WO2005074543A2 - Embouts compte-gouttes de haute precision pour composition ophthalmique et procedes associes - Google Patents

Embouts compte-gouttes de haute precision pour composition ophthalmique et procedes associes Download PDF

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Publication number
WO2005074543A2
WO2005074543A2 PCT/US2005/002710 US2005002710W WO2005074543A2 WO 2005074543 A2 WO2005074543 A2 WO 2005074543A2 US 2005002710 W US2005002710 W US 2005002710W WO 2005074543 A2 WO2005074543 A2 WO 2005074543A2
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Prior art keywords
dispensing
dropper tip
ophthalmic composition
dropper
conduit
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PCT/US2005/002710
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English (en)
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WO2005074543A3 (fr
Inventor
Nick Manesis
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Nick Manesis
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Publication of WO2005074543A2 publication Critical patent/WO2005074543A2/fr
Publication of WO2005074543A3 publication Critical patent/WO2005074543A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein

Definitions

  • the present invention relates to devices for administering compositions to an eye of a human or animal. More particularly, the invention relates to devices, including dropper tips, that deliver ophthalmic compositions to an eye of an individual with a high degree of precision and reproducibility.
  • the composition should be delivered as accurate and precise drops to ensure proper delivery of a pharmaceutical agent in the drop.
  • Current ophthalmic composition dropper tips deliver drops having volumes in the range from about 35 to 50 microliters with an approximate precision of +/- 15%.
  • Many ophthalmic formulations contain surfactants which tend to "wet out" plastic of dropper tips, and result in the production of erroneous drop size over time.
  • ophthalmic composition dropper tips are disclosed in the following U.S. Patents: 5,221,027 (Gibilsco) ; 5,417,349 (Stull) ; 5,664,704 (Meadows et al . ) ,- 5,997,518 (Laibovitz et al . ) ; 6,105,828 (Kanner et al . ) ; 6,129,248 (Hagele); 6,197,008 (Hagele); 6,612,469 (Lopez Pardo) ; 6,632,202 (Hagele) .
  • dropper tips which can administer precise amounts of medication to a patient by the dispensing of drops of compositions containing a medication onto an eye of the patient.
  • the present devices include dropper tips that are structured in dispensing drops of an ophthalmic composition onto an eye of an individual.
  • the drops are dispensed in a precise and reproducible manner which facilitates therapeutic treatment of one or more conditions of a patient.
  • the present dropper tips comprise a body.
  • the body has a first end, an opposing second end, and a conduit extending therethrough.
  • the dropper tip comprises an ophthalmic composition dispensing element located at the first end of the body.
  • the ophthalmic composition can be dispensed from the dropper tip as discrete drops.
  • the drops have a size, such as a volume or weight, that is precisely controlled by the structure of the dispensing element and is reproducible for each dispensement of the drops.
  • the dispensing element is structured to dispense drops having a maximum relative deviation less than 10%.
  • the drops have a maximum relative deviation less than 3%, and in further embodiments, the drops have a maximum relative deviation between about 1% and about 3%.
  • the conduit of the dropper tip body comprises a flow restrictor portion and a dispensing portion. The flow restrictor portion is effective in providing dropwise dispensing of the ophthalmic composition.
  • the dispensing element of this embodiment comprises a sidewall that is coextensive with the innerwall defining the conduit.
  • the sidewall forms a dispensing orifice of the dispensing portion of the conduit, and has a distal end surface oriented at a substantially ninety degree angle to the longitudinal axis of the dispensing element.
  • the thickness of the sidewall in this embodiment is substantially less than the diameter of the orifice.
  • the present dropper tips may also comprise a protection member structured to reduce or prevent contact between the dispensing element and a surface of the eye.
  • the protection member may be provided as a ring structure circumscribing the dispensing element at the first end of the body.
  • a method of producing the present dropper tips may comprise a step of forming a material, such as hard or elastomeric materials, into a dropper tip having a dispensing element as herein described.
  • FIG. 1 is a side plan view of an ophthalmic composition dropper tip comprising an ophthalmic composition dispensing element oriented along the longitudinal axis of the dropper tip.
  • FIG. 2 is a sectional view of the dropper tip of FIG. 1 coupled to an ophthalmic composition container.
  • FIG. 3 is a magnified perspective view of the ophthalmic composition dispensing element of the dropper tip of FIG. 1.
  • FIG. 4 is a side plan view of an ophthalmic composition dropper tip comprising a dispensing element oriented at a forty-five degree angle to the longitudinal axis of the dropper tip.
  • FIG. 5 is a sectional view of the dropper tip of FIG. 4 rotated by ninety degrees.
  • FIG. 6 is a perspective view of an ophthalmic composition dropper tip similar to FIG. 1 and including a protection member.
  • FIG. 7 is a sectional view of the dropper tip of FIG. 6.
  • FIG. 8 is a magnified perspective view of the dispensing element and protection member of the dropper tip of FIG. 6.
  • FIG. 9 is a sectional view of the dispensing element and protection member of the dropper tip of FIG. 8.
  • FIG. 10 is a sectional view of an ophthalmic composition dropper tip similar to FIG. 5 and including a protection member.
  • FIG. 11 is a magnified perspective view of the dispensing element and protection member of the dropper tip of FIG. 10.
  • FIG. 12 is a graph illustrating drop volume (microliters) versus drop number.
  • FIG. 13 is a perspective view of an ophthalmic composition dropper tip including a dispensing element and protection member similar to FIG. 6.
  • FIG. 14 is a side plan view of the dropper tip of FIG. 13.
  • the present invention involves devices that are useful in delivering compositions to an eye of an individual, such as a human or animal.
  • the devices are structured or constructed to administer ophthalmic compositions, such as topical ophthalmic compositions, to a patient as drops.
  • ophthalmic compositions useful in the present devices include liquids, solutions, formulations, suspensions, emulsions, and the like.
  • the compositions dispensed from the present devices may include, without limitation, glaucoma drugs, dry-eye products, anti- infectives, anti-allergy medications, contact lens care solutions, saline solutions, and the like.
  • the drops administered by the present devices have a high degree of precision with respect to drop size.
  • drops of the ophthalmic composition are administered at a size that is precise and reproducible from administration to administration.
  • the precise drop size is maintained for repeated uses of the device, and is independent of the angle of orientation at which the composition is administered to the eye.
  • Drop formation is a function of surface tension of a composition, and drop size is determined by the diameter of the dispensing orifice of a dropper tip and flow rate of the composition.
  • drop size is determined by the external surface area of the dropper tip that is in contact with the composition drop.
  • a container to which the dropper tip is attached may also play a role in the drop size.
  • container features such as container volume, composition volume, wall thickness, and the composition itself, may affect the drop sizes dispensed from the dropper tip.
  • the ophthalmic composition delivery devices disclosed herein comprise an ophthalmic composition dropper tip.
  • the dropper tip delivers an ophthalmic composition from a container in which the composition is contained, to an eye to provide a therapeutic benefit to the patient receiving the composition.
  • existing dropper tips do not provide precise drop sizes, such as drop sizes that vary in size less than 10% relative to other drops of the same composition dispensed from the same dropper tip. Therefore, the amount of medication administered to an eye can vary substantially from drop to drop.
  • the dropper tip disclosed in U.S. Patent No. 6,105,828 is constructed to deliver drops in the range of 25 +/- 5 microliters.
  • the drops delivered by the dropper tip have a relative deviation of about 20%.
  • other existing dropper tips provide inadequate reproducibility in drop size precision.
  • some dropper tips provide drops of ophthalmic compositions with a relative deviation of 10-15%.
  • the present dropper tips are structured to deliver drops of an ophthalmic composition that have a reduced deviation compared to existing dropper tips.
  • the present dropper tips are structured to dispense ophthalmic composition drops having a maximum relative deviation less than 10%.
  • the dropper tips are structured to dispense ophthalmic composition drops having a maximum relative deviation less than 3%.
  • the present dropper tips are relatively simple in design and are effective in dispensing small size drops with a high degree of precision and reproducibility, especially when compared to existing dropper tips .
  • precisely sized drops can be dispensed from the dropper tip onto a surface of an eye of a patient without any additional separate devices.
  • precisely sized drops can be delivered from the dropper tip without the use of a separate gas induction delivery device.
  • the drops can be dispensed without regard to the formation of bubbles in the dropper tip.
  • bubbles that may form in the dropper tip do not substantially negatively affect the reproducibility and precision of the drop sizes.
  • the present dropper tips can be constructed to dispense drops ranging in size from about 1 microliter to about 60 microliters. However, in certain situations, dropper tips may be constructed to dispense larger sized drops. Some of the present dropper tips are structured to dispense drops ranging in size from about 5 microliters to 50 microliters. It is to be understood, that due to the high precision obtained with the present dropper tips, that different dropper tips may be needed for dispensing different sized drops. For example, a dropper tip that dispenses 5 microliter drops will be different (e.g., it will have a different structural configuration) than a dropper tip that dispenses 10 microliter drops or 20 microliter drops.
  • dropper tips may be capable of dispensing drops having a volume of 35 +/- 0.35 microliters, 25 +/- 0.25 microliters, or 10 +/- 0.1 microliters (e.g., drops with about a 1% relative deviation) .
  • dropper tips that dispense drops having a 3% maximum relative deviation may dispense drops having a volume of 35 +/- 1.05 microliters, 25 +/- 0.75 microliters, or 10 +/- 0.3 microliters.
  • Other dropper tips encompassed by the present invention may administer larger or smaller sized drops.
  • "relative deviation” may be understood to refer to be the precision of drop size represented as a percentage.
  • relative deviation may also be referred to as relative error.
  • the dropper tip 20 comprises a body 22 having a first end 24, and a second end 26.
  • the second end 26 is structured or constructed, such as sized and/or shaped, to be coupled to a container that contains an ophthalmic composition.
  • the body 22 of the dropper tip 20 also has a longitudinal axis 1L, as shown in FIG. 1.
  • the body 22 has an inner wall 28 that defines a conduit 30.
  • the conduit 30 extends through the body 22 to pass or direct an ophthalmic composition from a container 100, which is coupled to the second end 26, to the first end 24.
  • the container may be any conventional container suitable for containing ophthalmic compositions, preferably in a sterile condition.
  • the composition is dispensed from the first end 24 as one or more drops. More specifically, the drops are dispensed from a ophthalmic composition dispensing element 32 that is located at the first end 24 of the body 22. As shown in FIG. 2, the dispensing element 32 comprises a dispensing orifice 34, a sidewall 36, and a distal end surface 38. In general, the dispensing orifice 34 is the distal end of the conduit 30. As discussed herein, the dispensing element 32 is structured, such as being sized and shaped, to dispense drops of the ophthalmic composition in a precise and reproducible manner.
  • each drop is dispensed having approximately the same size.
  • the size of the drop refers to the weight of the drop, the volume of the drop, or both.
  • the dispensing element 32 of the present dropper tip 20 is effective in dispensing drops that have a size with a maximum - relative deviation less than 10 percent.
  • the relative deviation of the drops is determined by measuring the size of a population of drops, such as two or more drops, and determining the mean size of the drops of the population, and determining the mean standard deviation of the drop size for the population. The mean standard deviation of the drop size is divided by the mean drop size and is multiplied by one hundred to obtain the relative deviation in the form of a percentage.
  • the dispensing element 32 is structured to dispense drops of the ophthalmic composition while maintaining minimal contact between the drop and the first end 24 of the body 22.
  • the present dropper tips dispense drops of the ophthalmic composition without the drop "rolling" or spreading across the distal end of the body 22.
  • FIG. 2 also illustrates that the conduit 30 may comprise a plurality of structurally distinct portions, such as two or more portions.
  • the conduit 30 comprises a first portion 40 defined by a first inner wall portion 42, and a second portion 44 defined by a second inner wall portion 46.
  • the first portion 40 may be understood to be a dispensing portion of the conduit 30.
  • the first portion 40 is located at the first end 24 of the body 22, and is illustrated as including the dispensing orifice 34 of the dispensing element 32.
  • the second conduit portion 44 may also be understood to be an ophthalmic composition flow restrictor portion, at least with respect to the illustrated embodiments of the present dropper tips.
  • the first conduit portion 40, or the dispensing portion, and the second conduit portion 44 each have diameters representing the respective sizes of the conduit portions.
  • the portions 40 and 44 may have a substantially constant diameter along the length of the portion (e.g., the portion of the conduit may be non-tapered) , or one or both portions may have multiple different diameters (e.g., the portion of the conduit may be tapered) .
  • the dispensing portion 40 illustrated in FIG. 2 has a length extending along the axis 2L illustrated in FIG. 1, and the diameter of the dispensing portion decreases from the dispensing orifice 34 toward the second conduit portion 44.
  • the dispensing portion 40 may not be tapered.
  • the dispensing portion 40 may have a length and the diameter of the dispensing portion 40 is substantially constant along the length.
  • the second conduit portion 44 may be understood to be a flow restrictor portion of the conduit 30.
  • the second conduit portion 44 has a maximum diameter that is less than a minimum diameter of the dispensing portion 40. In other embodiments, which do not comprise a flow restrictor portion as illustrated in the figures, the second conduit portion 44 may have a maximum diameter equal to the minimum diameter of the dispensing portion 40.
  • a magnified view of the dispensing element 32 is illustrated in FIG. 3. As shown in FIG. 3, the dispensing element 32 has an inner diameter ID and an outer diameter OD. The difference between the outer diameter OD and the inner diameter ID is equal to the thickness T of the sidewall 36. In order to obtain the precision in drop size disclosed herein, the thickness T of the sidewall 36 is small compared to the inner diameter ID or the outer diameter OD.
  • the distal end surface 38 is oriented at a substantially perpendicular, and preferably at a ninety degree angle, relative to the axis 2L of the dispensing element 32.
  • the ratio of the inner diameter to outer diameter of the dispensing element 32 is greater than or equal to 0.5:1.
  • the inner diameter is half the size of the outer diameter.
  • Some embodiments have a ratio of 0.93:1 (e.g., the inner diameter is 93% of the outer diameter) .
  • the dispensing element 32 may have a ratio of inner diameter to outer diameter in a range from about 0.5:1 to about 0.93:1.
  • the ratio of inner diameter to outer diameter of the dispensing element 32 is greater than 0.75:1 (e.g., the inner diameter is greater than 75% of the outer diameter) . It may also be understood that the thickness T of the sidewall 36 may be in a range from about 0.1% to about 20% of the dispensing orifice diameter. Some embodiments of the present dropper tips 20 have a sidewall thickness T that is between about 9.0% to about 16% of the dispensing orifice diameter. As shown in FIGS. 4 and 5, the dispensing element 32 may be oriented at a non-zero degree angle relative to the first longitudinal axis 1L of the body 22. More specifically, the embodiment of the dropper tip 20 illustrated in FIGS.
  • the 4 and 5 comprises a body having a first longitudinal axis 1L and a dispensing element 32 having a second longitudinal axis 2L.
  • the second longitudinal axis 2L is oriented at a forty- five degree angle relative to the first longitudinal axis 1L.
  • the dispensing element 32 may have a longitudinal axis 2L oriented at a zero degree angle relative to the first longitudinal axis 1L. In other embodiments, the dispensing element 32 may have a longitudinal axis oriented at a ninety degree angle relative to the longitudinal axis of the body of the dropper tip.
  • the present dropper tips may have a body and a dispensing element that is oriented at an angle from about zero degrees (including zero degrees) to about ninety degrees (including ninety degrees) relative to the longitudinal axis of the body.
  • the present dropper tips 20 may also comprise a protection member 48 structured or constructed to prevent the dispensing element 32 from contacting a surface of an eye.
  • the protection member 48 is illustrated as surrounding the dispensing element 32, for example, entirely surrounding the dispensing element 32. In other embodiments, the protection member 48 may partially surround the dispensing element and still provide the desired protection effect.
  • the protection member 48 is particularly useful in embodiments in which the body of the dropper tip and/or the dispensing element is made from a relatively rigid or hard material, such as plastics and the like. In embodiments in which the body of the dropper tip, or just the dispensing element of the dropper tip, is made of a resilient or elastomeric material, protection members may not be necessary, as shown in FIGS. 1-5. Referring back to FIGS. 6-11 and 13-14, the protection member 48 may be understood to be a ring circumscribing the dispensing element 32. The protection member 48 is illustrated as extending distally beyond the dispensing orifice 34 (see, e.g., FIGS. 9, 10, and 14) .
  • the dispensing orifice 34 is recessed relative to a distal end surface of the protection member.
  • the protection member 48 may contact the surface of the eye and would reduce the possibility that the dispensing element 32 contacts the eye.
  • the protection member 48 may form a cavity 52 having a bottom surface 50 from which the dispensing element 32 extends.
  • the bottom surface 50 may be radially angled or beveled. But, as shown in FIGS. 13-14, the bottom surface 50 may be substantially planar.
  • the precision of the drop sizes obtained with the present dropper tips can be seen in the graph of FIG. 12.
  • twelve drops of three different compositions having different viscosities were dispensed consecutively from three separate dropper tips, as disclosed herein.
  • the volume of each drop was measured.
  • Trace 102 represents the volumes of drops of a water composition.
  • the mean volume of the water drops was 23.9 microliters.
  • the standard deviation of the water drops was 0.8. Therefore, the relative deviation or relative error of the water composition drops is about 3.1%.
  • Trace 104 represents the volumes of drops of a composition having a viscosity of 15 centipoise.
  • the mean drop volume for this composition was 22.6 +/- 0.4 microliters.
  • the present dropper tips 20 comprise a dispensing element 32 that is structured to dispense drops having a size with a maximum relative deviation less than about 3%.
  • the maximum relative deviation of the drop size is in a range from about 1% to about 3%.
  • one embodiment of the present dropper tips may be understood to comprise a body 22 having a first end 24, an opposing second end 26, and an inner wall 28 defining a conduit 30.
  • the conduit 30 extends through the body to pass an ophthalmic composition from a container coupled to the second end 26 to the first end 24.
  • the conduit 30 comprises an ophthalmic composition dispensing portion 40 located at the first end 24 of the body 22.
  • the conduit 30 also comprises an ophthalmic composition flow restrictor portion 44 extending from the dispensing portion 40 towards the second end 26 of the body 22.
  • the flow restrictor portion 44 is effective in providing dropwise dispensing of the ophthalmic composition.
  • the dropper tip 20 also comprises an ophthalmic composition dispensing element 32 located at the first end 24 of the body 22.
  • the dispensing element 32 comprises a sidewall 36 that is coextensive with the innerwall 28 of the conduit 30, and forms a dispensing orifice 34 of the dispensing portion 40 of the conduit 30.
  • the sidewall 36 has a distal end surface 38 oriented at a substantially ninety degree angle to a longitudinal axis 2L of the dispensing element 32, and has a thickness T that is substantially less than the diameter of the dispensing orifice 34. Similar to the other embodiments described herein, this dropper tip may also comprise a protection member extending beyond the distal end surface of the dispensing element 32.
  • the dispensing element 32 of this embodiment is structured to dispense drops of the ophthalmic composition that have a size, such as a weight or volume, with a maximum relative deviation less than about 3 percent .
  • the dispensing element 32 is illustrated as a tubing-like member located at the first end 24 of the dropper tip body 22.
  • the tubing-like member includes an inside diameter, a relatively thin wall thickness, and an outside diameter, as discussed herein.
  • the tubing-like member also includes a distal end surface oriented at a substantially perpendicular angle to the longitudinal axis of the tubing-like member. The relatively thin wall and sharp edge at the distal end surface of the tubing-like member allow a composition drop to break away quickly and cleanly from the dropper tip body 22.
  • the drop When the drop is dispensed from the tubing-like member, the drop usually does not come into contact with any other portion of the dropper tip under normal administration of the composition to the eye.
  • the composition remaining in the tubing-like member returns toward the container after the drop is dispensed.
  • the small wall thickness and thus the small surface area of the distal end surface contribute to the enhanced drop-to-drop reproducibility of the present dropper tips.
  • the drop size of the present dropper tips is a function of the inner diameter of the dispensing orifice 34. The drop size of the present dropper tips is not affected by the external surface area of the dispensing tip.
  • dropper tips that have a dispensing orifice surrounded by curved surfaces or with surfaces having a relatively large area relative to the inner diameter of the orifice increase the amount of drop-to-drop variability dispensed from those tips.
  • the present dropper tips can be produced using conventional techniques, such as injection molding of a plastic resin material or machining of a solid plastic member.
  • the dispensing element 32 can be integrally formed with the body 22, or can be separately manufactured and attached thereto.
  • a method for producing an ophthalmic composition dropper tip in accordance with the disclosure herein may comprise a step of forming a material into a body having a first end, an opposing second end, and an inner wall de ining a conduit extending through the body to provide a flow path from the second end to the first end.
  • the first end of the body is formed to include an ophthalmic composition dispensing element which comprises a dispensing orifice of the conduit.
  • the dispensing element is formed to dispense drops of the ophthalmic composition from the body, the drops having a maximum relative deviation less than 10 percent with, respect to the sizes of the drops.
  • the dispensing element is formed to dispense drops with a maximum relative deviation from about 1.0% to about 3.0%.
  • the material used to form the dropper tip body can be any conventional material currently used in the production of dropper tips.
  • the material includes an anti-wetting agent, such as hydrophobic resins and the like, that are effective in reducing or preventing wetting effects on the first end of the body of the dropper tips. Hydrophobic resins and similar materials may also help reduce fouling or residual fluid remaining upon or within the dispensing element of the dropper tip.
  • Non-limiting examples of materials used to form the present dropper tips include polyethylene (PE) materials, polypropylene (PP) materials, cyclic olefin materials (CZ resin), fluorinatedethylenepropylene (FEP) materials, polyvinylidene fluoride (PVDF) materials, and other medical grade materials.
  • the material may also include an elastomeric material, such as polyisoprene, thermoplastic elastomers, silicone, and the like.
  • the present dropper tips 20 can be coupled to any container suitable for holding or containing an ophthalmic composition.
  • the present dropper tips can be coupled to a container, such as a bottle, by engaging the second end 26 of the body 22 with a receiving portion of the container.
  • the bottle may be a squeeze bottle.
  • the coupling of the dropper tip 20 to the container 100 can be obtained by a pressure or snap-fit between the dropper tip and the container, or the dropper tip can be screwed onto the container.
  • the dropper tip may also be covered by a screw-on or snap-on cap.
  • the coupling of the dropper tip to the container does not affect the sterility of the composition contained therein.
  • the present devices may be used by placing the present dropper tips in proximity to an eye of a patient, such as above the eye of trie patient.
  • the dropper tips are coupled to a container storing an ophthalmic composition.
  • the ophthalmic composition is then directed from the container through the conduit 30 of the dropper tip and out of the dispensing element in the form of drops .
  • Each of the drops has a size that is precise and reproducible .
  • the drops can be dispensed from the dispensing element by actively urging the composition through the conduit 30, including the second conduit portion or flow restrictor portion, as in certain embodiments, and the first portion 40 or dispensing portion.
  • the composition can be urged through the conduit by squeezing the container, such as a bottle, so that the composition moves from the container to the dispensing element.
  • the drops can be dispensed from the dispenser element as drops by allowing the composition to pass through the conduit 30. It may be understood that compositions that have relatively low viscosity may be more appropriate for the streaming application compared to the active urging application.
  • Dropper tips which dispense predetermined volumes of drops may have structural features, as described below.
  • the present dropper tips may have a body having a length of about one inch or less .
  • the length of the body corresponding to the length of the dispensing portion of the conduit and the flow restrictor portion is about 0.425 inches.
  • the length of the flow restrictor portion is about 0.100 inches.
  • the flow restrictor portion has a maximum diameter less than or equal to 0.010 inches.
  • the wall thickness of the protection member is 0.050 inches.
  • the protection member has a distal end surface that extends 0.005 inches distally beyond the distal end surface of the dispensing element.
  • One dropper tip which is structured to dispense 15 microliter size drops of a low viscosity composition has a dispensing orifice inner diameter of 0.030 inches, a sidewall thickness of 0.005 inches.
  • a dropper tip comprises a protection member, such as a safety ring
  • the inner diameter of the safety ring is 0.240 inches
  • the distance from the distal end surface of the dispensing element to the bottom surface of the surrounding cavity is 0.180 inches .
  • One dropper tip which is structured to dispense 35 microliter size drops of a low viscosity composition has a dispensing orifice inner diameter of
  • a dropper tip comprises a protection member, i such as a safety ring
  • the inner diameter of the safety ring is 0.320 inches
  • the distance from the distal end surface of the dispensing element to the bottom surface of the surrounding cavity is 0.240 inches
  • One dropper tip which is structured to dispense 60 microliter size drops of a low viscosity composition has a dispensing orifice inner diameter of 0.070 inches, a sidewall thickness of 0.005 inches.
  • a protection member such as a safety ring
  • the inner diameter of the safety ring is 0.380 inches
  • the distance from the distal end surface of the dispensing element to the bottom surface of the surrounding cavity is 0.285 inches .
  • a dropper tip that dispenses a mean 10 microliter drop size comprises a dispensing element with a dispensing orifice having an inner diameter of 0.020 inches.
  • a dropper tip that dispenses a mean 20 microliter drop size comprises a dispensing element with a dispensing orifice having an inner diameter of 0.040 inches.
  • a dropper tip that dispenses a mean 50 microliter drop size comprises a dispensing element with a dispensing orifice having an inner diameter of 0.065 inches.
  • Embodiments of the present dropper tips may provide one or more of the following benefits or advantages: (1) drop volume formation is independent of external surface area of the first end of the dropper tip body; (2) improved accuracy and/or precision of drop sizes; (3) drop fluid does not coat the outside of the first end of the dropper tip body; (4) reduced contamination of the dropper tip; (5) drop size reproducibility is independent of viscosity of the ophthalmic composition; (6) crusting or fouling of the dispensing element does not occur, even when used with compositions comprising a high surfactant content .
  • a port may be provided in the conduit, such as in the dispensing portion 40, to provide enhanced functionality.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)

Abstract

L'invention concerne des embouts compte-gouttes de haute précision comprenant un corps avec une première extrémité, une seconde extrémité opposée, et un conduit s'étendant dans le corps. La première extrémité du corps comprend un élément de distribution d'une composition ophtalmique. L'élément de distribution est structuré pour distribuer des gouttes de dimension précise et reproductible lors des multiples administrations de la composition dans l'oeil d'un individu. Les embouts compte-gouttes peuvent comprendre un élément de protection structuré pour réduire le contact entre l'élément de distribution et une surface de l'oeil. Les embouts compte-gouttes peuvent être placés sur un récipient, par exemple une bouteille, et peuvent comprendre un bouchon. L'invention concerne également des procédés de production et d'utilisation desdits embouts compte-gouttes.
PCT/US2005/002710 2004-01-30 2005-01-28 Embouts compte-gouttes de haute precision pour composition ophthalmique et procedes associes WO2005074543A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US54006004P 2004-01-30 2004-01-30
US60/540,060 2004-01-30

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WO2005074543A2 true WO2005074543A2 (fr) 2005-08-18
WO2005074543A3 WO2005074543A3 (fr) 2005-10-13

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007126852A2 (fr) 2006-04-03 2007-11-08 Insite Vision Incorporated Distributeur de gouttes pour la distribution de gouttelettes uniformes de liquides visqueux
EP2034934A2 (fr) * 2006-06-28 2009-03-18 Alcan Global Pharmaceutical Packaging, Inc. Embout compte-gouttes ophtalmique à conduit coudé
WO2014123140A1 (fr) * 2013-02-08 2014-08-14 ロート製薬株式会社 Récipient pour gouttes pour les yeux
ITTO20130941A1 (it) * 2013-11-20 2015-05-21 Pharmathen Sa Composizioni farmaceutiche prive di conservanti per somministrazione oftalmica
BE1022939B1 (nl) * 2015-08-19 2016-10-20 Hubert De Backer Nv Druppelverdeler en werkwijze voor het vervaardigen van een druppelverdeler
WO2018058715A1 (fr) * 2016-09-28 2018-04-05 尹振图 Bec de flacon compte-gouttes et compte-gouttes oculaire
WO2023137501A1 (fr) * 2022-01-17 2023-07-20 J4J, Llc Dispositif compte-gouttes oculaire

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2237213A (en) * 1939-05-31 1941-04-01 Ralph F Brown Pipette
US4936498A (en) * 1987-03-24 1990-06-26 Oy Star Ab Tip part of a dosage vessel
US5040706A (en) * 1989-03-17 1991-08-20 Insite Vision, Inc. Liquid droplet dispensing apparatus
US5221027A (en) * 1991-02-20 1993-06-22 Merck & Co., Inc. Fluid dispenser tip with recessed dispensing nozzle
US6129248A (en) * 1998-09-18 2000-10-10 Hagele; James Precision release tip for medicinal liquid dropper

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2237213A (en) * 1939-05-31 1941-04-01 Ralph F Brown Pipette
US4936498A (en) * 1987-03-24 1990-06-26 Oy Star Ab Tip part of a dosage vessel
US5040706A (en) * 1989-03-17 1991-08-20 Insite Vision, Inc. Liquid droplet dispensing apparatus
US5221027A (en) * 1991-02-20 1993-06-22 Merck & Co., Inc. Fluid dispenser tip with recessed dispensing nozzle
US6129248A (en) * 1998-09-18 2000-10-10 Hagele; James Precision release tip for medicinal liquid dropper

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007126852A2 (fr) 2006-04-03 2007-11-08 Insite Vision Incorporated Distributeur de gouttes pour la distribution de gouttelettes uniformes de liquides visqueux
EP2007469A2 (fr) * 2006-04-03 2008-12-31 Insite Vision Incorporated Distributeur de gouttes pour la distribution de gouttelettes uniformes de liquides visqueux
EP2007469A4 (fr) * 2006-04-03 2010-05-26 Insite Vision Inc Distributeur de gouttes pour la distribution de gouttelettes uniformes de liquides visqueux
EP2034934A2 (fr) * 2006-06-28 2009-03-18 Alcan Global Pharmaceutical Packaging, Inc. Embout compte-gouttes ophtalmique à conduit coudé
WO2014123140A1 (fr) * 2013-02-08 2014-08-14 ロート製薬株式会社 Récipient pour gouttes pour les yeux
ITTO20130941A1 (it) * 2013-11-20 2015-05-21 Pharmathen Sa Composizioni farmaceutiche prive di conservanti per somministrazione oftalmica
BE1022939B1 (nl) * 2015-08-19 2016-10-20 Hubert De Backer Nv Druppelverdeler en werkwijze voor het vervaardigen van een druppelverdeler
WO2018058715A1 (fr) * 2016-09-28 2018-04-05 尹振图 Bec de flacon compte-gouttes et compte-gouttes oculaire
WO2023137501A1 (fr) * 2022-01-17 2023-07-20 J4J, Llc Dispositif compte-gouttes oculaire
US11974944B2 (en) 2022-01-17 2024-05-07 J4J, Llc Eye dropper device

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