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Therapeutic Methods Using Controlled Delivery Devices Having Zero Order Kinetics

Inactive Publication Date: 2012-05-24
BOARD OF RGT THE UNIV OF TEXAS SYST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0018]In one embodiment the present invention describes a method for fabricating a controlled release delivery system for providing a unidirectional release one or more active agents with zero order release kinetics, wherein the active agents are selected from the group consisting of a drug, a diagnostic agent, a therapeutic agent, a prophylactic agent or combinations thereof comprising the steps of: (i) providing a silicon-wafer substrate comprising a trench; (ii) placing a non-planar polyimide housing comprising a hollow core within the trench; (iii) etching one or more passageways extending from the housing surface into the hollow core, wherein the etching is done by reactive ion etching, laser ablation or any other suitable technique; and (iv) loading an active agent supply comprising a drug depot or

Problems solved by technology

Additionally, the method creates a device that can provide for the release of the agent from the device is unidirectional and at a controlled and desirable rate.

Method used

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  • Therapeutic Methods Using Controlled Delivery Devices Having Zero Order Kinetics
  • Therapeutic Methods Using Controlled Delivery Devices Having Zero Order Kinetics
  • Therapeutic Methods Using Controlled Delivery Devices Having Zero Order Kinetics

Examples

Experimental program
Comparison scheme
Effect test

example i

Manufacture of a Single Passageway Impermeable Delivery Device

[0233]This example describes the manufacture of one embodiment of an impermeable zero order kinetic drug delivery device having a single passageway.

[0234]Lengths of polyimide tubes were provided having a length of 20 mm and a diameter of 125 microns. At the centre of each tube, a passageway with a diameter of 30 microns was made using standard chemical procedures.

[0235]Seven (7) tubes having the optimal passageways were selected and loaded with a concentrated solution of crystal violet in ethanol by capillary method. The tubes were then allowed to stand for 24 hours at room temperature to evaporate alcohol from the tubes, such that the tube is tightly packed with a solid crystal violet composition.

[0236]After taking an initial weight measurement, an average amount of 126 micrograms of crystal violet was estimated inside the tubes. The ends of the tubes were sealed with a bioglue and dried.

example ii

Release Kinetics of a Single Passageway Impermeable Delivery Device

[0237]This example describes one method that evaluates the release of an agent from a single passageway impermeable delivery device.

[0238]Single passageway tubes made according to Example I were placed in microvials containing 0.26 ml of phosphate buffered saline (0.01 M phosphate, pH 7.37). The vials were placed in a USP Disintegration Apparatus having dip rate of 30-32 dips per minute. The apparatus was connected to a waterbath maintained at 37° C. for the entire duration of study. The buffer was changed every 48 hours, sampled, and analyzed for the amount of crystal violet released using a UV-Vis Spectrophotometer for 28 days.

[0239]A significant linearity of release of the crystal violet was obtained from this single passageway device (see FIGS. 6 and 7). Additionally, the percentage release when extrapolated to 100% corresponds to the total duration of release of approximately 43 years.

example iii

Manufacture of a Double Passageway Impermeable Delivery Device

[0240]This example describes the manufacture of one embodiment of an impermeable zero order kinetic drug delivery device having two passageways.

[0241]Several drug delivery devices were constructed in accordance with in Example I except that two passageways were made located equidistant from the tube centre. The optimal seven (7) were selected and loaded with crystal violet in accordance with Example I.

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Abstract

An injectable or implantable medical device having orifice(s) on the surface that release an active agent with zero-order release kinetics is described herein. The device is a hollow matrix of any size or shape, which can be made from both metal and non-metal surfaces. The device comprises of a reservoir capable of releasing at least one therapeutic, diagnostic, or prophylactic agent via the orifices to the desired anatomical site. The developed device, due to its composite structure, has the ability to combine several release mechanisms, leading to zero-order release kinetics for most of the time. The composition provides zero-order kinetics, in part, because the diffusion rate of the drug from the device is slow which enables sink conditions. Hence, no back transfer or build up of drug occurs at anytime. Polymers are not required for controlled release.

Description

TECHNICAL FIELD OF THE INVENTION[0001]This invention relates to delivering therapeutic agents and methods of using a therapeutic agent delivery device that is capable of delivering a diagnostic, therapeutic, and / or prophylactic agents. Optionally, the delivery device may monitor bodily fluid analytes by incorporation of microelectronics. Additionally, the method creates a device that can provide for the release of the agent from the device that is unidirectional and at a controlled desirable rate. For example, the agent may include, but is not limited to, drugs, proteins, peptides, biomarkers, bioanalytes, and / or genetic material.BACKGROUND ART[0002]A number of implantable drug delivery devices have been suggested to be capable of delivering the drug to the body lumen. One universal advantage to implanted drug delivery devices is related to the local administration of a drug that inherently improves efficacy and decreases side effects, when compared to other routes of administration...

Claims

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Application Information

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IPC IPC(8): A61M1/00A61K38/00A61K31/7088A61K31/70A61K31/20A61P29/00A61P37/08A61P25/00A61K31/56A61P11/00A61P25/18A61P9/12A61P21/02A61P25/24A61P25/14A61P3/10A61P1/04A61P35/00A61K39/395A61K38/22A61K38/43B44C1/22B29C67/00A61M5/00A61K9/00
CPCA61F2/82A61F2/91A61F2/915A61F2250/0002A61F2250/0068A61L17/005A61F2230/0054A61L29/16A61L31/16A61L2300/602A61M2025/0057A61F2220/005A61F2230/0013A61L27/54A61F2240/001A61F2310/00017A61F2310/00179A61F2310/00329A61K31/573A61B90/30A61P1/04A61P3/10A61P7/02A61P9/00A61P9/10A61P9/12A61P11/00A61P21/02A61P25/00A61P25/08A61P25/14A61P25/16A61P25/18A61P25/24A61P27/02A61P29/00A61P31/10A61P35/00A61P37/08A61B5/076A61B5/4839A61B5/686A61B17/06166A61B2560/0219A61F2/0063A61F2/06A61F9/0017A61L31/06A61L2300/43A61M25/001A61M25/0017A61M25/0043A61M27/002
Inventor STAVCHANSKY, SALOMON S.BOWMAN, PHILLIPHO, PAUL S.RASTOGI, ASHISHLUO, ZHIQUANWU, ZHUOIJIE
Owner BOARD OF RGT THE UNIV OF TEXAS SYST
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