The most successful path in developing a drug is one that not only produces a new drug substance that is safe and effective, but one that is economically manufacturable. Often the development efforts in this area, also called Chemistry, Manufacturing, and Control (CMC), are hidden by the glare coming from the glamour of pharmacological research. However, it is every bit as important to determine the most efficient method of synthesis, most effective form of delivery and most stable set of materials. All of the effort expended in drug discovery and pre-clinical research will go for naught if the product cannot be manufactured.

Dionex understands the importance of this phase of drug development and has been partnering with pharmaceutical companies, large and small, to ensure timely investigations through the use of ion chromatography (IC) and liquid chromatography (LC). From the ICS 900 to 5000 and from the UltiMate^® RSLC to x2 Dual, Dionex offers the solutions that you can depend upon for reliability, flexibility and productivity.

PhysioChem

NCE’s coming from Drug Discovery which show pharmacological activity must be characterized to document its physicochemical properties. Multiply all of these physical and chemical tests by a large number of hit compounds and compounds with similar structures and you get an appreciation for the work load involved. Therefore, fast, accurate and reliable analyses are of utmost importance and can seriously impact time to market.

Dionex has repeatedly demonstrated the productivity improvement that can be realized using the UltiMate^® x2 Dual HPLC systems. In parallel mode, analytical throughput can be nearly doubled without breaking the budget or adding resources.

IC/LC Sensitivity and Selectivity for Process Optimization

Once a New Chemical Entity (NCE) moves from pharmaceutical Drug Discovery to Drug Development, its synthesis must be optimized. There is no point in investing in the tremendous expense of clinical trials with a potential drug that may exhibit the desired pharmacological activity but cannot be practically synthesized. This is the point where process optimization chemists and chemical engineers identify the most favorable starting materials and match them up with optimal reaction conditions in a minimal number of steps to produce the most cost effective process.

The optimization of the synthetic process is typically followed by a scale-up from milligrams of active pharmaceutical ingredient (API) synthesized on the laboratory bench to kilograms made in a pilot-scale environment and tons on the production line.

Each step in this process development requires analytical results with the high degree of selectivity and sensitivity that Dionex LC and IC instrumentation provide. With the new Integral system, process analytics can be incorporated in the early stages of drug development and follow the process all of the way into production.

Speed and Sensitivity for Pharmaceutical Formulation Studies

Depending on its intended use and physicochemical properties, a drug therapy can take on any of a number of forms such as tablets, capsules, caplets, and inhalants, for example. Pharmaceutical formulation is the drug development process for combining an Active Pharmaceutical Ingredient (API) with suitable inactive ingredients, called excipients, to create a product that is both stable and in a form appropriate to the application. Formulation development therefore requires a wide variety of studies to determine solubility, stability, consistency, drug load, disintegration, and container/closure compatibility.

HPLC and IC are the critical tools of the formulation scientist the provide selectivity, sensitivity and throughput required to support stability testing, forced degradation, impurity profiling and dissolution testing. Dionex RSLC, IC and x2 Dual system solutions combined with Chromeleon’s ease of use provide unprecedented productivity to labs involved in formulation development.