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Medical devices and methods including polymers having biologically active agents therein

A bioactive agent and medical device technology, applied in medical preparations containing active ingredients, organic active ingredients, medical preparations with non-active ingredients, etc., can solve the impact on the final performance of the device, the side effects of medical devices, and the side effects of bioactive agents And other issues

Active Publication Date: 2013-06-12
MEDTRONIC INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, these solvent-based coatings are problematic in application, for example, because solvents may have adverse effects on medical devices, especially when medical devices include polymeric materials that can be softened or dissolved by solvents
In addition, solvents can also have side effects on the bioactive agent itself, especially when the bioactive agent is a protein-based drug
Furthermore, damage to the coated medical device during manufacture or use of the device can adversely affect the ultimate performance of the device

Method used

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  • Medical devices and methods including polymers having biologically active agents therein
  • Medical devices and methods including polymers having biologically active agents therein
  • Medical devices and methods including polymers having biologically active agents therein

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0121] Example 1 - Preparation of spray-dried clonidine hydrochloride

[0122] Dissolve clonidine hydrochloride in methanol to form a 12% (w / w) solution. The solution was spray dried in a Buchi B-290 pocket spray dryer (Buchi Laboratorium AG, Switzerland) using a 120 kHz Sono-Tek ultrasonic nozzle (Sono-Tek Corp., Milton, NY). The processing parameters were set as follows: inlet temperature (70 °C), aspirator (80%), nitrogen inlet (50 mm), spray flow rate (80 mL / h), and ultrasonic generator (0.8 W). The spray-dried powder was collected and dried for an additional 24 hours at 70°C and 15 mmHg vacuum.

Embodiment 2

[0123] Example 2 -Preparation of spray-dried clonidine hydrochloride / PLGA8515

[0124] Clonidine hydrochloride and PLGA8515 were individually dissolved in acetone to form a 2% (w / w) solution. A mixed solution of 10% clonidine hydrochloride solution and 90% PLGA8515 solution was spray-dried in a Buchi spray dryer. The processing parameters were set as follows: inlet temperature (60 °C), aspirator (80%), nitrogen inlet (50 mm), spray flow rate (80 mL / h) and ultrasonic generator (0.8 W). The spray-dried powder was collected and dried for an additional 24 hours at 30°C and 15 mmHg vacuum.

Embodiment 3

[0125] Example 3 - Preparation of melt extruded rods

[0126] Three formulations with different clonidine hydrochloride preparation methods were prepared for melt extrusion. The first formulation contained PLGA8515 ground to a powder using a Retsch (Retsch GmbH, Germany) rotor mill with an 80 micron mesh filter and clonidine hydrochloride directly from the manufacturer. The second formulation contained milled PLGA8515 and spray-dried clonidine hydrochloride from Example 1. The third formulation contained spray-dried clonidine hydrochloride / PLGA8515 from Example 2. Each formulation contained 10% (w / w) clonidine hydrochloride and 90% (w / w) PLGA8515. The formulations were dry mixed with spatulas before being fed into a twin-screw extruder (Thermo Fischer Scientific, Waltham, MA) set at 120°C and 30 RPM. The rods were extruded from a die with a diameter of 0.75 mm.

[0127] Microscopic analysis

[0128] TOF-SIMS data acquisition was performed on the rods of Example 3 usin...

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Abstract

The implant design is a drug loaded polymer device, such as a rod, designed to control the release of a biologically active agent, such as clonidine or its derivatives, such as clonidine HCl for a prolonged period of time, such as 2 months, 3 months, 4 months, and even 4.5 months. The polymer is preferably a biodegradable polymer, such as poly(lactide-co-glycolide) or polylactic acid / polylactide. The challenge in using the HCl salt forms of drugs such as clonidine, is controlling the release of the highly water soluble drug for up to 4.5 months. It has been found that by controlling the particle size distribution of the drug powder, the drug distribution within the polymer matrix is more uniform and can be controlled. Therefore, the large aggregates, which cause rapid drug release can be eliminated.

Description

[0001] The patent application of the present invention is the international application number PCT / US2009 / 040916, the international application date is April 17, 2009, the application number entering the Chinese national phase is 200980100542.3, and the name is "medical device comprising a polymer containing a bioactive agent and method” is a divisional application of the invention patent application. [0002] This application claims priority to the following application: U.S. Patent Application, filed April 18, 2008, entitled "Meidical Devices and Methods Including Polymers Having Biologically Active Agents Therein" Provisional Application 61 / 046,213 and U.S. Patent Application 12 filed March 24, 2009, entitled "Meidical Devices and Methods Including Polymers Having Biologically Active Agents Therein" / 410,151, the above-mentioned application is hereby incorporated by reference. technical field [0003] The present invention belongs to the field of biomedicine, and in partic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/4168A61K31/58A61K31/573A61K31/192A61K47/34A61P29/00A61P25/04
CPCA61L2300/63A61L2300/204A61K9/0024A61L27/18A61K31/4162A61L27/54A61L2300/604A61K47/34A61L31/16A61L2300/622A61L2300/602A61L31/06A61K9/1688A61L27/58A61P19/00A61P25/04A61P29/00A61P9/12C08L67/04
Inventor P·E·麦克唐纳德
Owner MEDTRONIC INC
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