Nilesh Patel, managing director, Kashmik Formulation shares the role of formulation in modern pharmaceutical manufacturing.
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In pharmaceutical manufacturing today, formulation is no longer a backstage process. It’s a core player in how medicines are designed, delivered, and experienced. From unlocking the potential of complex molecules to improving how a tablet feels in the mouth, formulation is where science meets usability and where big ideas become real-world therapies.
What used to be seen as a supporting act has now moved into the spotlight. Formulation isn’t just about combining an active ingredient with a few excipients. It’s about solving real problems: How do we make a drug more stable? How do we help it reach the right part of the body at the right time? How do we make sure patients actually take it?
These questions are shaping the way modern pharmaceuticals are made and they all begin with formulation.
Beyond the molecule
A new molecule might show promise in a lab, but until it can be delivered safely, consistently, and effectively inside the human body, it remains just that a promise. This is where formulation steps in.
Take drugs with low solubility. No matter how powerful they are in theory, if they can’t dissolve properly in the body, they won’t be absorbed and won’t work. Formulation scientists tackle this by using approaches like nanoparticles, lipid-based carriers, or amorphous solid dispersions. These may sound technical, but at the heart of it, they’re practical solutions to ensure a drug works in real conditions.
And it’s not just about chemistry. It’s about people. A child who refuses to take bitter medicine, or an elderly patient who struggles with large pills these are daily realities. The role of formulation is to bridge this gap between science and human behaviour.
More than just stability
Stability and shelf life are key concerns in pharma, especially for markets with long distribution chains and extreme climate zones. But formulation doesn’t just ensure a product can sit on a shelf for two years. It ensures that when a patient finally takes that pill or injection, it performs the way it’s supposed to whether that’s a slow release over 24 hours or rapid action within minutes.
Formulation also directly impacts manufacturing. A powder that clumps or doesn’t flow well can bring production to a halt. Getting the right particle size, moisture level, or coating isn’t just a lab detail, it’s the difference between a scalable product and a bottlenecked line.
The rise of complex therapies
As medicine shifts towards more advanced therapies such as biologics, peptides, mRNA-based drugs, the demands on formulation have become more intense. These molecules are often fragile, sensitive to heat or light, and may degrade in the stomach. Traditional pill formats don’t always work.
This is why we’re seeing more innovation in delivery formats: oral films, microneedle patches, depot injections, and inhalable powders. These aren’t gimmicks. They’re necessities born out of what the therapy requires and what patients can realistically manage.
The ability to formulate these next-generation treatments is becoming a critical differentiator in the industry. It’s no longer just about what molecule you have, it’s how you formulate it that defines its success.
Keeping up with regulatory expectations
With increasing global scrutiny on drug quality and consistency, regulators expect a deep understanding of how a formulation behaves, not just in a lab, but across manufacturing batches, over time, and in various environments.
That’s where approaches like Quality by Design (QbD) come in. Rather than simply proving a formulation works, companies are now expected to explain why it works, what could go wrong, and how those risks are controlled. This means that formulation is not just a scientific task, it’s a documentation-heavy, strategy-driven process that must align with business, regulatory, and operational goals.
In short, good formulation now requires not just technical expertise but foresight.
Responding to market trends
Speed to market has become a key business goal, especially during public health crises or when competing in high-demand therapy areas. A smart formulation can significantly shorten development timelines by avoiding unnecessary iterations, simplifying manufacturing processes, and enabling faster regulatory approval.
At the same time, product differentiation is increasingly tied to formulation. Two companies might make the same drug, but one’s product dissolves faster, is easier to take, or requires fewer doses. That’s a major advantage, especially in markets where patient preference drives prescribing decisions.
Formulation has also become central to lifecycle management. Reformulating an existing drug into a more convenient or advanced delivery system can extend its commercial relevance well beyond the original patent expiry.
The formulation mindset
One of the most powerful shifts in recent years is the way formulation teams now operate. They’re no longer working in silos. They collaborate closely with clinical teams, manufacturing units, packaging specialists, and even marketing professionals. Because the choices made during formulation have ripple effects throughout a product’s lifecycle.
There’s also a growing creative element to formulation. Solving for taste, texture, or user experience requires thinking beyond data. It means understanding human behaviour, lifestyle trends, and cultural expectations. In many ways, formulation scientists are now part chemist, part designer, and part strategist.
Looking ahead
The future of pharmaceuticals is becoming more personalised, more targeted, and more global. This makes formulation even more central not just to how drugs are made, but how they're experienced.
As new technologies emerge like 3D printing of pills or smart drug-delivery systems formulation will continue to evolve. But its core mission remains the same: to make medicines that work not just in theory, but in real life.
In a world where innovation often begins at the molecular level, it’s the formulation that brings it to life. And in doing so, it turns potential into impact.