Prescription Process Evaluation/Optimization of Generic Drug

For generic drugs, the prescription and production process will directly affect the quality of the final drug. Especially when the prescription process is inconsistent with of that the Reference Listed Drugs (RLDs), the impact of the prescription change on the quality of generic drugs should be fully investigated such as the analysis of risks, and corresponding strategies of risk control should be proposed to ensure and prove the quality consistency of the product. Prescription process evaluation and optimization are the basis for production scale-up. An optimized prescription can effectively reduce the risk related with clinical trials and avoid the re-development of formulations. Therefore, generic drug manufacturers need to comprehensively analyze the prescriptions of RLDs, conduct prescription screening and process optimization for the proposed generic drugs, saving costs and time for the subsequent development and production of products. At Alfa Chemistry, our experts is committed to providing comprehensive pharmaceutical equivalence evaluation through performing compatibility research of drugs and excipients and prescription screening.

Figure 1. Parameters to be considered during a prescription process optimization. (Hasan, M. I.; et al. 2021)

Our Complete Solutions for Prescription Process Evaluation/Optimization

Excipient Compatibility Test of Generic Drug

Our experts provide different excipient compatibility research services according to the dosage form and process characteristics. For example, for oral solutions, we prepare solutions by adding the excipients and raw materials for the investigation; for compound preparations, in addition to studying the interaction between APIs and excipients, we also study the complex interaction between different raw materials. By comparing the test results of different formulation processes, we select better formulations for the subsequent optimization.

Prescription Screening of Generic Drug

By screening and determining the type and amount of key excipients, prescription screening has become a powerful tool to determine the important factors for the formulation quality. According to generic drugs of different dosage forms, such as solid oral dosage forms, liquid preparations, and injections, Alfa Chemistry adopts single factor test and orthogonal test to provide different prescription screening strategies.

Final Delivery of Alfa Chemistry

• Further optimization for the final confirmation of the identified key factors affecting the quality of the prescription
• Optimal selection of the type and amount of main raw materials used in the formulation
• Ensure the quality of the final delivered prescription meets the process requirements by comparing the test results of different prescription processes
• Provide additional support for the re-development of the prescription process

Our Advantages

• Knowledge of the latest laws, regulations, policies and procedures for drug applications
• Available for multiple dosage forms, including tablets, capsules, powders, extended-release capsules, etc.
• Provide sufficient data as support for the the optimized prescription process