Chromatographic processes to detect incompatibilities

ONE of the significant challenges facing nowadays by the drug making companies is the ability to produce a stable pharmaceutical product.

- Sumi

Several active pharmaceutical ingredients can respond unstably to oxidation, moisture or pH, affecting both the stability of the drug and the final formulation.

To achieve drug products with both superior quality and purity, there are several chromatographic processes developed by innovative companies. These processes remove impurities from pharmaceutical excipients without changing the fundamental structure of excipients in any way.

Chromatography is a primary analytical technique used to detect drug and excipient incompatibilities. It is highly valued in pre-formulation and formulation development studies due to its high resolution, sensitivity and ability to identify and separate individual components in a complex mixture, including potential degradation products.

Reactive impurities in pharmaceutical excipients could cause drug product instability and it will lead to decrease product performance, loss in potency, and/or formation of potentially toxic degradants.

The levels of reactive impurities in excipients may vary between lots and vendors.

Screening of excipients for these impurities and a thorough understanding of their potential interaction with drug candidates during early formulation development ensure robust drug product development.

The removal of impurities provides a range of added value to the pharmaceutical manufacturing companies containing enhanced active pharmaceutical ingredients stability, improved oxidative stability, reduced cellular irritation, enhanced skin permeation and reduced taste impact.

This process has been possible to eliminate many of the polar and oxidative impurities that are normally present in pharmaceutical pharmacopoeia grade ingredients. This process does not alter the chemical structure of the pharmaceutical excipients.