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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
Proteins are known to have complex structures. These structures also have the characteristic of being delicate and easily change when subjected to clinical tests. Hence they require specialized attention to ensure these inevitable changes do not alter the performance of end product. Therefore, adequate resources must be available for these extra care.
Sufficient shelf life needs to be determined under conditions to which the product will be exposed in the system of a patient. This however is not applicable as the shelf life of a pure protein strand is hard to achieve. The purification process is tasking and is requisite of a lot of resources, which would render the efforts of creating the drug uneconomical.
Scientists are faced by a further test where they have to uphold the reliability of the cleansed proteins. This is especially critical during storage, processing, handling as well as delivery to a patient. Despite these challenges, this can be achieved by developing an ideal formulations with the perfect stability, that is, no physical as well as biochemical change in the protein.The very nature of proteins and their distinct characteristic structure, being a compound of many various chemical compounds, brings about the challenge to identify a number of conditions to keep all of its constituent components stable.
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.
With the restrictions facing product development, the focus shifts to determining the degradation and fragmentation associated with the product. This is essentially foretold to avoid problems of losing vital information and product characteristics that are key in the formulation development. Regulatory frameworks also need to be followed to avoid jurisdictional problems.
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.
With these levels of advancement in the process of protein formulations development, regulatory framework limitations, as well as the challenges facing the medics and the process entirely, it is not easy to propagate such experiences to the real world to produce drugs for every need. There must be more research and development towards eliminating such barriers.
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
Proteins are known to have complex structures. These structures also have the characteristic of being delicate and easily change when subjected to clinical tests. Hence they require specialized attention to ensure these inevitable changes do not alter the performance of end product. Therefore, adequate resources must be available for these extra care.
Sufficient shelf life needs to be determined under conditions to which the product will be exposed in the system of a patient. This however is not applicable as the shelf life of a pure protein strand is hard to achieve. The purification process is tasking and is requisite of a lot of resources, which would render the efforts of creating the drug uneconomical.
Scientists are faced by a further test where they have to uphold the reliability of the cleansed proteins. This is especially critical during storage, processing, handling as well as delivery to a patient. Despite these challenges, this can be achieved by developing an ideal formulations with the perfect stability, that is, no physical as well as biochemical change in the protein.The very nature of proteins and their distinct characteristic structure, being a compound of many various chemical compounds, brings about the challenge to identify a number of conditions to keep all of its constituent components stable.
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.
With the restrictions facing product development, the focus shifts to determining the degradation and fragmentation associated with the product. This is essentially foretold to avoid problems of losing vital information and product characteristics that are key in the formulation development. Regulatory frameworks also need to be followed to avoid jurisdictional problems.
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.
With these levels of advancement in the process of protein formulations development, regulatory framework limitations, as well as the challenges facing the medics and the process entirely, it is not easy to propagate such experiences to the real world to produce drugs for every need. There must be more research and development towards eliminating such barriers.
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