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Microimplants for ocular administration

An implant and eye technology, applied in the field of implants, can solve problems such as difficulty in manufacturing, affecting the treatment of eye diseases or eye diseases, and different delivery amounts of active ingredients.

Active Publication Date: 2010-06-23
ALLERGAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, such small implants are difficult to manufacture, specifically because such small implants must have a uniform composition and must have a consistent shape, size and morphology in order to achieve the desired effect over a desired period of time. dose level
Even slight variations in the uniformity of composition of these small implants or in the consistency of shape, size, or morphology could result in significantly different than expected amounts of active ingredient delivered, affecting the ocular Treatment of diseases or eye conditions

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] Example 1: Preparation of Single Extrusion Microimplants

[0080]Microimplants for implantation into the vitreous cavity were prepared as follows. The active agent dexamethasone was mixed with the biodegradable polymer 50 / 50 polylactic-polyglycolic acid (PLGA). Agent and polymer were thoroughly mixed in the following weight ratios: dexamethasone (Pharmacia Corp., Peapack, NJ), 50 / 50 PLGA with free acid ends (RG502H, Boehringer Ingelheim GmbH, Germany) and 50 / 50 PLGA (RG502, Boehringer Ingelheim GmbH, Germany) in a ratio of 60:30:10, respectively.

[0081] A batch of drug-polymer mixture of 20 g or less was loaded into a 5 cc capacity (closed batch) twin-screw extruder capable of continuous mode (DACA MicroCompounder, DACA Instruments, Goleta, CA or Haake Minilab, Thermo Haake, Madison, WI). Extruders are equipped with conical screws and barrels as opposed to conventional cylindrical barrels. The working conditions of the extruder are a temperature of 90-110°C, a s...

Embodiment 2

[0084] Example 2: Preparation of Dual Extrusion Microimplants

[0085] An 80 g batch of the drug / polymer mixture described in Example 1 was used to prepare extruded filaments by the dual extrusion process using the Haake Minilab. As described in Example 1, an automatic ring knife was used to prepare the microimplants.

Embodiment 3

[0086] Example 3: Dexamethasone microimplants (700 μg) were tested and analyzed based on mass measurements filter

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Abstract

Implants and microimplants are provided comprising homogeneous mixtures of active ingredient and bioerodible polymer, including microimplant having diameters of (0.019) inches or less and which can be delivered to the eye using self-sealing methods. Methods of manufacturing the implants and microimplants are provided that yield batches of highly uniform implants and microimplants within very narrow tolerance ranges.

Description

technical field [0001] The present invention relates to implants containing active ingredients such as drugs or other therapeutic agents. More specifically, the present invention relates to implants that can be implanted into the eye to treat ocular diseases or conditions. Background technique [0002] A major difficulty in treating ocular diseases or conditions is how to introduce active ingredients such as drugs or other therapeutic agents into the eye and maintain such active ingredients in the eye at effective therapeutic concentrations for the period of time necessary. Systemic administration is not an ideal solution since high systemic doses are usually required to obtain effective concentrations in the eye, which increases the incidence of intolerable side effects of the active ingredient. Simple intraocular instillation or application is also difficult to apply in many cases because the active ingredient may be flushed out quickly by tearing action or enter the syst...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61F9/00A61K9/00
CPCA61F2210/0004A61F9/0017A61K9/204A61K9/0051A61P27/02A61P29/00A61F9/00A61K9/00A61N5/10A61F2/00
Inventor T·尼瓦格丽D·A·韦伯
Owner ALLERGAN INC
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