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Dry microparticles

A dry and particulate technology, applied in microcapsules, freeze-dried delivery, antibody medical components, etc., can solve problems such as water adsorption, no expected protein stability, and no expected performance of cyclodextrin

Pending Publication Date: 2021-12-17
UCB PHARMA SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, cyclodextrins do not have expected properties when used in spray-dried formulations, nor do they have expected stabilizing effects on proteins (Johansen et al., 1998)
Also, it has some disadvantages such as it absorbs water

Method used

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Examples

Experimental program
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Embodiment Construction

[0018] - The term "solvent" as used herein means an aqueous or non-aqueous liquid solvent.

[0019] When a solvent is used to resuspend the pharmaceutical compound, the choice of solvent depends primarily on the solubility of the pharmaceutical compound in the solvent and the mode of administration. For resuspending microparticles comprising proteins such as antibodies, aqueous solvents are preferred. Aqueous solvents may consist of water alone, or may consist of water and one or more miscible solvents, and may contain dissolved solutes, such as buffers, salts, or other excipients. According to the present invention, preferred solvents for resuspending one or more microparticles prior to administration to a patient are aqueous solvents, such as water or saline solvents.

[0020] When the solvent is used for solubilizing the polymers required to form the antibody-loaded microspheres, it is typically selected from acetonitrile, ethyl acetate, acetone, tetrahydrofuran, and chlor...

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PUM

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Abstract

The present invention is directed to pharmaceutical compositions, and in particular to slow release pharmaceutical compositions comprising antibody molecule-loaded polymeric microspheres, in the form of dry microparticles. The dry microparticles, and pharmaceutical compositions comprising said dry microparticles, are stable during manufacturing and upon storage and demonstrate interesting slow-release characteristics. In addition, the invention relates to methods for preparing said dry microparticles.

Description

[0001] field of invention [0002] The present invention relates to pharmaceutical compositions, and in particular to sustained release pharmaceutical compositions comprising polymer microspheres loaded with antibody molecules in dry particulate form. The dry microparticles and pharmaceutical compositions comprising the dry microparticles are stable during manufacture and storage and exhibit an interesting slow release profile. Furthermore, the invention relates to a method for preparing said dry microparticles. [0003] technical background [0004] Typically, therapeutic proteins, such as antibodies, are administered subcutaneously or intravenously. Nonetheless, patients and physicians may be reluctant to use these drugs due to pain and inconvenience if administered repeatedly through these invasive routes. Unfortunately, most therapeutic proteins on the market require frequent administration. [0005] One formulation form that can improve the dosing regimen for a given dr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K9/16C07K16/00
CPCC07K16/00A61K9/16A61K39/39591A61K9/5036A61K47/6951C08B37/0015A61K9/1647A61K9/1652A61K47/40A61K47/26A61K9/107A61K9/19A61K2039/505
Inventor A·F·阿里吉J·E·M·戈乐S·马凯特
Owner UCB PHARMA SA