Pneumatic Dry Granulation Process

The pneumatic dry granulation process is a new and patent-pending technology. The process, together with a set of well-known GRAS excipients, provides a solid platform for rapid product development. The platform minimizes the formulation design time and resource requirements.

The PDG Technology™:

• Is based on a pneumatic dry granulation process, a novel dry method for automatic production of granules,
• Enables flexible modification of drug load, disintegration time and tablet hardness,
• Can achieve:
  
  • High drug loading, even with ‘difficult’ APIs and combinations
  • Taste masking
  • Excellent stability,
• Is compatible with other technologies, such as sustained release, fast release, coating,
• Is suitable for heat labile and moisture sensitive drugs.

The PDG Technology™ produces porous granules with excellent compressibility and flowability characteristics.

     

Pneumatic Dry Granulation Replaces Wet Granulation

Today, wet granulation is the most commonly used granulation method. Formulation teams will usually target a direct compression or dry granulation formulation where possible but in approximately 70% of the cases they end up with a wet granulation formulation due to processing issues.

Compared to the PDG Technology™, wet granulation is complex and difficult to control.


Wet granulation is also unsuitable for moisture sensitive and heat sensitive drugs, it is more expensive than dry granulation (energy consumption, floor space needs, operator costs, solvent costs and can take a long time). There are a large number of process steps and each step requires qualification, cleaning, and cleaning validation. High material losses can be incurred because of the transfer between stages and there is the need for long drying times. Scale up is usually an issue, and there are considerable capital requirements. PDG Technology™ solves these problems.

Compressibility and Flowability

PDG Technology™ granules have excellent properties compared to granules produced by wet granulation or dry granulation. The granules show both high compressibility and flowability.  The results can be achieved without using exotic and expensive excipients.

 

Advantages of PDG Technology™

PDG Technology™ has a number of advantages to support the above claims including the following:

• Good granulation results even at high drug loading have been achieved even with materials known to be difficult to handle,
• Faster speed of manufacturing compared with wet granulation,
• Lower cost of manufacturing compared with wet granulation,
• The system is closed offering safety advantages due to low dust levels and potential for sterile production or handling of toxic materials,
• The end products are very stable - shelf life may be enhanced,
• Little or no waste of material,
• Scale-up is straightforward,
• The granules and tablets produced show fast disintegration properties, offering the potential for fast release dosage forms, and
• Release time can be tailored to requirements.