Stable pharmaceutical composition of Anti-PD-1 antibody
Amino acid combinations in pembrolizumab formulations address high viscosity issues, achieving reduced viscosity and improved stability for efficient drug delivery.
AU2024413271A1Pending Publication Date: 2026-07-09QILU PHARMA CO LTD
Patent Information
- Authority / Receiving Office
- AU · AU
- Patent Type
- Applications
- Current Assignee / Owner
- QILU PHARMA CO LTD
- Filing Date
- 2024-12-27
- Publication Date
- 2026-07-09
AI Technical Summary
Technical Problem
High-concentration biologic formulations face challenges in controlling viscosity, which affects handling, delivery, and stability, particularly in subcutaneous administration, and existing stabilizers like sucrose or trehalose may compromise product stability when reduced to control viscosity.
Method used
A pharmaceutical composition of pembrolizumab using a combination of amino acids, such as arginine and proline, or arginine and sucrose, along with other excipients like polysorbate 80 and hyaluronidase, to optimize viscosity and stability, with pH control between 4.0-6.0.
Benefits of technology
The formulation effectively reduces viscosity and enhances stability, improving SEC and IEC purity, facilitating drug delivery and maintaining product integrity.
✦ Generated by Eureka AI based on patent content.
Smart Images
Figure 00000024_0000 
Figure 00000024_0001 
Figure 00000025_0000
Abstract
Provided is a stable pharmaceutical composition comprising an anti-PD-1 antibody. More particularly, the present invention relates to a pharmaceutical composition of pembrolizumab. The stability of the composition is ensured while the viscosity of a formulation is reduced, effectively solving the problems of high-concentration antibody formulations in drug manufacturing, storage and transportation, and drug delivery.
Need to check novelty before this filing date? Find Prior Art