Address: 1 Broadway, Cambridge, MA02142 (America)
Tel: +1(626)986-9880
Address: Allia Future Business Centre Kings Hedges Road Cambridge CB4 2HY, UK
Tel: 0044 7790 816 954
Email: marketing@medicilon.com
Address: No.585 Chuanda Road, Pudong New Area, Shanghai (Headquarters)
Postcode: 201299
Tel: +86 (21) 5859-1500 (main line)
Fax: +86 (21) 5859-6369
Date: Saturday, June 3rd, 2023
Location: Boston Marriott Cambridge
Date: June 5-8, 2023
Location: Boston, MA
Booth: 2275-J
As of Beijing time The data is from a third-party organization and is only for reference.
For actual information, please refer to：www.eastmoney.com
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Business Inquiry
Global：
Email:marketing@medicilon.com
+1(626)986-9880(U.S. - West Coast)
0044 7790 816 954 (Europe)
China：
Email: marketing@medicilon.com.cn
Tel: +86 (21) 5859-1500
| 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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