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Drug cores for sustained release of therapeutic agents

A technology for the treatment of drugs and drugs, which can be used in ophthalmic treatment, drug combination, drug delivery, etc., and can solve problems such as drug shortage and continuous drug release.

Active Publication Date: 2011-03-09
MATI THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method may provide some improvements over eye drops, some potential problems with this method may include: implantation of the implant in the desired tissue location, retention of the implant in the desired tissue location, and prolonged Sustained drug release at desired therapeutic levels
For example in the case of glaucoma treatment, where visits to the treating physician may be months apart, premature reduction and / or premature release of drug from the implant may result in insufficient drug being delivered for a portion of the treatment time

Method used

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  • Drug cores for sustained release of therapeutic agents
  • Drug cores for sustained release of therapeutic agents
  • Drug cores for sustained release of therapeutic agents

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0758] Latanoprost Drug Core Elution Data

[0759] Drug cores as described above have been fabricated with different cross-sectional sizes (0.006 inches, 0.012 inches and 0.025 inches) and different drug concentrations in the silicone matrix (5%, 10% and 20%). These drug cores can be produced by mixing latanoprost with silicone using a Syringe Tube and Cartridge Assembly, and injecting the mixture into a polyimide tube, which is cut into the desired length and seal. The length of the drug core is about 0.80-0.95 mm for a diameter of 0.012 inches (0.32 mm), corresponding to about 3.5 μg, 7 μg and 14 μg of total Latanoprost content.

[0760]Syringe Tubing and Cartridge Assembly 1. Polyimide tubing was obtained in three different diameters, 0.006", 0.0125", and 0.025". 2. Cut polyimide tubing of different diameters into ~15 cm lengths. 3. Insert the polyimide tubing into the syringe adapter. 4. Incorporate polyimide tubing adhesive in the luer adapter (Loctite, low viscosity...

Embodiment 2

[0773] Cyclosporin Drug Core Elution Data

[0774] Drug cores were prepared as described in Example 1 with a cyclosporine concentration of 21.2%. Figure 8 A shows an elution profile showing the elution of cyclosporin from the drug core into surfactant-free buffer solution and surfactant-containing buffer solution, according to an embodiment of the present invention. Prepare buffer solutions as described above. The surfactant containing solution consisted of 95% buffer and 5% surfactant, UP-1005 Ultra Pure Fluid from Dow Corning, Midland MI. Work in connection with embodiments of the present invention indicates that, in at least some cases, in situ elution from the eye can be simulated in vitro using surfactants, since the eye can include natural surfactants in the tear film, such as surfactant protein D. The elution profile of cyclosporine into surfactant was approximately 50-100 ng per day from 30-60 days. Empirical data from tears from patient populations (eg 10 patient...

Embodiment 3

[0776] Bimatoprost Bulk Elution Data

[0777] A bulk sample of 1% bimatoprost with a known diameter of 0.076 cm (0.76 mm) was prepared. The height of each sample was determined from the weight and known sample diameter.

[0778] Table 3. Bulk Sample Sizes

[0779] sample

wt(mg)

diameter (cm)

calculated high

degree(cm)

exposed surface area

(cm 2 )

14-2-10

1.9

0.076

0.42

0.109

14-2-11

1.5

0.076

0.33

0.088

14-2-12

1.9

0.076

0.42

0.109

[0780] The calculated height is 0.33cm-0.42cm. The exposed surface area on each end of each bulk sample is about 0.045 cm 2 , providing 0.019cm for 0.42 and 0.33cm samples respectively 3 and 0.015cm 3 volume of. The area of ​​the exposed surface of the sample calculated from the height and diameter of the drug-free sheath was approximately 0.1 cm 2. Three formulations were evaluated: 1) Silicone 4011, 1% ...

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Abstract

A solid drug core insert can be manufactured by injecting a liquid mixture comprising a therapeutic agent and a matrix precursor into a sheath body. The injection can be conducted at subambient temperatures. The mixture is cured to form a solid drug-matrix core. The therapeutic agent can be a liquid at about room temperature that forms a dispersion of droplets in the matrix material. A surface ofthe solid drug core is exposed, for example by cutting the tube, and the exposed surface of the solid drug core releases therapeutic quantities of the therapeutic agent when implanted into the patient. In some embodiments, the insert body inhibits release of the therapeutic agent, for example with a material substantially impermeable to the therapeutic agent, such that the therapeutic quantities are released through the exposed surface, thereby avoiding release of the therapeutic agent to non-target tissues.

Description

[0001] Cross References to Related Applications [0002] Pursuant to 35 U.S.C. §119(e), this nonprovisional application claims US60 / 970,699, filed September 7, 2007; US60 / 970,709, filed September 7, 2007; US60 / 970,820, filed September 7, 2007 and the benefit of priority of US61 / 049,317 filed April 30, 2008. [0003] The subject matter of this application is related to that of U.S. Patent Application 11 / 695,537 (Attorney Docket No. SLW 2755.001US1), filed April 2, 2007, which claims U.S. Provisional Application filed December 26, 2006 60 / 871,864 entitlement. [0004] The subject matter of this application is identical to U.S. Patent Application 61 / 057,246, filed May 30, 2008 (Attorney Docket No. SLW 2755.036PRV) and U.S. Patent Application 61 / 132,927, filed June 24, 2008 (Attorney Docket No. SLW 2755.036PV2) , and with respect to the subject matter of U.S. Patent Application _________, entitled "LACRIMAL IMPLANTS AND RELATED METHODS," filed therewith (Attorney Docket No. SLW 2...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61M5/14A61F2/02A61F9/00
CPCA61L2300/41A61L27/54A61L2300/602A61F9/00772A61L2300/802A61F9/0017A61K9/0051A61K31/5575A61F2230/0069A61F2250/0067A61P25/04A61P27/02A61P27/06A61P29/00A61P31/00A61P31/04A61P31/10A61P37/08A61P43/00Y02A50/30A61K47/34A61K9/20A61K9/2036A61F2/02A61M5/14
Inventor D·尤塔克赫德R·W·清水R·简S·勃艾德H·S·基福德E·小德胡安C·J·赖克
Owner MATI THERAPEUTICS
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