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Formulations for alteration of biophysical properties of mucosal lining

A formulation and lining technology, applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of harmful mucous membranes

Inactive Publication Date: 2008-08-06
PULMATRIX
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Unfortunately, large amounts of these substances have been found to be harmful to mucous membranes

Method used

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  • Formulations for alteration of biophysical properties of mucosal lining
  • Formulations for alteration of biophysical properties of mucosal lining
  • Formulations for alteration of biophysical properties of mucosal lining

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0123] Example 1: Using SRM equipment to study the impact of different formulations on the number of particle counts in vitro

[0124] The four formulations were tested in vitro using the SRM apparatus as described above and compared to a mucus simulant alone (sham) used as reference. The mucus mimic product and SRM method described above were used in each experiment. The following formulations were tested: (1) 0.9% isotonic saline, (2) 1.29% calcium chloride (CaCl 2 ) in 0.9% isotonic saline solution, (3) 0.1% sodium dodecyl sulfate (SDS) in 0.9% isotonic saline solution, and (4) 1% polydextrose in 0.9% isotonic saline solution. For all tests, the simulated height applied to the tank was maintained at a fixed 2mm height (6.4ml total simulated volume). The simulants were allowed to crosslink for 15 minutes and each formulation was then aerosolized using the Aeroneb Go (Aerogen, Mountain View, CA) to the simulants for 2 minutes prior to testing. Each test was repeated at lea...

Embodiment 2

[0126] Example 2: In vitro measurement of formulation (in saline and aqueous solution) effects on reduction of exhaled particulates using SRM equipment

[0127] To further understand the mechanism of particle inhibition, the formulations were prepared in deionized (DI) water and saline. The mucus mimic product and SRM method described above were used in each experiment. For all tests, the simulated height applied to the tank was maintained at a fixed 2mm height (6.4ml total simulated volume). The simulants were allowed to crosslink for 15 minutes and each formulation was then aerosolized using the Aeroneb Go (Aerogen, Mountain View, CA) to the simulants for 2 minutes prior to testing. Each test was repeated at least 3 times and then average cumulative particle count and standard deviation values ​​were calculated. These results are graphically depicted in FIG. 3 .

[0128] As shown in Figure 3, when the saline used in a particular formulation was replaced by deionized (DI) ...

Embodiment 3

[0129] Example 3: The conductivity value of different formulations and the influence of formulation conductivity on the cumulative particle count when using SRM equipment in vitro measurement

[0130] To determine the effect of formulation charge / conductivity on the inhibition of particle formation, the conductivity of different formulations was measured and plotted against cumulative particle count. The following 10 formulations were tested: (1) 0.45% saline, (2) 0.9% isotonic saline, (3) 1.45% saline, (4) CaCl 2 In isotonic saline (1.29%), (5) CaCl 2 In DI water (1.29%), (6) CaCl 2 in DI water (1.87%), (7) SDS in isotonic saline (0.1%), (8) SDS in DI water (0.1%), (9) polydextrose in isotonic saline (1%), and (10) Polydextrose in DI water (1%). Conductivity values ​​for each of the different formulations and mucus simulants were measured using a Brookhaven ZetaPALS particle sizer (Brookhaven Instruments, Holtsville, NY). This instrument measures the zeta potential of a g...

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Abstract

The inventors have developed conductive formulations and methods of use thereof containing conductive agents that are ionic or readily ionizable in aqueous or organic solvent environments, such as salts, ionic surfactants, or other substances. The formulation may optionally contain one or more active agents, eg, antiviral, antimicrobial, anti-inflammatory proteins or peptides. The active agent can be co-administered or incorporated into the formulation, or can be administered after administration of the conductive formulation. When applied to a mucosal lining fluid, the formulation alters the physical properties of the mucosal lining, such as surface tension, surface elasticity, and bulk viscosity. The formulations are administered in amounts sufficient to alter the biophysical properties of the mucosal lining in vivo. The formulation can be administered for several different purposes: to reduce the spread of viral and bacterial infectious diseases such as SARS, influenza, tuberculosis, and RSV in humans, and foot-and-mouth disease in artiodactyls; Ambient pollution caused by particle formation when sneezing or talking is particularly important in the use of clean rooms; reducing or preventing the occurrence of obstructive sleep apnea and some cases of irritable bowel syndrome; and controlling the intake of drug molecules and pathogens into the dynamics.

Description

[0001] Cross-References to Related Applications [0002] This application claims priority to U.S.S.N. 60 / 682,356, filed May 18, 2005, entitled "Formulations for Alteration of Biophysical Properties of Mucosal Lining." technical field [0003] The present invention is in the field of formulations and methods for controlling the dispersion of particles from mucosal surfaces and altering the kinetics of drug molecule and pathogen uptake. Background technique [0004] Many organs have a fluid mucosal lining, whose biophysical properties can help or hinder normal function. Many adverse health effects are related to the properties of the mucosal lining, for example, particles shed from upper airway mucosal lining fluid (UAL) during normal exhalation may harbor viable infectious bacterial or viral pathogens, e.g., severe acute respiratory syndrome ("SARS"), influenza, tuberculosis, which can be spread to healthy individuals via inhalation; the surface tension of UAL has been shown...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K47/12A61K47/02
CPCA61K9/0014A61K9/0034A61K9/0043A61K9/0048A61K9/007A61K9/0078A61K47/02A61K47/12A61K31/255A61K31/721A61K33/14A61P1/00A61P1/12A61P1/14A61P11/00A61P11/06A61P11/12A61P31/04A61P31/12A61P43/00Y02A50/30A61K9/12A61K9/08A61K9/00
Inventor W·瓦塔纳贝M·托马斯J·卡茨特拉R·克拉克
Owner PULMATRIX
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