Dry Powder Inhaler

Inhalers have completely transformed asthma treatment over the last years. They enable children and adults with asthma to deliver medicines directly into the lungs.

The Axahaler® device, developed by S.M.B., is a ‘C.E.’ mark from the European Community and Device Master File. The aim of S.M.B. was to develop an inhaler that could be used for various drugs (already developed or in the pipeline of the company) and to satisfy the growing demand on drug self-administration for chronic disease.

 

 

What is a dry powder inhaler?

A dry powder inhaler is a delivery system for the lungs. This handheld device can deliver a precisely measured dose of medicine into the lungs and is mainly used in the treatment of obstructive lung diseases such as asthma, COPD and possibly in the future cystic fibrosis.

The energy from the inhalation redisperses the powder containing a micronized active ingredient and most often a carrier-excipient of more important granulometry, whose role is to improve the flowability and the delivery of the dry powder. The carrier must be able to bind to the active ingredient and to allow its separation for lung deposition.

Both reliever medicine (such as inhaled bronchodilators) and controller medicine (such as inhaled corticosteroids) can be delivered to the airways using a DPI.

The inhalation process

The invention consists in the choice of the carrier used for administering the micronized active ingredient to the lungs. As shown in the figure hereinbelow, the carrier must be able to bind to the active ingredient strongly enough to allow the obtention of a homogenous blend during manufacturing, and weakly enough to allow the redispersion of the active ingredient during inhalation.

The suitable excipient found by SMB is anhydrous roller-dried  β-lactose. It has been proven using several active ingredients that the use of this excipient in a DPI formulation allows to obtain a very high and reliable respiratory fraction of the active ingredient.

What are the advantages of inhaling asthma medicines with the Axahaler® device?

The main advantage of using such technology is that there is no need for the coordination of activation and inhalation of the medication.

Dry powder inhalers are very convenient and easy to use. The medicine is directly dispensed into the lungs where it is needed allowing for a reduction of the side effects in comparison to oral dosage forms for other well used formulations such as regular tablets or capsules.

The dispersion of the drug is also very rapid since there is no need for absorption, digestion and circulation.

Inhaling asthma medicines directly into the airways and into the lungs offers two main advantages : very good effectiveness of the medicine which goes directly into the lungs where it is needed and a reduced risk of side effects since the drug is not being significantly absorbed into the body. This is the best way of taking asthma drugs because it is very versatile. Inhaled drugs can improve your breathing day and night. They can reduce mucus production, and hence, wheezing and coughing. Inhaled bronchodilators will give you a short and long term relief from asthma symptoms.

General advantages of a dry powder inhaler vs. a multidose inhaler :

•  Usually a higher stability than a multidose inhaler
•  Easy check of the entire dose intake
•  Modest cost
•  Possibility to wash the device after use

Main advantages of S.M.B.’s dry powder inhaler :

•  Formulations can provide higher drug deposition than the reference products
•  Improved and more patient friendly breath activated device for an optimum drug delivery :
  * Larger loading chamber for easier breath activated capsule rotation and hence  better patient compliance.
  * Use of HMPC capsules (not sensitive to moisture) and a specially designed capsule piercing system (one percing needle instead of 4 regular needles for reference devices) to minimize the risk of breaking the capsule shell.
  * Shorter mouth piece to enhance powder release and API administration.
  * lower adhesion of the powder to the HPMC capsule (12%) than to the gelatine capsule (20%) to enhance powder release and API administration.
•  Reliable feed back on the intake of the effective delivered dose using 3 senses :
  * Audition: During intake, the breath activated device makes a clearly audible sound corresponding to the rotation of the HPMC capsule in the release chamber of the device.
  * Taste : After intake, the light sweet taste of the lactose excipient is a sign that the dose has been well administered.
  * Vision : After intake, the transparent HMPC capsule should be completely empty to confirm that the entire dose has been taken.
•  Possibility to load the device ready for use for a whole day (stability studies made on unpacked capsules) thus enabling the patient after the morning intake to carry the device loaded with one capsule for the remaining daily evening treatment without having to bring extra capsules along.
•  Axahaler® device certified for use on up to 200 capsules.
•  Stable lung deposition profile versus the reference product (in-vitro comparisons).
•  Advantages versus multidose devices :
  * Less variability in the delivered dose : lower resistence to the patient’s inhalation
  * Washable device to avoid contamination
•  Drug deposition less dependent on the air flow rate
•  Better safety/efficacy profile for glucocorticosteroids
•  Facility of use and pocket size
• Possibility of administering a high pulmonary dose of active ingredient (antiinfective, mucolytic, …)

Moreover, the Axahaler® device is covered by two patent applications :

          * Axahaler device and HPMC capsule
          * Type of lactose used in the DPI formulation

Can our children use a dry-powder inhaler?

Children from 5 years old can easily use it (with careful instruction and supervision).