Ready-made PFIs: What are they and why do they matter?

Pharmaceutical Formulation Intermediates (PFIs) are blends of different substances used as raw materials for producing drugs and other pharmaceutical products. Since it’s an integral part of the drug, it has a huge impact on the end results of the drug, especially in deciding on its safety and efficacy.For drug manufacturers, it is a matter of both quality and cost.  That’s why it’s important for drug manufacturers to not only look at the quality of the PFIs but also look at how much it costs in making to ensure that the final product can be sold at a reasonable price without losses. However, making PFIs in-house can become extremely taxing and time-consuming for drug manufacturers.

The Pressing Need for PFIs

Buying ready-made PFIs has become the need of the hour as manufacturing tablets demand more attention in production than trying the right granulation blend. However, the right granulation blend isn’t something that can be neglected as well. That’s why PFI manufacturers focus on the manufacturing stage and the blending of excipients in a form that is ready for the processing of tablet form. To produce in-house PFIs, companies need to source the required excipients just like APIs and test their quality and compressibility. Each active pharmaceutical ingredient has its unique features of flow and compressibility. Moreover, PFI machinery is complex and expensive, which is why it is not financially feasible for every drug manufacturer to make their own PFIs. In addition to this, most drug manufacturers tend to buy small-scale equipment to manufacture and meet their immediate needs. This increases the cost of production since they need to test for each batch and reduce flexibility in case the demand rises. So, what can be the solution?Well, it would be economically viable to purchase PFIs from a specialized manufacturer. Customers can reduce the cost and increase ROI since they need not invest in machinery, technical know-how, and personnel.

Here’s why drug manufacturers opt for PFIs instead of APIs

• Reduces development cost for vendors

You can save money on vendor development costs as they have to deal with only one vendor for all the materials and processes required to manufacture PFIs.

• Easy supply chain management

An in-house PFI manufacturer has to bear the high testing costs, complex supply chain processes to buy excipients, and also deploy technological resources to develop PFI. As customers, the same companies will be dealing with one vendor who takes care of all the supply chain management processes and systems.

• Ensures efficient manufacturing process

An in-house PFI manufacturer might be able to granulate the medications, but they might not be able to garner efficiency in all the products developed. It is through practice and experience that one can understand the unique features and characteristics of an API to manufacture a PFI that meets the required flow. A drug manufacturer with its R&D team can put in combined efforts to garner the efficiencies required to create a cost-effective product.

• Saves expenses incurred on testing costs

As customers conduct only a single test, it helps in huge savings. This is because PFIs can be designed to duplicate the release properties of a brand’s finished dosage. This, in turn, eases the drug manufacturers to pass the bioavailability tests.

• Saves time and money invested on technical resources

PFIs help customers to avoid huge expenses on pre-formulation studies, research, and process development.

Key takeaways for drug manufacturers

Many pharmaceutical companies are yet to switch to the PFI concept. However, the future of the pharma industry is quite promising. In a report titled “Global Use of Medicine in 2019 and Outlook to 2023”, it’s stated that the global spending on medicine will exceed approx. $1.4 trillion by the end of 2021. This is a steady increase as compared to the prior years. As you can see, there is a rapid increase in the number of people affected by chronic diseases in India, for which the demand for drug formulations is at its peak. That said, pharmaceutical drug formulations (PFIs) have remained the key to managing chronic diseases and other related health conditions.

About ZIM Laboratories

ZIM Labs is an innovative drug delivery solution provider focusing on improving patient convenience and adherence to drug intake. We offer a range of technology-based drug delivery solutions and non-infringing proprietary manufacturing processes for the production and supply of innovative and differentiated generic pharmaceutical products to our customers globally. At ZIM Labs we provide our customers a comprehensive range of value-added solid dosage differentiated generic products in semi-finished and finished categories/formulations. These include granules, pellets (sustained, modified, extended-release), taste-masked powders, suspensions, tablets, capsules, and recently developed Oral Thin Films (OTF).