The Production Process of Veliparib dihydrochloride

Veliparib dihydrochloride is an anticancer drug that is currently under development by Pfizer.
The production process for this drug involves several steps, from the synthesis of the starting material to the final formulation of the drug.
In this article, we will take a closer look at the production process for Veliparib dihydrochloride, including the chemical reactions and equipment used in each step.

1. Synthesis of the starting material

The starting material for the production of Veliparib dihydrochloride is 2-[(4S)-4-(difluoromethyl)-2-oxo-1,3-oxazolidin-3-yl]-N-(4-fluorophenyl)acetamide.
This compound is synthesized using a combination of chemical reactions and purification steps.
One common synthesis route for this compound involves a three-step reaction sequence, starting with the reaction of N-(4-fluorophenyl)acetamide with para-nitrophenyl chloride and then followed by a desulfurization step and an oxidation step.

2. Coupling reaction

The next step in the production process is the coupling reaction, which involves the reaction of the synthesized starting material with another compound to form the final product.
In the case of Veliparib dihydrochloride, this compound is 1,1'-carbonyldiimidazole.
The coupling reaction is carried out in the presence of a solvent, such as dichloromethane, and a catalyst, such as pyridine.

3. Hydrolysis

After the coupling reaction, the resulting product is hydrolyzed using hydrochloric acid.
This step is necessary to remove the protecting group that was added during the coupling reaction.
The hydrolysis reaction is carried out in a suitable solvent, such as water or acetonitrile.

4. Purification

The resulting product from the hydrolysis step is purified using a variety of methods, including column chromatography and high-performance liquid chromatography (HPLC).
This step is necessary to remove any impurities that may have been introduced during the previous steps.

5. Formulation

Finally, the purified product is formulated into the final dosage form, which in the case of Veliparib dihydrochloride is a powder for oral administration.
This step involves mixing the drug with excipients, such as lactose or mannitol, and then compressing the mixture into Tablets.

In conclusion, the production process for Veliparib dihydrochloride involves several chemical reactions and purification steps.
The success of this process depends on the accuracy and precision of each step, as well as the quality of the starting materials used.
With careful control and monitoring of the process, it is possible to produce high-quality Veliparib dihydrochloride that is effective in treating cancer.