Inhalation and Nasal Products Testing

Pharmaceutical Quality of Inhalation and Nasal Products

 

Pharmaceutical inhalation and nasal products are used ubiquitously. No one family passes any flu season (and not only) without them. In winter and spring, their use is especially high.

Nasal spray and inhalation products usually include a delivery device. The site of intended action of the active ingredient may be local or systemic:

• Inhalation medicines are intended to be deposited in the respiratory tract
• Nasal spray medicines are intended to be deposited in the nasal or pharyngeal region

The range of inhaler products and medicaments has grown to encompass alternative drug delivery systems, namely those based on:

1. The dry powder inhaler (DPI, particle size less than 6 microns):

 

EasyHaler®	Novolizer®
HandiHaler®	Genuair®
Breezhaler®	Nexthaler®
Diskus®	Spiromax®
Ellipta®	Turbohaler®
Diskhaler®	Spinhaler®
Rotahaler®	Accuhaler®

 

An important thing to note with commercially available DPIs (Dry-powder inhaler) is that they are all passive devices; passive devices rely on the patients’ inspiratory flow rate to generate the energy for powder dispersion.

2. Nebulizers.

3.  pMDIs:

The canister is typically a formed single aluminum component with a metering valve, crimped to the canister lid. The metering valve isolates the pressurized formulation’s local environment (typically 4–5 atmospheres of pressure) from the surrounding environment (1 atmosphere), and upon actuation releases a known quantity of propellant formulation (typically 25–100 μL) to the surrounding environment. The formulation is either solubilized or suspended in the propellant, and the local concentration of drug in the canister determines the therapeutic dose.

The pMDI is an active device, delivering a single dose over a period of microseconds.

4. Nasal products.

 

Due to GUIDELINE ON THE PHARMACEUTICAL QUALITY OF INHALATION AND NASAL PRODUCTS 2006, they are tested in a variety of ways, some of which are Particle / droplet size distribution and Fine particle mass.

Dear customer, as a specialized manufacturer of various equipment for outdoor air quality, occupational health, emissions and laboratory equipment, we are pleased to offer a complete system for testing inhalation and nasal products according to the Pharmacopeia (Pharmaceutical Development Studies for Inhalation Products for Particle / droplet size distribution, Pharmaceutical Development Studies for Nasal Products for Particle / droplet size distribution, Drug Product Specification Tests for Inhalation Products for fine particle mass etc).

 

 

Principle:

Aerosol particles of the pharmaceutical products are spread through Inhalation tube at the certain flowrate (using Pre-separator if necessary) to the Andersen Cascade Impactor (ACI) 8 Stages and, therefore, distributed through the Stages of the Impactor and deposited to the collection plates. Different analytical tests for the particles are provided.

Codes:

ACI 8 Stages (non-viable)	AC99-120-0020SP
Conversion kit 28,3-90 L/min	AC99-120-0029SP
Conversion kit 28,3-60 L/min	AC99-120-0027SP
Conversion kit 60-90 L/min	AC99-120-0028SP
Inhalation tube	AC99-120-0023SP
Pre-separator	AC99-120-0026SP
Mouthpiece adaptor	AC99-120-0053SP
Pump Bravo X Bio	AA99-000-0740SP
Pump Bravo X Bio H	AA99-000-0745SP

 

Any Doubt or Request? Write directly to our Specialist ↓