Crystallization in the Pharmaceutical Industry
GM Regulatory Affairs
SHAH TC Overseas Private Limited, Delhi, INDIA
22 years of industrial Exp,
M.Sc, MBA, Doctor of Science.
Crystallization has the vital role in the pharmaceutical industry as it is started from intermediates separation process and the final manufacture step as active pharmaceutical ingredients (APIs).
Crystallization is a key component of almost all processes in the manufacturing of pharmaceuticals. Whether for purification of intermediates, formation of the product, or prevention of crystallization in amorphous products, crystallization is essential in both processing and development.
Crystallization can be natural or artificial process of formation of solid crystalsprecipitating from a solutionmelts or more rarely deposited directly from a gas.
Crystallization is also a chemical solid–liquid separation technique, in which mass transfer of a solute from the liquid solution to a pure solid crystalline phase occurs.
In chemical engineering crystallization occurs in a crystallizer. Crystallization is therefore an aspect of precipitation, obtained through a variation of the solubility conditions of the solute in the solvent, as compared to precipitation due to chemical reaction.
If we take an example of third generation, semisynthetic, broad-spectrum cephalosporin Ceftriaxone sodium, which belongs to β-lactam antibiotics.
This is most in demand able anti-infectious productin India and abroad.
The continuous methodical studies and development of R&D have been performed to resolve the problems faced in the industry manufacture of ceftriaxone sodium, for example the low yield of batches, less commercial batches and no uniform of the quality so on.
With the help of R and D the problem is studied and continuous lab batches taken and data evaluated and further research on crystallization of ceftriaxone sodium was achieved.
A new process of dilution crystallization has been successfully used for industry manufacture of ceftriaxone sodium, and the product quality, yield and size were enhanced much more than that of the old technology.
In past the India has done more studies and research on the crystal formation of ceftriaxone sodium.
By evaluating the type of equipment for crystallization, solvent quality, maintaining temperature, recovering solvent, time for reflux, effects of seeds, stirring RPM (speed) control, purification and concentration of motherliquior the crystallization process is developed.
After intensive work on the crystallization of ceftriaxone sodium has been determined, and the product quality, yield and size are improved.