Biodegradable intraocular implants containing prostamides

A prostamide and biodegradable technology, applied in the field of intraocular implants and the preparation and use of the implants, can solve unwelcome problems and achieve the effect of prolonging the release time

Inactive Publication Date: 2007-04-18
ALLERGAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This side effect is undesirable from a purely cosmetic point of view, although it remains unclear whether this effect has other as well as deleterious clinical consequences

Method used

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  • Biodegradable intraocular implants containing prostamides
  • Biodegradable intraocular implants containing prostamides
  • Biodegradable intraocular implants containing prostamides

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0137] Example 1 Preparation and testing of implants containing bimatoprost and a biodegradable polymer matrix

[0138] A biodegradable implant was prepared by combining bimatoprost and a biodegradable polymer composition. 800 mg polylactic acid (PLA) was combined with 200 mg bimatoprost. The composition was then dissolved in 25 ml of dichloromethane. The mixture was placed under vacuum at 45°C overnight to evaporate the dichloromethane. The resulting mixture was in the form of cast slabs. The cast plates were sheared and milled in a high shear mill with dry ice until the particles passed through a screen with a pore size of approximately 125 [mu]m. The microparticles were analyzed for the percentage of bimatoprost using high pressure liquid chromatography (HPLC). Dialysis was used to characterize the percent release of bimatoprost from the microparticles. The recovered granules were analyzed by HPLC for the percentage of residual bimatoprost.

[0139] Table 1 describes ...

Embodiment 2

[0142] Example 2 Production of Bimatoprost-Containing Biodegradable Intraocular Implants by Extrusion and Compression

[0143] The bimatoprost is combined with the biodegradable polymeric composition in a mortar and mortar. The composition was then mixed for about 15 minutes on a shaker set at about 96 RPM. Scrape the powdered mixture from the sides of the mortar and mix for an additional 15 minutes. The blended powder mixture was heated at the specified temperature for a total of 30 minutes to achieve a semi-molten state and form a polymer / drug melt.

[0144] Rods are manufactured as follows: Polymer / drug melt is granulated using 9-gauge polytetrafluoroethylene (PTFE) tubing, the granules are loaded into barrels and the material is extruded into filaments at a specific core extrusion temperature . The filaments are then cut into approximately 1 mg size implants or drug delivery systems. The stick size is approximately 2mm long x 0.72mm diameter. Rod implants weighed appr...

Embodiment 3

[0149] Example 3 Bimatoprost / PLA / PLGA intraocular implant for treating glaucoma

[0150] A 72 year old female with bilateral glaucoma was placed in each eye with an intraocular implant containing bimatoprost and a combination of PLA and PLGA. The implant weighs about 1 mg and contains about 500 mg bimatoprost. One implant is placed into the vitreous of each eye using a syringe. After about two days, the patient reported significant relief of eye discomfort. Examination indicated a decrease in intraocular pressure, with mean intraocular pressure falling from 28 mm Hg to 14.3 mm Hg measured at 8:00 AM. Patients were monitored monthly for about six months. Intraocular pressure levels below 15 mm Hg were maintained for six months, and the patient reported relief from ocular discomfort.

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Abstract

Biocompatible intraocular implants include a prostamide component and a biodegradable polymer that is effective in facilitating release of the prostamide component into an eye for an extended period of time. The prostamide component may be associated with a biodegradable polymer matrix, such as a matrix of a two biodegradable polymers. The implants may be placed in an eye to treat or reduce a at least one symptom of an ocular condition, such as glaucoma.

Description

technical field [0001] The present invention relates to devices and methods for treating the eye of a patient, and more particularly, to intraocular implants and methods of making and using the same, which implants provide extended release of therapeutic agents to the implanted Intraocularly, for example to treat ocular hypertension by reducing or at least maintaining intraocular pressure. Background technique [0002] Ocular hypotensive drugs are used in the treatment of a number of different ocular hypertension conditions such as post-surgical trabeculectomy or post-laser trabeculectomy episodes of ocular hypertension, glaucoma and preoperative adjuncts. [0003] Glaucoma is an eye disease characterized by increased intraocular pressure. Depending on the etiology, glaucoma can be classified as primary or secondary. For example, primary glaucoma (congenital glaucoma) in adults can be open angle glaucoma, acute or chronic angle closure glaucoma. Se...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5575A61K9/00A61P27/06A61K9/20
CPCA61K9/0019A61K31/216A61K47/34A61K9/0051A61K9/204A61K31/5575A61P3/10A61P7/10A61P9/10A61P9/12A61P9/14A61P27/02A61P27/06A61P27/10A61P27/12A61P27/14A61P27/16A61P31/00A61P31/04A61P31/10A61P31/12A61P35/00A61P41/00A61P43/00A61K9/20A61K9/48A61F9/0017A61K9/1647
Inventor P·M·休斯
Owner ALLERGAN INC
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