The types of pharmaceutical excipients are numerous, generally categorized by function into fillers, disintegrants, lubricants, binders, colorants, etc. The factors that influence these excipients are also very complex, which have various impacts on their safety performance. Therefore, it is crucial to pay great attention to the design and production processes of pharmaceuticals. In recent years, many pharma excipients, during inspection, might encounter issues such as counterfeit excipients, using incorrect excipients, or using excipients with inappropriate grade levels, all of which pose safety hazards to drug formulations. Additionally, incorrect use of certain excipients regarding their grade and function can affect the quality of drugs during usage, depending on different specifications and purposes.
Safe medications must employ excipients that are safe in material and reasonable in composition. During correct utilization, it is essential to study and analyze their toxic and side effects, avoiding excipients with significant side effects if possible. If such excipients cannot be substituted, their safety dosage should be strictly controlled. When choosing pharmaceutical excipients, there are two aspects we need to pay attention to.
During the production process of pharmaceuticals, appropriate excipients must be selected according to the characteristics of the production process. Different processes require different excipients. For example, for certain herbal medicine components, the required excipients should be of higher quality, and the amount of excipients should be minimized. For low-dose medicines, we need to consider the uniformity of the formulation to improve the quality of the medicine and ensure better dispersibility of the drug during the use of pharmaceutical excipients.
Before the excipients enter the facility, their standards must be verified to prevent substandard excipients from being mixed into the drugs. With the increasing awareness of medication, relevant enterprises must strictly control excipients from the source and take related measures to minimize adverse reactions of excipients.
Enterprises play a crucial role in ensuring the safety and quality of drugs, especially in the selection of pharma excipients. The responsibilities borne by the enterprises are significant. Only pharmaceutical manufacturing companies can strictly control excipients to ensure the safety and effectiveness of the entire drug. Therefore, manufacturers must clearly indicate the use, composition, and content of excipients in the instructions, and even label possible adverse effects. In the event of incidents or issues, timely handling is essential to take the most appropriate measures to ensure rational medication use.
Overall, controlling the quality of drugs starts with the strict inspection of excipients from the source. Only when pharmaceutical excipients meet relevant standards can drugs be safe, stable, and effective, thereby promoting continuous progress in national healthcare.