Dosating dispenser for topical formulations

A dispenser is provided which is especially useful in dispensing measured doses of topical preparations such as creams or ointments. The dispenser includes a container for holding a supply of topical preparation. A plunger assembly is operatively mounted to the container and includes a plunger piston and a plunger shaft which carries a series of longitudinally disposed teeth. The piston and plunger shaft include communicating openings. A cap seals off the mouth of the container. A portion of the plunger shaft extends through the cap externally of the container. A lever assembly is pivotally mounted on the cap and is operatively associated with the plunger shaft and piston, the lever assembly including teeth engaging means adapted to interact with the teeth of the plunger shaft. Upon depressing the pivotally mounted lever assembly, the teeth engaging means thereof engages the teeth of the plunger shaft thereby forcing the plunger shaft and connecting plunger piston downwardly and forcing topical preparation, stored in the container, upwardly out through the plunger piston and shaft.

FIELD OF THE INVENTION 
The present invention relates to dosating dispensers for topical 
preparations such as creams or ointments. 
BACKGROUND OF THE INVENTION 
Upon completing his diagnosis, a physician will prescribe a suitable drug 
therapy including the drug to be dispensed, its potency, its dosage along 
with the regimen that must be followed. While most pharmaceutical forms 
are well adapted to these needs, creams and ointments packaged in their 
most prevalent format (tubes and jars) do not permit a quantitative 
application of the medication. The amount of medication being dispensed 
cannot be controlled. This is a very troublesome situation, indeed, since 
many topical drugs are quite potent and use of excessive amounts thereof 
could lead to undesirable side-effects. Accordingly, a package which would 
permit a quantitative measurement of a topical medication would be a most 
welcomed addition to the pharmaceutical packaging industry. 
BRIEF DESCRIPTION OF THE INVENTION 
In accordance with the present invention, a dosating dispenser is provided 
which may deliver a preset fixed measured dosage of medication, comparable 
to other dosage forms. In one embodiment of the invention, the incremental 
dosage delivered may be varied, within a specified range, as desired, to 
deliver, at any given moment, a specific preset fixed dosage. The dosating 
dispenser of the invention is especially adapted for dispensing preset 
fixed amounts of creams and ointments and includes, in combination. 
a container for holding a supply of cream or ointment, including side 
walls, bottom and mouth opening; 
a plunger assembly adapted to be operatively mounted in said container, the 
plunger assembly including a plunger piston adapted to slidably move and 
snugly fit within the interior walls of the container, the plunger piston 
including an orifice extending therethrough; 
and a plunger shaft including a series of teeth extending along at least a 
portion of the length thereof and further including a longitudinal bore 
extending from a first end to a second end, the second end terminating in 
a dispensing orifice which extends beyond the mouth of the container, the 
first end of the plunger shaft being connected to the plunger piston with 
the longitudinal bore thereof in communication with the orifice of the 
plunger piston; 
cap means adapted to fit over and seal off the mouth of the container and 
including an opening through which the plunger shaft passes as it extends 
beyond the mouth of the container; and 
a lever assembly mounted on the cap means and operatively associated with 
the plunger shaft, the lever assembly including lever means and lever 
mounting means for pivotally mounting the lever means on the cap means, 
the lever means including an opening through which the plunger shaft 
extends and teeth engaging means for engaging the lever means with the 
teeth of the plunger shaft, whereby upon depressing the lever means, the 
teeth engaging means of the lever means engages the teeth of the plunger 
shaft thereby forcing the plunger shaft and plunger piston connected 
thereto downwardly into the container and forcing a cream or ointment held 
in said container upwardly through the orifice of the plunger piston, 
through the longitudinal bore of the plunger shaft and out the dispensing 
orifice of the plunger shaft. 
In one embodiment of the present invention, the dosating dispenser includes 
means for varying or presetting the fixed desired dosage to be delivered. 
Thus, in this embodiment the actual fixed dosage may be preset to deliver 
cream or ointment in a dose within a range of from about one-quarter to 
one-half milliliter.

DETAILED DESCRIPTION OF INVENTION AND FIGURES 
Referring to the accompanying Figures wherein like parts are represented by 
like numerals in the several views, FIGS. 1 to 7 illustrate one of the 
preferred embodiments of the dosating dispenser of the invention indicated 
generally by the numeral 10. Dispenser 10, as shown, includes container 12 
for storing a topical preparation such as a cream or ointment. As seen in 
FIGS. 2A and 7, container 12 will normally be of circular cross-section 
(although other shapes may be employed as well) and includes side walls 
14, bottom 16, and mouth 18 which includes outer lip 20 having a recessed 
peripheral area 22 which extends to the mouth opening 24. Cap 25, which 
includes internal bore 27, is adapted to seat over recessed peripheral 
area 22 to seal off the mouth opening 24. 
As best seen in FIGS. 1, 3 and 3A, the dispenser 10 also includes a plunger 
assembly 28 which is formed of plunger piston 30 having internal bore 32, 
and plunger shaft 34 having longitudinal bore 36 and includes a series of 
teeth such as external threads 42 running preferably from end 38 to 
dispensing end 40. The plunger shaft 34 is connected at end 38 to plunger 
piston 30 in a manner such that bores 32 and 36 are in alignment with each 
other and define a path of travel for cream or ointment ultimately to be 
dispersed through end 40. 
As seen in FIG. 3A, the plunger piston 30 will preferably be of circular 
design (or whatever the cross-sectional shape of the container 12) and is 
adapted to snugly but slidably and movably fit within the interior walls 
14 of container 12 but will not allow for passage of container material 
between the piston and container walls. 
As seen in FIGS. 1 and 2, when the plunger assembly is seated in place in 
container 12 with the plunger piston fitted snugly within the container 
walls, the plunger shaft 34 extends through bore 27 of cap 25 and beyond 
the mouth opening 24 of the container. 
A lever assembly is generally identified by the numeral 44 and includes 
lever mounting means 46 which as seen in FIGS. 4 and 6 may be comprised of 
a pair of spaced upright posts 48 mounted on cap 25 and lever 50 which is 
disposed within and pivotally mounted to posts 48 via pivot pin 52. The 
lever 50 includes a bore 54 through which plunger shaft 34 extends as seen 
in FIGS. 1 and 2, and teeth engaging means 56 extending downwardly 
therefrom as shown. 
In the embodiment illustrated in FIGS. 1 to 3, the teeth engaging means 56 
is comprised of a member connected to and extending downwardly from lever 
50 and which includes teeth or threads adapted to engage the threads 42 of 
plunger shaft 34 as lever 50 is depressed. Spring 60 is disposed about the 
plunger shaft 34 and teeth engaging means 56 between lever 50 and cap 25 
and functions to maintain the teeth engaging means 56 in contact with 
threads 42 of plunger shaft 34 while ensuring that lever 50 when released 
will return to its intended initial rest position as shown in FIGS. 1 and 
3. 
In an alternative embodiment of the invention, as shown in FIG. 5, the 
teeth engaging means may comprise a series of threads 56a (or other thread 
or teeth gripping means such as one or more projections) disposed in bore 
54a of lever 50a. The threads 56a will grip corresponding threads on 
plunger shaft 34 as lever 50a is depressed. 
Where the teeth engaging means of FIG. 5 are employed, the spring 60 may 
still be disposed about plunger shaft 34; alternatively, as seen in FIG. 
6, spring 60a may be disposed and retained between lever mounting posts 48 
and between lever 50 and cap 25. 
In operation, the dosating dispenser 10 is initially filled with cream or 
ointment. This is accomplished by simply grasping a portion of the lever 
assembly 44, plunger shaft 34 and/or cap 25 and lifting thereby removing 
the plunger shaft and piston out of container 12. Cream or ointment is 
then added and the plunger shaft and piston inserted into the container 
and cap 25 seated over container mouth opening 24 to seal same. It would 
be well advised to place a stopper over the dispersing end 40 of piston 
shaft 34 prior to seating cap 25 over container mouth opening 24 to 
prevent accidental discharge of cream or ointment. 
When it is desired to dispense container contents, the lever 50 is simply 
depressed thereby forcing spring 60 to compress in turn causing the teeth 
engaging means 56 to engage threads 42 of plunger shaft 34. As the lever 
50 is depressed the teeth engaging means 56 forces the plunger shaft 34 
and plunger piston 30 downwardly into the container. Continued downward 
movement of plunger shaft 34 causes plunger piston 30 to press against and 
force cream or ointment downwardly and finally up through piston bore 32 
and longitudinal bore 36 and out the dispensing end 40. 
When lever 50 is released, spring 60 forcing lever 50 to return to its 
starting position as shown in FIGS. 1 and 2. 
The dispenser as described dispenses a known measured volume of medication 
based on the depth to which the plunger shaft and piston penetrate into 
the container as well as the size of the bores 32, 36 and orifice 40 all 
of which would be directly proportional to the volume of medication 
dispensed. The actual depth of penetration of the plunger shaft and piston 
will be determined by the number of teeth or threads carried by the teeth 
engaging means 56 (whether they are carried by appendage 56 of FIG. 1 or 
are disposed in bore 56a of lever 50a as shown in FIG. 5) and the distance 
that the lever 50 may be moved downwardly before it is restricted by 
spring 60 or obstructed by the cap 25. Where the spring is positioned as 
in FIG. 6, then the distance between the cap 25 and lever 50 will be used 
for calibration purposes. Thus, if the teeth engaging means 56 carries 
four (4) threads, for example, each depression of lever 50 will cause the 
plunger shaft and piston to move downwardly a distance equal to four (4) 
threads and will thereby cause a fixed volume of cream or ointment to be 
dispensed. The actual amount of cream or ointment delivered will be in the 
range of from about one-quarter to about one-half milliliter depending 
upon the calibration with proper number of threads of the plunger shaft 
engaged by the teeth engaging means 56 and the characteristics of spring 
60. Once calibration is established in equal increments, a physician could 
then presribe any multiple of the basic increment, for example 1/4 ml, for 
the treatment of an ailment. If desired, the dispensing pharmacist may 
adjust the teeth engaging means so that the desired quantity of medication 
will be dispensed or preset the delivery system to deliver an integer of 
the basic increment, for example 1.times.1/4, 2.times.1/4, 3.times.1/4, 
etc. 
The orifice and the dispensing end 40 of plunger shaft 34 may be designed 
so that the medication is dispensed in a gentle stream the shape of which 
would be dictated by the geometry of the orifice and the canal 41 leading 
to the orifice. If a particularly wide orifice is used, a large blotch of 
material will be dispensed which then must be spread onto the affected 
area by the patient's forefinger. However, if the bore size is too 
restricted, there may be an undesirable increase in flow restrictions 
which would require more applied pressure to dispense material. 
Acoordingly, to promote desired spreadability and activation pressure, it 
is preferred that the orifice and the portion of the plunger shaft leading 
thereto have an elliptical cross-section, for example, minor axis 3/4 mm, 
major axis 5-6 mm. However, it will be understood that the dispensing 
orifice and adjacent canel portion 41 of the plunger shaft 34 may also be 
of circular, rectangular, square or of other shape. 
The actual container 12 may be fashioned to hold a standard desired volume 
of material, for example, 6 to 20 ml, so that it will be capable of 
delivering the desired number of incremental doses, for example, 50 doses 
of 1/4 ml each. 
The container material as well as the other components of the dosating 
dispenser will preferably be comprised of plastic, such as high density 
polyethylene or other material adaptable to an injection blow molding 
process. 
Referring now to FIGS. 8 to 14, there is shown another preferred embodiment 
of the dosating dispenser of the invention indicated generally by the 
numeral 60. The dispenser 60 includes a container 12 and cap 25 which is 
employed to seal off the mouth opening of container 12 in a manner similar 
to that described with respect to FIGS. 1 to 7. As shown in FIG. 13, the 
cap 25 may be fashioned with a locking mechanism, such as a protruding 
knob 72 which fits and is locked into slot 74 on cap 25. 
Dispenser 60 includes a plunger assembly similar to that shown in FIG. 1 
except that the plunger shaft identified by numeral 34a includes a series 
of teeth formed upwardly pitched ratchet teeth or notched tracks 42a best 
shown in FIGS. 8 and 9. 
The plunger shaft 34a and bore 27 in cap 25 will preferably have a square 
cross-section in order to accommodate the ratchet teeth 42a which, in such 
case, need only be located on one side of the plunger shaft. 
The lever assembly 44a is similar to that employed in FIGS. 1 to 7 with the 
following exceptions. The teeth engaging means 56 will comprise a spring 
loaded ratchet pin 76 which is adapted to engage ratchet teeth 42a. The 
lever 50a is fashioned with an internal canal 77 extending from end 78 to 
internal bore 54. Pin 76 is fitted into the internal canal 77 followed by 
spring 80 and plug 82 which retains spring 80 into contact with pin 76, as 
shown in FIGS. 11 and 12. 
It is by means of spring loaded pin 76 that the lever 50a contacts ratchet 
teeth 42a of plunger shaft 34a and allows plunger shaft 34a and piston 30 
to be forced downwardly into container 12. 
The lever 50a may optionally be fashioned with a lever limiting pin 86 
which may screw in or otherwise be attached to the undersurface of lever 
50a, as shown. Upon depressing lever 50a, the limiting pin 86 will 
eventually strike and be obstructed by cap 25 thereby limiting downward 
movement of lever 50a and plunger shaft 34a and thus defining a limit on 
amount of material to be dispensed. The size or length of the limiting pin 
86 may vary and, in fact, may be changed from time to time, as desired, 
depending upon the incremental amount of material to be dispensed. 
As seen in FIGS. 8 and 13, spring 60a is located between posts 80 and 
between lever 50a and cap 25 to ensure continuous return of the lever to 
its original position once it has been released. However, as with the 
dispenser of FIG. 1, spring 60 may be disposed about plunger shaft 34a 
between the lever 50a and cap 25. 
As in the case of the dispenser described with respect to FIGS. 1 to 7, the 
amount or volume of material to be dispersed will depend upon the distance 
or number of ratchet teeth that plunger shaft 34a is moved downwardly, as 
well as on the size of the bores 32 and 36 and the size of the canal 41a 
and orifice 40a. The actual number of notches or ratches that the plunger 
shaft 34a will move downwardly is, of course, dependent upon the distance 
that lever 50a may be forced downwardly before movement of the lever 50a 
is limited by cap 25. This distance may be calibrated with the number of 
ratchet teeth that plunger shaft 34a is moved downwardly and the desired 
incremental volume to be delivered. Thus, in one mode, the lever 50a may 
be employed without limiting pin 86 so that lever 50a may be depressed 
until it strikes cap 25; the volume of material delivered in this case may 
be, for example, 1/2 ml. However, if a limiting pin 86 is inserted in 
lever 50a, the lever 50a may move only one-half the distance (without pin 
86) before it is obstructed by cap 25 so that only 1/4 ml increments are 
dispensed. As will be apparent, the length of the limiting pin 86 may be 
shortened to allow for incremental delivery of some amount between 1/4 and 
1/2 ml. It will also be apparent that by moving the position of the 
limiting pin closer to the bore 54 of lever 50a, the distance required for 
the lever 50a to be moved before it strikes the cap 25 will also be 
shortened. 
The dispenser embodiment shown in FIG. 8 to 14 will operate in a manner 
similar to that shown in FIGS. 1 to 7. Upon depressing lever 50a, teeth 
engaging pin 76 will engage ratchet teeth 42a of plunger shaft 34a causing 
the plunger shaft and piston to be forced into container 12 which in turn 
causes container contents to be forced through bores 32 and 36 and out of 
orifice 40a. 
It will be appreciated that the engaging thread mechanism of FIGS. 1 to 7 
and the ratchet mechanism of FIGS. 8 to 14 allow the plunger piston 30 to 
be moved in only one direction, that is downwardly, so that the contents 
of the container may be protected at all times from the atmosphere. In 
addition, the plunger piston 30 will fit snugly within the container 12 
leaving little, if any, room for cream or ointment to pass between the 
piston and the internal walls of the container.