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Claims for Patent: 5,110,806

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Claims for Patent: 5,110,806

Title: Lung surfactant compositions
Abstract:An improved synthetic lung surfactant consists essentially of dipalmitoyl phosphatidyl choline, a C-14 to C-18 fatty alcohol (preferably hexadecanol), and a non-toxic nonionic surface active agent (preferably tyloxapol). The surfactant is prepared in a powdered lyophilized form that can be stored for extended periods at room temperature. The powdered product can be readily reconstituted by simply adding distilled water.
Inventor(s): Clements; John A. (Tiburon, CA)
Assignee: The Regents of the University of California (Oakland, CA)
Application Number:07/335,101
Patent Claims: 1. Synthetic lung surfactant compositions consisting essentially of

dipalmitoyl phosphatidyl choline,

a fatty alcohol having 14 to 18 carbon atoms, and

a non-ionic physiologically non-toxic surface active agent,

wherein the dipalmitoyl phosphatidyl choline is the major component by weight, present in at least 80% by weight of the sum of the weight of the dipalmitoyl phosphatidyl choline and fatty alcohol in the composition, and the fatty alcohol and surface active agent are each minor components by weight, and the fatty alcohol is hexadecanol.

2. Synthetic lung surfactant compositions consisting essentially of

dipalmitoyl phosphatidyl choline,

a fatty alcohol having 14 to 18 carbon atoms, and

a non-ionic physiologically non-toxic surface active agent,

wherein the dipalmitoyl phosphatidyl choline is the major component by weight, present in at least 80% by weight of the sum of the weight of the dipalmitoyl phosphatidyl choline and fatty alcohol in the composition, and the fatty alcohol and surface active agent are each minor components by weight, and the surface active agent is tyloxapol.

3. In artificial lung surfactant compositions including dipalmitoyl phosphatidyl choline as a major component by weight present in at least 80% by weight of the sum of the weight of the dipalmitoyl phosphatidyl choline and fatty alcohol in the composition, and a C14 to C18 fatty alcohol as a minor component by weight, the improvement comprising including a non-ionic physiologically non-toxic surface active agent a third component by weight which is present in a minor amount, and the non-toxic surface active agent is an alkyl aryl polyether alcohol.

4. A powdered lyophilized lung surfactant composition consisting essentially of a dipalmitoyl phosphatidyl choline, a C-14 to C-18 fatty alcohol, and a physiologically non-toxic non-ionic surface active agent, wherein the dipalmitoyl phosphatidyl choline is a major component by weight, present in at least 80% by weight of the sum of the weight of the dipalmitoyl phosphatidyl choline and fatty alcohol in the composition, the fatty alcohol and surface active agent are each minor components by weight, the fatty alcohol is hexadecanol, and the surface active agent is tyloxapol.

5. The compositions of claim 3 wherein the surface active agent is tyloxapol.

6. Synthetic lung surfactant compositions consisting essentially of

dipalmitoyl phosphatidyl choline,

a fatty alcohol having 14 to 18 carbon atoms, and

a non-ionic physiologically non-toxic dispersing surface active agent,

wherein dipalmitoyl phosphatidyl choline is the major component by weight, present in at least 80% by weight of the sum of the weight of the dipalmitoyl phosphatidyl choline and fatty alcohol in the composition, and the fatty alcohol and surface active agent are each minor components by weight.

7. The compositions of claim 6 wherein the fatty alcohol is hexadecanol.

8. The compositions of claim 6 suspended in saline solution.

9. In artificial lung surfactant compositions including dipalmitoyl phosphatidyl choline as a major component by weight present in at least 80% by weight of the sum of the weight of the dipalmitoyl phosphatidyl choline and fatty alcohol in the composition, and a C14 to C18 fatty alcohol as a minor component by weight, the improvement comprising including a non-ionic physiologically non-toxic dispersing surface active agent, as third component by weight which is present in a minor amount.

10. A powdered lyophilized lung surfactant composition consisting essentially of a dipalmitoyl phosphatidyl choline, a C-14 to C-18 fatty alcohol, and a physiologically non-toxic non-ionic dispersing surface active agent, wherein dipalmitoyl phosphatidyl choline is the major component by weight, present in at least 80% by weight of the sum of the weight of the dipalmitoyl phosphatidyl choline and fatty alcohol in the composition, and the fatty alcohol and surface active agent are each minor components by weight.

11. An improved synthetic lung surfactant composition having improved dispersant properties in aqueous suspension, as compared to a lung surfactant composition consisting essentially of dipalmitoyl phosphatidyl choline and a fatty alcohol having from 14 to 18 carbon atoms, which improved synthetic lung surfactant consists essentially of:

(a) dipalmitoyl phosphatidyl choline, which is present in at least 80% by weight of the total weight of the dipalmitoyl phosphatidyl choline and fatty alcohol,

(b) a fatty alcohol having from 14 to 18 carbon atoms, which is present relative to the sum of the weights of the organic components of dipalmitoyl phosphatidyl choline, fatty alcohol and surface active agent in between about 7% and 10% by weight, and

(c) a non-ionic physiologically acceptable non-toxic surface active agent having an alkyl aryl polyether alcohol type of the structure: ##STR3## wherein R=--CH.sub.2 CH.sub.2 O(CH.sub.2 CH.sub.2 O).sub.m CH.sub.2 CH.sub.2 OH;

R'=--C(CH.sub.3).sub.2 CH.sub.2 C(CH.sub.3).sub.2 CH.sub.3 ;

m=6 to 8; and

n=4 to 5, which is present in about 6 percent to 11 percent by weight of the total organic components of the composition.

12. The composition of claim 11 wherein the surface active agent is tyloxapol.

13. The composition of claim 11 wherein the dipalmitoyl phosphatidyl choline is at least 90 percent by weight of the total weight of the dipalmitoyl phosphatidyl choline and fatty alcohol.

14. The composition of claim 13 wherein the surface active agent is tyloxapol.

15. An improved powdered lyophilized lung surfactant composition which consists essentially of dipalmitoyl phosphatidyl choline, a C-14 to C-18 fatty alcohol, a physiologically acceptable non-toxic non-ionic surface active agent of the alkyl aryl polyether alcohol type of the structure: ##STR4## wherein R=--CH.sub.2 CH.sub.2 O(CH.sub.2 CH.sub.2 O).sub.m CH.sub.2 CH.sub.2 OH;

R'=--C(CH.sub.3).sub.2 CH.sub.2 C(CH.sub.3).sub.2 CH.sub.3 ;

m=6 to 8; and

n=4 or 5;

wherein

(a) the dipalmitoyl phosphatidyl choline is present in at least 80% or greater by weight of the total weight of the dipalmitoyl phosphatidyl choline and fatty alcohol,

(b) the fatty alcohol is present relative to the sum of the weights of the components of dipalmitoyl phosphatidyl choline, fatty alcohol and surface active agent in between about 7 and 10 percent by weight, and

(c) the surface active agent is present in between about 6 to 11 percent by weight of the sum of the total organic components of the composition.

16. The composition of claim 15 wherein the dipalmitoyl phosphatidyl choline is present in at least 90% by weight of the total weight of the dipalmitoyl phosphatidyl choline and fatty alcohol.

17. The composition of claim 15 wherein the surface active agent is tyloxapol.
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