Dried biotherapeutic composition, uses, and device and methods for administration thereof

A technology of biological therapy and composition, which is applied in the direction of drug combination, medical packaging, medical preparations containing active ingredients, etc., and can solve problems such as adverse gastrointestinal side effects and high blood pressure

Inactive Publication Date: 2009-04-22
THE BIO BALANCE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these nonsteroidal agents often produce adverse gastrointestinal side effects, renal failure, edema, and hypertension

Method used

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  • Dried biotherapeutic composition, uses, and device and methods for administration thereof
  • Dried biotherapeutic composition, uses, and device and methods for administration thereof
  • Dried biotherapeutic composition, uses, and device and methods for administration thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0108] Embodiment 1: the method for preparing bacterium

[0109] Bacteria of choice are first prepared for growth to obtain a concentration range in 0.3%-0.6% NaCl solution10 11 -10 12 CFU / ml of biomass to generate autolysates.

[0110] liquid medium

[0111] For the preparation of bacterial biomass, standard fermentation vessels with aeration can be used. Nutrients necessary for bacterial growth are added in two stages: in the first stage, as part of the initial batch medium, and in the second stage, as a continuous supplemental feed after the nutrients have been depleted in the production reactor liquid.

[0112] During a typical fermentation, the medium may consist of a suitable nitrogen source, glucose, sodium chloride, and a combination of disodium hydrogen phosphate and potassium dihydrogen phosphate sufficient to provide a neutral or slightly alkaline pH (7.2 ± 0.2).

[0113] Exemplary media contain phosphates, such as sodium and potassium phosphate; magnesium sulf...

Embodiment 2

[0131] Example 2: Preparation of Biotherapeutic Compositions - Exemplary Methods

[0132] Compositions according to the invention may optionally be prepared according to the following exemplified methods. Using standard microbial fermentation techniques, with optional probiotic Escherichia coli (10 8 -10 9 cells) to inoculate liquid or solid media components. Growth conditions preferably include continuous aeration, maintenance of neutral pH, and glucose supplementation. Such organisms are preferably not genetically engineered in any way, but are isolated from microflora obtained from the gastrointestinal tract of a normal human.

[0133] Manufacturing is optionally and preferably controlled with respect to the following critical control points:

[0134] Carefully receive and handle cultures;

[0135] Controlling processes to ensure proper culture conditions;

[0136] maintain sterility;

[0137] Processes are controlled to ensure the correct level of probiotics in the ...

Embodiment 3

[0146] Example 3: Exemplary Applicator

[0147] This example describes a number of different non-limiting, exemplary device embodiments for storing and administering biotherapeutic compositions according to the invention.

[0148] As shown in Figure 1, an exemplary device 100 in accordance with the present invention features a body 102 having a plurality of compartments (not shown, see Figure 2). Body 102 preferably communicates with a nozzle 104 for administering the mixture to a subject. The nozzle 104 is preferably covered with a cap 106, which can be removed for administration.

[0149] The main body 102 is preferably divided into a plurality of sections, the function of which is described in more detail below with reference to FIGS. 2 and 3 . The device 100 also preferably provides a handle 112, the function of which is described in more detail below also with reference to FIGS. 2 and 3 .

[0150] 2 and 3 show device 100 in cross-section. In FIG. 2 , the display devic...

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PUM

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Abstract

A biotherapeutic composition containing rapidly activatable bacteria in a dry form, a device for administering such a composition and methods of treatment thereof are disclosed. A method for preparing the biotherapeutic composition itself, as well as a method for preparing the bacteria for such a composition is also disclosed.

Description

field of invention [0001] The present invention relates to biotherapeutic compositions, and more particularly to dry biotherapeutic compositions comprising non-pathogenic bacterial strains, uses, compositions, methods of treatment, and means and methods of administration thereof. Background of the invention [0002] Probiotics refer to those bacteria that are beneficial to humans and / or animals. Known in the art is the use of probiotics for improving the microbial balance in the intestinal tract of mammals to prevent or treat gastrointestinal infections and other diseases or disorders that implicate and / or cause intestinal microbiota Changes in the composition of the microbiota, and / or lead to any changes in the composition of the microbiota, and / or maintain these changes, and changes in the composition of the microbiota that actively cause or enhance these diseases or disorders. [0003] However, the results of studies performed to date have been inconsistent and / or ambigu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J1/05A61K9/00A61K9/19A61K35/74A61P1/06A61P1/12A61J1/10A61J1/20A61KA61K9/22A61K35/741
CPCA61J1/065A61K35/74A61K9/19A61K9/0095A61J1/2093A61J2001/2041A61J2001/2027A61J7/0053A61K35/741A61J1/2041A61J1/2027A61P1/04A61P1/06A61P1/12A61P31/04A61P37/00Y02A50/30A61J7/00
Inventor A·E·康特D·C·卡特茨R·L·迪林哈姆
Owner THE BIO BALANCE
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