From Formula to Shelf: The Pharmaceutical Formulation Development Journey
An active ingredient on its own is rarely a medicine. It has to be turned into a dosage form that patients can take easily, that stays stable over its shelf life and that releases the drug in the right way. This process is called formulation development.
Stage 1: Pre-formulation
Scientists study the physical and chemical properties of the API, including solubility, particle size, polymorphism, hygroscopicity and compatibility with common excipients. These findings guide every decision that follows.
Stage 2: Choosing the dosage form
Based on the target patient, the route of administration and the API’s properties, the team selects a dosage form: tablets, capsules, oral liquids, topicals, injectables or others.
Stage 3: Prototype development
Several trial formulas are prepared with different excipients and processes. Each prototype is tested for parameters such as dissolution, hardness, content uniformity and appearance.
Stage 4: Optimisation
The most promising prototype is refined. Many teams use a Quality by Design (QbD) approach, described in ICH Q8, to understand which material attributes and process parameters most affect product quality.
Stage 5: Stability studies
The product is stored under defined temperature and humidity conditions, as per ICH Q1A guidance, and tested over time to establish its shelf life and storage conditions.
Stage 6: Scale-up and technology transfer
A process that works for a small lab batch must be proven at pilot and then commercial scale. Exhibit or validation batches confirm that the process is reproducible.
Stage 7: Commercial manufacturing
Once the process is validated and approvals are in place, routine production begins under GMP, with every batch tested and released by Quality Assurance.
Why the right partner matters
Formulation development decisions made early have a long-lasting impact on cost, stability and patient experience. Working with an experienced development partner reduces trial-and-error and helps avoid costly reformulation later.
Marigold Pharma offers formulation development and manufacturing across a wide range of dosage forms. Explore our formulations or get in touch.