Characterizing Drug Substance Properties Early Can Optimize Drug Product Formulation.

For pharmaceutical companies, improved R&D productivity is a big challenge at the present time. There is always pressure to increase the development speed for the drugs and making it better as well as cost effective for the customers. The Pharmaceutical organisations are trying to hit the markets with the most promising and cost-effective drug products to provide the benefits to the maximum number of patients. However, there is always a big requirement of speeding up the development process by completing all the stages of the drug development process.




As you know, there will be different stages during the process of drug development. It is very important to characterize the properties of drug substances in the early stages so that it can be easy to optimise the formulation of a drug product in the market. During the early stages of drug substance development, the companies understand the requirement of efficiency as well as safety. The formulation development can be prioritised in the further stages but there will not be any compromise on the safety and efficiency in the early stages. 

Need of characterizing drug substance properties in early stages:

There is a big need of characterizing the drug substances and properties in the early stages otherwise it can affect the drug product formulation stages. The properties of drug substance will also change without characterizing the properties. The drug substance manufacturing companies should definitely evaluate and optimise the process conditions, synthetic route crystallization solvents and more in the early stages. It is very important to understand and track all these kinds of changes and discuss it with drug product formulation companies to anticipate the challenges in drug product formulation.

For the drug product contract manufacturing companies, it is very crucial to collect the data of drug substance characterization so that they can go for the further process of drug development with the complete information about the properties of the substance. In this kind of data, the properties and characteristics like purity, particle size distribution, morphology, extension and rate of dissolution are considered on priority.

When it comes to developing the patient-friendly drug the companies will need to focus on the overall process with the proper steps and drug substance and drug product phases are relatively important to each other from the early stages. Without characterizing every kind of property of the drug substance at the beginning of the process, there will be a big risk of change in the properties of the final drug product and it will not be same for the use for any kind of treatment in the medical sector.

With the process of characterizing the drug substance properties in early stages, the companies and Pharmaceutical organisations make sure that they can focus on all the further stages and steps to create the final drug product for the markets. They also make sure that they can save the properties of the final drug product without any kind of changes so that it can be used by the patients for the proper treatment.

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