Evaluation of Consistency Between Pharmaceutical Excipients and Drugs

Generic drugs are replicas that are identical to branded drugs in terms of dosage, safety and efficacy, quality, action, and indications. Both generic drugs and original brand drugs are pharmaceuticals, but they differ in excipients, impurity levels, bioavailability, and side effects, which means their clinical safety and efficacy also differ. The purpose of pharma excipients market consistency evaluation is to improve the safety and efficacy of drugs, ensuring the safe and effective use of medications by the public. 

Consistency evaluation of pharmaceuticals has always been highly valued by pharmaceutical companies worldwide. Understanding how the quality of generic drugs can reach the standard of original brand drugs has consistently been an important aspect of drug research for pharmaceutical companies and is crucial for their competitive survival. The most notable comparison between generic drugs and original brand drugs is their bioavailability.

The relevance of pharmaceutical excipients in consistency evaluation

During consistency evaluation, pharmaceutical excipients affect pharmaceutical research and bioequivalence tests. The main content of pharmaceutical research is the preparation process, and excipients are crucial materials in drug preparation and serve as important evaluation indicators in pharmaceutical research. In vitro dissolution rates are closely related to the quality and specifications of pharma excipients; in experiments, pharmaceutical excipients affect the drug's metabolism and absorption in the body.

Therefore, pharmaceutical companies should rigorously assess whether suppliers' production is standardized, the quality characteristics of excipients, which physicochemical indicators determine the role of excipients in formulations, how changes in these indicators affect formulation properties, the differences among similarly named excipients produced by different companies, and how parameter changes in excipient production processes lead to product changes. All these factors determine the final outcome of the quality consistency evaluation.

These factors impose higher quality control requirements on excipient companies. In the past, many technicians focused only on selecting the chemical names of raw excipients used in branded drugs when designing formulations, ignoring the physicochemical properties and quality differences among products from different companies with the same chemical name. The quality consistency evaluation of generic drugs has driven the pharmaceutical industry to raise the quality standards for raw excipients, inevitably standardizing the overall quality control and process management of the excipient industry.

Whether the impurity levels in formulations are consistent with those in original brand drugs

Factors affecting drug efficacy mainly include the properties of the drug, the properties of the formulation, and biological factors. The properties of the formulation mainly depend on the dosage form, excipients, and preparation process. Pharmaceutical excipients ensure that drugs are selectively delivered to specific tissues, prevent drugs from becoming inactive before release in the body, and allow drugs to be released in the body at a certain rate and time. Dosage form, excipients, and process all affect drug efficacy to some extent, and excipients significantly influence the other two. Consistency evaluation has raised the technical requirements for excipient quality, elevating pharmaceutical excipients to the same status as active pharmaceutical ingredients, thus changing the previous emphasis on active ingredients over excipients.

Before the implementation of drug consistency evaluation, the pharmaceutical industry had long focused on raw materials, particularly neglecting pharmaceutical excipients. In addition, due to less developed quality standard systems and management systems for pharmaceutical excipients compared to foreign countries, the quality of pharmaceutical excipients has become a shortcoming in the development of drug formulations. The performance and quality of pharmaceutical excipients play a crucial role in drug formulation efficacy and occupy an important position in drug formulation production. With the implementation of drug consistency evaluation, pharmaceutical companies will face the challenge of finding high-quality and high-efficiency pharmaceutical excipients. This presents both new development opportunities and a severe test.