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United' States Patent Office Patented Oct. 11, 1949 2,484,637 UNITED’ STATES PATENT OFFICE 2,484,637 POWDERED OINTMENT BASE OF METHYL CELLULOSE AND SORBITOL Albert M. Mattocks, Jr., and Wilbur A. Lazler, Birmingham, Ala., assignors to Southern Re search Institute, Birmingham, Ala., a corpora tion of Alabama No Drawing. Application August 20, 1946, ‘ Serial No. 691,867 . ' 1 Claim. (Cl. 167—63) 1 This invention relates to new therapeutic prep were encountered in the general use of such an arations and more particularly refers to dry, ointment since the prepared paste was biologically stable therapeutic powders capable on addition unstable and it was troublesome to prepare it in of Water of rapid transformation into gelatinous fresh condition as needed. ointments or ointment vehicles. From the foregoing it is evident that despite It is well known in the pharmaceutical ?eld the great need for hydrophilic ointments, the that the formulation, storage, and dispensing of difficulty of storing them“ or preparing them when drugs in water-miscible solid vehicles has pre needed has been such that these ointments have sented such extraordinary dif?culties that hydro not received the widespread use which their effec philic ointments have been very little used. Wet 10 tiveness warrants. This is true not only for oint . jellies such as starch paste and colloidal suspen ments which are particularly adapted for the sions of the soluble proteins and vegetable gums treatment of burns but also for hydrophilic oint not only are bulky and tend to “leak” as a result ments generally as vehicles for the application of of syneresis, but often give rise to various forms medicaments to the skin. of microbial deterioration. Moreover, they tend 15 It is an object of this invention to produce an to dry out, thus defeating the purpose for which entirely new class of easily wettable therapeutic they were compounded. Once dried, it is well ointment powders. It is a further object to pro known that such ointment bases are not easily duce ointments in powder form that are compact, rehydrated to give jellies having the proper tex biologically and chemically stable, and easily and 20 ture. ' quickly convertible on addition of water into ther Notwithstanding the foregoing difficulties, oint apeutically active jellies suitable for the treatment ment bases of hydrophilic character have been of wounds. A still further object is to produce demonstrated repeatedly to be useful in releasing an ointment vehicle in powder form having the medicaments for absorption through the skin, aforesaid properties, to which may be added what when applied to local areas of the body. For 25 ever medicament is desired at the time of use. example, extensive experiments in the use of sulfa Additional objects will become apparent from a , drugs have indicated the superiority of water consideration of the following description and dispersible preparations for the application of claims. these compounds. In the same manner, clinical These objects are attained in accordance with tests have demonstrated the value of hydrophilic 30 the present invention by mixing a cellulose ether ointments as a means of bringing powerful anti with a wetting agent and ?nely comminuting biotics into contact with surfaces of the body. the mixture either before or after incorporation A special problem in this connection is removal therein of the desired medicament. In a more of necrotic tissue from the site of burned tissue. restricted sense this invention is concerned with~ The removal of such tissue is important to avoid dry, stable therapeutic powders which speedily infection and permit granulation ofv new tissue dissolve in water to form jellies capable of pro which protects and heals the wound. In the past, ducing an adherent coating over wounds com mechanical debridement of burns by scrubbing prising a finely comminuted cellulose ether or surgery was common, but it caused consider throughout which is uniformly incorporated a able, pain and increased the danger from shock. 40 wetting agent, and if desired, a medicament. In In addition, it has been found to damage or re its preferred embodiment the cellulose ether is move residual islands of epithelial cells capable methyl cellulose and the wetting agent is sorbitol. of regenerating new tissue. Ethers of cellulose have been found to be sur~ In an endeavor to avoid the disadvantages of prisingly satisfactory swelling agents for the the customary mechanical debridement treatment powders of this invention since they are substan for burns, attempts have been made to remove tially unattacked by microorganisms, remain necrotis tissue therefrom by chemical means. stable when stored under widely varying condi G. Connor and S. C. Harvey (Ann. Surgery 120, tions, and form excellent jellies when dissolved 362 (1944)) found that jells containing organic in water. Unfortunately, cellulose ethers are acids such as pyruvic acid or succinic acids cause notoriously slow in dissolving in water, as a result removal of slough in a single tough pellicle, leav of which their application for therapeutic pur ing a clean granulating surface. Connor and poses has been seriously retarded. For instance, Harvey used cornstarch paste containing pyruvic when a chemist wishes to make an aqueous solu acid in a sufficient concentration to yield a jelly tion of methyl cellulose he ordinarily soaks it in having a pH of 1.9. Serious objections, however, cold water in a refrigerator overnight. If one adds 2,484,687 3 4 sorbitol or some other wetting agent to the water agent may be carried out in avariety of standard the time required to dissolve the cellulose ether mills such as the micropulverizer, the ball mill, is not substantially lowered. the hammer mill, the burr mill, or the micronizer. _ We have found that by mixing sorbitol or This invention may be more readily understood other suitable wetting agent with the cellulose by a consideration of the following illustrative ether and ?nely comminuting the mixture in a examples wherein the vquantities, unless other hammer mill or other efficient grinding device, a wise indicated, are stated in parts by weight. dry, stable powder is obtained which dissolves in water almost instantaneously, in contrast with Example 1 the inordinate periods formerly considered to be One hundred parts of methyl cellulose and 20 essential. In accordance with this invention, the parts of an 85% aqueous solution of sorbitol was powdered cellulose ether may be mixed in a dry thoroughly mixed and passed several times form with a wetting agent to which has been through a hammer mill. The product was a ?ne added, if desired, a medicament, and the mixture white powder. Whereas the original methyl cel thereafter ?nely comminuted by passing through lulose dissolved very slowly, it was found that the a hammer mill or similar device. However, op ?ne powder produced as aforesaid could be easily timum results are obtained if the cellulose ether wetted in less than a minute. is ?rst added to an aqueous solution of the wet ting agent (with or without medicament) and Example 2 the mixture stirred for a prolonged period until One hundred parts of methyl cellulose was in a homogeneous ointment is formed. Thereafter corporated with 20 parts of Xynomine (wetting this ointment is dehydrated in thin layers, such agent) and 9.5 parts of pyruvic acid. The mix as by spreading the mixture on sheets of glass ture was ?nely ground in a hammer mill until in layers about one-half centimeter thick and the whole mass would easily pass through a ?ne drying for 24 hours in an oven’ at about 75° C. - screen. The resulting ?ne white powder had a The dehydrated sheets thus produced are then fluffy appearance and swelled rapidly in eight ?nely comminuted in a pulverizing mill. The re ‘parts of water to give a. sticky semitransparent sulting powder has the surprising property of paste of a proper consistency for application as completely redissolving in water in approximately an ointment. The acidityof the aqueous oint 1 minute, so that it can be converted to an oint ment measured pH 1.87. The ointment was found ment whenever needed, and if desired medica to be very effective when applied as a dressing for ment may be added at the time of use. the debridementiof thermal or chemical burns. By the unique methods referred to above we Example 3 have succeeded for the ?rst time in preparing dry, easily wettable, biologically stable, solid ther- ' One hundred parts of methyl cellulose, 20 parts apeutic ointment bases wherein the gelling agent of 85% sorbitol syrup, and 12.3 parts of pyruvic is a cellulose ether. These powders may have acid was thoroughly mixed and passed through a the medicament incorporated therewith before pulverizing mill. The resulting ?ne powder wet comminution in the manner referred to previous ted with water in 2 minutes to give a clear jelly, ly. or if=an all-purpose ointment vehicle is de having a pH of 2.28. Similarly, another acid de sired the medicament may be omitted, to be bridement composition was prepared by substi added at the time of use. Preparation of these tuting 16.7 parts of phosphoric acid for the pvru powders with methyl cellulose, hydroxyethyl‘ cel vic acid used above. The pH of this composition lulose or other cellulose ethers as the gelling was 1.6. agents, imparts speci?c desirable characteristics 45 to the resulting ointments. These agents have Example 4 good body and cling to undersurfaces without One hundred parts of high viscosity hydroxy tendency to ?ow. They are free from irritation ethyl cellulose was formulated with 8.9 parts of and are inert towards microbial attack. Their pyruvic acid and 25 parts of Arlacel C (wetting viscosities may be varied within a wide range by 50 agent).
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