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Biodegradable implants with controlled bulk density

A technology of bulk density and implants, applied in the field of solid water-permeable implants, which can solve the problems of harmful substances entering the body, no biocompatibility, and inability to provide long-term drug delivery rates.

Inactive Publication Date: 2014-06-18
DURECT CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The problem of pulse entry is overcome since the drug never enters the body fluids at too high a concentration, and the metabolic half-life is not a factor of regulatory importance
[0004] Despite these advantages of drug delivery from implants, prior art devices designed for this purpose also suffer from one or more disadvantages that limit their acceptability and efficacy
Such disadvantages include: non-biodegradability, which may require surgical manipulation to remove them; non-biocompatibility, which may lead to undesirable, even harmful substances entering the body; Requirement of antigen bodies; and difficulty in controlling drug release rate
In addition, conventional delivery devices do not provide sufficient long-term dosing rates to facilitate long-term dosing and may suffer from excessively high one-day cumulative drug release

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Embodiment 1 (test 1-3):

[0062] Implants were prepared as follows: 25.28 g of ground leuprolide acetate and 74.84 g of 90 / 10 poly(DL-lactide-co-glycolide)-formazol on an Inversina Mixer The oxypoly(ethylene glycol) 750 was mixed for 10 minutes in a stainless steel vessel.

[0063] The mixture was processed through a Randcastle 3 / 8" extruder under the following process conditions: screw speed 10 rpm, extruder temperature Zone 1 = 175°F, Zone 2 = 215°F, Zone 2 = 215°F, 3 Zone (Zone 3) = 238°F, and die temperature was 238°F. The extrudate was pelletized and cryogenically ground in a Retsch mill (Retsch mill) at 14000rpm with liquid nitrogen to further reduce the volume. The cryogenically ground material was heated in the dry environment of the glove box under compressed dry air for approximately 18 hours in the glove box. This fed material was used to produce the final implant using an extrusion process.

[0064] The adjusted feed was fed into a Rancastle 3 / 8" single s...

Embodiment 2

[0068] Embodiment 2 (test 3):

[0069] Implants were prepared as follows: 24.657 g of ground leuprolide acetate and 70.339 g of 90 / 10 poly(DL-lactide-co-glycolide)-formazol on an Inversina Mixer The oxypoly(ethylene glycol) 750 was mixed for 10 minutes in a stainless steel vessel.

[0070] The mixture was processed through a Randcastle 3 / 8" extruder under the following process conditions: screw speed 10 rpm, extruder temperature zone 1 = 170°F, zone 2 = 205°F, zone 3 = 213°F, and die The temperature was 213°F. The extrudate was pelletized and cryogenically ground in a Retsch mill (Retsch mill) at 8000 rpm with liquid nitrogen to further reduce the size. The cryogenically ground material was placed in a glove box under compressed dry air Heated for about 15 hours in a dry environment in the anterior chamber.The material from this feed was used to produce the final implant using an extrusion process.

[0071] The conditioned feed was fed into a Rancastle 3 / 8" single screw extr...

Embodiment 3

[0073] Embodiment 3 (test 4):

[0074] Implants were prepared as follows: 39.872 grams of ground leuprolide acetate and 110.148 grams of 90 / 10 poly(DL-lactide-co-glycolide)-formazol on an Inversina Mixer The oxypoly(ethylene glycol) 750 was mixed for 10 minutes in a stainless steel vessel.

[0075] The mixture was processed through a Randcastle 3 / 8" extruder under the following process conditions: screw speed 10 rpm, extruder temperature zone 1 = 175°F, zone 2 = 215°F, zone 3 = 238°F, and die The temperature was 238°F. The extrudate was pelletized and cryogenically ground in a Retsch mill (Retsch mill) at 14000rpm with liquid nitrogen to further reduce the size. The cryogenically ground material was placed in a glove box under compressed dry air Heat in a dry environment in the anterior chamber for approximately 18 hours.The material from this feed is used to produce the final implant using an extrusion process.

[0076] The conditioned feed was fed into a Rancastle 3 / 8" sin...

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Abstract

Disclosed solid water permeable implants that include a water permeable polymer and an osmotically active drug formulation that comprises a drug; wherein the solid water permeable implant has a ratio R of bulk density of the solid water permeable implant to osmotic pressure of the drug formulation wherein R is greater than about 0.244 grams / milliliter-atm. Also disclosed are methods of making and using such solid water permeable implants.

Description

[0001] This application claims priority to US Application Serial No. 60 / 999,609, filed October 18, 2007, which is hereby incorporated by reference in its entirety for all purposes. field of invention [0002] In one aspect, the invention relates to solid water permeable implants; in particular, to solid water permeable implants comprising a water permeable polymer and an osmotically active drug formulation comprising a drug. Background of the invention [0003] Sustained, long-term drug delivery methods may have certain advantages in that they can achieve the desired blood concentration of the drug in circulation over an extended period of time. Various modes of administration with continuous dose, long-term delivery devices have been used or proposed. One of these modes of administration is the use of subcutaneous implants, which offer a particularly desirable combination of properties allowing the administration of substances on a local or systemic basis. To this end, sub...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K38/09
CPCA61K9/0024A61K9/0004A61K38/09A61P5/10
Inventor 苏·贾姆二世萨恩贾·格斯空达学青·苏
Owner DURECT CORP
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