STABLE COMPOSITIONS COMPRISING HEPARINOID, ACUTE-ACTING ANESTHETIC, AND BUFFER

摘要

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.

主权项

1. A method for preparing a composition useful for treatment of a lower urinary tract disease or condition comprising a heparinoid, an acute-acting anesthetic, and a buffer, the method comprising the steps of:
(a) providing a heparinoid, either as a solid or as an aqueous liquid, in a quantity of about 100 units to about 250,000 units per unit dose, or, alternatively, from about 0.5 mg to about 1250 mg per unit dose; (b) providing an acute-acting anesthetic, either as a solid or as an aqueous liquid, in a quantity of from about 5 mg to about 1000 mg per unit dose; (c) combining the heparinoid and the acute-acting anesthetic; and (d) buffering the combination of the heparinoid and the acute-acting anesthetic of step (c) to a pH value of greater than about 6.8 to about 8.3 with a buffer and the possible addition of a base selected from the group consisting of sodium hydroxide and potassium hydroxide compatible with both the heparinoid and the acute-acting anesthetic to form a stable solution, wherein the stability of the heparinoid and the acute-acting anesthetic in the stable solution is at least 90% after one year, up to 18 months.