Generic Active Pharmaceutical Ingredients (APIs) are upstream of generic medicines, and they are not strictly "eaten" by patients because they are not drugs, but like other chemical products, they are raw materials. For a drug, the active ingredient is the main ingredient of the drug, and the other ingredients are called excipients. The generic APIs and the original APIs may not be identical, and there may be differences in individual cases where the original drug has a crystal form or other patents that need to be avoided. However, the final clinical effectiveness has also been clinically verified, and there is no statistical difference, which can be used with confidence.
Qualitative or other quality characteristics will largely directly determine the effectiveness, safety, and other key properties of the final product. Especially for insoluble drugs, the crystal shape, particle size distribution, purity, impurity and other factors of generic APIs can directly affect the production and quality of the final preparation products.
Generic APIs quality analysis requires a comprehensive comparative study between in vitro and in vivo evaluation methods. In vitro evaluation methods are mainly based on the key indicators of internal quality, such as raw material crystal type. Many APIs have specific crystal structure types, cell size, the number of atoms, ions or molecules in the cell and their location are also specific, so they can give specific polycrystalline diffraction patterns. The distribution position and intensity of the diffraction lines have characteristic rules, which become the basis of mutual identification. In vivo evaluation methods mainly focus on bioequivalence tests (BE) and clinical efficacy tests to ensure that the quality of generic APIs are the same as that of the original APIs.
As a major structural fragment of an API, the starting material is combined to form the structure of the API. The most important characteristics of API starting materials are chemical stability and structural stability. The starting material should be incorporated into the structure of the API as an important structural fragment, while avoiding the possibility that the starting material already includes the main structure of the API. The starting material is not only a structural fragment of the API, but also should not be structurally too close to the API. There are many reasons that affect the starting material. For example, the structure of the starting material is too complex and the main structure of the API has been formed. The starting material quality control standard is not perfect and the impurity control is not sufficient.
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