Development process and technology for API mfg

AN active pharmaceutical ingredient (API) manufacturing process needs to maximize the yield of a product with suitable purity and particle characteristics.

- Paul Thottian

A bottom-up operation process primarily refers to a strategy for creating fine particles, specifically nanoparticles, by assembling smaller molecular components.

As a bottom-up operation, crystallization can control what version of it is manufactured (hydrate, solvate, salt, cocrystal and polymorphic form), the impurity levels it contains, and the particle size distribution.

The active pharmaceutical ingredient must possess proper chemical and physical attributes to assure that it should deliver the intended pharmacological effect.

The chemical attributes describe the appropriate purity and impurity limits. Impurity specifications are established from clinical toxicological studies and are also based on reasonable minimum expected from regulatory authorities and consumers.

The physical attributes describe the necessary characteristics for reliable pharmaceutical processing into a final medical product. These attributes are determined by empirical evidence from formulation trials to produce uniform and a stable product of adequate bioavailability.

Controlled crystal growth is a function of active pharmaceutical ingredient solution saturation and crystal formation, which can be controlled by using a seed of the active pharmaceutical ingredient of the desired form or version.

There are a number of complex parameters that affect the properties of the final crystalline solid, including nucleation rate, growth rate and growth mechanism, while the expertise of solid-state scientists is vital to understand how the concentration of the active pharmaceutical ingredients in solution, temperature and cooling profiles affect the process, yield, and quality of the isolated active pharmaceutical ingredient.