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Summary for Patent: 3,888,995
|Title:||Fatty alcohol-propylene glycol vehicle|
|Abstract:||A substantially non-aqueous medicant vehicle containing from 15 to 45 parts saturated fatty alcohol having from 16 to 24 carbons, from 45 to 85 parts glycol solvent, from 0 to 15 parts plasticizer, from 0 to 15 parts coupling agent, 0 to 20 parts penetrant, and if desired, other pharmaceutical adjuvants. This base is a suitable vehicle for all types of therapeutic agents for topical application including antibiotics, steroids, antihistamines, antiseptics, anesthetics, antibacterials, fungicides, and the like. The vehicle has shown particular advantages with anti-inflammatory topical corticoids.|
|Inventor(s):||Katz; Martin (Atherton, CA), Neiman; Herbert M. (Philadelphia, PA)|
|Assignee:||Syntex Corporation (PM)|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for patent 3,888,995|
1. A substantially anhydrous pharmaceutical vehicle of cream-like consistency consisting essentially of
a. from 20 to 35 parts by weight saturated fatty alcohol having from 16 to 24 carbon atoms,
b. from 55 to 80 parts by weight of a glycol solvent selected from the group consisting of 1,2-propylenediol, 1,3-propylenediol, dipropylene glycol, and mixtures thereof,
c. from 0 to 15 parts by weight of compatible plasticizer,
d. from 0 to 15 parts by weight of compatible coupling agent,
e. from 0 to 20 parts by weight of penetrant, and
f. from 0 to 3 weight percent water, the composition being substantially free from petrolatum, mineral oil, monohydric fatty alcohols and fatty acids which are unsaturated, and monohydric alcohols, fatty acids and fatty amides which have less than 16 carbon atoms, said vehicle being particularly suitable for providing an occlusive film for releasing topically active cortico-steroids, and for distributing medication over the skin surface and maintaining it there until beneficial action occurs.
2. The vehicle of claim 1 wherein said vehicle includes
c. from 2 to 10 parts by weight of compatible plasticizer, and
d. a concentration of coupling agent sufficient to prevent visible exudation of the glycol solvent from the composition after storage for 48 hours at 45.degree.C,
e. and from 0 to 10 parts by weight penetrant.
3. The composition of claim 1 wherein the compatible plasticizer is polyethylene glycol having a molecular weight of from above 800 up to 20,000, hexanetriol, sorbitol, glycerol or mixtures thereof.
4. The composition of claim 1 wherein the compatible coupling agent is fatty acid having from 16 to 24 carbons, fatty amide having from 16 to 24 carbons, fatty acid monoester with aliphatic alcohols or mixtures thereof.
5. The vehicle of claim 1 wherein said glycol solvent is propylene glycol, said propylene glycol being admixed with a polyethylene glycol which is liquid at room temperature.
6. A vehicle of claim 5 wherein said propylene glycol is 1,2-propylenediol.
7. A vehicle of claim 5 wherein said polyethylene glycol has an average molecular weight of about 400.
8. A vehicle of claim 5 wherein said propylene glycol is 1,2-propylenediol and said polyethylene glycol has an average molecular weight of about 400.
9. The vehicle of claim 1 wherein the glycol solvent is 1,2-propylenediol.
10. The vehicle of claim 1 wherein said vehicle contains about 30 parts by weight stearly alcohol.
11. The vehicle of claim 1 wherein said vehicle contains about 30 parts by weight stearly alcohol, 5 parts by weight polyethylene glycol 6000, 5 parts by weight 1,2,6-hexanetriol and about 60 parts by weight 1,2-propylenediol.
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