Why drug manufacturers should choose PFIs over APIs?

Vijay Ramanavarapu

Making Pharmaceutical Formulation Intermediates (PFIs) involves taking Active Pharmaceutical Ingredients (APIs) and adding excipients to make a proper blend for the finished dosage. So an in-house PFI manufacturer has to contend with the high testing costs, complex supply chains to buy excipients and also allocate technological resources to develop the PFI.

Finished dosage manufacturers usually purchase APIs from suppliers and manufacture PFIs in-house in order to prepare the material for finished dosage manufacturing. However, since most of the manufacturers only produce low volumes, they create PFIs on a small-scale basis, which increases their testing costs.

Manufacturers can also increase capacity utilisation by running a continuous campaign of select products instead of making small batches of multiple products. Running a long campaign will reduce downtime since it will minimise cleaning between product changeovers.

In addition, finished dosage manufacturers need to have a complex supply chain as they need several excipients. All this entails additional costs since the manufacturer would need to audit their suppliers and also keep a ready inventory of material in the warehouse.

Buying PFIs is a good business strategy

Focus on producing tablets instead of trying to create the proper granulation blend. PFIs require their own unique manufacturing equipment. PFI machinery is expensive and complex, which is why it is not economically feasible for every drug manufacturer to make their own PFIs. Due to the complexity of the machinery, PFIs contribute to 80 per cent of the total cost of manufacturing of a finished dosage. In addition, there are many different processes and equipment which a manufacturer can choose such as opting for a fluid bed dryer or a rapid shear mix. The manufacturer should know about the nuances of the machine and understand which technology is ideal for a particular finished dosage. Also, most drug manufacturers tend to buy small-scale equipment to suit their immediate needs. This increases the cost since they need to test for each batch and also reduces flexibility in case the demand increases. By purchasing PFIs from a specialised manufacturer, customers can reduce their costs and increase their return on investment since they do not need to invest in machinery, technical know-how and personnel.

Lower regulatory costs – ensure regulatory compliance

PFIs can be designed to replicate the release properties of a brand leader’s finished dosage. So it will be easier for the drug manufacturer to pass the bio-availability studies. A drug manufacturer may not have the know-how to granulate APIs correctly to ensure this.

Simplify the supply chain

In addition, drug manufacturers need to have a complex supply chain since they require several excipients. In addition, PFIs have a more stable shelf-life which provides flexibility for customers since they can store material, if necessary. PFIs resolve many of the shortfalls of APIs and are less prone to temperature variations.

Make the manufacturing process more efficient

Manufacturers are able to granulate in-house, but they might not be able to garner efficiencies if they’re trying to master dozens of products or if they only produce the product for a few days at a time. It takes time and experience to understand the unique characteristics of an API in order to manufacture a PFI that meets the required flow and compressibility characteristics. Most companies have focused R&D efforts on API or finished dosage production. Companies that do not actively research PFI production will not be able to garner the efficiencies that are required to create a cost-competitive product.

Some of our customers also approached us after facing operational problems in the consistent manufacture of PFIs. The result was that they were unable to get the desired properties of the PFI.