CASE STUDY

Upperton receives regular approaches from customers who express an interest in evaluating the potential of spray drying in the formulation of their pharmaceutical product. The quickest way of answering this question is to undertake a short feasibility study. Below we describe a typical study from initial contact to generating batches of spray dried powder.

Stage 1: Defining the study protocol

Upperton will usually produce an outline protocol defining the planned work programme, after discussions with the customer. To do this we will usually need to define the following key parameters:

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

After initial studies, it is quite common for the feasibility protocol to be changed. We keep in close contact during the feasibility stage, relaying results back to the customer and adjusting the protocol where necessary

Stage 2: Undertake Feasibility study

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

Our experience enables us to identify the likely key variables in the spray drying process and evaluate their impact on a customer’s product in a cost-effective, time efficient manner.

Once we have received the API from the customer, we will spray dry a number of small batches of material. 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.

Stage 3: Evaluating the results

The spray dried powders 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 analysis
• residual solvent analysis
• bulk/tap density measurements

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.

Our costs to the customer are charged on a simple, daily-rate basis

Click to return to FEASIBILITY STUDIES page