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Macromolecule-containing sustained release intraocular implants and related methods

A technology of sustained release and macromolecules, applied in the directions of medical preparations containing active ingredients, non-active ingredients of polymer compounds, medical preparations of non-active ingredients, etc.

Inactive Publication Date: 2008-01-09
ALLERGAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Another challenge is how to maintain therapeutically effective amounts of these therapeutic macromolecules in the eye for a sustained period of time

Method used

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  • Macromolecule-containing sustained release intraocular implants and related methods
  • Macromolecule-containing sustained release intraocular implants and related methods
  • Macromolecule-containing sustained release intraocular implants and related methods

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0144] Production and testing of implants containing therapeutic agents and biodegradable polymer matrix

[0145] The biodegradable implant is prepared by combining a therapeutic agent such as the above-mentioned agent with a biodegradable polymer composition in a stainless steel mortar. The composition was mixed with a Turbula shaker at 96 RPM for 15 minutes. Scrape the powder mixture from the wall of the mortar and mix for another 15 minutes. The mixed powder mixture is heated to a semi-molten state for a total of 30 minutes at a specific temperature to form a polymer / drug melt.

[0146] The rod formulation is prepared by the following method: the polymer / drug melt is made into pellets with a No. 9 polytetrafluoroethylene (PTFE) metering tube, the pellets are filled into a cylinder, and the material is extruded at a specific core extrusion temperature Into filaments. The filaments are then cut into approximately 1 mg size implants or drug delivery systems. The size of the rod ...

Embodiment 2

[0152] Treatment of eye diseases with intraocular implants with anti-inflammatory agents

[0153] Controlled release drug delivery systems can be used to treat eye diseases. The system may contain steroids such as anti-inflammatory steroids such as dexamethasone as the active agent. Alternatively, the active agent may be a non-steroidal anti-inflammatory drug, such as ketorolac (available from Allergen, Irvine, California, in the form of a ketorolac tromethamine ophthalmic solution, trade name Acular). Therefore, for example, the dexamethasone or ketorolac extended release implant system prepared according to Example 1 can be implanted into the eye area or location (ie, intravitreal) of patients with ocular diseases to obtain the desired therapeutic effect. The eye disease may be inflammation such as uveitis, or the patient may suffer from one or more of the following diseases: macular degeneration (including non-exudative age-related macular degeneration and exudative age-relat...

Embodiment 3

[0155] Preparation and therapeutic application of anti-angiogenesis extended release implant

[0156] The implant for treating eye diseases according to the present invention may contain a steroid such as an anti-angiogenic steroid such as anecort as an active agent. Therefore, the method of Example 1 can be used to prepare a biodegradable implant system for prolonged delivery of anecortacetate (an angiogenesis-inhibiting steroid). The one or more implants can load a total of about 15 mg of Anecort.

[0157] The anecortamine acetate extended-release implant system can be implanted into the eye area or location (i.e., intravitreal) of patients with eye diseases to obtain the desired therapeutic effect. The eye disease may be an angiogenic disease or inflammation such as uveitis, or the patient may suffer from one or more of the following diseases: macular degeneration (including non-exudative age-related macular degeneration and exudative age-related macular degeneration) ; Choro...

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Abstract

Drug delivery systems suitable for administration into the interior of an eye of a person or animal are described. The present systems include one or more components which are effective in improving a release profile of a drug from the system, improving the stability of the drug, and improving the ocular tolerability of the drug. The present systems include one or more therapeutic agents in amounts effective in providing a desired therapeutic effect when placed in an eye, and an excipient component with reduced toxicity to retinal cells. The excipient component may include a cyclodextrin component that may be complexed with the therapeutic agents to provide advantages over existing intraocular drug delivery systems. The cyclodextrin component of the present systems have a reduced toxicity relative to benzyl alcohol or polysorbate 80. The drug delivery systems include one or more drug delivery elements such as microparticles, bioerodible implants, non-bioerodible implants, and combinations thereof. Methods of using and producing the drug delivery systems are also described.

Description

[0001] Cross-reference of related applications [0002] This application claims to be based on the U.S. patent application filed on April 30, 2004 with the application serial number 60 / 567,423 as the basis of priority, and the entire content of the application is hereby incorporated by reference. Technical field [0003] The present invention mainly relates to a device and method for treating a patient’s eye, and more specifically to a drug delivery system that can prolong the release of a macromolecular therapeutic agent into the eye with the device, and also relates to a method of preparing and using the device for For example, treating or alleviating one or more symptoms of eye diseases to improve or maintain the patient's vision. Background technique [0004] In recent years, there has been increasing interest in the use of proteins and antibody fragments in the treatment of ocular diseases. One problem for large molecules is how to deliver them to the vitreous body close to t...

Claims

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Application Information

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IPC IPC(8): A61F13/00A61F2/00A61F9/00A61K9/00A61K9/16A61K31/724A61K39/395A61K47/34A61K47/40A61K47/48A61K48/00
CPCA61K9/1647A61K31/724A61K9/0051A61K47/40A61F9/0008A61F9/0017A61K47/34A61P9/00A61P27/02A61P27/06A61P27/10A61P29/00A61P43/00A61K9/00A61K9/16A61K47/50
Inventor P·M·休斯T·马隆G·W·德弗里斯J·埃德尔曼W·M·布兰达L·T·斯帕达P·巴修S·M·惠特卡普
Owner ALLERGAN INC
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