SPRIX® (Kétorolac Trométhamine), Nasal Spray, which uses an Aptar Pharma nasal spray pump, is the first non-opioid nasal spray to hit the U.S. market in the field of pain management. World leader in the development and manufacturing of nasal...

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SPRIX® (Kétorolac Trométhamine), Nasal Spray, which uses an Aptar Pharma nasal spray pump, is the first non-opioid nasal spray to hit the U.S. market in the field of pain management.

 

World leader in the development and manufacturing of nasal and pulmonary drug delivery devices, Aptar Pharma worked closely with Roxro Pharma for over 7 years to develop the perfect nasal delivery system for SPRIX®.

 

In December 2010, Roxro was acquired by Luitpold Pharmaceuticals. The newly formed Regency Therapeutics Division of Luitpold launched SPRIX® last week and the product is now commercially available.

 

SPRIX® uses an Aptar Pharma nasal spray pump, and is the first systemic non-opioid nasal spray to be approved by the FDA for the U.S. market in the field of pain management.

 

The Aptar Pharma nasal device allows ketorolac tromethamine (a potent NSAID) to be delivered intranasally to adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level. Ketorolac tromethamine injection is currently widely used in hospitals and was previously marketed in the U.S. as Toradol® by Roche Laboratories.

As a nasal spray, SPRIX® is a non-invasive, easy-to-use and rapid-acting treatment. Studies have shown that SPRIX® can take effect as quickly as an intramuscular injection, making it a great option for ambulatory pain control.

 

 

Systemic drug delivery via the nasal route: a dynamic market

 

Estimated at over 2 billion US dollars in 2009, the world market for nasally administered systemic drugs has seen strong growth in the last few years. Systemic nasal sprays include such products as Miacalcin® (Calcitonin) for osteoporosis; Stimate® and Minirin® (Desmopressine) for enuresis; Imitrex®(Sumatriptan Succinate) and Zomig® (Zolmitriptan) for migraine attacks; and opioids for severe pain. Now Regency Therapeutics' SPRIX® provides a convenient non-narcotic treatment for the short term management of acute moderate to moderately severe pain for ambulatory patients.

 

 

Systemic drug delivery via the nasal route: a proven alternative to injectables

 

After being delivered into the nasal cavity and initially absorbed by the nasal mucosa, the medication enters the vascular system directly, allowing the active ingredient to take effect rapidly. Systemic drug delivery by the nasal route has several advantages over injection: it is non-invasive, removing any associated needle stick pain or anxiety; it is easy-to-use; and the patient has control over the treatment.

These advantages all help to improve patient compliance, making treatment more effective. From a managed care perspective, no medical staff are needed to administer the medication, decreasing administration costs.

 

 

The 'Classic' spray pump – making drug delivery easier and improving patient comfort

 

Aptar Pharma's high-performance 'Classic' spray pumps are widely used in the Pharma market for both systemic and local applications. For SPRIX®, the 'Classic' modular pump was selected. With the help of Aptar Pharma's technical team, Regency Therapeutics' pump was customized to include an ergonomic nasal actuator designed to be comfortable for all patient populations. To prevent accidental actuation during transport and storage, the pump is equipped with a safety clip.

The 'Classic' pump's modular system is recognized globally for its comfort and use by patients and physicians alike, not only for its precise dose delivery and spray performance, but also for its safety.

 

"Aptar Pharma is very excited about this new collaboration with Regency Therapeutics, and we are particularly proud of bringing them a customized device" said Pierre Carlotti, Vice President Marketing and Communication for Aptar Pharma Prescription Division.

 

"Aptar Pharma's reputation for performance and quality was an important consideration in our acquisition of SPRIX®; we look forward to working with Aptar Pharma for many years to come" said Eric Hohenschuh, Sr. Manager, Marketing for Regency Therapeutics.

 

 

For more information about SPRIX®, visit www.sprix.com.

 

 

About Aptar Pharma

Aptar Pharma is part of the Aptargroup family of companies, along with Aptar Beauty + Home and Aptar Food + Beverage. We create innovative drug delivery systems that meet the evolving needs of biotechnology, healthcare and pharmaceutical companies around the world. We provide our customers with a wide range of delivery technologies and analytical services backed by years of proven expertise.

Aptargroup (NYSE: ATR) is headquartered in the US and has manufacturing sites in North America, Europe, Asia and South America.

For more information, visit www.aptar.com

 

 

Press Contacts

Elisa Eschylle, Events and Press relations manager

Tel.: +33 (0)1 39 17 20 41 - Email : elisa.eschylle@aptar.com

Marion Baschet Vernet , Press attaché

Tel.: +44 (0)797 609 41 00 - Email : mbvernet@gmail.com

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RDD® Europe 2011 in Berlin brought together pulmonary and nasal drug delivery experts from more than 30 countries for a unique exchange of knowledge, expertise, science and business networking. 465 delegates involved in pulmonary and nasal d...

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RDD® Europe 2011 in Berlin brought together pulmonary and nasal drug delivery experts from more than 30 countries for a unique exchange of knowledge, expertise, science and business networking.

465 delegates involved in pulmonary and nasal drug delivery attended the fourth RDD (Respiratory Drug Delivery) Europe conference in Germany last week.

 

The largest RDD Europe meeting to date

RDD Europe 2011 (May 3-6) attracted a record attendance from across Europe (70%), the United States (22%) and the rest of the world (8%).

 

The joint organizers of this increasingly prestigious meeting, RDD Online® and Aptar Pharma, were delighted that this scientific conference was such a success, which they largely attribute to the hard work of 24 speakers, 65 scientific poster presenters, 56 company exhibitors, and 12 technical workshop facilitators; and to the participation of a large and lively audience.

A unique scientific event bringing the Respiratory World together

Feedback from meeting participants shows that RDD Europe has a large following and is considered to be one of the leading international scientific conferences in this niche pharmaceutical sector. This is due to the active engagement of academic, industrial and regulatory scientists involved in research, development, clinical evaluation and marketing of existing and new medicines delivered through the lungs or nose.

 

At RDD Europe 2011 the program and debates focused on 'Drug Development Challenges – New Drugs, Formulations and Devices,' 'Science in Product Development : Advances in Processing, Formulation and Characterization' ,'LABA and LABA-ICS Post-Market Trial Design', 'Comprehending Drug Delivery through Advanced Imaging' and 'Debating Efficient Data Analysis Methods for Abbreviated Impactor Measurements'.

 

Following a model established at RDD 2010 in the United States with the Product Quality Research Institute (PQRI), RDD Europe 2011 was coordinated with a satellite meeting hosted by the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). This coordinated meeting delved into 'Perspectives on Efficient Data Analysis Methods and Abbreviated Impactor Measurements as Quality Assessment Tools.'

 

"When facilitating coordinated meetings, we try hard to program topics of value to the widest possible audience and attempt to save delegates from wasted travel time and unnecessary expense", noted Dr. Richard Dalby, one of the organizers from the University of Maryland.

 

"With Aptar Pharma and RDD Online expertise driving it, RDD Europe has become the reference in terms of scientifi c conferences", said Pierre Carlotti, Vice President Marketing and Communication, Aptar Pharma, Prescription division.

 

 

Next Meetings: RDD 2012 in Phoenix, Arizona, USA and RDD Europe 2013 in Athens, Greece

 

 

RDD Online and Virginia Commonwealth University are planning RDD 2012. If the 20+ year history of these meetings is a guide to future attendance, over 700 participants, 120 poster presenters and 75 exhibitors will converge on Phoenix, Arizona, from May 13-17, 2012, for the next Respiratory Drug Delivery conference.

 

Building on the success of the latest meeting in Europe, Aptar Pharma and RDD Online are working hard to develop an exciting program for RDD Europe 2013 in Athens, Greece, from May 21-24, 2013.

 

About Aptar Pharma

Aptar Pharma is part of the Aptargroup family of companies, along with Aptar Beauty + Home and Aptar Food + Beverage. We create innovative drug delivery systems that meet the evolving needs of biotechnology, healthcare and pharmaceutical companies around the world. We provide our customers with a wide range of delivery technologies and analytical services backed by years of proven expertise.

Aptargroup (NYSE: ATR) is headquartered in the US and has manufacturing sites in North America, Europe, Asia and South America.

For more information: www.aptar.com

About RDD Online

RDD Online manages the organization of Respiratory Drug Delivery meetings in the US, and partners with Aptar Pharma to run RDD meetings in  Europe. Other RDD Online services available at www.rddonline.com include providing scientific and technical publications, 24/7 web-based training, textbook publishing, service directories and recruiting services of interest to companies active in pulmonary and nasal drug delivery.

For more information: www.rddonline.com.

 

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Aptar Pharma's French manufacturing sites in Le Vaudreuil and Val-de-Reuil have been registered as Contract Test Laboratories for extractables testing with the U.S. Food and Drug Administration (FDA).

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Aptar Pharma's French manufacturing sites in Le Vaudreuil and Val-de-Reuil have been registered as Contract Test Laboratories for extractables testing with the U.S. Food and Drug Administration (FDA).

 

A number of pharmaceutical and biotechnology companies working with Aptar Pharma drug delivery devices have expressed a requirement to use Aptar Pharma extractables testing for batch release of their drug products. They can now benefit from this advantageous Aptar Pharma service.

 

 

Aptar Pharma enlarges its service scope

 

Through decades of experience working closely with its pharmaceutical and biotechnology customers in a spirit of continuous improvement, Aptar Pharma understands their evolving needs. As the world-leading supplier of innovative non-invasive drug delivery devices, Aptar Pharma has developed a variety of analytical capabilities, of which extractables data is critical for customers. Now that Aptar Pharma analytical laboratories have been registered with the FDA, customers can reduce their own testing burden, further enhancing the value of their partnership with Aptar Pharma.

 

 

Extractables are key to drug manufacturers

 

Pharmaceutical and biotechnology drug manufacturers are responsible for identifying and quantifying extractables and leachables and for evaluating any associated potential toxicity. Drug delivery device components are typically made of materials such as polymers and elastomers. The measurement of extractables from materials which are in contact with drug product is growing in importance due to increased regulatory scrutiny from organizations such as the FDA. Regulators are concerned about the interaction of the drug delivery device components with drug products. Extractables assessment of plastic and elastomeric components forms an integral part of the submission for approval, as well as for the routine controls used to release batches of the drug product.

 

Aptar Pharma manufacturing sites in France have been inspected by the FDA with an excellent outcome

 

The Aptar Pharma sites at Le Vaudreuil and Val-de-Reuil have been inspected twice by the FDA in recent years.These inspections were very satisfactory, with no observations being made (also known as the FDA 483 Inspectional Observations notice).

 

With this FDA registration Aptar Pharma French sites, which are already ISO-15378 certified and which operate with a robust and mature cGMP-compliant quality system, will further improve service and commitment to support their drug manufacturer customers.

 

 

 

About Aptar Pharma

 

Aptar Pharma is part of the Aptargroup family of companies, along with Aptar Beauty + Home and Aptar Food + Beverage.

We create innovative drug delivery systems that meet the evolving needs of biotechnology, healthcare and pharmaceutical companies around the world. We provide our customers with a wide range of delivery technologies and analytical services backed by years of proven expertise.

 

Aptargroup (NYSE: ATR) is headquartered in the US and has manufacturing sites in North America, Europe, Asia and South America.

 

For more information, visit www.aptar.com.

 

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The Respiratory Drug Delivery (RDD®) Europe 2011 scientific conference will welcome pulmonary and nasal drug delivery experts from all over the world to Berlin, Germany, May 3-6, 2011. The joint organizers of this prestigious event, RDD Onlin...

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The Respiratory Drug Delivery (RDD®) Europe 2011 scientific conference will welcome pulmonary and nasal drug delivery experts from all over the world to Berlin, Germany, May 3-6, 2011. The joint organizers of this prestigious event, RDD Online® and Aptar Pharma, today announce the opening of registration at www.rddonline.com/rddeurope2011.

RDD conferences take place in Europe and the USA in alternate years and are widely regarded as the premier venue for presenting up to date pulmonary and nasal delivery advances. RDD Europe 2009 was held in Lisbon, Portugal, and brought together approximately 450 pulmonary and nasal drug delivery experts from across Europe (70%), the United States (22%) and the rest of the world (8%).

RDD Europe 2011 is expected to attract high level academic, industrial and regulatory scientists involved in the research, development, investigation, and marketing of existing and new therapeutic medicines delivered through the lungs or nose.

This year topics and debates will emphasize 'Drug Development Challenges – New Drugs, Formulations and Devices,' 'Science in Product Development : Advances in Processing, Formulation and characterization,' 'LABA and LABA-ICS Post-market Trial Design', 'Comprehending Drug Delivery through Advanced Imaging' and 'Debating Efficient Data Analysis Methods for Abbreviated Impactor Measurements'.

Immediately following the RDD Europe 2011, a coordinated conference hosted by the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) will address several 'Perspectives on Efficient Data Analysis Methods and Abbreviated Impactor Measurements as Quality Assessment Tools.'

RDD conferences highlight innovative research contributions through podium and scientific poster sessions, augmented by technical interactive workshops from vendors and service providers in the industry. RDD Europe 2011 also features a high-profi le technology exhibition showing the latest technologies and equipment used in this exciting field.

Global reaction to RDD Europe conferences has been extremely positive. Here's what attendees had to say about RDD Europe 2009:

"This was the best meeting about drug delivery to the lungs I have ever attended!"

"The programme was excellent! RDD goes from strength to strength and able to keep momentum!"

"It was a very successful event and we look forward to the next event. On to RDD Europe 2011 we go!"

All previous RDD Europe events have been over-subscribed so early registration is strongly recommended. Further details on RDD Europe 2011, as well as registration information, are available now at www.rddonline.com/rddeurope2011.

 

About RDD Online

RDD Online manages the organization of Respiratory Drug Delivery meetings in the US, and partners with Aptar Pharma to run RDD meetings in Europe. Other RDD Online services available at www.rddonline.com include providing scientifi c and technical publications, web-based training, textbook publishing, service directories and recruiting services of interest to companies active in pulmonary and nasal drug delivery.

For more information, please visit www.rddonline.com.

 

About Aptar Pharma

Aptar Pharma is part of the Aptargroup family of companies, along with Aptar Beauty + Home and Aptar Food + Beverage. We create innovative drug delivery systems that meet the evolving needs of biotechnology, healthcare and pharmaceutical companies around the world. We provide our customers with a wide range of delivery technologies and analytical services backed by years of proven expertise.

Aptargroup (NYSE: ATR) is headquartered in the US and has manufacturing sites in North America, Europe, Asia and South America.

For more information, visit www.aptar.com.

 

Press Contact

Elisa Eschylle, Events and Press relations manager
Tel.: + 33 (0)1 39 17 20 41 - Email : elisa.eschylle@aptar.com

Marion Baschet Vernet
Tel.: +44 (0)797 609 4100 - Email : mbvernet@gmail.com

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Aptar Pharma unveiled the brand name of its latest innovation,Latitude®, at the CPhI/ICSE international exhibition which was held in Paris from October 5th to 7th 2010. This novel side-actuated nasal spray is protected by several patents. The...

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Aptar Pharma unveiled the brand name of its latest innovation, Latitude®, at the CPhI/ICSE international exhibition which was held in Paris from October 5th to 7th 2010. This novel side-actuated nasal spray is protected by several patents. The results of the latest acceptance studies held in the UK and the US were also presented at the exhibition. Both patients and doctors confi rm the advantages of Latitude® in ergonomics and hygiene which provide this spray device with optimized handling characteristics for easier nasal spray drug delivery.

 

 

Aptar Pharma in tune with the market, patients and prescribers

Always attentive to the market and its pharmaceutical industry customers, Aptar Pharma had  already carried out a series of investigations and acceptance studies with healthcare professionals to determine nasal spray user expectations and preferences before starting development of its side-actuated device. This research highlighted a need for improved ergonomics, as well as a better grip and a lower actuation force to make drug delivery more comfortable and safer.

 

Aptar Pharma carried out new research in the UK in November 2009 and in the US in May 2010 involving regular nasal spray users as well as doctors (general practitioners and ENT specialists). The results confi rmed that Latitude® met expectations perfectly, and had the support of both patients and prescribers.

 

 

Excellent ergonomics and ease of use: real benefits for both doctors and patients

 

The results of the research clearly identifi ed the major advantages of Latitude®: not only does it have excellent ergonomics providing intuitive and constant handling characteristics, but it requires only a very slight effort to depress the actuator completely, letting the patient know that a full drug dose has been delivered. These results also confi rm that the device is easy to use by everyone, both in patient self-administration and in third party drug administration, especially for pediatric use.

 

Hervé Pacaud, Aptar Pharma Business Development Director, Allergy and C.N.S , will be pleased to present Latitude® to you and answer your questions on the Aptar Pharma stand 4D58.

 

 

Aptar Pharma is a member of the Aptargroup family of companies, together with Aptar Beauty + Home and Aptar Food + Beverage.

Aptargroup (NYSE :ATR) is headquartered in the US and has manufacturing sites in North America, Europe, Asia and South America.

 

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This market-focused realignment will make it even easier for customers to do business with Aptargroup through a wider and innovative range of products and services available under the new Aptar Pharma brand.

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This market-focused realignment will make it even easier for customers to do business with Aptargroup through a wider and innovative range of products and services available under the new Aptar Pharma brand.

 

 

A market-focused realignment

 

For many years Pfeiffer and Valois have been members of Aptargroup, a family of companies who, together, are leaders in the consumer dispensing and drug delivery systems industry.

 

Aptargroup recently announced a strategic realignment of its businesses under three market-focused business segments: Aptar Beauty + Home, Aptar Food + Beverage and Aptar Pharma. Peter Pfeiffer, Aptargroup President and CEO said about this strategy: "We have always been driven to better serve our customers by enhancing our understanding of their needs and the changing markets in which they operate. This realignment will make it even easier for customers to do business with us, and we will be able to offer our full product range in each of our three segments. This next strategic step will put us in position to continue our long-term growth and lead our industry for many years to come."

 

 

The new market-focused Aptar Pharma brand

 

The Aptar Pharma organization will be implemented progressively during 2010, and will be fully operational starting in 2011. This new organization will have a much greater capacity for understanding customer needs and preferences in order to provide innovative and patient-friendly drug delivery solutions. Moreover, this organization will lead to simplified customer relations.

 

Aptar Pharma will have two divisions: Consumer Health Care, focused on drug delivery solutions adapted to over-the-counter medications; and Prescription, focused on drug delivery solutions specific to physician-prescribed medicines.

 

 

A structure dedicated to accelerating innovation

 

For over 60 years, the strategy of both Pfeiffer and Valois has been based on innovation. Their R&D organizations have been continuously expanding, and strong and sustainable links have been forged with a network of partners, which include academia, contract research as well as manufacturing organizations, inventors, design and industrial consulting companies and preferred suppliers.

 

Approximately 6% of Aptar Pharma's annual turnover is dedicated to research, development and industrialization of novel products. Aptar Pharma R&D and Marketing staff will work closer together in a global market-focused team of 200 people dedicated to satisfying customer needs.

 

Aptar Pharma also holds a strong intellectual property portfolio of over 450 patent families which can be leveraged to provide customers with protected innovative solutions.

 

 

Aptar Pharma is a part of the Aptargroup family of companies, along with Aptar Beauty + Home and Aptar Food + Beverage. Aptargroup (NYSE: ATR) is headquartered in the U.S. with facilities in North America, Europe, Asia and South America.

For more information, visit www.aptar.com

 

 

Press contact Aptar Pharma

Pierre Carlotti, VP Marketing and Communication
Dir +33 (0)1 39 17 20 01 - Fax +33 (0)1 39 58 12 98 - Email: pierre.carlotti@aptar.com

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Valois Pharma, world leader in nasal and pulmonary drug delivery devices, has co-organized with the SFDA (Chinese State Food and Drug Administration) training centre, through Aptar Pharma Asia, the first Chinese training session on HFA pMDI d...

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Valois Pharma, world leader in nasal and pulmonary drug delivery devices, has co-organized with the SFDA (Chinese State Food and Drug Administration) training centre, through Aptar Pharma Asia, the first Chinese training session on HFA pMDI development, held in Shanghai on October 27th and 28th 2009.

 

Transition from CFC to HFA propellant: a complex issue for the pMDI industry Production of CFCs (chlorofluorocarbon), which deplete the ozone layer, was banned by the developed nations in 1996, in accordance with the 1987 Montreal Protocol. However an "essential use exemption" was granted to the pharmaceutical industry, notably for pMDI manufacture, to allow replacement products using HFA to be brought to market. As there are differences in physico-chemical properties between the two propellants, moving to HFA meant that both the drug formulation and the components of pressurized inhalers, and in particular metering valves and elastomer gaskets, had to be completely redesigned. China is currently organizing this transition from CFC to HFA pMDIs.

 

A head start for Valois Pharma

Valois Pharma was ahead of the game in gaining expertise in HFA formulations from the early 1990s, especially about the way that they interact with metering valve components. Combining in-house development and manufacturing of elastomer gaskets with the deployment of a dedicated HFA valve development team (internally managing component design, analytical tests, control of extractible materials and compatibility tests) has allowed the company to become world leader in this segment.

 

Sharing expertise for the first Chinese training on pMDI development

The two-day training session was co-organised with the SFDA training center. The SFDA is the State Chinese regulatory body in charge of supervising development, approval, manufacturing, sale and use of foodstuffs and drugs. The session was dedicated to pMDI HFA formulation development and pMDI quality controls during filling and production processes. About 60 delegates attended 13 presentations given by highly respected experts, who included:

 

• Mr. Wang Ping, SFDA: "2010 Chinese pharmacopie-inhaler standard update"

• Mr. Sunhuimin, SFDA: "pMDI HFA134a quality standard in China"

• Dr. Chenguiliang, SFDA: "The quality control and measurement during pMDI production and finished product"

• Chris Baron, Valois Pharma, Associate Director Business Development Pulmonary: "pMDI HFA formulation patents / Importance of valves and their elastomer gaskets within pMDIs"

• Dr. Gerallt Williams, Valois Pharma Director Laboratory Services: "HFA pMDIs - some product development challenges/ pMDI in-vitro testing"

• Dr Xianming Zeng, TEVA Global Respiratory R&D Director: "Next challenge in respiratory drugs development"

• Dr. Youyizhong, Professor and doctor at Changzhou N°1 Hospital: "The situation of pMDI in China and some good advice on pMDI development"

 

A significant investment by Valois Pharma / Aptar Pharma in China

The training session was a great success, as it built on the significant industrial investment made by Valois Pharma in China through Aptar Pharma Asia, which was established in Suzhou in 1996. Today there are more than 220 Aptar Pharma Asia employees at the 4,500 sqm² factory in China, manufacturing and selling, among others, Valois Pharma brand metering valves for pressurized inhalers. Valois Pharma is a recognized market leader in China and continues to expand its activity, leveraging an in-depth network of local partners to forge strong links with a wide range of local players in China, including those in research, industry, academia and regulating bodies.

 

 

Valois Pharma, a division of Valois S.A.S, specializes in nasal and pulmonary drug delivery technologies with a broad product range that also provides solutions for other drug delivery routes such as buccal/sub-lingual, throat and dermal/transdermal.

 

Valois S.A.S., founded in 1947, is a world leader in the design, development and manufacture of proprietary spray, aerosol and alternative dispensing systems for the Pharmaceutical, Perfumery and Cosmetics markets. Valois S.A.S. is a wholly owned subsidiary of AptarGroup, Inc., a publicly traded company listed on the New York Stock Exchange (NYSE: ATR).

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World leader in nasal and pulmonary drug delivery devices, Valois Pharma worked closely with Nycomed to develop the spray device which allows fentanyl to be delivered intranasally for the first time to cancer patients suffering from breakthro...

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World leader in nasal and pulmonary drug delivery devices, Valois Pharma worked closely with Nycomed to develop the spray device which allows fentanyl to be delivered intranasally for the first time to cancer patients suffering from breakthrough pain. As well as being noninvasive and easy-to-use, fentanyl delivered by nasal spray has fast onset of action.

 

A new step forward in systemic drug delivery via the nasal route

Estimated at 2 billion dollars in 2008, the world market for systemic drug delivery by the nasal route has seen strong growth in the last few years, with the launch of products such as those containing calcitonine for osteoporosis, desmopressine for enuresis and triptans for migraine attacks. Now Nycomed's Instanyl® provides treatment for breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. These episodes of moderate to severe pain, which often are difficult to anticipate, can now be managed by patients themselves.

 

Systemic drug delivery by the nasal route has a number of advantages. After being sprayed into the nasal cavity and absorbed by the nasal mucosa, the medication enters the vascular system directly allowing the active ingredient to take effect rapidly. In addition, because it is easy to use, delivery by the nasal route allows the patient to have autonomous control over the treatment.

 

The VP7 spray pump - making drug delivery easier and improving patient comfort

Valois Pharma's high-performance VP7 spray pump is widely used in drug delivery for both systemic and local treatment. For Instanyl®, Nycomed chose the VP7D version, which is designed to be used with preservative-free medication. The pump is fitted with a nasal actuator of ergonomic design that is comfortable to use. The VP7 range is recognized globally for its comfort of use by patients as well as for its total security coupled with excellent dose

accuracy and spray performance.

 

Instanyl® is a registered trademark of Nycomed

 

 

Valois Pharma, a division of Valois S.A.S, specializes in nasal and pulmonary drug delivery technologies with a broad product range that also provides solutions for other drug delivery routes such as buccal/sub-lingual, throat and dermal/transdermal.

 

Valois S.A.S., founded in 1947, is a world leader in the design, development and manufacture of proprietary spray, aerosol and alternative dispensing systems for the Pharmaceutical, Perfumery and Cosmetics markets. Valois S.A.S. is a wholly owned subsidiary of AptarGroup, Inc., a publicly traded company listed on the New York Stock Exchange (NYSE: ATR).

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In association with the Indian Pharmaceutical Association, Pfeiffer and Valois Pharma, world leaders in nasal and pulmonary drug delivery devices, co-organized, through Aptar Pharma India, the Fourth International Symposium on Nasal and Pulmo...

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In association with the Indian Pharmaceutical Association, Pfeiffer and Valois Pharma, world leaders in nasal and pulmonary drug delivery devices, co-organized, through Aptar Pharma India, the Fourth International Symposium on Nasal and Pulmonary Drug Delivery, held in Mumbai, India, on September 17th and 18th, 2009.

 

Regulatory Challenges, a topical theme for this mature Indian conference

The first such Indian scientific conference tailored specifically to Nasal and Pulmonary Drug Delivery was held in 1999. Now a mature event, this year's symposium saw more than 150 paying delegates attending fifteen presentations over the two days, with major participation of scientists and technical experts from India's pharmaceutical industry and academia. Speakers included globally-recognized international experts such as Prof. Richard Dalby, from Maryland University in the U.S. and Jag Shur from the University of Bath in the U.K.

 

This year's event focused on Regulatory Challenges, as the Indian Pharma Industry has shown great interest over the years in introducing drug products to highly regulated markets like the US and Europe.

 

A major scientific contribution from Pfeiffer and Valois Pharma

The program was structured into three sessions: podium presentations and scientific posters covering Pulmonary (pMDIs and DPIs) and Nasal (Spray) Drug Delivery; workshops featuring research innovation and practical sessions; a lecture session providing an insight into Regulatory Challenges (formulation development, leachables and extractables, current regulatory device challenges, dossier submissions).

 

Four experts from Valois Pharma and Pfeiffer gave lectures and facilitated workshops :

• Guillaume Brouet, Valois Pharma Director Business Development Pulmonary: "Advances in the development of components for portable inhalers"

• Hervé Pacaud, Valois Pharma Director, Business Development Pumps: "Rx nasal market and new trends in nasal devices"

• Dr Gerallt Williams, Valois Pharma Director, Laboratory Services: "Current Regulatory Device Challenges: a Perspective".

• Matthias Birkhoff, Pfeiffer Pharma Division Vice-President Marketing "New technologies in Liquid Drug Delivery: Preservative Free Ophthalmic Systems"

 

The Valois Pharma presentations are available on the Valois Pharma website:

www.valois.com/pharma/en/publication/publication.php

 

A significant investment by Pfeiffer and Valois Pharma in India

Pfeiffer and Valois Pharma have been operating in India for the last ten years and have been working closely with the Indian Pharmaceutical Association to make this symposium a success. Pfeiffer and Valois Pharma are now organized under the name of Aptar Pharma India. Pfeiffer and Valois Pharma are the recognized market leaders in India for both pulmonary and nasal drug delivery devices.

 

Pfeiffer and Valois Pharma continue to expand their activity, leveraging an in-depth network of local partners to forge strong links with a wide range of players in India, including those in research, industry, academia and regulating bodies.

 

Jointly organizing this 4th symposium in India is part of Pfeiffer and Valois Pharma's global strategy to promote and develop nasal and pulmonary drug delivery technology and expertise internationally.

 

 

Pfeiffer and Valois Pharma, a division of Valois SAS, specialize in inhalation drug delivery technologies with a broad range of innovative products and services. Pfeiffer and Valois S.A.S. are wholly owned subsidiaries of AptarGroup, Inc., a publicly traded company listed on the New York Stock Exchange (NYSE: ATR).

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RDD® Europe 2009 brought together pulmonary and nasal drug delivery experts from 30 countries for a unique exchange of knowledge and expertise.

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RDD® Europe 2009 brought together pulmonary and nasal drug delivery experts from 30 countries for a unique exchange of knowledge and expertise.

 

(25 May, 2009) – From 19 to 22 May, 430 participants interested in pulmonary and nasal drug delivery attended the Respiratory Drug Delivery Europe 2009 symposium in Lisbon. During this intensive conference, leading experts presented the latest research and innovations in this dynamic field. The organisers were delighted by the high quality science presented and the unexpectedly large number of delegates who attended despite the current economic downturn.

 

Feedback from participants also confirmed that RDD® Europe 2009 continues to enhance its reputation as one of the leading international scientific forums for academic, industrial and regulatory scientists involved in the research, development, delivery and commercialization of pulmonary and nasal drug products.

 

 

Unique mix of innovation, new ideas and real news

 

"RDD meetings continue to provide the highest quality in technical and scientific content covering our area of drug delivery. The unique mix of innovation and real news at this symposium is exceptional and rare. The organisers combine attention to detail with experience in the field to create opportunities for learning, debate and networking," said David Morton, Senior Lecturer at the Monash Institute of Pharmaceutical Sciences. A panel of invited international speakers addressed topics as diverse as the 'Expansion of Local and Systemic Therapies', 'Controlling Critical Quality Attributes during Manufacture', 'Powder Inhaler Design', 'Advances in Nasal Drug Delivery' and 'Assessing Critical Powder Properties'. Animated debate occurred around key questions associated with regulatory approval of inhalation devices.

 

 

Comprehensive and interactive program

 

Expanded workshop sessions showcased research innovations, practical advice and current regulatory thinking. RDD delegates selected which of 12 interactive workshop demonstrations by technology and services providers they wanted to attend. Podium and workshop presentations were augmented by scientific posters and a technology exhibition which ran throughout the symposium and covered all aspects of regulatory science, formulation development, new research methods and advanced drug delivery technologies. A total of 44 ingredient, device and equipment designers, plus

component and service suppliers from 11 countries presented their latest products and systems. A participant from the nebuliser workshop commented, "The workshop was very well constructed and provided an excellent overview regarding the regulatory situation, stimulating the required level of debate in the key areas."

 

 

Next Meeting, RDD 2010, Orlando, Florida

 

RDD Europe 2009 was jointly organized by RDD Online®, Pfeiffer and Valois Pharma. Based on the success of the Lisbon meeting, this team will host RDD Europe 2011. "Over 700 participants, 100 poster presenters and 75 exhibitors are expected to converge on Orlando, April 25-29 for Respiratory Drug Delivery 2010. In this vibrant field new inventions and discoveries arise continuously, so there's plenty to keep us busy between European meetings," commented one member of the US organizing committee.

 

RDD Online

RDD Online manages the organization of Respiratory Drug Delivery meetings in the US, and partners with Pfeiffer and Valois Pharma to run RDD meetings in Europe. Other RDD Online services available at www.rddonline.com include providing scientific and technical publications, web-based training, and recruiting services of interest to companies active in pulmonary and nasal drug delivery.

 

Pfeiffer and Valois Pharma

Valois Pharma, a division of Valois S.A.S., and Pfeiffer are world leaders in nasal and pulmonary drug delivery technologies with a broad range of innovative drug delivery devices, technologies and services. Pfeiffer and Valois S.A.S. are wholly owned subsidiaries of AptarGroup, Inc., a publicly traded company listed on the New York Stock Exchange (NYSE: ATR).

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For World Asthma Day, Valois Pharma is unveiling the results of a clinical study with patients suffering from asthma and chronic obstructive pulmonary disease (COPD) using its proprietary Dry Powder Inhaler Prohaler®.

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For World Asthma Day, Valois Pharma is unveiling the results of a clinical study with patients suffering from asthma and chronic obstructive pulmonary disease (COPD) using its proprietary Dry Powder Inhaler Prohaler®.

 

The dry powder inhaler, an innovative drug delivery device contributing to the treatment of asthma

According to the WHO, there are 300 million asthma sufferers worldwide. Asthma is a serious global health problem, and is still under-diagnosed and under-treated. Today, the majority of respiratory treatments are via the pulmonary route, using either Metered Dose Inhalers (MDIs) or more recent Dry Powder Inhalers (DPIs). Patients find DPIs easier to use because they eliminate the problem of synchronization between actuation and inhalation. And as DPIs do not contain propellant, they are more environmentally-friendly.

 

Prohaler® technology, a patient-centric design approach

To make sure Prohaler® would be intuitive and easy-to-use, Valois Pharma placed the patient at the centre of the development process from the start of the project in 2004. An initial set of studies was carried out with a focus on patient handling of the device. Results publicized in June 2008 confirmed that Prohaler® was easy to handle and intuitive to use. Three simple steps are all it takes for a patient to use Prohaler®: open the device, inhale, and close it. Inhaling triggers the release of a dose of medication. A dose counter reminds the patient how many doses are left in the device.

 

The next step was to take these investigations further by understanding the patient/device interface during inhalation and verifying that all the necessary conditions were met for the correct dose of medication to be administered. A major hospital-based study was carried out from December 2007 to April 2009 at the CHRU in Tours, France, led by Professor Patrice Diot, an eminent respiratory physician and President of ISAM (the International Society for Aerosols in Medicine), and Dr. Steve Newman, an expert in inhaled dosage forms, founder of Pharmaceutical Profiles Ltd and a consultant with a worldwide reputation. 60 patients suffering from asthma or COPD took part in the two-phase study. Some of these patients had very poor lung capacity, as low as 30% of that of a normal healthy person. The results of the study showed that all the patients, regardless of how ill they were, were able to trigger the device and inhale enough air for the medication to reach their lungs. This excellent result validated the effectiveness of the Prohaler® technology and showed that most patients would be able to correctly inhale a dose of medication.

 

Results from the first phase of the study were presented by Dr. Steve Newman at the Drug Delivery to the Lungs scientific conference held in Scotland last December. Final results from the study will be published in the coming months in an internationally scientific journal.

 

With Prohaler®, Valois Pharma, the world leader in nasal and pulmonary drug delivery devices, and partner of major pharmaceutical companies, is contributing to the enhancement of patient compliance, which will lead to improved drug effectiveness, especially in the treatment of asthma and COPD.

 

 

 

Valois Pharma, a division of Valois S.A.S, specializes in nasal and pulmonary drug delivery technologies with a broad product range that also provides solutions for other drug delivery routes such as buccal/sub-lingual, throat and dermal/transdermal.

 

Valois S.A.S., founded in 1947, is a world leader in the design, development and manufacture of proprietary spray, aerosol and alternative dispensing systems for the Pharmaceutical, Perfumery and Cosmetics markets. Valois S.A.S. is a wholly owned subsidiary of AptarGroup, Inc., a publicly traded company listed on the New York Stock Exchange (NYSE: ATR).

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Valois Pharma will unveil a new and innovative side-actuated device for nasal drug delivery at the upcoming Nasal Drug Delivery conference, organized by Management Forum and to be held in London on April 1st and 2nd. This easy to use device, ...

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Valois Pharma will unveil a new and innovative side-actuated device for nasal drug delivery at the upcoming Nasal Drug Delivery conference, organized by Management Forum and to be held in London on April 1st and 2nd. This easy to use device, designed for improved patient comfort, is highly customizable.

 

An optimized device, the fruit of many years of research and two years of development

Always listening to what the market is saying and what patients are asking for, Valois Pharma conducted a series of patient acceptance studies in the UK and the US to understand nasal spray user preferences and expectations. Valois Pharma's R&D teams worked for a number of years to deliver a patented and market-ready side-actuated device that would make nasal drug delivery easier and meet the concerns of some patients who were dissatisfi ed with classic top-actuated nasal sprays.

Ease of use and comfort : real benefits for patients

The fi rst benefi t that Valois Pharma's side-actuated device delivers is that it is easy to use. Not only for self-administration, but also for third-party administration, especially in pediatric use. Compact, ergonomically designed and intuitive to use, the device requires only moderate eff ort to actuate it. This means that it can be used by a wide range of people, from adolescents to the elderly.

 

Next, but by no means least, is patient comfort. Using the side-actuator removes any possibility of axial movement of the nozzle inside the nostril when the actuator is pressed. This eliminates any risk of the nozzle entering the nostril too deeply. Moreover there is no contact between fi ngers and nostrils which improves hygiene during treatment. In addition, the device is fi tted with a level indicator which allows the patient to easily see the amount of drug left and to replace medication early before it runs out. Finally, as the movement to actuate the device is perfectly natural, it is much easier to obtain delivery of a full dose.

 

A customizable device for the pharmaceutical industry

Valois Pharma's side-actuated nasal spray device consists of a standard actuator coupled with a customizable shell and cap. This modular design is a real market advantage for pharmaceutical companies who want to reinforce their branding with an in-house style. The current focus is on nasal delivery of Rx drugs, and in particular treatment of allergic rhinitis. However future development and improvements such as integration of a dose counter could see the device being used for systemic nasal drug delivery as well.

 

Aiming for optimal patient compliance

Valois Pharma off ers integration of its side-actuated nasal spray device, which combines ease of use with patient comfort, with Equadel®, the fi rst pump that dispenses the same dose and spray every time, regardless of how much pressure is exerted by the patient. This solution reinforces patient compliance which in turn will lead to improved drug eff ectiveness.

 

 

 

Valois Pharma, a division of Valois S.A.S, specializes in nasal and pulmonary drug delivery technologies with a broad product range that also provides solutions for other drug delivery routes such as buccal/sub-lingual, throat and dermal/transdermal.

Valois S.A.S., founded in 1947, is a world leader in the design, development and manufacture of proprietary spray, aerosol and alternative dispensing systems for the Pharmaceutical, Perfumery and Cosmetics markets. Valois S.A.S. is a wholly owned subsidiary of AptarGroup,Inc., a publicly traded company listed on the New York Stock Exchange (NYSE: ATR).

Download the press release in pdf format Clik here >>>

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