Spray Drying Feasibility Studies

One of the most cost effective ways of determining whether your product will benefit from the use of spray drying is to undertake a short feasibility study with Upperton.

 

A typical feasibility study might progress in the following way:

Defining the study protocol

After some initial discussions with the customer, we will agree an outline protocol defining the work programme. To do this we will need to understand a number of key parameters related to your product and target profile such as:

  • Physical properties of the drug (stability, solubility, safe handling etc)
  • Target product profile (particle size, additional excipients, residual solvent)
  • Amounts required by customer to undertake additional testing
  • Product characterisation (assays to be undertaken).

Undertake Feasibility study

Feasibility studies are usually undertaken on a Buchi laboratory scale spray dryer.

A typical study may involve producing 3 to 6 batches (1-5g each) of spray dried powder, produced under a range of spray drying conditions.

Evaluating the results

Spray dried powders we produce in the feasibility study are usually characterised using a range of analytical tests (although this is not essential and on some occasions the customer prefers to undertake their own product testing). Tests may include:

  • Particle size
  • Residual solvent analysis
  • Physical properties (x-ray diffraction, DSC)
  • Solubility/stability testing

Batches of spray dried powder are then returned to the customer along with a comprehensive technical report containing details of the spray drying conditions used and the analytical results obtained.

Timelines and costs

The time taken from initial contact to undertaking a short feasibility study and returning samples to the customer can be as short as 1 week. The contractual paperwork required to do the study is minimal and all arising intellectual property belongs to the customer.