US3618604A - Ocular insert - Google Patents

Ocular insert Download PDF

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Publication number
US3618604A
US3618604A US831761A US3618604DA US3618604A US 3618604 A US3618604 A US 3618604A US 831761 A US831761 A US 831761A US 3618604D A US3618604D A US 3618604DA US 3618604 A US3618604 A US 3618604A
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United States
Prior art keywords
drug
medication
polymeric material
dispensing tablet
tablet
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
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US831761A
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English (en)
Inventor
Richard A Ness
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Alza Corp
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Alza Corp
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    • 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
    • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts, ocular implants

Definitions

  • Drug-dispensing ocular insert is comprised of a flexible body of polymeric material that is insoluble in tear liquid and has an imperforate surface.
  • the polymeric material contains a drug which is dispensed to the eye in a therapeuti cally effective amount by diffusion through the polymeric material.
  • the ocular insert is adapted for insertion in the culde-sac of the conjunctiva between the sclera of the eyeball and the lower lid, to be held in place against the eyeball by the pressure of the lid.
  • PATENTEUNUV 91971 3.618504 mvsmron RICHARD A. NESS BACKGROUND OF THE INVENTION This invention relates to an ocular insert for dispensing drugs to the eye over a prolonged period of time.
  • U.S. Pat. No. 3,416,530 granted Dec. 17, 1968, and assigned to the assignee of this invention, is directed to my invention of a drug-dispensing ocular insert that truly acts as a depot or drug reservoir, retaining and slowly releasing drug to the eye for prolonged periods of time.
  • ocular inserts are fabricated of flexible polymeric materials that are biologically inert, nonallergenic, and insoluble in tear liquid.
  • the ocular insert is placed in the culde-sac of the conjunctiva between the sclera of the eyeball and the lid.
  • the polymeric material from which the ocular insert is formed is insoluble in tear liquid it retains its integrity and remains intact during the course of therapy, acting as a reservoir to continuously release drug to the eye and sur rounding tissues at a rate which is not affected by dissolution or erosion of the polymeric material.
  • the ocular insert is removed from the cul-de-sac.
  • a single such ocular insert provides the complete ophthalmic dosage regime for a particular time period, on the order of 24 hours or longer. Frequent repeated applications, as is necessary with liquids, ointments, or watersoluble lamellae, often requiring awakening the patient during the night, are avoided.
  • U.S. Pat. No. 3,416,530 describes using polymeric materials which are perforated with capillary openings. While these capillary openings are effective to release drug to the eye, they add considerable complexity to the manufacture of ocular inserts; for its is difficult to control the size of these openings in large-scale manufacturing using various polymers.
  • Still another object of this invention dependent upon the size and pores in the polymeric body of the is to provide a drugdispensing ocular insert which is comfortable to wear for long resides in a drug-dispensing ocular insert periods and does not cause discomfort during sleeping and normal daily wear.
  • one feature of this invention to deliver during to the eye over aprolonged period of time comprising a flexible ody of polymeric material insoluble in tear liquid and having an imperforate surface, the body containing a drugwhichis dispensed to the eye in a therapeutically effective amount by diffusion through the polymeric material.
  • the ocular insert of this invention is adapted for insertion in the cul-de-sac of the conjunctiva betweenthe sclera of the eyeball and the lower lid, to be held in place against the eyeball by the pressure of the lid.
  • insert is designed for placement and eyelid and is fabricated of a perforate surface, that therethrough.
  • Polymeric materials used in forming the ocular insert are flexible, biologically inert, insoluble in tear liquid, and nonallergenic. It is important that thepolyrneric material be capable of transferring the drug through its unbrokenwalls by the diffusion of drug or drug solution therethrough. By utilizing the mechanism of difiusion to dispense drug to the eye, the rate of drug release can be controlled with precision and reproducibility. In each case, selection of the polymeric material is dependent on the particular drug and drug form to be used in the device.
  • Exemplary materials forfabricating the ocular insert include hydrophobic polymers such as plasticized or unplasticized polyvinylchloride, plasticized nylon, unplasticized soft nylon, plasticized polyethylene terephtahalate, and silicone rubber; and hydrophilic polymers such as the hydrophilic hydrogels of esters of acrylic and methacrylic acid (as described in U.S. Pat. Nos. 2,976,576 and 3,220,960 and modified collagen, cross-linked hydrophilic polyether gels (as described in U.S. Pat. No. 3,419,006), cross-linked polyvinylalcohol, and cross-linked partially hydrolyzed polyvinylacetate.
  • various plasticizers kriown to the art can be employed, such as long-chain fatty amides, higher alcohols, and dioctyl phthalate.
  • hydrophilic polymers suitable for use in this invention absorb forming a hydrogel therewith. Tear liquid entering to form the swollen hydrogel molecules dissolves the drug within the polymeric body, and the resulting drug solution then diffuses outwardly from: the the hydrogel structure. Therefore, as used in this specification and the appended claims, the term diffusion? refers to the movement of a drug through an imperforate polymeric body, as well as to the movement of adrug solution through an imperforate body.
  • insoluble in tear liquidf means that the polymeric materials do not dissolve and erode as a result of the action of tear liquid, but may absorb tear liquid, forming a swollen hydrogel.
  • any of the drugs used to treat the eye and surrounding tissues can be incorporated in the ocular insert of this invention.
  • drugs which will pass through the eye or the tissue surrounding the eye to the bloodstream, but which are not used in therapy of the eye itself can be incorporated in the ocular insert.
  • Suitable drugs for use in therapy of the eye with the ocular insert include, without limitation: Anti-infectives: such as antibiotics, including tetracycline, chlortetracycleine, bacitracin, neomycin, polymyxin, gramicidin, oxytetracycline, chloramphenicol, and erythromycin; sulfonamides, including sulfacetamide, sulfamethizole, and sulfisoxazole; antivirals, including idoxuridine; and other anti-infectives including nitrofurazone and sodium propionate; Antiallergenics such as antazoline, methapyrilene, chlorpheniramine, pyrilamine and prophenpyridamine; Anti-inflammatories such as hydrocortisone, hydrocortisone acetate, dexamethasone, dexamethasone 2l-phosphate, fluocinolone, medrysone, prednisolone, pred
  • Drugs can be in various forms, such as uncharged molecules, components of molecular complexes, or nonirritating, pharmacologically acceptable salts, such as hydrochloride, hydrobromide, sulfate phosphate, nitrate, borate, acetate, maleate, tartrate, salicylate, etc.
  • pharmacologically acceptable salts such as hydrochloride, hydrobromide, sulfate phosphate, nitrate, borate, acetate, maleate, tartrate, salicylate, etc.
  • simple derivatives of the drugs such as ethers, esters, amides, etc., which have desirable retention and release characteristics but which are easily hydrolyzed by body pH, enzymes, etc. can be employed.
  • the amount of drug incorporated in the ocular insert varies widely, depending on the particular drug, the desired therapeutic effect, and the time span for which the ocular insert will be used.
  • the ocular insert is intended to provide the complete dosage regime for eye therapy for but a particular time span, such as 24 hours, there is no critical upper limit on the amount of drug incorporated in the device. For when the device is removed and disposed of it makes little difference whether any drug remains in the device. The lower limit will depend on the activity of the drug and its capability of being released from the device. Thus it is not practical to define a range for the therapeutically effective amount of drug incorporated into the device. However, typically, from I microgram to l milligram of drug is incorporated in the ocular insert.
  • the polymeric material used to form the ocular insert is chosen for its compatibility with a particular drug and its capability of releasing that drug by diffusion at an appropriate rate over a prolonged period of time.
  • Specific, but nonlimiting, examples of combinations of drugs and polymers for use in forming the ocular insert are: (l) chloramphenicol incorporated into polyethylene terephthalate plasticized with higher alcohols; (2) promethazine trichloroacetate incorporated into polyvinylchloride plasticized with dioctylphthalate; (3) chloramphenicol dispersed throughout polydimethylsiloxane rubber; (4) pilocarpine or pilocarpine perfluorobutyrate incorporated into polyvinylchloride plasticized with dioctylsebecate; and (5) dexamethasone incorporated into nylon-plasticized with higher alcohols.
  • the ocular insert can be fabricated in any convenient shape for comfortable retention in the cul-de-sac. It is important, however, that the device have no sharp, jagged, or rough edges which can irritate the sensitive tissues of the eye.
  • the marginal outline of the ocular insert can be ellipsoid, beanshaped, rectangular, etc. In cross section, in can be concavoconvex, rectangular, etc.
  • the ocular insert is flexible and, in used, will assume essentially the configuration of the scleral curvature, the original shape of the device is not of controlling importance. Dimensions of the device can vary widely.
  • the lower limit on the size of the device is governed by the amount of the particular drug to be applied to the eye and surrounding tissues to elicit the desired pharmacologic response, as well as by the smallest sized device which conveniently can be inserted and removed from the eye.
  • the upper limit on the size of the device is governed by the limited space within the culde-sac that conveniently and comfortably can be filled with an ocular insert.
  • the ocular insert is 4 to 20 millimeters in length, l to 12 millimeters in width, and 0.1 to l millimeter in thickness.
  • it is ellipsoidal in shape and about 6 X4 0.5 millimeters in size.
  • the ocular insert can be a polymeric matrix with the drug dispersed therethrough or can be a sealed container with walls of polymeric material and having the drug in an interior chamber thereof.
  • One such container has a circular or ellipsoidal cross section and is tapered at the ends.
  • Drug can be incorporated in the ocular insert in many ways. When the ocular insert is in the form of a container, any of the encapsulation, bonding, and coating techniques conventionally used in the art can be employed.
  • the ocular insert When the ocular insert is a solid matrix with the drug dispersed therethrough, it can be fabricated by adding the drugs to the monomers prior to polymerization; adding the drug to the polymer in liquid form, molding and curing; or by impregnating the polymeric material, either before or after shaping to the form of the ocular insert, with the drug.
  • the ocular insert 10 (shown by dot and dash lines in FIG. 1), it is placed in the cul-de-sac ll of the conjunctiva 12 between sclera 13 of the eyeball l4 and the lower lid 15.
  • the pressure of the lower lid 15 maintains the ocular insert 10 in place.
  • the ocular insert 10 With the ocular insert 10 under the lower lid 15, the device is comfortable to the wearer and does not contact the cornea 16 during sleeping nor during normal ocular motion.
  • the ocular insert 10 functions as a drug reservoir gradually releasing drug to the eye and surrounding tissue. Drug 17 leaving the ocular insert by diffusion is transported to the eyeball 14 by the flow of tear liquid and by the blinking action of the eyelids.
  • the eye is continuously bathed with drug 17 over a particular time span. Normally, the ocular insert 10 will be retained in place for a period of 24 hours, thereby supplying the complete dosage regime for eye therapy over that period of time.
  • the polymeric body 18 of the ocular insert does not dissolve or erode in tear liquid and a predictable and reproducible dosage regime is provided.
  • liquid polydimethylsiloxane (dow Corning Silastic 382) is mixed with chloramphenicol antibiotic.
  • stannous octoate catalyst 0.5 percent by weight is added to the mixture is poured into a mold having an ellipsoidal cavity 6 millimeters by 4 millimeters by 0.5 millimeter to cure the silicone rubber at room temperature.
  • the resulting ocular insert formed of silicone rubber contains 0.5 milligram of chloramphenicol.
  • the ocular insert When inserted in the cul-de-sac of the conjunctiva between the sclera of the eyeball and the lower lid, the ocular insert is effective to deliver to the eye the dose of chloramphenicol antibiotic required for 24 hours of treatment of infection. After that period of time, the ocular insert, with its dimensions unchanged, is removed from the cul-desac and an identical insert placed in its stead to continue the therapeutic program for an additional 24 -hour period.
  • the improved ocular insert of this invention offers many advantages. As it is formed of a polymeric material, insoluble in tear liquid, the ocular insert does not dissolve or erode in tear liquid during the course of therapeutic program. This permits the therapeutic program to be precisely controlled and the release of drug predicted with accuracy. That the ocular insert releases drug by diffusion is most important, since this too provides for close control over the rate of drug release from the polymer.
  • a medication-dispensing tablet for a human eyeball comprising a reservoir of drug formulation confined within a flexible, imperforate and continuous-surfaced body of nonallergenic polymeric material which is insoluble in tear liquid, said body being formed of a drug-release rate-controlling polymer to continuously meter the flow of drug by diffusion from the reservoir to the eye at a controlled, predetermined and reproducible rate over a prolonged period of time, said body being adapted for insertion into the cul-de-sac of the conjunctiva between the sclera of the eyeball and eyelid, to be held in place against the eyeball by the pressure of the lid, and said body having a marginal outline and cross section adapted to assume essentially the configuration of the scleral curvature; said drug being capable of transport through the unbroken walls of said body by diffusion and said body being so constructed and arranged that, when applied to the eyeball, to dispense said drug leaving said body by diffusion is transported to the eyeball by the flow of tears and by
  • polymeric material is selected from the group consisting of plasticized or unplasticized polyvinyl chloride, plasticized nylon, unplasticized soft nylon, plasticized polyethylene terephthalate, silicone rubber, hydrophilic hydrogel of an ester of acrylic or methacrylic acid, modified collagen, cross-linked hydrophilic polyether gel, cross-linked polyvinyl alcohol, and cross-linked partially hydrolyzed polyvinyl acetate.
  • polymeric material is selected from the group consisting of plasticized unplasticized polyvinyl chloride, plasticized nylon, unplasticized soft nylon, plasticized polyethylene terephthalate, silicone rubber, hydrophilic hydrogel of an ester of acrylic or methacrylic acid, modified collagen, cross-linked hydrophilic polyether gel, cross-linked polyvinyl acetate.
  • the medication-dispensing tablet as defined by claim I wherein same ranges from 4 to 20 millimeters in length, l to 12 millimeters in width, and 0.1 to l millimeter in thickness.
  • Claim 7, line 2 insert or between “plasticized” and “unplasticized”. Claim 7, line 7, after "polyvinyl delete “acetate.” and insert alcohol, and cross-linked partially hydrolyzed polyvinyl acetate.--. Claim 20, line 47, "perfluorbutyrate” should read perfluorobutyrate.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Preparation (AREA)
US831761A 1969-06-09 1969-06-09 Ocular insert Expired - Lifetime US3618604A (en)

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Cited By (116)

* Cited by examiner, † Cited by third party
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