Inhalation products

Pharmaceutical application of the high pressure homogenization

Treatment of respiratory diseases like asthma and chronic obstructive pulmonary disease is advantages via inhalation route compared to the oral route since the active substances are available directly.

Effective therapies directed against asthma have advanced since 1956 when the first pressurized metered dose inhaler was developed. The target for these anti-asthma medications is the smooth muscle cells concentrated in the pulmonary airways. Delivery of drugs directly to the lungs is an effective and relatively safe means of both local and systemic treatment of a variety of medical conditions. Medication delivery may be inefficient if particles aggregate in the inhaler itself, if they are filtered by the throat and mouth, and if mucociliary clearance processes remove them. In order to keep dry powder aerosols from depositing in the oropharyngeal cavity and inhaler, most have a geometric diameter of 1-3 um and particle mass density of ~ 1g/cm3.

Usually drugs are dissolved in an acqueous system, e.g. isotonic salt solution, and aerosolized droplets are generated by the very high pressure homogenization of particles.

The homogenization process

It is a wholly mechanical process, obtained by forcing a flow of product through a homogenizing valve.

Due to well-known physical laws, inside the valve they take place some contemporaneous effects of compression, acceleration, and so on, which are the cause of the homogenizing process, that acts by shattering and dispersing the solid and semisolid suspended particles.

The solution is pumped to the high pressure homogenizer. The product is homogenized at room temperature and at 500 -1000 bar using one single stage and Rupture homogenizing valve.

The homogenization results

The high pressure homogenization treatment allows to reduce the average size of big particles.

Particle size distribution

The suspension is more stable due to the reduced sedimentation rate. The bioavailability increases and the tolerance of some otherwise irritating drugs can improve.

The aspect of the product is more clear and transparent.

Homogenizing machine to be used

The homogenizer used for the treatment is a machine designed for 1000bar for

• High abrasion
• Low viscosity
• 3A execution and Electropolishing of wetted parts, final surface roughness Ra<0,5μm.
• Certification Manual for Pharma validation cGMP.