Stable compositions comprising heparinoid, acute-acting anesthetic, and buffer

A technology of buffer solution and composition, applied in the field of stable composition, can solve the problems of reducing the curative effect of the composition, reducing the bioavailability and the like

Inactive Publication Date: 2016-01-20
URIGEN PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the mixing of heparin, lidocaine and buffer solvents must be done in a precise manner to avoid precipitation of lidocaine, which in the above case would produce precipitation above pH 7, which would decrease its bioavailability, and reduce the efficacy of the composition

Method used

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  • Stable compositions comprising heparinoid, acute-acting anesthetic, and buffer

Examples

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Effect test

Embodiment 1

[0128] Composition comprising heparin, lidocaine and bicarbonate

[0129] Heparin (50,000 units or 250 mg plus lidocaine (200 mg), buffered with sodium bicarbonate to pH 7.5 and a final volume of 15 ml. After 12 months and 18 months, both heparin and lidocaine remain Stability above 95%.

Embodiment 2

[0131] Composition comprising heparin, lidocaine and phosphate

[0132] (Predictive Example)

[0133] Heparin (50,000 units or 250 mg plus lidocaine (200 mg), buffered with phosphate to pH 7.5 and a final volume of 15 ml. After 12 months and 18 months, both heparin and lidocaine remain at Stability is above 95%.

Embodiment 3

[0135] Stability and absorption rate of composition including heparin, lidocaine and phosphate

[0136] Clinical trials are used to evaluate the stability and absorption rate of a composition comprising heparin, lidocaine and phosphate relative to lidocaine alone. Based on the standard of lidocaine concentration in the blood, a 25 ml solution composed of heparin and lidocaine includes 333 mg of lidocaine hydrochloride and 50,000 units of heparin, buffered with phosphate to a pH of 7.1-7.2, Available at professional compound pharmacies. For lidocaine, a 25 ml solution prepared with lidocaine hydrochloride contains 333 mg of lidocaine hydrochloride and has a pH of approximately 6.3 (unbuffered). The above-mentioned products were injected into the urethra and bladder of patients with interstitial cystitis, and blood was drawn 45 minutes later to measure the concentration of lidocaine in the blood, and the concentration of lidocaine was measured by high performance liquid chromatogr...

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Abstract

Improved methods for preparing compositions including a heparinoid, an acute-acting anesthetic, and a buffer are described. These methods result in compositions in which the heparinoid and the acute-acting anesthetic are at least 90% stable for one year. Compositions prepared by these methods and having such improved stability properties are also described, as well as methods for use of these compositions for treating, ameliorating, or preventing lower urinary tract disorders such as interstitial cystitis.

Description

[0001] References for related applications [0002] This case claims the priority right of the U.S. Provisional Application No. 61 / 757,592 filed by CL Parsons on January 28, 2013. The name of the provisional application: a stable composition containing heparinoids, emergency anesthetics and buffers, The disclosure content is incorporated herein by reference. Technical field [0003] The present invention relates to a stable composition, in particular to a composition comprising heparinoid, emergency anesthetic and buffer and a preparation method thereof. Background technique [0004] Interstitial cystitis (IC) is a chronic, progressive disease of the lower urinary tract that causes urgency and frequency of urination and / or pelvic pain. For many years, urologists considered interstitial cystitis to be a rare disease, and therefore, they did not have a broad and effective treatment. But in fact, the aforementioned diseases are quite common. In 1999, the prevalence of interstitial c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/727
CPCA61K45/06A61K31/167A61K9/0034A61K47/02A61K31/727A61P13/00A61P13/02A61P13/08A61P13/10A61P15/00A61P23/02A61P31/04A61P31/10A61P43/00A61K2300/00
Inventor 罗威尔·C·帕森斯
Owner URIGEN PHARMA INC
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