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Methods for treating pruritus

a technology of uremic pruritus and treatment methods, which is applied in the field of treatment methods of uremic pruritus, can solve the problems of difficult treatment and management of uremic pruritus, and the uremic pruritus in patients with kidney failure and/or patients undergoing dialysis can be quite disabling

Inactive Publication Date: 2014-11-27
TREVI THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a method of treating uremic pruritus (a condition that causes itching and burning sensations in patients with kidney disease) by administering an anti-pruritus agent called nalbuphine or a pharmaceutically acceptable salt or ester thereof. The method involves administering the anti-pruritus agent at an effective dose for at least one day, with the option of increasing the dose over several days. The anti-pruritus agent can be administered as a single dose or in a combination with other anti-pruritus agents. The method may also involve administering the anti-pruritus agent in an extended release oral dosage form. The invention provides a method for treating uremic pruritus that is effective and safe, with minimal side effects.

Problems solved by technology

Uremic pruritus in patients with kidney failure and / or among patients undergoing dialysis can be quite disabling.
Despite advances in the care of patients with kidney disease and end-stage renal disease (ESRD) patients, the treatment and management of uremic pruritus remains a challenge.

Method used

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  • Methods for treating pruritus

Examples

Experimental program
Comparison scheme
Effect test

examples 1 to 3

[0176]Three sustained release delivery systems were prepared by dry blending xanthan gum, locust bean gum, calcium sulfate dihydrate, and mannitol in a high speed mixed / granulator for 3 minutes. While running choppers / impellers, water was sprayed to the dry blended mixture, and granulated for another 6 minutes. Then the granulation process was stopped and the mixer / granulation bowl was scraped. While running choppers / impellers, the granulation was mixed for one more minute. After the granulation was checked for consistency, while running choppers / impellers additional water was added to the granulation and granulated for additional 3.5 minutes. The granulation was then dried to LOD (loss on drying) of less than about 4% by weight. The granulation was then milled using screen #1521-0033. The relative quantities of the ingredients are listed in Table 1.

TABLE 1Sustained Release DeliveryExample 1Example 2Example 3System Excipient%%%Xanthan Gum, NF8.012.020.0Locust Bean Gum, FCC12.018.030...

examples 4 to 7

[0177]A series of tablets containing different amounts of gum were prepared using the sustained release delivery system of Example 3. The quantities of ingredients per tablet are listed in Table 2.

TABLE 2Ex. 4Ex. 5Ex. 6Ex. 7ComponentMgMgmgmgNalbuphine60  60  60  60  HCI, USPSustained601 1201  1801  901 release deliverysystemMagnesium0.51.81.2 0.75stearate, NFTotal Weight120.5 181.8 241.2 150.75 Active:Gum1:0.51:11:1.51:0.75Tooling Size  0.2812″  0.2812″  0.3125″  0.2812″Hardness (Kp)1.28.88.97.21Sustained release system of Example 3

[0178]The tablets were prepared by mixing nalbuphine with the sustained release delivery system in a mixer. The magnesium stearate was passed through a #30 mesh screen sieve and then mixed with the dry blend containing nalbuphine and the sustained release delivery system. This lubricated blend was compressed using the tooling as specified in Table 2 to make tablets of the total weight indicated.

[0179]The tablets of Examples 4-7 were tested for in vitro % ...

examples 8 to 10

[0180]A series of tablets containing different amounts of gum and different sustained release delivery systems were prepared using the sustained release delivery systems of Examples 1 and 2. The quantities of ingredients per tablet are listed in Table 4.

TABLE 4Ex. 8Ex. 9Ex. 10ComponentmgMgmgNalbuphine606060HCI, USPSustained225215031003release deliverysystemMagnesium   1.43  1.1  0.8stearateTotal weight 286.4 211.1 160.8Active:Gum1:0.751:0.751:0.5Tooling Size    0.3125″    0.3125″    0.2812″Hardness (Kp)2017202Sustained release delivery system of Example 13Sustained release delivery system of Example 2

[0181]The tablets were prepared by first mixing nalbuphine with the sustained release delivery system in a mixer for Example 8 and in a high shear granulator for Example 9 and 10. For Examples 9 and 10, the blend was then granulated with water until consistent granulation was achieved, followed by drying in a fluidized bed dryer for 30 minutes at 70° C. The dried granules were then pass...

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Abstract

The present invention relates to methods for treating uremic pruritus with anti-pruritic compositions.

Description

RELATED APPLICATIONS[0001]This application is related to PCT International Application PCT / US2013 / 075096, U.S. application Ser. No. 14 / 106,673, and U.S. application Ser. No. 14 / 106,677, each of which claims priority to U.S. Provisional Application No. 61 / 737,488, filed Dec. 14, 2012, and U.S. application Ser. No. 13 / 715,625, filed Dec. 14, 2012. The application is also a Continuation of U.S. application Ser. No. 13 / 715,625. The contents of each of the aforementioned applications are incorporated by reference in their entireties for all purposes.FIELD OF THE INVENTION[0002]The present invention relates to methods for treating uremic pruritus with anti-pruritic compositions.BACKGROUND[0003]Uremic pruritus is a disorder associated with chronic kidney disease. Pruritus, or itch, is a sensation that stimulates the desire or reflex to scratch, which can be either generalized or localized. The cause of uremic pruritus is not fully understood. Overactivity of type 1 T helper cells (TH1) has...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/485
CPCA61K31/485A61K9/2018A61K9/205A61K9/2054A61K9/2077A61K9/209
Inventor SCIASCIA, THOMAS
Owner TREVI THERAPEUTICS
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