The Basics Of Protein Formulation Development

By Stacey Burt


In medical circles, preparation and formulation of a new drug is not an easy task. However it still has to be undertaken since the lives of patients depend on it. These form the basis of protein formulation development which is the process tasked with combining two or more elements to form a drug for a given medical purpose.

Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. For orally taken drugs, this usually involves incorporating the drug into a tablet or a capsule. However, a tablet contains a variety of other substances apart from the drug itself, and studies have to be carried out to ensure that the drug is compatible with these other substances

It is also important to consider the competitiveness of the formulation as compared to other products available in the market. This is in terms of the stability of the drug as well as the resources it needs in its development process. This is in light of the fact that proteins have issues pertaining to their stability, which is caused by their delicate structural makeup.

Due to the complexity of its structure, and since it is also very delicate, it is practically impossible to extract a pharmaceutical drug containing only the native and pure protein. The process would prove futile due to inefficiencies from the denatured and degraded protein forms. The very process would prove to be too expensive resource wise.

There exists a major challenge in maintaining the integrity of a purified protein. This is especially the case during pharmaceutical procedures of processing, storage, handling, and delivery to the patient. This goal could nevertheless be achieved l by developing a formulation with perfect stability. This perfectly stable strand would have no physical and chemical change.

Chemists and researchers have come to the realization that it is practically impossible to keep any protein sample pure and stable. This is caused by their complex structures, which are predominantly three dimensional. Therefore, medical research and further formulations development is carried out with the mindset that the change in chemical composition is inevitable.

Safety should always be a concern during the formulation development process. Proper maintenance of this strand will be key to maintain the stature of protein during testing, development, handling and transportation of substance. Appropriate Safety and storage mechanisms should be in place to ensure the viability is preserved.

There are certain matters that need to be handled with pin point accuracy and extreme care since they correlate to the end functionality of final product. The proper maintenance of the profile of protein drug should be of key importance during all times especially handling and transportation. Proper measures need to be set to ensure they remain frozen at the prescribed temperatures. This should not be tampered with as the results would end up compromised.

The intrinsic details of the process of formulation development should be appreciate in regard to the extensive nature of this process. Some of its aspects are not viable nor applicable in real essence and further research is recommended to ensure the untapped nature of this process is determined. Some of these regulations should also be reviewed to give leeway for further intricate research and tests. Much have been done but does not mark the end of it. Researches are ongoing.




About the Author:



No comments:

Post a Comment