Medical uses of in situ formed gels

a technology of in situ formation and gel, which is applied in the field of medical uses of in situ formation gel, can solve the problems of fragmentation occurring upon exceeding the flexibility of the collagen shield, unsatisfactory, and limited acceptance of the gel

Inactive Publication Date: 2003-07-31
VIEGAS TACEY X +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These are often not satisfactory because they lack sufficient flexibility to adequately conform to the individual corneal curvature.
Wetting a collagen shield will increase conformance of the shield to the cornea but fragmentation can occur upon exceeding the flexibility of the collagen shield.
Refractive surgery has been promoted in the United States and Russia over the past few years but its acceptance has been limited because of the poor predictability of the final optical results which include resulting glare from incisions that encroach upon the optical zone.
Techniques that rely upon the surgical production of corneal incisions have yielded inconsistent results because these surgical incisions in the cornea have been found to vary considerably in depth and length.
Since the primary locus of astigmatism is in the cornea, surgical intervention for astigmatism is more important than for the correction of other refractive errors, especially since spectacle or contact lens correction is of limited value in compensating for large astigmatic errors.
A complete listing of useful water soluble, film forming polymers is not possible.
In addition, it is noted that a large percentage of drugs administered to the eye are lost as a result of lacrimal drainage.
While progress has been made in the delivery of drugs by the use of solid implants, many patients find it difficult to tolerate the introduction of the implants into the conjunctival areas.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

examples 2 and 3

[0082] In these Examples there are described compositions of the invention for ophthalmic use as a corneal protective mask or as a laser ablatable corneal mask. Utilizing the same procedure as described in Example 1, an aqueous composition containing sodium hyaluronate and sodium alginate was prepared in two separate compositions. Sodium hyaluronate is commercially available from Meiji Seika Inc. Example 2 was hypoosmotic having an osmotic pressure of 249 mOSM / Kg and Example 3 was hyperosmotic having an osmotic pressure of 319 mosm / Kg. Both compositions were characterized as neutral in pH. The formulations have the following proportions by weight:

2 Example 2 Example 3 Sodium hyaluronate 1.0 1.0 Sodium Alginate, high viscosity 1.0 1.0 Glycerin 96.0 0.5 Boric acid-sodium borate buffer 98.0 97.5

[0083] These compositions were evaluated as described in Example 1 by spreading a small amount of the formulation a glass slide and subsequently spraying the coated slide with a 5% by weight aqu...

example 4

[0085] In this Example there is described a composition of the invention for ophthalmic use as a protective corneal shield or a laser ablatable corneal mask. An aqueous mixture comprising polyvinyl pyrrolidone and sodium alginate, high viscosity was prepared as follows: The percentages below are by weight.

3 Polyvinyl pyrrolidone 0.8 Sodium Alginate, high viscosity 1.0 Glycerin 0.3 Boric acid-sodium borate buffer 97.9

[0086] The composition was characterized as neutral in pH having a pH of 7.2. The composition was hypoosmotic having an osmolality of 270 mOsm / Kg.

[0087] The product was further characterized by measuring the average penetration in millimeters determined using a Precision Penetrometer with a 1 / 4 (9.38, ASTM D-1043) cone and plunger. The penetration of the aqueous solution of polymers prepared above was greater than 20 mm. Subsequent to treatment of this solution with a few drops of a 5% by weight aqueous solution of calcium chloride, a gel was formed in which the penetrat...

example 5

[0088] In this Example there is described a composition of the invention for ophthalmic use as a laser ablatable mask or as a protective corneal shield. In accordance with the procedure of Example 1, chondroitin sulfate and sodium alginate were prepared as an aqueous solution utilizing the percentages by weight indicated below.

4 Sodium Chondroitin sulfate 2.0 Sodium Alginate, high viscosity 1.0 Glycerin 0.3 Boric acid-sodium borate buffer 96.7

[0089] The aqueous solution was characterized as neutral in pH having a pH of 7.0. The aqueous solution was hyperosmotic having a measured osmolality of 354 mOsm / Kg. The penetration utilizing a Precision Penetrometer with a 1 / 4 size cone, as described above, was greater than 20 mm prior to treatment with a few drops of a 2%-5% aqueous solution of calcium chloride. Subsequent to treatment with the aqueous calcium chloride solution, a gel was formed in which the penetration was reduced to 5.1 mm.

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Abstract

Balanced pH, hyperosmotic, hypoosmotic, or isoosmotic gels are ideal vehicles for drug delivery. They are especially suited for topical body cavity or injection application of drugs or diagnostic agents; for drug or diagnostic agent delivery to the eye of a mammal; as protective corneal shields; or as ablatable corneal masks useful in laser reprofiling of the cornea. The compositions without the addition of a drug or diagnostic agent are useful as medical devices, for instance, in separating surgically or otherwise injured tissue as a means of preventing adhesions.

Description

[0001] This application is a continuation of U.S. Ser. No. 09 / 628,227, filed Jul. 28, 2000, which is a continuation of U.S. Ser. No. 09 / 330,618, filed Jun. 11, 1999, now U.S. Pat. No. 6,136,334, which is a continuation of U.S. Ser. No.08 / 773,755, filed Dec. 23, 1996, now U.S. Pat. No. 5,958,443 which is a continuation of U.S. Ser. No. 08 / 174,101 filed Dec. 28, 1993, now U.S. Pat. No. 5,587,175, which is a divisional of U.S. Ser. No. 07 / 785,305, filed Oct. 30, 1991, now U.S. Pat. No. 5,318,780.[0002] This invention relates to drug delivery system, the prevention of post-surgical adhesions, ophthalmic corneal protective devices, and a surgical device used in the correction, for instance, of corneal ulcers, irregularities, scarring, astigmatism, myopia, and hyperopia.DESCRIPTION OF THE PRIOR ART[0003] Over the years, methods have been developed to achieve the efficient delivery of a therapeutic drug to a mammalian body part requiring pharmaceutical treatment. Use of an aqueous liquid w...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61F9/008A61K9/00A61L15/22A61L15/44A61L24/00A61L24/04A61L27/26A61L27/52A61L27/54A61L31/04A61L31/16
CPCA61F9/00819Y10S623/905A61K9/0048A61L15/225A61L15/44A61L24/0015A61L24/0031A61L24/043A61L27/26A61L27/52A61L27/54A61L31/041A61L31/16A61L2300/00A61L2430/16A61F2009/00872Y10S514/967Y10S514/966Y10S514/914Y10S514/913Y10S514/912Y10S514/944C08L5/04C08L1/26
Inventor VIEGAS, TACEY X.REEVE, LORRAINE E.HENRY, RAYMOND L.
Owner VIEGAS TACEY X
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