Gel compound of monoclonal antibody drugs

Abstract

The invention relates to a gel compound of monoclonal antibody drugs, which can be provided for patients to perform intradermal injection, surrounding-tumor injection or intratumor injection on clinic, and belongs to the technical field of medicinal preparation. The gel compound of the monoclonal antibody drugs comprises monoclonal antibodies, at least one kind of extracellular matrix degrading enzymes, such as collagenase or hyaluronidase, a temperature-sensitive gel material, menstruum, a buffering agent, a stabilizing agent, a nonionic surfactant and an osmotic regulating agent. The invention further provides a method and uses of the gel compound of the monoclonal antibody drugs. The gel compound of the monoclonal antibody drugs, which is disclosed by the invention, has the effects of prolonging the release of the monoclonal antibodies, and promoting the tissue osmosis of monoclonal antibodies or the osmosis of the monoclonal antibodies into tumors; the gel compound of the monoclonal antibody drugs has the advantage of reducing drug administration times and enhancing treatment effects.

Description

technical field [0001] The invention relates to a gel composition containing a monoclonal antibody, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] With the development of biotechnology, biopharmaceuticals represented by monoclonal antibodies have gradually entered people's field of vision, and have increasingly become the mainstream in the treatment of malignant tumors and autoimmune diseases. Monoclonal antibody drugs can overcome the disadvantages of poor selectivity and high toxicity of common chemotherapy drugs because of their high specificity in their effects. [0003] In the treatment of malignant tumors and autoimmune diseases, monoclonal antibody drugs specifically bind to the corresponding antigen on the cell surface, with high affinity and complex mechanism of action. Single or multiple pathways work together to achieve the purpose of killing tumor cells. These include 1. Direct effects of antibodies: receptor b...

AI Technical Summary

Problems solved by technology

[0005] Nowadays, while making great progress, monoclonal antibody drugs also have unavoidable shortcomings

Because of the nature of protein drugs, monoclonal antibody drugs are more difficult to extract and purify, and have poor stability during storage and use, and their biological activity is easily affected, resulting in high cost for patients. Monoclonal antibody low availability of medicines

Due to the nature of the protein, monoclonal antibody drugs are easily degraded by proteases in the gastrointestinal tract during oral administration. In addition, their biomacromolecule (molecular weight up to 150,000 Da) characteristics make it difficult to cross biological barriers such as small intestinal epithelium, making monoclonal antibody drugs Not for oral use

In the course of clinical use, monoclonal antibody drug administration is mostly a single intravenous infusion, which may be accompanied by severe "infusion reactions" during the infusion process, and it needs to be used for a long time, for example: in Her-2 positive breast cancer In the process of cancer treatment, patients need intravenous infusion once every week or every three weeks, and the treatment time is as long as 52 weeks, which brings great pain to patients and poor compliance

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