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Elpenhaler®

The Elpenhaler® Inhaler is a proprietary, internationally patented, dry powder inhaler of ELPEN used for the administration of multiple single doses of medicines for respiratory diseases.

Elpenhaler®
Elpenhaler®
Elpenhaler®
Elpenhaler®

These medicines are included in the packaging within specially designed single-dose aluminum strips.

Today, the Elpenhaler® Inhaler is used for the administration of preparations containing active substances such as tiotropium, formoterol and fluticasone, as well as fixed combinations of fluticasone/salmeterol and budesonide/formoterol.

For more information, please contact us at bdelpenhaler@elpen.gr

Patents

The Elpenhaler® Inhaler holds more than one hundred (100) patents (in Europe, USA, Canada, China, Japan, Australia, Russia, etc.), which ensure legal protection and exclusivity for all pharmaceutical preparations available with the Elpenhaler® Inhaler.

Both the Elpenhaler® Inhaler and all pharmaceutical preparations administered with it (Tioresp®, Formopen®, Fluticapen®, Rolenium®, Pulmoton®) are branded medicines with registered trademarks at a national, European and international level.

Description

The Elpenhaler® Inhaler consists of 3 parts that are connected to each other, but open independently:

  • The mouthpiece with its protective cap
  • The surface on which the single-dose strip is placed (strip placement surface)
  • The storage compartment containing 30, 60 or 120 single-dose strips

Depending on the specific product, the package may include additional storage space with 60 single-dose strips. Each package contains a total of 30, 60 or 120 doses.

The Elpenhaler® inhalers are designed so that the strip placement surface has one or two slots, depending on whether the single-dose strip of each medicine has one or two blisters, respectively.

The dual-blister Elpenhaler® Inhaler is the second generation device, designed for the co-administration of two active substances separately, rather than as a mixture.

In this case, the active substances are not stored on the same strip, but in separate compartments, so that mixing only occurs during inhalation by the patient.

The strip

The single-dose strip includes:

  • Two aluminum foils that can be easily separated from each other
  • One or two blisters containing the dose of medicine
  • A hole that allows the strip to be secured onto the strip placement surface

Strip placement surface

The strip placement surface is uniquely designed and consists of:

  • The connection point where the strip is secured
  • One or two cavities that accommodate the strip's blisters
  • Two guides that direct the strip into the correct position on the placement surface
Instructions for Use

The Elpenhaler® Inhaler is a new, innovative device for the administration of inhaled powdered medicines in doses. Each medicine is packaged in specially designed single-dose strips, which are stored within the Elpenhaler® Inhaler. Each strip contains one dose of the administered medicine.

The following are instructions for the patient on the proper inhalation of their medicines.

Click HERE to print the Instructions for Use of the Elpenhaler® Inhaler®

Product Portfolio

The Elpenhaler® Inhaler was developed for the administration of medicines used in the prevention and treatment of lower respiratory tract diseases (Asthma and Chronic Obstructive Pulmonary Disease).

The products administered via the Elpenhaler® Inhaler are:

Medicine
Active Ingredient		 Strength - Dosage
Formopen®
Formoterol		 12 mcg x 60
Fluticapen®
Fluticasone propionate		 250 mcg x 60
500 mcg x 60
Rolenium®
Fluticasone propionate
Salmeterol xinafoate		 (100+50) mcg x 60
(250+50) mcg x 60
(500+50) mcg x 60
Pulmoton®
Budesonide
Formoterol fumarate		 (200+6) mcg x 120
(400+12) mcg x 60
TIORESP®
Tiotropium		 10 mcg x 30

Rolenium® Elpenhaler®, developed and owned by ELPEN, approved for the treatment of lower respiratory tract diseases in 47 countries.

Pulmoton® Elpenhaler®, approved for the treatment of lower respiratory tract diseases in 19 countries.

Tiotropium® Elpenhaler®, approved for the treatment of lower respiratory tract diseases in 10 countries.

Clinical Trials

All products administered via the Elpenhaler® Inhaler are supported by an extensive clinical trial program, including Phase III and Phase IV studies.

The clinical development program is based on current EMEA/CPMP guidelines.

At the same time, continuous monitoring of all developments in this constantly evolving environment ensures that the clinical documentation for each product administered via the  Elpenhaler® Inhaler remains aligned with the latest data enabling product approval in as many countries as possible.

In accordance with international regulations and ELPEN’s responsibility and transparency policy, an open communication policy is followed throughout all clinical trials.

ELPEN - The leading greek pharmaceutical company
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