JP2002516714A - Limited dose dispenser for ophthalmic solutions - Google Patents

Abstract

A solution dispensing system is disclosed that includes a sealed container forming an interior chamber for holding an absorbent material, wherein the interior chamber has a sufficient volume of at least one dose of solution in the formation of a droplet. Holds ophthalmic solution. The absorbent material is positioned in the chamber such that the tapered end projects from an opening in the container after removing the separable portion of the envelope. The taper of the absorbent material forms droplets when the package is held with the opening down and presses on both sides of the package.

Description

DETAILED DESCRIPTION OF THE INVENTION

BACKGROUND OF THE INVENTION Field of the Invention The present invention relates to a limited dosing dispenser for applying ophthalmic solutions to the eye. The dispenser was sealed with the absorbent material soaked in the ophthalmic solution so that the ophthalmic solution was manually squeezed into the eye in the form of droplets from the absorbent material when the end of the package was removed. With package.

2. Description of the Related Art Many temporary or chronic causes of eye pain, eye irritation, eye redness, eye irritation, dry eyes, itchy eyes, and / or burning of the eyes There is an eye condition. Ophthalmic products may be used locally for such situations, including antihistamine or other allergic drugs, antibiotics, anti-inflammatory drugs, medicaments for the treatment of glaucoma or ocular hypertension, and artificial tears for dry eye Used for

In addition, many people wearing contact lenses for vision correction or physical appearance can sometimes experience lens discomfort due to dryness. Ophthalmic solutions for rewetting or lubricating contact lenses can be applied to contact lenses in the form of droplets while worn on the eye to provide temporary relief.

[0004] Typically, dispensers for these types of solutions are small plastic bottles with a dispensing tip or a drop-forming tip. The dispenser can be designed for multiple use over a number of days, where a preservative or disinfectant is typically used to keep the solution safe for repeated use.
The solution therefore remains protected against accidental contamination. However, there are certain disadvantages of having a disinfectant in the ophthalmic solution applied to the eye in the form of droplets. First
Chemical disinfectants tend to be irritating, especially if the droplets are intended to make the eye comfortable, and it is desirable that ophthalmic solutions be as gentle as possible. Second
The eyes and surrounding tissues are particularly sensitive, and many people have hypoallergenic preparations (hyp
allergenic). This makes it difficult to formulate multidose solutions, and in some cases may even have side effects.

[0005] An alternative to stored multi-dose solutions is a preservative-free unit solution system, which can be sterilized before or after packaging. However, when the dispenser is opened and used, the liquid in the dispenser can be used for a relatively short time (
(Typically within 24 hours). Often such a solution is 1
It is intended to be used each time, after which the dispenser and any remaining liquids are discarded.

[0006] Unit dose products are typically packaged in smaller bottles than multi-dose dispensers. Bottle tips are commonly used to help apply solution to the eye area. Both the bottle and the tip may be a one-piece molded plastic. A potential problem with such small bottles exists because of their small size and handling difficulties. The bottle can be difficult to squeeze, and the tip is a potential danger to the eyes.

[0007] A typical size for a bottle of ophthalmic solution is 15 ml or less. Unit dose containers typically have a smaller volume (usually from 0.3 ml to 1.0 ml),
It is a "filled seal" container. These types of containers are usually made from high or low density plastic. The bottle can be anything from half-filled to fully-filled liquids. The dilemma of relatively small unit dose bottles is that they can be more difficult to handle and squeeze, but relatively large unit dose bottles
Contains more empty space or more wasted fluid.

[0008] The shipping cost of any liquid agent comes at a cost, and additional costs when packaged in partially filled bottles. Generally cylindrical bottles already leave a significant amount of empty space in the container. In addition, partially filled bottles that are not packaged under reduced pressure pose an additional problem of evaporation, thereby affecting the concentration of active ingredients contained in the solution, and then the efficacy of the product or other Affect the nature of

[0009] In contrast, if a bottle contains a significant excess of ophthalmic solution, the consumer will be able to use the ophthalmic solution longer than recommended, even if the bottle contains non-storable ophthalmic solution intended for unit dosage use. May be used. However, in use, if the tip contacts the eyeball site, bacteria can migrate to the solution and can grow,
It then potentially returns to the eyes of the consumer. Family members are also unusual,
Sharing bottles, where repeated use of unit dose solutions spreads the infection.

Sample bottles for ophthalmic solutions, as well as non-preservable unit dose containers, also generally tend to contain relatively small amounts of the solution. Sample bottles (whether or not the bottles contained preservative or non-preservative solutions) were used to provide samples of product to potential consumers for pilot use. Sample bottles are distributed free to potential consumers and, unlike commercially available products, intentionally contain a volume of solution for treatment over a limited period of time. For example, it is undesirable for an allergic sample bottle containing a sufficient amount of droplets to persist over the entire allergy season.

Finally, bottles conventionally used for dispensing ophthalmic solutions in the form of limited droplet volumes, even if small, are always convenient to carry (especially in pockets or purses). Not exclusively. The smaller the size of the dispenser, the more difficult it is to grip and handle for dispensing, while the larger the size of the dispenser, the less convenient it is to carry in personal possession.

[0012] Various bottles have been disclosed for dispensing ophthalmic solutions. US Patent 5,
No. 238,157 discloses a package that is impermeable and completely inert to the environment, including the contents of the package and rigid paper or cardboard coated with plastic, metal foil, or the like. U.S. Pat. No. D237,942 discloses a conventional type of container having a breakable cap. This design is similar to many containers or dispensers currently used to hold unit dose ophthalmic solutions. Typically, this type of medication bottle has an elongated body, a narrowed upper body that forms the medication tip for droplet formation, and a fragile, removable tab for opening the bottle in use. However, when the bottle is opened, the liquid agent is applied by pressing the side of the bottle. The bottle is then discarded and cannot be capped again. The volume of this container tends to be quite small, and the container itself
Made from a somewhat flexible plastic material. The containers are packaged individually or collectively. For example, a container arrangement may be formed having containers attached to each other on the container side. Further examples of such containers can be found in U.S. Patent Nos. D362,304, D312,209, and D255,492.

[0013] Although not in the field of ophthalmic products, US Pat. No. 4,998,984 discloses a pre-packaged single-use disposable wiper pad saturated with liquid.
These pads have many uses, including disinfecting the surface of a telephone mouthpiece, or cleaning infant hands or buttocks. Other patents that disclose pre-packaged and pre-moistened disposable articles include U.S. Patent Nos. 4,601,081,
Nos. 117,187 and 4,781,974.

US Pat. No. 4,627,936 discloses a product that includes a wiper pad sealed with a moisture and light impermeable barrier packet or envelope. A nozzle is inserted into the open end of the envelope, a measured amount of fluid is squeezed into the envelope, and the envelope is sealed. The wiper is saturated by capillary action. By opening the envelope, the wiper is readily available for use.

US Pat. No. 4,437,567 discloses a sterile product in a sealed package,
In particular, a method for a medical or surgical product is disclosed. The package can be manufactured from any conventional material. One embodiment includes two laminated sheets joined together along the edges of the two laminated sheets by a suitable adhesive to form a hermetically sealed package.

US Pat. No. 4,150,744 discloses packaging for light-sensitive and oxygen-sensitive solutions. The solution is packaged with a gas impermeable envelope, preferably a ternary laminate of nylon, aluminum foil, and polypropylene.

US Pat. No. 3,369,656 discloses a disposable container for storing and processing contact lenses. The container is made from a flexible, liquid impermeable sheet. It is immersed in a solution suitable for treating contact lenses inside the soft inner fabric.

In view of the above, there is a need for lighter, more compact packages for ophthalmic products that are easy for consumers to carry and handle and that are safe to use. At the same time there is a need for a container for sterile ophthalmic droplets that are non-preservable, which ophthalmic droplets do not have excess liquids that are easily misused, nor excessive unfilled space and waste in the container . Finally, there is a need for an improved dispenser that allows consumers to test ophthalmic product quality for topical treatment of the eye in the form of eye drops.

SUMMARY OF THE INVENTION The present invention relates to a dispensing system comprising a sealed container defining an interior chamber for holding an absorbent material, wherein the dispensing system comprises at least one administration of a solution in the form of droplets. A sufficient amount of the ophthalmic solution is absorbed by the absorbent material. The absorbent material is placed in the chamber such that, after removal of the distal end, the focusing portion protrudes from the opening. That is, when the package is held with the opening facing down, and when the opposite surface is pressed with a finger, the focusing portion of the absorbing material forms droplets. In one embodiment of the invention, the package is formed by at least two sheet-like liquid impermeable materials, preferably at the outer ends of each two sheets, wherein the at least two sheets are sealed from each other. Is attached. The package is opened by tearing along the line joining the two sealed ends of the package.
The absorbent material is located inside the package, so after removal of the package edge,
The end protrudes from the opening. In a second embodiment of the present invention, the dispensing system comprises an elongated container having a circular, square or rectangular cross-section, in which the absorbent material forms a droplet for application to the eye. Therefore, it has a substantially conical tip.

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a dispenser containing an ophthalmic solution that can be used for treatment of the eye. Preferably, the dispenser comprises a container having a wall that is impervious to the contents of the dispenser and its environment and that is completely inert.

Referring to the drawings of FIGS. 1 and 2, the container is generally indicated at 11 and is resistant to plastic coated metal, plastic film or sheet, plastic coded metal foil, metallized paper, or liquid. It can be made from any conventional material, such as other packaging materials that are permeable and inert to the contents of the container.

In one embodiment of the invention, the container is a sealed gas-impermeable envelope or pouch that prevents oxygen ingress and loss of water vapor, thereby allowing the combination to be stored for long periods of time. Most preferably, the envelope is a metal / polymer laminate and the two layers are heat sealed, RF sealed, ultrasonic sealed, or adhesively sealed to form a pouch along the edges of the polymer surface. obtain. A typical laminate has two layers, but preferably has an additional outer polymer layer, which may promote abrasion resistance and printing. Typically, the three-layer laminate comprises, from the outside to the inside, (i) a nylon, polyester, polyethylene or polypropylene layer for abrasion resistance, (ii) an aluminum foil layer,
And (iii) including an internally heat sealable polymer layer such as polyethylene, polypropylene, polyvinylidene chloride, or nylon. The total thickness of the laminate is preferably about 25 μm to 250 μm, more preferably the total thickness is 50 μm to 125 μm. Aluminum foil layers are preferred to form a water barrier that protects the inner solution from outer contaminants and prevents harmful evaporation of the inner solution. The two polymer layers that cover the sides of the aluminum foil in the preferred laminate form an oxygen barrier and protect the aluminum from destructive effects. However, those skilled in the art will appreciate that other types of laminates, with or without aluminum, or even non-laminates, may be used to form containers according to the present invention.

[0023] The envelope or pouch includes a removable portion for opening the pouch to apply its contents. The removable part is a tear strip, tear notch,
It can be designed to be separated by a variety of means, including a line of weakness, or other convenience that facilitates opening the pouch. For example, linearly oriented polypropylene and polyethylene for tearing may be used to form the outer and inner layers of the laminate. Referring to the embodiment of FIG. 1, the package has two notch notches 13 located on both sides of the pouch, thereby assisting in tearing and opening the pouch.

An absorbent material 15 is included in the pouch 11. The absorbent material is thereby defined as a solution permeant formed from an absorbent matrix material, preferably a foam or web material that reversibly retains an aqueous solution in a state of being absorbed until squeezed. . Preferably more than half, more preferably at least 80 percent of the weight, and most preferably essentially all of the solution in the container is in a steady state (pressed) by the solution permeant in the final product. Until absorbed). The solution permeant is preferably saturated with the solution to maximize its storage capacity. The shape of the absorbent material, including either a flat pad or a more three-dimensional shape, can vary, for example, due to cross-sectional symmetry. Preferably, for at least the latter configuration, except for the converging edge or tip due to droplet formation, the solution permeant conforms to the shape of the container to minimize excessive space.

The absorbent material can be formed from any suitable material that reversibly absorbs the ophthalmic solution by squeezing, such as a medical grade absorbent foam or fiber. For ophthalmic use, it is important that the absorbent material is not essentially in particle form and does not produce particles or fibers that can be transferred to the eye, in which case the absorbent material will cause tingling. One way to prevent this is to remove any fibers in the end product absorbent material. Types of absorbent materials having prewashed low particulate matter include cellulose, nylon, and polyester fibers.

As mentioned above, various ophthalmic solutions that can be used in the present dispensers include solutions for treating allergies, dry eyes, inflammation, infections, glaucoma, and ocular hypertension. Such solutions also include drops, artificial tears, and solutions for wetting or treating contact lenses during contact lens wear. However, due to the absorbent material, such solutions must not contain particles in suspension.

The amount of solution contained in the dispenser is such that both eyes can be treated at least once. For example, if the procedure requires two drops per eye (30-50 μl), the dispenser should contain enough solution to moisten the absorbent material and at least a total of 200 μl should be easily dispensed.

In one preferred embodiment of the present invention in FIGS. 1 and 2, the dispenser container is substantially flat, has square to rectangular sides on the sides, and the absorbent material is 1/4 " Less than thickness (0.635 cm) For ease of handling, the dimensions of the sides of the straight enclosing package are preferably at least 1/2 inch (1.27 cm) per side, for example 1 / 2 "x 1/2" (1.27cm x 1
. 27 cm), but less than 3 inches (7.62 cm) per side. The preferred size is about 1/3/4 "x 2 and 1/4" (4.445 cm x 5.715 cm)
). Other shapes can be used, for example, rectangular or square with rounded edges.

In the embodiment of FIGS. 3 and 4, the container 21 for the absorbent material 23 has an elongated shape and a round cross-section as shown in FIG. The absorbent material also has a round cross section and a conical tapered tip. If the rupture 27 is removed, its tip protrudes from the opening in the container so that the container and then the absorbent material can form droplets when squeezed. Droplets can be applied to the eye for treatment as described herein. One of ordinary skill in the art can readily appreciate that other conventional container shapes can be used as long as both sides of the container can be squeezed. For example, the container and / or absorbent material may have an elliptical, rectangular, square, or hexagonal cross-section.

In manufacturing a dispenser according to the present invention, any of a variety of conventional methods can be used. For example, the absorbent material is first saturated with an ophthalmic solution and then encapsulated in a package, or the dispenser is partially assembled,
Prior to final sealing of the dispenser, the solution may be dispensed to the absorbent material. Alternatively or alternatively, the absorbent material can be enclosed dry in a package or envelope, and then the volume of solution measured is injected as described in US Pat. No. 4,627,936.

[0031] The dispenser can be sterilized by conventional methods used in packaging ophthalmic solutions. Autoclave and gamma irradiation are two methods of terminal sterilization. Pulsed light sterilization is another alternative. A preferred method of sterilizing the dispenser and its contents is aseptic packaging under clean room conditions.

Whenever it is desired to use a dispenser, it is only necessary to open and dispense the package. The package is inexpensive so that it is practical to dispense the droplet to one eye and then to the other eye, and then use the package for easy disposal It is devised as follows.

The solution is dispensed by grasping the package between the thumb and a finger other than the thumb, preferably the index finger. Pressing the thumb and non-thumb together, the pad is squeezed and the liquid is pushed out toward the opening and collects at the tapered end. When enough liquid collects at the tapered end, a droplet forms. The droplet may be directed such that the droplet falls into the eye.

The packaging of such dispensers allows for flexibility. The dispenser may be packaged as a single unit or in multiple units. In the case of multiple units, multiple dispensers may form a strip with a single row of dispensers, or a sheet with more than one row of dispensers, with perforations between individual units, or another separation. There are means. The strip can be fan-folded or rolled. The consumer may then sequentially remove the end unit when in use. The strip may be wound and placed in a container to facilitate separation of the end units. The consumer can then easily remove each unit dispenser as needed. An advantageous configuration for transport is one in which the dispenser forms a plurality of flat strips or flat sheets so that the dispensers are tightly stacked together within the package.

The dispenser according to the invention is ideally suited for carrying around in a personal belongings of a person. Due to its relatively small size, the dispenser is easily stored and can be carried in a pocket, purse or briefcase.

[Brief description of the drawings]

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates an invention including a package containing a pad having absorbed an ophthalmic solution and a tear to open the package and expose the pad for applying droplets to the eye. 3 shows a dispensing system according to the invention.

FIG. 2 shows a cross-sectional view of the dispensing system of FIG.

FIG. 3 shows a second embodiment of the invention in which the dispenser is cylindrical and the pad has a conical tip.

FIG. 4 shows a cross-sectional view of the dispensing system of FIG.

──────────────────────────────────────────────────続 き Continuation of front page (81) Designated country EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE ), OA (BF, BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, KE, LS, MW, SD, SL, SZ, UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AL, AU, BA, BB, BG, BR, CA, CN, CU, CZ , EE, GD, GE, HR, HU, ID, IL, IN, IS, JP, KP, KR, LC, LK, LR, LT, LV, MG, MK, MN, MX, NO , NZ, PL, PT, RO, SE, SG, SI, SK, SL, TR, TT, UA, UZ, VN, YU

Claims (17)

[Claims] 1. An ophthalmic solution dispensing system, comprising: (a) a sealed container forming an interior chamber, the container having a removable end; An ophthalmic solution dispensing system comprising: an absorbent material having a tapered end in the interior chamber; and (c) a sterile or preservative ophthalmic solution absorbed by the absorbent material, wherein the container comprises: The tapered end of the absorbent material is manually squeezed together with the absorbent material by removing the separable end from the rest of the container to form an opening of the tapered end. When held with the part facing down,
An ophthalmic solution dispensing system that protrudes from the opening such that drops of the ophthalmic solution are formed for application to the eye. 2. The ophthalmic solution dispensing system according to claim 1, wherein the absorbent material is selected from the group consisting of urethane, cellulose, and nylon. 3. The ophthalmic solution dispensing system according to claim 1, wherein the solution is an ophthalmic solution for treating dry eye. 4. The ophthalmic solution dispensing system according to claim 1, wherein the solution is for treating allergies. 5. The ophthalmic solution dispensing system according to claim 1, wherein the solution comprises a treatment selected from the group consisting of agents for the treatment of inflammation, infection, glaucoma, and ocular hypertension. 6. The ophthalmic solution dispensing system according to claim 1, wherein the container is a unit dose dispenser containing 30-400 μl of the solution. 7. The ophthalmic solution dispensing system according to claim 1, wherein the container is a unit dose dispenser containing 50-200 μl of the solution. 8. The sealed container is a pouch formed by at least two sheets of a liquid-impermeable material, the sheets around an outer edge to form the interior chamber. And the detachable end may be removable by tearing across a line joining the two edges of the pouch, and wherein the absorbent material has a tapered end. The ophthalmic solution dispensing system according to claim 1, wherein the ophthalmic solution dispensing system is positioned within the interior chamber so as to protrude from the opening formed by removal from a separable end. 9. The sealed container is elongated with a substantially round, square, or rectangular cross-section, and wherein the absorbent material has a substantially conical shape after removing the end. The ophthalmic solution dispensing system according to claim 1, wherein the system is positioned within the internal chamber so as to protrude from an opening in the container. 10. An ophthalmic solution dispensing system comprising: (a) a sealed pouch formed by two sheets of a liquid-impermeable material, the sheets forming an inner chamber. Separable ends that are sealably attached to each other around an edge and can be separated by tearing across a line joining the two edges of the pouch so that the pouch forms an opening in the pouch A sealed pouch having a portion, wherein the separable end can be discarded after separation; and (b) an absorbent pad for holding an ophthalmic solution, wherein the absorbent pad has an edge. Positioned within the interior chamber to project from the opening formed by removal of the separable end, the pouch is held with the opening down and both sides of the package pressed with fingers. If The absorbent pad has a tapered edge for the formation of droplets, comprising an absorbent pad, the ophthalmic solution dispensing system. 11. A method of applying a drop of an ophthalmic solution to the eye, comprising: (a) removing the end of the container, thereby exposing the tapered end of the absorbent material that holds the ophthalmic solution. (B) locating the tapered end on and near the eye; and (c) the container with the absorbent material for squeezing liquid from the absorbent material to the eye. Pressing a finger on both sides, and applying a droplet of the ophthalmic solution to the eye. 12. The method of claim 11, wherein said solution is an ophthalmic solution for treating dry eye. 13. The method of claim 11, wherein the ophthalmic solution is for treating allergies.
The method described in. 14. The method of claim 11, wherein the ophthalmic solution comprises a treatment selected from the group consisting of a treatment for inflammation, infection, glaucoma, and ocular hypertension. 15. The method of claim 11, wherein said container is a unit dose package containing 30-400 μl of solution. 16. The method of claim 11, wherein said container contains 50-200 μl of solution. 17. The method of claim 11, wherein said container is a unit dosage container that holds a sterile but non-preservative solution.