7 results about "Nalmefene" patented technology

This invention discloses a stable nalmefene hydrochloride injection and its preparation method, relating to the field of biomedical technology. The injection consists of nalmefene hydrochloride, sodium chloride, hydrochloric acid, and water for injection, and contains no metal ion chelating agents, with a pH value controlled between 3.5 and 3.6. The method includes: preparing the solution and adjusting the pH under high-purity nitrogen protection in a solution preparation system with low metal ion introduction risk; filtering the solution through a polyethersulfone membrane with low metal leaching, and then filling it into ampoules with a vulcanized inner surface. This invention, through the systematic integration of multiple measures such as source control of the solution preparation system, inert atmosphere protection, precise pH control, surface passivation of packaging materials, and the use of high-purity materials, synergistically inhibits the metal ion catalytic oxidation of the active ingredient, ensuring that the content of the key degradation impurity II (2,2'-bisnalmefene) remains stably below the quality standard during long-term storage, solving the problem of chemical stability control of products in chelator-free formulations, and combining safety and process robustness.

The presently disclosed subject matter is directed to an effective method of treating chronic kidney disease-associated pruritus. Particularly, the method comprises the transmucosal administering of nalmefene to treat chronic kidney disease-associated pruritus, as well as cholestatic pruritus and / or prurigo nodularis. The nalmefene can be configured in a single layer film comprising at least two distinct domains. The film can include a first discrete domain comprising about 50-100 weight percent polymer matrix and the second discrete domain can comprise the nalmefene or pharmaceutically acceptable nalmefene salt.

This application discloses nalmefene base, its preparation method, and its application, belonging to the field of pharmaceutical technology. The preparation method of nalmefene includes the following steps: mixing nalmefene hydrochloride with water to form an aqueous solution of nalmefene hydrochloride; reacting the aqueous solution of nalmefene hydrochloride with an aqueous solution of an alkaline component to form nalmefene base; the pH of the nalmefene hydrochloride is 4.0-6.5; the alkaline component includes at least one selected from sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, sodium acetate, ammonia, and sodium dihydrogen phosphate. This application uses nalmefene hydrochloride with a pH of 4.0-6.0 to undergo a desalting reaction with an aqueous solution of a strong base-weak acid salt or a weak base, crystallizing out nalmefene base. This effectively controls the particle size and shape of nalmefene base, obtaining small-particle-size, low-content, stable, and poorly soluble tablet-shaped nalmefene base without pulverization. It is less prone to burst release, meeting the requirements for sustained-release formulations, and the reaction is mild, green, and economical.

This disclosure provides devices, delivery systems, medicaments, and methods for use to rescue a subject identified in need thereof from opioid overdose. In certain embodiments, the device is an injection device (such as, an autoinjector) for intramuscular or subcutaneous administration of a medicament comprising a therapeutically effective amount of nalmefene or a pharmaceutically acceptable salt thereof.

The application is directed to an efficient process for crystallizing nalmefene hydrochloride in a hydrated form from an aqueous hydrochloric acid solution (or a mixture) with a high yield.

The invention provides an in-situ gel composition containing xenomeline. The in-situ gel composition containing xenomeline is prepared from 1 to 30 percent of xenomeline, 25 to 50 percent of a slow-release carrier material and 30 to 70 percent of a solvent. The slow-release carrier material is selected from one or more of sucrose acetate isobutyrate (SAIB), polyorthoester (POE) and poly (lactic-co-glycolic acid) (PLGA). The composition can be applied by injection, forms a gelatinized medicine storage cavern at an administration part, continuously delivers medicines, and has a remarkable long-acting slow-release effect and good stability and safety.

To provide a method and device for treating pruritus associated with chronic kidney disease. [Solution] The subject matter of this disclosure relates to an effective method for treating pruritus associated with chronic kidney disease. Specifically, the method comprises administering nalmefene transmucosally to treat pruritus associated with chronic kidney disease, as well as cholestatic pruritus and / or nodular prurigo. The nalmefene is disposed on a monolayer film comprising at least two distinct domains. The film may contain a first distinct domain comprising about 50–100 weight percent of a polymer matrix, and the second distinct domain may contain nalmefene or a pharmaceutically acceptable nalmefene salt.