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Novel aerosol formulations of ondansetron and uses thereof

Inactive Publication Date: 2020-08-27
LUXENA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a method for minimizing the first pass metabolism of a drug by using pulmonary administration of an aerosol formulation. This method also avoids gastrointestinal intolerance often associated with nausea and vomiting sufferers.

Problems solved by technology

Patients receiving highly emetogenic agents may postpone, or even refuse, potentially curative treatments.
Injection of ondansetron, although effective in reducing or preventing nausea and vomiting, is inconvenient, invasive and causes pain to the patients.
Existing forms of oral ondansetron tablets can be difficult to swallow and may be undesirable to some patients requiring anti-emetic therapy, especially those patients who have severe nausea or vomiting.

Method used

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  • Novel aerosol formulations of ondansetron and uses thereof
  • Novel aerosol formulations of ondansetron and uses thereof
  • Novel aerosol formulations of ondansetron and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

on of Spray Dried Ondansetron Fine Powder

[0150]Powdered ondansetron was prepared by spray drying with SPRAY DRYER SD-MICRO™ (manufactured by GEA Process Engineering, Inc., Columbia, Md., USA). The experiments were done at GEA Process Engineering, Inc., Columbia, Md., USA.

TABLE 1Parameters of Spray Drying to Prepare Ondansetron Fine PowderInletOutletSprayNozzleConc.N2Temp.Temp.RateDiameterRun(wt %)(kg / hr)(° C.)(° C.)(g / min)(mm)12.2730170855.80.522.2730170853.40.532.27301951005.00.5

example 2

Size Distribution of Spray Dried Ondansetron Fine Powder

[0151]The Particle Size Distribution of the Ondansetron Fine Powder, prepared by Spray Drying using the above parameters was measured by Malvern Mastersizer (Malvern Instruments, UK) at GEA Process Engineering, Inc., Columbia, Md., USA.

[0152]The typical Particle Size Distribution:

[0153]Mean Size: 4.80 μm

[0154]Std. Dev.: 1.59 μm

[0155]D10: 3.23 μm

[0156]D50: 5.01 μm

[0157]D90: 7.22 μm

[0158]Cumulative % on <10 μm: 99.5%

[0159]FIG. 2 shows the typical Particle Size Distribution of the Spray Dried Ondansetron.

example 3

icle Fraction by Laser Diffraction

[0160]The Fine Particle Fraction (FPF) of the dry powder ondansetron aerosol formulations was measured by Laser Diffraction at Drug Dynamics Institute, College of Pharmacy, The University of Texas at Austin, Austin, Tex., USA.

[0161]The dry powder formulation measured by NGI included:

[0162]Spray Dried Ondansetron (SDO): 14 mg;

[0163]Excipient: None.

[0164]A Malvern Spraytec equipped with an inhalation cell and induction port was used for measuring the aerosol emitted from a HandiHaler® operated at 60 LPM. Neat SDO was filled into size 3 hypromellose capsules and inserted into the HandiHaler®. Measurements were carried out over a 4 second duration at 10 measurements / second. The Refractive Index used for SDO was 1.68 with an imaginary index of 0.01. Particles were assumed to be spherical.

[0165]The results showed that the FPF (defined as % <5.41 μm) of the dry powder ondansetron formulation was 15.6%.

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Abstract

Aerosol formulations of ondansetron useful for pulmonary delivery are provided. The formulations are useful in the reduction, elimination or prevention of nausea and vomiting associated with chemotherapy, radiation therapy, and surgery. Also provided are novel methods to treat chemotherapy-induced nausea and vomiting (CINV), radiation-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV) using the inhalation formulations.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. Nonprovisional application Ser. No. 15 / 154,431, filed on May 13, 2016, which is a continuation of U.S. Nonprovisional application Ser. No. 14 / 323,115, filed on Jul. 3, 2014, now, abandoned, which claims benefit to U.S. Provisional Application Ser. No. 61 / 842,791, filed on Jul. 3, 2013, and U.S. Provisional Application Ser. No. 61 / 909,972, filed on Nov. 27, 2013, which are herein incorporated by reference in their entirety.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT[0002]Not Applicable.THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT[0003]Not Applicable.INCORPORATION-BY-REFERENCE OF THE MATERIAL ON THE COMPACT DISC[0004]Not Applicable.BACKGROUND OF THE INVENTIONField of the Invention[0005]Provided herein are novel aerosol inhalation formulations of ondansetron for pulmonary delivery; and uses thereof in the reduction, elimination or prevention of nausea and vomiting assoc...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/4178A61K9/16
CPCA61K9/008A61K31/4178A61K9/1623A61K47/26A61K9/0075A61K9/16A61P1/08
Inventor LI, XIAODONGLU, GEORGELU, BIAO
Owner LUXENA PHARMA
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