Claims for Patent: 5,364,615

Summary for Patent: 5,364,615

Title:	Prophylaxis of pneumocystis carinii with aerosilized pentamidine
Abstract:	A method of preventing clinically manifest Pneumocystis carinii pneumonia in immunocompromised humans is provided wherein an aerosol of pentamidine is administered to the patient in a manner which delivers the aerosol to the patient\'s alveoli. Also provided is a method of treating Pneumocystis carinii pneumonia in HIV seropositive individuals comprising administering a therapeutically effective amount of pentamidine aerosol to the HIV positive individual through inhalation. In addition, a method is provided of administering pentamidine to a human comprising aerosolizing a pentamidine solution in a nebulizer system having a one-way valve disposed between the nebulizer and the mouthpiece of the nebulizer system.
Inventor(s):	Debs; Robert J. (Mill Valley, CA), Montgomery; Alan B. (Redwood City, CA), Conte; John E. (Corte Madera, CA), Golden; Jeffrey A. (San Francisco, CA)
Assignee:	Regents of the University of California (Oakland, CA)
Application Number:	07/928,534
Patent Claims:	1. A method for prevention of Pneumonia caused by Pneumocystis carinii in human patients, by inhalation of an aerosolized pentamidine or salt thereof, said salt chosen from the group consisting of pentamidine isethionate, pentamidine glutamate, pentamidine lactate and pentamidine hydrochloride, and by delivery of said aerosolized pentamidine salt into the patients' alveoli in an amount which suppresses the growth of Pneumocystis carinii organisms improves patients' arterial oxygenation and vital capacity and reduces dyspnea and respiratory rate, wherein said method comprises the steps of: (a) preparing a solution consisting of about 300 mg of said pentamidine salt in sterile water; (b) nebulizing said pentamidine salt solution into particles having a mean particle diameter from about 0.25 to about 5 .mu.m using a nebulizer which consists essentially of: (ii) a tube providing an oxygen flow into the nebulizer; (ii) a nebulizer container holding the pentamidine solution for generation of aerosoiized particles in a conduit; (iii) the conduit; (iv) a mouthpiece; (v) a one way valve having a baffle for reducing larger particles to the particles having a mean diameter from about 0.25 to about 5 .mu.m; (vi) a one way valve leading to the particle filter for removal of residual pentamidine during exhalation; and (c) administering said pentamidine salt nebulized in step (b) for 15-60 minutes to patients once in two to four weeks. 2. The method of claim 1 wherein oxygen flows through the tube at a rate of 5-7 liters per minute into the nebulizer container filled with the pentamidine salt solution and aerosolizes pentamidine and generates particles between 0.5 to 5 microns in conduit; wherein the patient being treated draws on the mouthpiece drawing the air through the one-way valve, and the airstream entrains the pentamidine particles in the conduit; wherein the airstream containing the pentamidine aerosol particles passes around the baffle of the one-way valve which baffle reduces the particles having a mean particle size larger than 2 .mu.m to the particles having a mean diameter in a range from about 1 to about 2 .mu.m microns; and wherein the patient draws the nebulized particles through the mouthpiece into the lungs. 3. A method for prophylaxis of Pneumonia caused by Pneumocystis carinii in human patients by inhalation of an aerosolized pentamidine isethionate, and delivery of said aerosolized pentamidine isethionate into the patients' alveoli in an amount which suppresses and improves patient's arterial oxygenation and vital capacity and reduces dyspnea and respiratory rate, comprising the steps of: (a) preparing a solution consisting of about 300 mg of said pentamidine isethionate in sterile water; (b) nebulizing said pentamidine isethionate solution into particles having sizes predominantly from about 0.25 to about 5 .mu.m using a nebulizer which consists essentially of: (i) a tube providing an oxygen flow into the nebulizer; (ii) a nebulizer container holding the pentamidine isethionate solution for generation of aerosolized particles in a conduit; (iii) the conduit; (iv) a mouthpiece; (v) a one way valve having a baffle for reducing larger particles to the particles having a mean diameter from 0.25 to 5 .mu.m; (vi) a one way valve leading to particle filter for removal of residual pentamidine during exhalation; and (c) administering said pentamidine isethionate nebulized in step (b) for 15-45 minutes to patients once every three to four weeks. 4. The method of claim 3 wherein oxygen flows through the tube at a rate of 5-7 liters per minute into the nebulizer container filled with the pentamidine isethionate solution and aerosolizes pentamidine and generates particles between about 0.5 to about 5 microns in conduit; wherein the patient being treated draws on the mouthpiece drawing the air through the one-way valve, and the airstream entrains the pentamidine particles in the conduit; wherein the airstream containing the pentamidine isethionate aerosol passes around the baffle of the one-way valve which baffle reduces the particles having a mean particle size larger than about 2 .mu.m to the particles having a mean diameter in the range from about 1 to about 2 .mu.m; wherein the patient draws the nebulized particles through the mouthpiece into the lungs. 5. The method of claim 4 wherein 300 mg of pentamidine isethionate is dissolved in around 6 ml of sterile water and nebulized. 6. The method of claim 4 wherein the aerosolized pentamidine is administered once in three weeks. 7. A method for prophylaxis of Pneumonia caused by Pneumocystis carinii in human patients by inhalation of an aerosolized pentamidine isethionate, and delivery of said aerosolized pentamidine isethionate into the alveoli in an amount which suppresses the growth of the Pneumocystis carinii organisms, comprising the steps of: (a) preparing a solution consisting of about 300 mg of said pentamidine isethionate in 6 ml of sterile water; (b) nebulizing said pentamidine isethionate solution into particles having a mean particles diameter from about 0.25 to about 5 .mu.m using a nebulizer which consists essentially of: (i) a tube providing an oxygen flow into the nebulizer; (ii) a nebulizer container holding the pentamidine isethionate solution of step (a) for generation of aerosolized particles in a conduit; (iii) the conduit; (iv) a mouthpiece; (v) a one way valve having a baffle for reducing larger particle to particles having a mean diameter from about 0.25 to about 5 .mu.m; (vi) a one way valve leading to particle filter for removal of residual pentamidine during exhalation; and (c) administering said pentamidine isethionate nebulized in step (b) for 15-45 minutes to the patients daily for 4-21 days; wherein oxygen flows through the tube at a rate of 5-7 liters per minute into the nebulizer container filled with the pentamidine isethionate solution and generates particles between 0.5 to 5 microns in conduit of aerosolized pentamidine; and wherein the patients being treated draws on the mouthpiece drawing the air through the one-way valve, and the airstream entrains the pentamidine particles in the conduit; wherein the airstream containing the pentamidine isethionate aerosol passes around the baffle of the one-way valve which baffle reduces the particles having a mean particle size larger than about 2 .mu.m to the particles having a mean diameter in the range from about 1 to about 2 .mu.m; and wherein the patient draws the nebulized particles through the mouthpiece into the lungs.

Details for Patent 5,364,615

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2011-11-15