Color-Coded Polymeric Particles of Predetermined Size for Therapeutic and/or Diagnostic Applications and Related Methods

a technology of color-coded polymeric particles and diagnostic applications, applied in the field of polymeric particles, can solve the problems of increasing the overall risk associated with performing a given treatment, and achieve the effect of reducing the probability of user-introduced or procedural errors

Inactive Publication Date: 2010-02-04
VARIAN MEDICAL SYSTEMS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0007]Various embodiments are directed to color-coded and size-calibrated polymeric particles comprising an acrylate-based hydrogel core incorporating one or more chromophores of interest, and an outer shell comprising polyphosphazenes of formula I, useful for various therapeutic and / or diagnostic procedures. In various embodiments, the color-coded and size-calibrated polymeric particles can be employed in any particle-mediated procedure, including as embolic agents, dermal fillers, and various implantable devices for a broad range of clinical and cosmetic applications. The incorporation of a particular chromophore formulation that correlates with a pre-determined size specificity for implantable and loadable polymeric particles (“color-coded and size-calibrated”) enables the visual detection and identification of particles exhibiting a particular size of interest, and minimizes the probability of user-introduced or procedural errors.

Problems solved by technology

Substantial human errors can be inadvertently introduced during the preparatory procedures that may increase the overall risk associated with performing a given treatment.

Method used

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  • Color-Coded Polymeric Particles of Predetermined Size for Therapeutic and/or Diagnostic Applications and Related Methods
  • Color-Coded Polymeric Particles of Predetermined Size for Therapeutic and/or Diagnostic Applications and Related Methods
  • Color-Coded Polymeric Particles of Predetermined Size for Therapeutic and/or Diagnostic Applications and Related Methods

Examples

Experimental program
Comparison scheme
Effect test

example 1

Physical Incorporation of Indigo Dyes as Precipitates

[0092]Indigo dye can be incorporated into acrylate-based microparticles as follows. The vat can be prepared by mixing 5 g Indigo, 2.5 ml ethanol, 150 ml hot water, 6.5 ml concentrated sodium hydroxide solution and 7.5 g sodium dithionite. The mixture can be stirred for 15 minutes at 50-60° C. until the mixture converts to yellow-greenish. The concentrated solution can be given into 3 L of hot (50-60° C.) water with 3 ml of ammonia (25% solution) and additional 2 g of sodium dithionite. The amount of water can be varied from 0 to 31 to receive different color intensity. After stirring of the solution becomes yellow-greenish the particles can be added, and gently stirred for additional 15 minutes. After decanting and rinsing of the particles with water they become blue. Alternatively, Indigo red can be incorporated following the same protocol.

example 2

Physical Incorporation of Dyes Containing Sulfonic Acid Side Groups as Precipitates

[0093]Dyes containing sulfonic acid side groups can be incorporated into acrylate-based microparticles as follows. Dyes containing sulfonic acid side groups have a high capacity in precipitating with barium ions to form a water insoluble compound. For example, 3 ml Reactive Blue 21 (20 mg / ml physiological saline) can be added to 3 ml hydrated polymethylacrylate beads (400-600 μm) in physiological saline (total volume 6 ml). The suspension can be gently shaken for 10 to 15 min to reach diffusion equilibrium. Afterwards, the aqueous phase can be removed. 5 ml 0.5 molar aqueous barium chloride can be added to the particles and shaken over 30 min at ambient temperature. The suspension was stored over night at 70° C., than extensively washed with physiological saline until the solution remained optically colorless. The solution can be substituted by 0.5 molar barium chloride and heated for 30 min to approx...

example 3

Physical Incorporation of Dyes Containing Sulfonic Acid Side Groups as Precipitates

[0094]Dyes containing sulfonic acid side groups can be incorporated into acrylate-based microparticles as follows. Reactive Blue, Reactive Blue 4, Reactive Blue 19, Reactive Blue 163, Reactive Black 5, Reactive Yellow 86, Reactive Yellow 15, Reactive Orange 78, Reactive Red 11, Reactive Red 180, Chinolin Yellow, Allura Red AC, and any combinations thereof can be used to obtain different color shades by using mixtures of various ratios / percentage. Color intensities can be altered by varying the total dye amount (1 mg to 400 mg).

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Abstract

Various embodiments are directed to color-coded and size-calibrated polymeric particles comprising an acrylate-based hydrogel core incorporating one or more chromophores of interest, and an outer shell comprising polyphosphazenes of formula I, useful for various therapeutic and / or diagnostic procedures. In various embodiments, the color-coded and size-calibrated polymeric particles can be employed in any particle-mediated procedure, including as embolic agents, dermal fillers, and various implantable devices for a broad range of clinical and cosmetic applications. The incorporation of a particular chromophore formulation that correlates with a pre-determined size specificity for implantable and loadable polymeric particles (“color-coded and size-calibrated”) enables the visual detection and identification of particles exhibiting a particular size of interest, and minimizes the probability of user-introduced or procedural errors.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation-in-part of U.S. patent application Ser. No. 11 / 924,674, filed on Oct. 26, 2007, currently pending, which:[0002]is a continuation-in-part of U.S. patent application Ser. No. 11 / 257,535, filed Oct. 25, 2005, currently pending, which claims the benefit of U.S. Provisional Patent Applications: No. 60 / 621,729, filed Oct. 25, 2004; and the No. 60 / 684,307, filed May 24, 2005; and[0003]also which claims the benefit of U.S. Provisional Patent Application No. 60 / 962,015, filed Jul. 25, 2007;the entire disclosures of which are incorporated herein by reference.TECHNICAL FIELD[0004]This disclosure relates to various polymeric particles incorporating chromophores and other agents of interest that can be employed as implantable devices in animal subjects, for various diagnostic and therapeutic applications.BACKGROUND[0005]Various cosmetic, clinical, and interventional procedures involve in vivo administration of synthe...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/14A61K49/00A61K47/34A61K48/00
CPCA61K47/32A61K9/5026A61K47/34A61K49/04A61K49/0404A61K49/1824A61K49/225A61M5/007A61M2205/60
Inventor FRITZ, ULFFRITZ, OLAFGORDY, THOMAS A.WOJCIK, RONALDBLUMMEL, JACQUESKULLER, ALEXANDER
Owner VARIAN MEDICAL SYSTEMS
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