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Analysis on the Selection of Excipients for Oral Solid Forms Process Research

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It is well known that medicine is a special commodity that can meet people’s needs for treatment and rescue. However, pharmaceutical preparations involve a lot of content in the process of research and development. The development of medicines may suffer from problems such as low level of drug development, more repetitive drugs, and drug development. Due to factors such as the need to increase the variety and insufficient investment funds of enterprises, the outsourcing of preparation process will help promote the research and development of drugs. There are many factors involved in the development of pharmaceutical preparations, among which the selection and determination of excipients is an important factor.

The quality of the drug is not only related to the raw material drug, but also closely related to the excipients. The excipients should be “inert substances”, stable in nature, not react with the main drug, and have no physiological activity, do not affect the determination of the main drug content, and have a good effect on the dissolution and dissolution of the drug. No adverse effects on absorption. At present, the domestic management of excipients used in medicine has also been strengthened, their quality has been supervised, and relevant standards have been formulated. The outsourcing of the preparation process needs to analyze the raw and auxiliary materials in the preparation process to determine whether the raw materials and auxiliary materials are available. If necessary, a compatibility test of the raw and auxiliary materials is also required.


(1) Researchers should consider and use auxiliary materials that can improve the solubility of drugs with low solubility when studying the formulation design. If the drug has poor stability, you should consider choosing a metal ion complexing agent to moderate it.

(2) For the design of chemical drug formulations, it is required to simplify the prescription design plan as much as possible on the premise that the efficacy of the drug is guaranteed, not only to avoid waste in the use of materials, but also to prevent the introduction of auxiliary materials Destroy the efficacy of the drug, or cause unpredictable effects on the drug.

When screening and researching new chemical structure drugs, attention should be paid to the investigation of the interaction between the main drug and the excipients. The compatibility test of the raw materials and excipients is very important in the formulation development process. Medicilon provides preparation process outsourcing services, which can conduct process research based on the characteristics of the dosage form, combined with the physical and chemical properties and stability of the drug, consider the production conditions and equipment, and initially determine the preparation process of laboratory samples, and establish the corresponding process Control indicators.

Compatibility test of raw materials and excipients is one of the important service contents of preparation process outsourcing agencies, which can provide effective data for the selection and determination of preparation auxiliary materials and preparation process. The properties of the auxiliary materials and various external factors may affect the compatibility of the raw materials and auxiliary materials. To investigate the compatibility of the raw materials and excipients, generally a small amount of the mixture can be taken to determine the stability of the pharmaceutical preparation under high temperature, high humidity, and strong light conditions. The properties of the drug can be analyzed in a short time for different combinations to determine whether the drug has changed.

If conditions are available, the original and excipients can be separated for parallel control experiments to determine the root cause of changes in drug properties. If you do not know the relevance of the raw materials at all before conducting the preparation experiment, or if the stability of the raw materials is found to be poor through relevant data verification, even if the formulation of the pharmaceutical preparation and the raw and auxiliary materials are the same as the original prescription, then the raw and auxiliary materials are compatible The inspection cannot be ignored. Because the selected manufacturer cannot guarantee the same, the slight difference in the ratio will also cause the difference in the shape.

When testing the compatibility of raw materials and auxiliary materials, it is necessary to make full use of limited research information to ensure that the selected raw materials are stable. Generally speaking, there are not many requirements for the various qualities of auxiliary materials. When the prescription of the original drug can be searched by a series of methods, and the excipients selected for production and experiment are completely consistent with the prescription, model, and manufacturer of the original drug, the compatibility of raw materials and excipients can be completely checked.

If the excipients used are not exactly the same as the prescription of the original drug, or if other excipients are added to the original excipients, the compatibility of the raw materials and excipients cannot be neglected. Of course, sometimes the compatibility test of excipients can also be used to make the test simple. The specific operation steps can be guided by drug stability.

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