Inhaled product expertise

Expertise in inhaled product & pharmaceutical development

INHALEXPERT’s offer is based on a broad expertise and high skills in inhaled product development.

Expertise based on 25 years’ experience in pharmaceutical development, including 16 years in GlaxoSmithKline, worldwide leader in respiratory field.

More than a dozen products studied including development of Nasal spray, Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) with the Seretide Diskus, 2nd worldwide drug product, leader in asthma and COPD treatment.

This specialist skill combines with strong experience in project management allows INHALEXPERT to design, structure and manage all the product development and to bring expertise in inhaled product development.

From consulting to the lead of inhaled product development, Inhalexpert is your partner.

• Pharmaceutical development strategy and tactics
• Preparation of development plans, project management, management of CRO’s
• Device design and development of inhalation system adapted to the strategy in line with the targeted therapeutic needs
• Pharmaceutical development (Formulation, micronisation/process, analytic and physical properties activities)
• Coupling product formulation and device
• Industrialization and launch
• Critical aspect of regulatory CMC dossier

• Offers new opportunities and alternatives to molecules, R&D valued and profitable
• Creates intellectual property and a product hard to copy
• Opens access to new market share

 

One of the oldest route
potentially suitable for the delivery of a wide range of drugs

One of the oldest routes for the administration of drugs. Anesthetics, aerosolized drugs, smoke or steam inhaled for medical purposes for centuries.
In India 4000 years ago, leaves of the Atropa Belladonna plant, containing atropine as bronchodilator, were smoked as a cough suppressant.
Modern inhalation therapy began in the nineteenth-century with the invention of the glass bulb nebulizer.
First patented DPI (granted in 1852), no evidence of commercial success.
Over the past decades inhalation therapy has established itself as a valuable tool in the local therapy of pulmonary diseases, such as asthma or COPD.
The development of the first p-MDI for asthma therapy in 1956 was a major advance. However, the required hand-lung coordination of the patient and the use of environmentally damaging CFC propellants, are major drawbacks of the traditional p-MDI.
Dry powder inhalers (DPI’s) were introduced to overcome these drawbacks. From the first introduction of a DPI in 1971 (Spinhaler), several DPI’s have been added to the collection of available inhalers. They are breath-controlled and so coordination problems have been overcome.
DPI’s are also potentially suitable for the delivery of a wide range of drugs, such as anti-asthmatics, peptides and proteins. DPI’s can also deliver a wide range of doses from 5 μg to more than 20 mg via one short inhalation.
Dry powder inhaler (DPI) and Metered dose inhaled (MDI) systems are widely accepted as an alternative to injection and oral administration. In contrast to oral therapy, pulmonary administration eliminates the potential for poor absorption and high metabolism in the gastrointestinal tract and it also evades first-pass effects in the liver. Inhalation therapy does not cause pain, unlike injection therapy, and this reduces the strain on the patient, possibly leading to improved treatment outcomes.

Inhaled route benefits

Act quickly, more rapid than the subcutaneous route
Absorption area of about 100m2 very permeable with important vascularization:

• Homogeneous infused surface
• 300-500Mi of alveoli
• Thin barrier cell / capillary: 2.2 microns
  Systemic absorption higher than by oral route

• Minimize the dose required,
• Minimize side effects,
• Reduction of API cost

No degradation due to gastrointestinal tract passage
Avoid hepatic first-pass metabolism
Non-invasive, improved patient comfort

Go directly to the lung, so act quickly and low absorption according to aerodynamic diameter:

• Minimize the dose required
• Minimize side effects
• Reduction of API cost

No degradation due to gastrointestinal tract passage
Avoid hepatic first-pass metabolism
Non-invasive, improved patient comfort

COPD is the fourth worldwide leading cause of death
There are 300 million people with asthma

Mastering inhaled route may represent a significant advantage in the context of a worldwide increase in the number of patients: COPD is the fourth worldwide leading cause of death, 3rd in 2025, according to WHO ; there are 300 million people with asthma, 400 million by 2025, according to WHO.
Moreover, asthma and COPD major treatments will lose their patents in the years to come.
Mastering the development of inhaled products may represent an opportunity for the development of new treatment and to develop generic products.

“The respiratory market traditionally represents one of the most significant sources of revenue for the branded pharmaceutical industry, with high barriers to entry for new companies and generics manufacturers”.

Business insights: The Asthma, COPD & Allergic Rhinitis Market Outlook to 2011

Fields of application

Few examples of potential or existing pulmonary local treatment-no

Potential or existing treatment using inhaled route for systemic effect-no