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Natriuretic polypeptide delivery systems

a delivery system and natriuretic polypeptide technology, applied in the direction of peptides, peptide/protein ingredients, chemistry apparatus and processes, etc., can solve the problems of high occurrence of re-admission and mortality rate associated with discharged patients, and achieve the effect of improving hf symptoms, high occurrence of re-admission and mortality ra

Inactive Publication Date: 2014-12-04
MAYO FOUND FOR MEDICAL EDUCATION & RES +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The polymer gel composition effectively maintains therapeutic levels of natriuretic peptides in circulation for extended periods, improving treatment outcomes for heart failure and related conditions by reducing blood pressure, increasing urinary cGMP excretion, and providing sustained bioactivity, thereby decreasing re-admission and mortality rates.

Problems solved by technology

However, despite the improvements in HF symptoms as a result of the treatment during hospitalization, there is still a high occurrence of re-admission and mortality rate associated with discharged patients.

Method used

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  • Natriuretic polypeptide delivery systems
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  • Natriuretic polypeptide delivery systems

Examples

Experimental program
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Effect test

example 1

Sustained Delivery of Natriuretic Polypeptides for Three Weeks with In Situ Polymer Precipitation Delivery System

[0036]0.45% percentage weight / weight (w / w) of CD-NP was mixed with 40% poly(lactic-co-glycolic acid) in 39.55% (w / w) N-methyl-2-pyrrolidinone and 20% (w / w) triacetin. The resulting mixture was allowed to homogenize overnight. Three groups of 5 rats (Wistar male, 250-300 g) were injected subcutaneously with the gel. A fourth group (n=5) was injected with blank gels as vehicles. Rats sacrificed at respective time points (1 week, 2 weeks, or 3 weeks) for plasma and urinary evaluation.

[0037]Plasma CD-NP levels were significantly higher than vehicle: 32,700±2888 pg / mL, 13,977±3302 pg / mL, and 7,566±1115 pg / mL at weeks 1, 2, and 3 after gel injection. 24-hour urinary CD-NP excretion levels were significantly elevated at 107.3±12.7 pg / minute, 33.7±29.7 pg / minute, and 16.5±8.2 pg / minute at weeks 1, 2, and 3 as compared to 2.02±0.10 pg / minute pre-injection. No significant differenc...

example 2

In Vivo Evaluation of an In Situ Polymer Precipitation Delivery System for Natriuretic Polypeptides

Materials

[0039]Poly D,L-lactic-co-glycolic acid (PLGA) (17 kDa, 50:50 dl-LA to GA ratio, inherent viscosity: 0.2 dL / g; obtained from Purac Biomaterials, Gorinchem, Netherlands) was used to form gel formulations. HPLC grade N-methyl-2-pyrrolidinone (NMP; obtained from Sigma Aldrich) and triacetin (obtained from Fisher Scientific) were used as solvents. Both solvents were of low toxicity. CD-NP polypeptide preparations were obtained from Nile Therapeutics, Inc.

Synthesis of In Situ Polymer Precipitation Delivery System

[0040]Preparation of the injectable gel formulation was as followed. Briefly, CD-NP was dissolved in NMP solvent, and the resulting suspension was allowed to stir for at least 3 to 4 hours before the addition of pre-weighed polymer and triacetin solution. The quantities added were such that the polymer and triacetin content was 40% and 20% by weight, respectively, with the C...

example 3

Natriuretic Polypeptide Release Properties

[0072]In vitro studies were performed to determine the release properties of CU-NP polypeptides from polymer gels. An injectable gel system was designed and used to evaluate sustained release of CU-NP polypeptides over one month. Several gel parameters were investigated. First, three types of polymers were investigated: PLGA (50 / 50) with an intrinsic viscosity 0.4 dL / g (IV0.4), PLGA (50 / 50) with an intrinsic viscosity of 0.2 dL / g (IV0.2), and acid-capped PLGA (50 / 50) with an intrinsic viscosity of 0.2 dL / g (IV0.2A). Second, three different percentages of polymer within the gel preparation were investigated: 20 percent polymer (PGLA), 30 percent polymer (PGLA), and 40 percent polymer (PGLA). Third, different levels of triacetin solvent were evaluated: zero percent triacetin, 10 percent triacetin, and 20 percent triacetin. Fourth, two drug loading concentrations were tested: 0.15 percent CU-NP polypeptides and 0.3 percent CU-NP polypeptides. A...

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Abstract

This document provides natriuretic polypeptide delivery systems. For example, methods and materials related to natriuretic polypeptide delivery systems, methods and materials related to the use of such delivery systems to deliver natriuretic polypeptides to a mammal over a pro-longed period of time (e.g., weeks to months), and methods and materials related to treating heart failure conditions are provided.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. application Ser. No. 13 / 788,309, filed Mar. 7, 2013, which claims the benefit of U.S. Provisional Application Ser. No. 61 / 740,652, filed Dec. 21, 2012. The disclosure of the prior applications are considered part of (and are incorporated by reference in) the disclosure of this application.STATEMENT AS TO FEDERALLY SPONSORED RESEARCH[0002]This invention was made with government support under grant numbers HL83231 and HL76611 awarded by the National Institutes of Health. The government has certain rights in the invention.BACKGROUND[0003]1. Technical Field[0004]This document relates to natriuretic polypeptide delivery systems. For example, this document provides methods and materials related to natriuretic polypeptide delivery systems and methods and materials related to the use of such delivery systems to deliver natriuretic polypeptides to a mammal over a pro-longed period of time (e.g., weeks to ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K47/34A61K38/22
CPCA61K38/2242A61K47/34A61K9/0024A61K47/14A61K47/22
Inventor CHEN, HORNG H.BURNETT, JR., JOHN C.GHIM, LIM SOOVENKATRAMAN, SUBRAMANIAN K.
Owner MAYO FOUND FOR MEDICAL EDUCATION & RES
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