US3480014A

US3480014A - Method for ointment storage and dispensing

Info

Publication number: US3480014A
Application number: US579705A
Authority: US
Inventors: John C Callahan
Original assignee: American Cyanamid Co
Current assignee: Wyeth Holdings LLC
Priority date: 1966-09-15
Filing date: 1966-09-15
Publication date: 1969-11-25
Anticipated expiration: 1986-11-25

Description

Nov. 25, 1969 J. c. CALLAHAN METHOD FOR OINTMENT STORAGE AND DISPENSING Filed Sept. 15. 1966 H T a m mm Blair, Bzukies & (esarl United States Patent Office 3,480,014 Patented Nov. 25, 1969 3,480,014 METHOD FOR OINTMENT STORAGE AND DISPENSING John C. Callahan, Orangebnrg, N.Y., assignor to American Cyanarnid Company, Stamford, Conn. Filed Sept. 15, 1966, Ser. No. 579,705 Int. Cl. A61m 35/00; A61j 3/04 US. Cl. 128261 1 Claim ABSTRACT OF THE DISCLOSURE This invention relates to a method for storing and dispensing ointment. More particularly, it relates to an airand moisture-tight cartridge assembly particularly adapted for use with a syringe-applicator to dispense medicinal ointment for dental purposes.

In the past, medicaments in the form of ointments, creams, pastes, and the like (herein generically termed ointments) have been stored in and dispensed from collapsible squeeze tubes made of metal or plastic. These tubes have been found to contain residual air and moisture, and their construction readily permits entry of further air and moisture through seams or through the tube orifice upon removal of the cap. Accordingly, medicinal ointment susceptible to oxidation will often decompose or discolor during storage in such a tube. Other ointments may harden upon exposure to air or moisture. Such deterioration of a medicinal ointment will usually necessitate its discard because of actual or suspected loss of potency and, thus, the shelf life of many medicinal ointments has been unsatisfactory in prior art containers.

Further, collapsible squeeze tubes, particularly those made of metal, are unsatisfactory for the dispensing of high-viscosty ointments. The pressure produced in squeezing such an ointment from the tube often will cause tube rupture resulting in waste and the possibility of contamination.

The use of metal collapsible squeeze tubes may also result in contamination of the ointment due to metal corrosion caused by either air, moisture, the ointment itself, or a combination of these factors.

Accordingly, an object of the present invention is to provide an improved storage and dispensing container for medicinal ointment.

Another object of the invention is to provide a novel method for storing and dispensing medicinal ointment.

A further object of the invention is to provide a container of the above character in which ointment may be stored for substantial periods of time without deterioration.

Another object of the invention is to provide a container of the above character suited for use with high-viscosity ointment.

Another object of the invention is to provide a container of the above character which is particularly adapted for use in applying medicinal ointment to the teeth or gums for therapeutic purposes.

A further object of the invention is to provide a container of the above character adapted for use in a syringe applicator.

Another object of the invention is to provide a container of the above character which is simple in concept, inexpensive, and safe and convenient in use.

Other objects of the invention will in part be obvious and will in part appear hereinafter.

The invention accordingly comprises the several steps and the relation of one or more of such steps with respect to each of the others, and the apparatus embodying features of construction, combinations of elements, and arrangement of parts which are adapted to effect such steps, all as exemplified in the following detailed disclosure, and the scope of the invention will be indicated in the claim.

For a fuller understanding of the nature and objects of the invention, reference should be had to the following detailed description, taken in connection with the accompanying drawings, in which:

FIGURE 1 is a perspective view of the cartridge dispenser of the invention as used in a syringe applicator to apply medicinal ointment to a tooth cavity;

FIGURE 2 is a partly exploded, side elevation view of the cartridge dispenser and syringe applicator assembly, ,shown partly in section;

FIGURE 3 is an enlarged, exploded, perspective view of one end of the cartridge assembly illustrating the stopper thereof;

FIGURE 4 is an enlarged, side sectional view of the stopper taken along the line 44 of FIGURE 3;

FIGURE 5 is a partly exploded, side elevation view of another embodiment of the cartridge assembly, shown partly in section; and

FIGURE 6 is a side elevation view of the cartridge assembly with protective caps secured to the ends thereof.

Similar reference characters refer to similar parts throughout the several views of the drawings.

Generally, referring to FIGURES 1 and'2, the container of the invention is a cartridge assembly 8 constructed for use in the storage of medicinal ointment and the dispensing thereof in conjunction with a syringe applicator 9. Cartridge assembly 8 comprises a tubular member 10 having identical air-

tight stoppers

12 and 14 sealing either end. Either

stopper

12, 14 is slidable within the bore of tubular member 10 to eject the ointment therefrom when actuated manually by means of the plunger 16 of syringe applicator 9. As shown, the dispenser of the invention is particularly adapted to the manual administration of medicinal ointment to a tooth cavity 18.

Specifically, with reference to FIGURE 2, the tubular member 10 is preferably formed of glass so as to be non-reactive with the medicinal ointment contents 11. However, other non-corrosive materials such as styrene and other resinous plastics may also be used. Where the contents of the cartridge are also light-sensitive, the glass or plastic may be tinted or covered to screen out harmful wavelengths A pair of identical stoppers 12, 14 (FIGURES 3 and 4) are tightly fitted within the ends of tubular member to render each end airand moisture-tight. Preferably, the

stoppers

12, 14 are of a resilient material such as rubber or plastic. Each stopper is formed with a pair of

grooves

20, 22 encircling its periphery so as to produce three gaskets a, b, and c. The

grooves

20, 22 serve a dual function. First, they provide three barriers (gaskets a, b, and c) to the intrusion of air or moisture into cartridge assembly 8. Since each gasket is independently affected by stopper movement through the bore of tubular member 10, the chances of air or moisture leakage past all three is remote. Secondly, the grooves diminsh the area of contact between tubular member 10 and the stopper. Thus, sliding friction is substantially reduced and each stopper can be readily pushed through the bore of tubular member 10 to expel the contents thereof.

As shown most clearly in FIGURE 4, an opening 24 is formed into one end of and partially through each stopper, thus leaving a membrane 26 sealing the other end. Membrane 26 should be thin enough to be readily puncturable so that either stopper can function adjacent the needle end of the syringe applicator; however, it should be strong enough to withstand the pressure of plunger 16 so that either stopper can function adjacent the plunger end of the syringe applicator as well.

With the provision of two identical stoppers, the problem of properly aligning cartridge assembly 8 in syringe applicator 9 is eliminated. Thus, convenience is attained, while the possibility of waste due to inadvertent puncture of the wrong stopper is removed.

The present cartridge assembly tends itself ideally to multiple dosage applications. For this purpose, gradua tion indicia 28 may be provided on tubular member 10 as shown in FIGURE 1, to facilitate the determination of proper dosage size.

Where highest standards of purity are to be maintained for the contents of the cartridge assembly, the stoppers may be covered with a protective cap 30 (FIG- URE 6) made from a suitable material such as aluminum. Cap 30 is removed only when the cartridge assembly is ready for use. As broadly discussed above, preferably used in conjunction with a syringe applicator as shown in FIGURES 1 and 2. Specifically, syringe applicator 9 comprises a cylindrical, tubular body 31 having a cutout portion 32 for receipt of cartridge assembly 8. One end of tubular body 31 is necked down and threaded at 34 for engagement with a needle member shown generally at 35.

Needle member 35 comprises a relatively long injection portion 36 secured to a threaded cap 38. Injection portion 36 extends through cap 38 producing a rearwardlyextending, relatively short puncture portion 40, Injection portion 36 and puncture portion constitute a single, continuous hollow needle. Needle member 35 is fastened to syringe applicator 9 by threading cap 38 onto threads 34.

the cartridge assembly is It can be seen that when needle member 35 is fastened to syn'nge applicator 9, puncture portion 40 enters the stopper of a pre-positioned cartridge assembly 8 through opening 24 (FIGURE 4), puncturing membrane 26 and coming into contact with the medicinal ointment contents.

The gauge of

needle portions

36 and 40 should be sufficiently large to convey ointment constituents without clogging. For most dental ointments, a needle size of 14-18 gauge has been found satisfactory.

A finger grip 42 is attached to tubular member 31 at the end opposite needle member 35 and is held in position by a screw cap 44.

Plunger 16 comprises a shaft 46 slidably mounted in cap 44 and terminating at one end in a plunger tip 48 positioned within cutout portion 32 (FIGURE 2). A pressure pad 50 is attached at the other end of shaft 46.

To expel the ointment from cartridge assembly 8, the operator grasps syringe applicator 9 with his index and .4 middle fingers behind finger grip 42 and his palm against pad 50. Then, by exerting pressure, tip 48 is brought to bear against the adjacent stopper of cartridge assembly 8, pushing it through the bore thereof and expelling ointment at the other end through needle member 35.

As a specific example, a cylindrical glass cartridge as sembly in accordance with the invention, having nonreactive butyl rubber stoppers, has been used to store and dispense a dental ointment of the following composition:

Percent Calcium dimethylchlortetracycline 3.15 Triamcinolone acetonide 1.05 Calcium chloride 3.0 Triethanolamine 2.3 Zinc oxide 16.7 Sodium bisulfite 0.3 Polyethylene glycol 4000 50.0 Water Balance This ointment is of high viscosity at room temperature and is quite sensitive to oxidation. Previous packaging of the ointment in conventional squeeze tubes had proven unsatisfactory, and difliculty was encountered in dispenslife of the order of one or two months was common ing the high-viscosity ointment, Also, a very short shelf due to residual air and moisture in the tube.

However, when packaged in the cartridge assembly of the invention under a nitrogen atmosphere, samples of the same ointment stored six months showed no sign of deterioration. Moreover, the ointment thus packaged has proven readily administrable through use of a syringe applicator with an 18-gauge needle.

While in a preferred embodiment the cartridge assembly has been shown as comprising a cylindrical, tubular member sealed with circular, disk-shaped stoppers, it will be understood that the tubular member may be of oval or polygonal shape in cross-section and may be sealed with correspondingly shaped stoppers, for use in other than cylindrical syringes.

Alternatively, as shown in FIGURE 5, the cartridge assembly may be used without a syringe applicator. A separate, hollow, dispensing needle 52 is provided for insertion through one stopper, having a sharpened end 54 for that purpose. A gasket 56 of rubber or like material is provided adjacent sharpened end 54. When needle 52 is inserted into opening 24 of one stopper, sharpened end 54 punctures membrane 26 (FIGURE 4), while gasket 56 seals opening 24 and serves to prevent the expulsion of needle 52 upon actuation of the plunger 58.

Plunger 58 is a separate member comprising a shaft 60 having a stud 62 protruding from one end and a pressure pad 64 at the other. Stud 62 engages opening 24 in the other stopper for positioning and preventing slippage. Thus, plunger 58 provides a convenient means for manually moving the stopper through the bore of tubular member 10. The length of plunger 58 should be sutficient to move the stopper the entire length of the bore to effect total discharge of the contents 11.

Thus, the cartridge assembly of the invention provides an airand moisture-tight means for storing and dispensing medicinal ointments which are susceptible to deterioration upon exposure to the atmosphere, greatly increasing the shelf life of such ointments as compared with prior art squeeze tube packaging. Its strong constructon makes the cartridge assembly particularly suitable for use with highly viscous medicaments, and it can be conveniently and safely used in conjunction with a syringe applicator.

It will thus be seen that the objects set forth above, among those made apparent from the preceding de scription, are efliciently attained and, since certain changes may be made in carrying out the above method and in the constructions set forth without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

Having described my invention, what I claim as new and desire to secure by Letters Patent is:

1. The method of handling a viscous air-sensitive medicinal ointment subject to deterioration upon exposure to the atmosphere to insure potency after storage, comprising the steps of prepackaging a quantity of said ointment for storage in an airand moisture-tight cartridge assembly comprising a rigid tubular member sealed by substantially identical resilient stoppers at either end, said stoppers each having a puncturable membrane and each being adapted for movement axially through the bore of said tubular member while maintaining a substantially air-tight sealing relationship therewith, and dispensing said ointment directly from said cartridge assembly by placing said cartridge in a syringe applicator having a needle member with an inwardly directed puncture portion, with either end of said cartridge adjacent said puncture portion, puncturing the membane of either one of said stoppers with said puncture portion and pushing the other one of said stoppers through the bore of said tubular member by means of the plunger of said syringe applicator to expel the ointment contents through said needle member.

References Cited UNITED STATES PATENTS 1,564,048 12/1925 Cook l28--218.1

772,114 10/ 1904 Pappenheim 128-218 1,687,324 10/1928 Cook 128-2l8.1 1,718,602 6/1929 Smith 128218.1 1,783,956 12/1930 Cook l28272 2,717,601 9/1955 Brown 128218.l 2,724,385 9/1955 Lockhart 128272 2,847,011 8/ 1958 Jones 128261 3,314,429 4/1967 Boehm et a1. 128232 FOREIGN PATENTS 701,758 12/ 1953 Great Britain.

RICHARD A. GAUDET, Primary Examiner M. F. MAJESTIC, Assistant Examiner US. Cl. X.R. 128272