US20050279779A1

US20050279779A1 - Controlled drop dispensing tip

Info

Publication number: US20050279779A1
Application number: US10/860,525
Authority: US
Inventors: Scott Gerondale; Rodney Terwilliger
Original assignee: Allergan Inc
Current assignee: Allergan Inc
Priority date: 2004-06-03
Filing date: 2004-06-03
Publication date: 2005-12-22
Also published as: WO2005120975A1

Abstract

A controlled drop dispensing tip includes a body suitable for attachment to a dispensing bottle and a nozzle having a lumen therethrough for flow of liquid formulation. An orifice is provided in the nozzle which is in fluid communication with the lumen therethrough for formulation of droplets. The nozzle is formed from a material enabling uniform droplet dispensment of the liquid formulation independent of downward angular orientation of the tip.

Description

The present invention is generally related to a control drop dispensing system and is more particularly directed to such a system including a dispensing tip enabling uniform droplet dispensment.
Applicators or systems for the delivery or instillation of the liquid formulations into an eye by a user have long been known.
Generally, bottles or vials, which contain eye drop formulations, are flexible and have walls sufficiently thin to enable squeezing of the bottle through a nozzle and dispensing orifice.
In use, the user suspends the bottle over an eye to be treated in an inverted or semi-inverted position in order to direct the nozzle toward the eye. The formulation is expelled as the user manually squeezes the wall of the bottle body or a bottom of the bottle. This pressure differential within the bottle drives out a quantity of formulation which exits the vial or bottle via the nozzle orifice as a droplet and descends through gravity into the eye positioned below the nozzle.
While this procedure appears to be straightforward, it often cannot be performed satisfactorily with small volume bottles in order to dispense uniform drops. In addition to handling problems associated with over squeezing or unintentional squeezing of the bottle, the angle of the bottle and nozzle with regard to the eye is significant in determining the droplet size produced.
The droplet size is important in that the dose prescribed to the patient must often be accurately adhered to. If the quantity which is effectively delivered is insufficient, the treatment may not be efficient. On the other hand, if the quantity delivered is too large the surplus in certain cases may cause side effects.
Accordingly, it is important to be able to administer an exact dose of the formulation required and the present invention provides for a controlled drop dispensing tip and system enabling uniform droplet dispensment of the liquid formulation independent of downward angular orientation of the tip.

SUMMARY OF THE INVENTION

A controlled drop dispensing tip in accordance with the present invention generally includes a body suitable for attachment to a dispensing bottle and a nozzle having a lumen therethrough for flow of liquid formulation and an orifice in fluid communication with the lumen for the formation of droplets.
A nozzle is formed from a material which enables uniform droplet dispensement of the liquid formulation which is independent of downward angular orientation of the tip.
A system in accordance with the present invention includes a bottle and a liquid formulation disposed in the bottle in combination with the hereinabove described dispensing tip.
More particularly, the tip in accordance with the present invention may be a nanocomposite including a polymer and a nanofiller. The polymer may be low-density polyethylene and the nanofiller may be present in an amount of between about 9% and about 11% by weight, preferably about 10% by weight.
Thus, the present invention provides for a nozzle which is formed from a material comprising a nanocomposite in an amount enabling uniform droplet size dispensement of liquid formulation which is independent of the downward angular orientation of the tip. Preferably, a liquid formulation is Alphagan® or Refresh Liquigel®.
Accordingly, a method for controlling dispensed droplet size includes providing a squeezable bottle, disposing a liquid formulation within the bottle and attaching a dispensing tip to the bottle, the tip being formed from a material enabling uniform droplet dispersement of said liquid formulation independent of downward angular orientation of the tip. Subsequently, the bottle is squeezed with the tip oriented in any downward direction.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention may be more clearly understood with reference to the following detailed description in conjunction with the appended drawings, of which:
FIG. 1 is an illustration of a prior art bottle system indicating a variance in droplet formation which is dependent upon the downward angular orientation of the tip;
FIG. 2 is an illustration of a tip and bottle system in accordance with the present invention similar to the illustration shown in FIG. 1 indicating uniform drop dispensement despite angular downward orientation of the tip; and
FIG. 3 is a cross-section of a nozzle tip suitable for use in the present invention.

DETAILED DESCRIPTION

With reference to FIG. 1, there is shown a conventional prior art bottle 10 having a nozzle 12 for the dispensement of droplets 14, 16.
As illustrated, the droplet size is dependent upon the angular orientation indicated by the letter A of the nozzle 12 to an ordinance 20, as hereinafter described. This variance in droplet size may vary up to 50% or more. For example, a prior art bottle may dispense a droplet size of about 12 microliters at 90%, whereas at an angle A of 45% the same prior art bottle may dispense a droplet size of about 26 microliters.
This variation in droplet size is also dependent upon the droplet size. For example, droplet sizes between 40 and 50 microliters are not as dependent upon orientation of delivery as are droplets of smaller size.
The present invention overcomes this effect through the utilization of nanocomposites.
With reference to FIG. 2 there is shown a system 30 in accordance with the present invention which includes a bottle 32, a liquid formulation 34 disposed within the bottle 32 and a tip 36 having a body 38 suitable for attachment to the bottle 32 in a conventional manner, see also FIG. 3.
The tip 36 includes a nozzle 42 having a lumen 44 and an orifice 48 in fluid communication with the formulation 34 for the dispensement of droplets 50 of uniform size independent of a downward angular orientation A of the tip 36.
Preferably, the bottle 34 is formed from a low-density polyethylene and droplet size is unexpectedly found to be uniform despite a downward angular orientation of the tip 36 through the use of nanofillers in the low-density polyethylene (LDPE), preferably Dupont resin 206064. Such nanofilled LDPE material may be produced in a conventional manner such as, for example, set forth in U.S. Pat. No. 6,602,966. This patent is to be incorporated herewith in its entirety for the purpose of illustrating the manufacture of a nanocomposite filled polymer useful in the present invention.
A variety of nanofillers for use in nanocomposites are suitable for use in the present invention. Such nanofillers include natural clays (mined, refined and treated); synthetic clays; nanostructured silicas; nanoceramics; and nanotubes (carbon based) as set forth in an article entitled “Enhancing Medical Device Performance With Nanocomposite Polymers in Medical Device and Diagnostic Industry” pp. 114-123 (May 2002). This article is to be incorporated herewith in its entirety for the purpose of describing suitable nanofillers for formation of the nanocomposite in accordance with the present invention for the use within the nozzle 42.
Unexpectedly, it has been found that utilization of a nanofilter such as a montmorillonite clay (Merck Index [1318-93-0]) available from Aldrich Chemical Company, Milwaukee, Wis. in an amount of between about 9% and 10% by weight, preferably about 10% enable a uniform droplet 50 formation independent of downward angular orientation A of the tip 36, as shown in Table 1. Table 1 reports droplet 50 size in microliters as a function of downward angular orientation between 45° and 90° for a nanocomposite of LDPE and nanofiller between 5% and 10% compared with a conventional Teflon material.
As shown for the formulations Alphagan® and Refresh Liquigel® droplet sizes are uniform compared to droplet sizes at 45° and 90° for Teflon and lower percentages of nanofiller. This effect is not as strong with formulations such as Lumigan.

These droplets were formed utilizing the nozzle 36 shown in FIG. 3 which further includes an arcuate surface of revolution 60 surrounding the orifice 48 and depending from the orifice 48. It should be appreciated that the nozzle 36 is shown for illustrative purposes and that other nozzles may be utilized when formed from a material having interfacial tension with the liquid formulation 34 enabling uniform droplet dispensement of liquid formulation independent of downward orientation of the tip 36.

TABLE 1


Alphagan	Lumigan	Refresh Liquigel

Nozzle Material	45 Degrees	90 Degrees	Overall	45 Degrees	90 Degrees	Overall	45 Degrees	90 Degrees	Overall

10% Nanocomposite	15.8	17.9	16.9	26.4	14.7	20.6	15.4	17.9	16.7
8% Nanocomposite	35.1	18.7	26.9	23.9	12.8	18.4	33.2	18.2	25.7
5% Nanocomposite	34.5	18.8	26.7	26.5	12.1	19.3	33.7	21.4	27.6
Teflon Blend	33.0	25.9	29.5	33.3	20.6	27.0	26.3	12.0	19.2

As hereinabove summarized a method in accordance with the present invention includes disposing a liquid formulation such as, for example, Alphagan® or Refresh Liquigel® into a squeezable bottle and attaching a dispensing tip to the bottle, the tip being molded, shaped or otherwise formed with a material enabling uniform droplet dispersement of said liquid formulation independent of downward angular orientation of the tip, the material comprises nanocomposites such as hereinbefore discussed.
Uniform droplet dispersement is effected through squeezing the bottle with the tip orientation in a downward direction, such as, for example, between 45° and 90° as illustrated by the angle A in FIG. 2.
Although there has been hereinabove described a specific controlled drop dispensing tip in accordance with the present invention for the purpose of illustrating the manner in which the invention may be used to advantage, it should be appreciated that the invention is not limited thereto. That is, the present invention may suitably comprise, consist of, or consist essentially of the recited elements. Further, the invention illustratively disclosed herein suitably may be practiced in the absence of any element which is not specifically disclosed herein. Accordingly, any and all modifications, variations or equivalent arrangements which may occur to those skilled in the art, should be considered to be within the scope of the present invention as defined in the appended claims.

Claims

1. A controlled drop dispensing tip comprising:

a body suitable for attachment to a dispensing bottle; and

a nozzle having a lumen therethrough for flow of a liquid formulation and an orifice in fluid communication with said lumen for the formation of droplets, said nozzle being formed from a material enabling uniform droplet dispensement of said liquid formulation independent of downward angular orientation of said tip.

2. The tip according to claim 1 wherein said material is a polymer.

3. The tip according to claim 2 wherein said polymer comprises a nanocomposite.

4. The tip according to claim 3 wherein said polymer comprises low-density polyethylene.

5. The tip according to claim 4 wherein said nanocomposite includes a nanofiller present in an amount of between about 9 and about 11% by weight.

6. The tip according to claim 4 wherein said nanocomposite includes a nanofiller present in an amount of about 10% by weight.

7. A controlled drop dispensing system comprising:

a bottle;

a liquid formulation disposed in said bottle;

a tip having a body suitable for attachment to said bottle and a nozzle formed from a material enabling uniform droplet dispensement of said liquid formulation independent of downward angular orientation of said tip.

8. The system according to claim 7 wherein said material is a polymer.

9. The system according to claim 8 wherein said polymer comprises a nanocomposite.

10. The system according to claim 9 wherein said polymer comprises low-density polyethylene.

11. The system according to claim 10 wherein said nanocomposite includes a nanofiller present in an about of between about 9 and about 11% by weight.

12. The system according to claim 10 wherein said nanocomposite is present in an amount of about 10% by weight.

13. The system according to claim 12 wherein said liquid formulation comprises Alphagan®.

14. The system according to claim 12 wherein said liquid formulation comprises Refresh Liquigel®.

15. A controlled drop dispensing tip comprising:

a body suitable for attachment to a dispensing bottle; and

a nozzle having a lumen therethrough for flow of a liquid formulation and an orifice in fluid communication with said lumen for the formation of droplets, said nozzle being formed from a material enabling uniform droplet size dispensement of said liquid formulation independent of downward angular orientation of said tip.

16. The tip according to claim 15 wherein said material is a polymer.

17. The tip according to claim 16 wherein said polymer comprises a nanocomposite.

18. The tip according to claim 17 wherein said polymer comprises low-density polyethylene.

19. The tip according to claim 18 wherein said nanocomposite includes a nanofiller present in an amount of between about 9 and about 11% by weight.

20. The tip according to claim 18 wherein said nanocomposite includes a nanofiller present in an amount of about 10% by weight.

21. A method for controlling dispensed droplet size, said method comprising:

providing a squeezable bottle;

disposing a liquid formulation in the bottle;

attaching a dispensing tip to the bottle, the tip being formed from a material enabling uniform droplet dispensement of said liquid formulation independent of downward angular orientation of the tip; and

squeezing the bottle with the tip oriented in a downward direction to produce the uniform droplets of said liquid formulation.