Minoxidil gel

Details Minoxidil gel Minoxidil gel

1990-08-17

1993-07-06

Page, Thurman K.

Drug, bio-affecting and body treating compositions

Live hair or scalp treating compositions

Amphoteric or zwitterionic surfactant containing

424 7802, 514929, A61K 706, A61K 31505

Patent

active

052251896

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

The present invention relates to a novel composition of matter. More particularly, the present invention relates to a topical gel for the administration of minoxidil. The chemical name for minoxidil is 2,4-diamino-6-piperidinylpyrimidine-3-oxide and is the active ingredient of Loniten.RTM. tablets which are marketed by the Upjohn Company for hypertension. See, Physician's Desk Reference, 38th Edition, page 2033 (1984). The preparation and antihypertensive use of this compound is described in U.S. Pat. No. 3,461,461. This compound is also useful when applied topically to grow hair as described and claimed in U.S. Pat. No. 4,139,619.


INFORMATION DISCLOSURE

The prior known topical pharmaceutical compositions of minoxidil are disclosed in U.S. Pat. No. 4,139,619. This patent describes topical compositions comprising minoxidil and a topical pharmaceutical carrier selected from the group consisting of ointments, lotions, pastes, jellies, sprays, and aerosols. In addition, pharmacies in the U.S. have made and sold gels of topical minoxidil containing carbomer, propylene glycol, and rubbing alcohol. Similarly, the pharmacists' column "Compounder's Corner", printed in, e.g., "The Missouri Pharmacist", page 35, (January 1987) suggests the preparation of a minoxidil gel containing carbopol, ethanol, and water. Neither of these latter formulations are believed to be pharmaceutically elegant.


SUMMARY OF THE INVENTION

The present invention particularly provides: components on a percent weight to weight basis (% w/w)


______________________________________ Component % weight to weight ______________________________________ (a) water q.s. 100 (b) carbomer 0.25-1.5 (c) minoxidil 0.001-3 (d) pharmaceutically acceptable 0.01-30 glycol (e) ethanol or isopropanol 20-40 (f) a water and alcohol 0.25-1.5 soluble amine ______________________________________ for a saturated solution of minoxidil; the specified ranges, calculated on the basis of the final gel composition, expressed as percent weight-to-weight:


______________________________________ % w/w ______________________________________ Part I (i) water q.s. 100 (ii) carbomer 0.25-1.5 Part II (iii) minoxidil 0.001-3 (iv) a pharmaceutically 0.01-30 acceptable glycol (v) ethanol or isopropanol 12.9-30 (vi) a water and alcohol 0.25-1.5 soluble amine; ______________________________________ for a saturated solution of minoxidil;


______________________________________ % w/w ______________________________________ Part III (vii) ethanol or isopropanol 27.1-15 (viii) a water and alcohol 0-0.4 soluble amine; ______________________________________ uniform gel is obtained.
The present invention thus provides a novel, pharmaceutically elegant means to topically administer minoxidil.
Pharmaceutically acceptable gels of minoxidil have not been previously described in any reference of which the inventor is aware.
Gels are semisolid systems consisting of either suspensions made up of small inorganic particles or large organic molecules interpenetrated by a liquid. Single-phase gels, as used herein, consist of organic macromolecules uniformly distributed throughout a liquid in such a manner that no apparent boundaries exist between the dispersed macromolecules and the liquid. Single-phase gels may be made from synthetic macromolecules (e.g., Carbomer) or from natural gums (e.g. Tragacanth).
The instantly claimed gel is a single phase gel made from a class of synthetic macromolecules called carbomers. A carbomer is a synthetic, high molecular weight, cross linked polymer of acrylic acid. Preferred for use in the instant invention is Carbopol.RTM. 934P, a pharmaceutical grade commercial product sold by B. F. Goodrich Company. Carbopol.RTM. 934P has an approximate molecular weight of 3.times.10.sup.6. Carbomers are well known to those of ordinary skill in the pharmaceutical art.
Attempts to form pharmaceutically elegant carbomer gels of minoxidil by conventional means are hamp

REFERENCES:
patent: 4139619 (1979-02-01), Chidsey, III
patent: 4478853 (1984-10-01), Chaussee
Allen, L. V. and M. L. Stiles, "Compounder's Corner", The Missouri Pharmacist, p. 35 (Jan. 1987).

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