| Rx | ❖ The excipient type and quantity (Q1 and Q2) of the generic drug is equivalent to the reference listed drug (RLD). ❖ Effects of excipient’s quantity on permeation of skin were studied. ❖ Primary objective was to analyze excipient parameters such as viscosity, degree of polymerization, molecular distribution, etc, . ❖ Method was modified to prevent batch variation, nonuniformity and rheological properties change in the final product. |
| Process | ❖ Preprocessing of raw materials, alternative method of addition, melting point, shear velocity, preparation temperature and time. |
| Rx Background | ❖ An improved new drug, category 2.3. ❖ A compound tincture with low API proportion and complex excipients . ❖ Antibacterial efficacy studies was conducted to select the proper bacteriostatic agents and quantity. |
| Process | ❖ Method of addition of raw materials, the order of adding excipients, time and temperature for emulsification, shear velocity and time. |
| Packaging | ❖ Comparison and selection of alternative packaging materials from validated vendors. |
| Analysis | ❖ Sample preprocessing. ❖ Impurity profiling. |
| Technical Challenges and Resolution | ❖ Medicilon CMC team modified the addition method and determined adding API after cooling as a solution can solve the lows stability issue. ❖ Conducted extensive literature and market research on individual formulations on behalf of the client. ❖ Focused on tincture rheology and provided formulation development of the current Rx. ❖ Improve and ensure the feasibility of the process for scale-up, from 2kg→5kg→20kg→50kg→200kg. ❖ Complete curve of shear stress and shear velocity, yield stress and creep test and viscoelasticity. ❖ Study the relationship between emulsion size and stability, and control the appropriate particle size of the sample. |
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