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
Inhaler Products Graphic TCR Tecora

Scheme 1: Types of Inhaler Products

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):

DPI Powder Inhaler Graphic

Scheme 2: Types of DPIs


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

Picture 1: Examples of DPI devices


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.

Schematic of the major components of a pMDI

Schematic of the major components of a pMDI

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).


Whole System for DPI

Scheme 1: Whole system for testing DPI, which comprehends: 1- Mouthpiece adapter, 2- Induction tube, 3- Cascade impactor: 4- Bravo X Bio Sampler.



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.


ACI 8 Stages (non-viable)


Conversion kit 28,3-90 L/min


Conversion kit 28,3-60 L/min


Conversion kit 60-90 L/min


Inhalation tube




Mouthpiece adaptor


Pump Bravo X Bio


Pump Bravo X Bio H



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