar Pharma’s analytical services companies Nanopharm, Next Breath and Gateway Analytical will be on hand to discuss how their value-added services can help customers accelerate and derisk their drug development journey.

Aptar CSP Technologies, part of the Aptar family, will be presenting their extensive portfolio of active packaging solutions including the award-winning XcelerateTM Development Services which can help expedite time-to-market for moisture- and oxygen-sensitive drugs.

On Wednesday, November 6, Aptar Pharma will present three free-to-attend Pharma Insight Briefings:

  • “Driving Foreign Particulate Analysis: How to Choose Between Manual and Automated,” presented by David Exline, President, Gateway Analytical, an Aptar Pharma company
  • “Advantages of Nasal Powders for Drug Repurposing,” presented by Dr Gerallt Williams, Director Scientific Affairs, Aptar Pharma
  • “Beyond Pharmaceutical Packaging: New Solutions to Old Challenges,” presented by Badre Hammond, Vice-President, Commercial Operations, Aptar CSP Technologies.

CPhI Worldwide, the world’s largest pharmaceutical exhibition, is celebrating its 30th anniversary this year and expects to welcome more than 45,000 visitors and 2,500 international exhibitors.

Download the full press release.

October 6, 2019

Aptar Pharma’s Nasal Unidose Device Approved for Tosymra™ Sum...

Aptar Pharma, a leading provider of drug delivery devices worldwide today announced that its patented Unidose Liquid System is the device which delivers Tosymra™ (sumatriptan) Nasal Spray 10mg, for the acute treatment of migraine in adults.

Now available in the U.S., Tosymra was approved by the U.S. Food and Drug Administration (FDA) in January 2019 and is being commercialized by Upsher-Smith Laboratories, LLC.

For migraine sufferers, there is a continued need for reliable and efficacious treatment options. Tosymra nasal spray is formulated using a proprietary excipient to achieve blood levels similar to a 4-mg sumatriptan subcutaneous injection. Aptar’s Unidose device delivers one dose of Tosymra as a single spray providing a convenient, patient-friendly delivery approach.

This approval and launch again demonstrates Aptar Pharma’s expertise in developing patient-friendly drug delivery solutions for medicines. Aptar offers a broad portfolio of innovative technologies and wide array of services to meet the highest quality standards of the pharmaceutical industry.

This migraine treatment is an example of a Combination Product submission, and benefited from Aptar Pharma’s Services offering, a comprehensive portfolio of stage-specific development packages. Aptar’s dedicated Regulatory Affairs experts and analytical scientists help customers proactively address regulatory needs to obtain approval.

“We are pleased that Aptar Pharma’s Unidose System has once again been approved by the FDA and launched with an important new nasal treatment for acute treatment of migraine that provides a patient-friendly delivery approach,” commented Gael Touya, President, Aptar Pharma. “Our lab and analytic service capabilities combined with our unique drug delivery devices create tremendous value for our customers and help them secure approval. The ultimate end result is that we help expand access to treatments with our life-improving, patient-friendly systems, something for which we are very proud.”

See full Press Release for details.

October 2, 2019

Aptar’s Nasal Unidose Device Approved by US FDA for First Needl...

Crystal Lake, Illinois, July 25, 2019 – AptarGroup, Inc., a global leader in dispensing and drug delivery solutions, today announced that its Unidose Powder System was recently approved by the U.S. Food and Drug Administration (FDA) for an intranasal, needle-free rescue treatment drug intended to treat severe hypoglycemia in people with diabetes. This marks the first FDA approval of a prescription drug using Aptar’s patented Unidose Powder System and is Aptar’s first combination of a drug delivery device with a protective active packaging container.

This approval again demonstrates Aptar’s expertise in developing patient-friendly drug delivery solutions for breakthrough medicines. Aptar offers a broad portfolio of innovative technologies and wide array of services to meet the highest quality standards of the pharmaceutical industry.

Solution for Nasally Administered Powder Treatments

Aptar’s Unidose Powder System is a single-use, ready-to-use one-step nasal delivery device which can deliver a powder formulation in an emergency situation quickly and easily. During such an event, the patient or caregiver presses a small plunger on the bottom of the device to release the drug in a single powder puff into the nose, where the drug can be quickly absorbed via the nasal mucosa. Aptar’s Unidose Powder System is an alternative to injectable kits that may require assembly, including a multistep, time-consuming process of mixing powder and liquid.

Patented Unidose and Bidose Technology Platforms

Aptar’s Unidose and Bidose platforms are robust, primeless, and easy-to-use systems with 360° functionality and precise nasal drug delivery. They offer biotech and pharmaceutical companies effective and reliable single or two-shot intranasal delivery for a variety of medicines including potential life-saving drugs and treatments of severe conditions. The devices can also integrate wireless connectivity technologies.

Unidose Device Protected by Aptar’s Integrated Active Packaging Container

This is the first approval and customer launch combining the technologies of Aptar Pharma and Aptar CSP Technologies. The novel container, which protects and stores the Unidose Powder System, was developed by Aptar CSP Technologies, the global material science unit of Aptar, providing innovative, highly engineered advanced active packaging solutions that protect sensitive drug products. The container incorporates Aptar’s three phase Activ-Polymer™ technology which ensures extended moisture protection for the shelf-life of the drug, mitigating the impact of changing environmental conditions associated with temperature and relative humidity.

Accelerated Development Support via Aptar Pharma Services

This innovative therapy in the field of diabetes is an example of a Combination Product submission, and benefited from Aptar Pharma’s Services offering, a comprehensive portfolio of stage-specific development packages. Aptar’s dedicated Regulatory Affairs experts and analytical scientists help customers proactively address regulatory needs to accelerate approval.

“We are pleased to announce that Aptar Pharma’s Unidose Powder System has been approved by the FDA for the first intranasally-delivered, needle-free rescue treatment for severe hypoglycemia that provides a more patient-friendly delivery approach. Our active packaging container helps to protect the device and better ensure its quality until the moment of use,” commented Gael Touya, President, Aptar Pharma. “This project marks a nearly 10-year customer collaboration and once again demonstrates Aptar Pharma’s ability to help our customers develop and launch complex treatments with patient-friendly delivery systems worldwide.”

Stephan Tanda, Aptar’s President and CEO added, “This successful approval confirms the value that we are bringing to our customers in the highly competitive pharmaceutical and biotech industries. With decades of experience in the long-term testing and development phases that are required by regulatory agencies, we are building a stronger solutions platform for the future, and this launch is a glimpse of that future. Our lab and analytic service capabilities combined with our unique drug delivery devices and active packaging solutions create tremendous value for our customers and help them secure approval. The ultimate end result is that we help expand access to life-saving treatments with our patient-friendly systems.”

Download the full Press Release.

 

July 25, 2019

Aptar Pharma Unveils PureHale in Latin America during FCE Pharma ...

Aptar Pharma is pleased to be a key exhibitor at this year’s FCE Pharma exhibition, taking place from May 21-23 at the São Paulo Expo, Sao Paulo, Brazil.

Aptar Pharma has been exhibiting at this key industry event for a number of years and is looking forward to once again sharing our latest innovations at this year’s show.

At Booth No. H021, Hall H, visitors are invited to meet with our drug delivery experts, who will be on hand to present Aptar Pharma’s expanding portfolio of drug delivery solutions and technology innovations across nasal, pulmonary, eye care, dermal and injectable routes.

A highlight of our presence at FCE Pharma 2019 will be the unveiling of Aptar Pharma’s PureHale for the first time in Latin America.  PureHale is a portable and ready-to-use nebulizer-like device, designed to deliver natural care to upper airways.

With growing customer interest in the Latin American market for preservative-free formulations, visitors to the Aptar Pharma booth will have the opportunity to find out more about our Ophthalmic Squeeze Dispense (OSD).  With more than 200 market references worldwide, the Aptar Pharma Ophthalmic Squeeze Dispenser is the first and only FDA approved preservative-free dispensing technology, is suitable for a wide range of viscosities, and was recently approved across Europe for Glaucoma prescription treatment.

FCE Pharma is considered the key annual pharmaceutical and cosmetics tradeshow in Latin America, bringing together all the major players in the pharmaceutical industry to share their knowledge and expertise, exchange ideas and showcase the latest trends and innovations. More than 23,000 visitors are expected to attend this year’s event.

Visit Aptar Pharma at FCE Pharma 2019.  We look forward to welcoming you.

May 17, 2019

Aptar Pharma’s Freepod® Nasal Spray Device with GlaxoSmithKlin...

Aptar Pharma, a leading provider of innovative drug delivery systems, has announced that its patented Freepod® nasal spray device with GlaxoSmithKline’s Otrivin® has won a Medical & Pharma category award at the World Packaging Organization (WPO) 2019 WorldStar Packaging Awards ceremony, which took place on May 15, 2019 in Prague.

GlaxoSmithKline’s Otrivin® is well-known globally for providing temporary relief of nasal congestion.  Aptar Pharma’s Freepod®, a multi-dose preservative-free nasal spray pump, with GlaxoSmithKline’s Otrivin® was recognized by the WorldStar Awards jury for its sustainability impact.

Howard Burnett, Aptar Pharma Vice-President Global Account Management, commented, “We congratulate GlaxoSmithKline on this prestigious WorldStar Packaging Award win. At Aptar Pharma, we’re very proud that our patented Freepod® technology has been recognized with GlaxoSmithKline’s Otrivin® as a deserving winner in the Medical & Pharma category of the WorldStar Packaging Award.”

The WorldStar Awards Competition, hosted by the WPO, recognizes the continual advancement and excellence in packaging design and technology, and is considered to be one of the most prestigious international packaging awards events.

Full details found in the Press Release.

 

May 16, 2019

Aptar Pharma to Demonstrate its Expertise in Multi-dose Preservat...

Aptar Pharma, a leading provider of drug delivery systems, services and active packaging solutions worldwide, is pleased to be a key exhibitor at ARVO 2019, taking place on April 28 – May 2 at the Vancouver Convention Center, Vancouver, Canada.

ARVO is an annual international conference, bringing together eye and vision researchers to provide the public, patients and policymakers with insight into how their sight-saving work greatly benefits society.  The theme for ARVO 2019 – ‘From bench to bedside and back’ – will highlight the importance of the full journey that often takes place from research labs to the patient and back to the bench again, in the search for a novel treatment.

Aptar Pharma will exhibit at Booth No. 928, where we will demonstrate our expertise in the field of multi-dose preservative-free packaging for Eye Care to ARVO’s 11,000 expected delegates.

With over 200 references for both prescription medications and consumer products, Aptar Pharma will have a special focus on our Preservative-free multidose Ophthalmic Squeeze Dispenser, which was recently approved for Santen’s prescription treatment for glaucoma in 26 European countries.

Our versatile Ophthalmic Squeeze Dispenser Technology Platform allows for a wide range of configurations and applications, enabling customized solutions for specific ophthalmic formulations. With Aptar Pharma known for creating the first and only FDA-reviewed preservative free dispensing technology, our experts will provide delegates with insight into how we can accelerate customers’ speed-to-market in line with industry standards.

To connect with Aptar Pharma and meet our team of experts, register here for ARVO 2019 today.

 

 

 

April 19, 2019