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Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof

A diagnostic and therapeutic agent technology, applied to particles and suspensions containing therapeutic or diagnostic agents and their use, can solve the problem of unavailability

Pending Publication Date: 2019-08-02
ELEKTROFI INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, this formulation property is usually not available in aqueous solutions

Method used

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  • Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof
  • Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof
  • Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof

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Embodiment

[0149] The methods disclosed herein have been used on separate occasions to produce particles comprising bovine serum albumin (BSA), particles comprising fully human IgG, and particles comprising one of three discrete monoclonal antibodies. Various analytical techniques have been applied to assess the physical properties of the particles themselves as well as the structural and functional properties of the proteins they contain. Scanning electron microscopy and associated image analysis have been used to study particle morphology and size distribution, respectively. For certain excipient profiles, smooth particles of high sphericity are achieved, while the average size can be easily controlled over a wide range and have low dispersibility. In some cases, the particle surface is modified with excipients. Density and water content measurements indicated that the particles were close to crystalline packing efficiency and retained very low levels of residual moisture, especially ...

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Abstract

The invention provides particles, compositions including the particles, and methods of making the particles using electrospray. In certain embodiments, the particles allow for high concentrations of atherapeutic or diagnostic agent to be delivered at low viscosity. Particles may also exhibit beneficial properties with respect to stability.

Description

[0001] Background of the invention [0002] There is an urgent and unmet need for therapeutic and diagnostic agents that are reliably, conveniently and cost-effectively administered. This is especially true with regard to therapeutic proteins, such as monoclonal antibodies, which are increasingly important in the treatment of a wide range of life-threatening and debilitating diseases. Desirable formulations contain high concentrations of the therapeutic or diagnostic agent and impart appropriate stability so that a minimal volume of formulation can be used to administer high doses of the agent. In some cases, this helps to shorten the time to deliver the required dose and the pain or discomfort experienced by the patient. In some cases, it may also help to reduce the frequency of administration of the agent. However, such formulation properties are generally not available in aqueous solutions. High concentrations of aqueous therapeutic or diagnostic agents are often typified ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B01J13/04B05B5/00B05B5/025
CPCA61K9/14B05B5/025A61K9/1682A61K39/395A61K9/5089
Inventor C.科夫曼L.查尔斯P.布朗D.B.达顿L.刘C.罗宾逊
Owner ELEKTROFI INC