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.
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.
Maintaining the integrity of this protein would be difficult, even with the extraction of pure strands. The shelf life would be drastically reduced and the instability of the same heightened. The processes of handling and transportation and delivery would need to be done with extreme caution. However, the strand would have the advantage of having neither chemical nor physical change.
Proteins have complex yet delicate structures characterized by a three dimensional look. When it comes to identifying conditions for their stability, it proves infinitely impossible. When developing the strands for commercial purposes, it is inevitable to have some physiochemical changes. Formulations development focuses on determining potential degradation pathway, assessing the significance of each and optimizing variables to reduce degradation products which are clinically significant.
Commercially viable and market competitive formulations have some common features. Most of all, the formulation should maintain the safety and efficacy profile of the protein drug during all the handling and uses specified on the label. Since commercial distribution channels are not always equipped for frozen products, shipping and storage at refrigerated temperature or higher are required.
Various methodical studies need to be carried out to ensure full compliance with regulatory requirements for registration. However, the challenge is that it takes a year or two to collect the results. For efficiency purposes, the commercial formulation should continue in the process of development while preclinical studies and clinical trials are underway.
Commercial formulation should be introduced before the commencement of clinical trials because clinical experience is the most effective way to confirm the safety and efficacy aspects of formulation. In addition, formulations change after this point may introduce formidable challenges to the clinical program and to obtaining regulatory approval.
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.
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.
Maintaining the integrity of this protein would be difficult, even with the extraction of pure strands. The shelf life would be drastically reduced and the instability of the same heightened. The processes of handling and transportation and delivery would need to be done with extreme caution. However, the strand would have the advantage of having neither chemical nor physical change.
Proteins have complex yet delicate structures characterized by a three dimensional look. When it comes to identifying conditions for their stability, it proves infinitely impossible. When developing the strands for commercial purposes, it is inevitable to have some physiochemical changes. Formulations development focuses on determining potential degradation pathway, assessing the significance of each and optimizing variables to reduce degradation products which are clinically significant.
Commercially viable and market competitive formulations have some common features. Most of all, the formulation should maintain the safety and efficacy profile of the protein drug during all the handling and uses specified on the label. Since commercial distribution channels are not always equipped for frozen products, shipping and storage at refrigerated temperature or higher are required.
Various methodical studies need to be carried out to ensure full compliance with regulatory requirements for registration. However, the challenge is that it takes a year or two to collect the results. For efficiency purposes, the commercial formulation should continue in the process of development while preclinical studies and clinical trials are underway.
Commercial formulation should be introduced before the commencement of clinical trials because clinical experience is the most effective way to confirm the safety and efficacy aspects of formulation. In addition, formulations change after this point may introduce formidable challenges to the clinical program and to obtaining regulatory approval.
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