26-01-2017 дата публикации
Номер: US20170020862A1
Принадлежит:
A stable transmucosal composition consisting essentially of naltrexone hydrochloride in water is provided. The composition is surprisingly stable at room temperature and can be used for simple, rapid and effective opioid overdose rescue. 1. A pharmaceutical composition consisting essentially of naltrexone hydrochloride and water , the composition capable of maintaining at least about 90% of said naltrexone hydrochloride in undegraded form after storage for 180 days at room temperature.2. The composition of claim 1 , wherein the composition is capable of maintaining at least about 95% of said naltrexone in undegraded form after storage for 180 days at room temperature.3. The composition of claim 1 , wherein the naltrexone hydrochloride is present in the composition in an amount between about 0.001 mg/mL and 20 mg/mL.4. The composition of claim 3 , wherein the naltrexone hydrochloride is present in the composition in an amount between 0.5 mg/mL and 5 mg/mL.5. The composition of claim 1 , wherein the composition consists of naltrexone hydrochloride and water.6. The composition of claim 1 , wherein the composition does not contain a preservative.7. The composition of wherein the composition does not contain a buffering agent.8. The composition of wherein the composition does not contain a tonicity agent.9. The composition of claim 1 , wherein the composition does not contain a pH adjusting agent.10. The composition of claim 1 , wherein the composition consists of naltrexone hydrochloride dissolved in water at a concentration in the range of from about 0.001 mg/mL to about 20 mg/mL in sterile water or water for injection.11. A method for treating a patient suffering from claim 1 , or suspected of suffering from claim 1 , an opioid agonist overdose claim 1 , the method comprisingadministering transmucosally to the patient a first dose of a pharmaceutical composition consisting essentially of a pharmaceutically effective dose of naltrexone hydrochloride and water; wherein ...
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