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Submucosal bioabsorbable drug elution platform

A platform, drug technology, applied in the field of injectable or implantable drug delivery platforms, which can solve problems such as side effects

Pending Publication Date: 2022-05-13
INTERSECT ENT INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The use of these treatments is a systemic therapy that dilutes the effects of steroids on the local target tissue and can lead to undesirable side effects due to the systemic effects of steroids
Furthermore, ensuring compliance of patients who have been prescribed this type of steroid regimen can be challenging

Method used

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  • Submucosal bioabsorbable drug elution platform
  • Submucosal bioabsorbable drug elution platform
  • Submucosal bioabsorbable drug elution platform

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0188] Example 1: Drug Release and Pharmacokinetics

[0189] Figure 8A and 8B is a graph depicting the experimental results of the first study for this drug delivery platform, showing cumulative drug release over time in the sheep turbinate model. Specifically, the cumulative release over time (mean %) of mometasone furoate-loaded implants in subject animals was studied. Figure 8A shows the comparative cumulative drug release over time, while Figure 8B Comparative concentrations of drug within tissues over time are shown.

[0190] Regarding the implant, the drug delivery platform loaded with mometasone furoate was prepared by micro-blending with 50% mometasone furoate in poly(D,L-lactide-co-glycolide) 50:50 or poly(D,L-lactide-co-glycolide) 75:25. This formed material was cut to 10mm lengths. Each drug delivery platform (an example specifically as Figure 1A indicated) contained an average of 450 μg mometasone furoate ("MF"). Samples were sterilized by electron be...

example 2

[0198] Example 2: Implant Delivery and Retrieval Feasibility; Formulation Analysis; Drug Release and Pharmacokinetics

[0199] In a second study on this drug delivery platform, the feasibility of implant delivery and retrieval (using sheep tissue) and drug release from tissues recovered from sheep were evaluated in three cohorts (A, B1 and B2) Efficacy and Pharmacokinetics. Furthermore, two alternative formulations of the tested API (in this case mometasone furoate) were compared to each other. All implants were prepared similarly to those described in Example 1 above, specifically reloaded with 450 μg MF. The second study was expanded to have three cohorts as more samples, time points and formulations were added to the analysis.

[0200] An exemplary drug delivery platform with a first drug formulation was implanted into various sinus anatomies of ovine subjects, then explanted at various time points, and the relevant tissues were examined for mometasone furoate concentra...

example 3

[0220] Example 3: Drug Dose and Distribution Analysis

[0221] In a third study on this drug delivery platform, drug delivery was tested by varying the number of drug delivery platforms implanted within the turbinate. All implants were prepared similarly to those described in Example 1 above, specifically reloaded with 450 μg MF. The mixture of MF and implants used the formulation identified as Formulation 2 in Example 2 above. In Table 7, "minimum dose" of two (2) implants in the turbinate, "low dose" of three (3) implants in the turbinate and The "nominal dose" of the six (6) implants in the turbinates was used to check dosing. The implant is positioned within the turbinate at an opposite cranial or caudal position so that the other end of the turbinate is free of the implant in the immediate vicinity of this tissue. Each turbinate tissue from the samples was tested in two sections, with the section of the turbinate with the implant separated from the section without th...

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Abstract

Described herein are systems and methods for delivering an active agent to a target tissue of the ear, nose, or throat using a drug delivery platform having a therapeutic drug embedded as part of the drug delivery platform. The drug delivery platform is implanted in a target tissue, and the active agent is eluted from the body of the drug delivery platform for a target period of time, thereby delivering a therapeutic dose of the drug for the period of time. The duration of therapy of the implant into sinus tissue may be 3 to 12 months or longer, thereby providing an entire duration of alleviation for the duration of the allergy season. Furthermore, the duration of the therapy provides remission to an individual suffering from a symptom of a chronic paranasal sinus condition for a longer period of time than currently available therapies, thus allowing the therapy to be administered only every half a year or year.

Description

[0001] related application [0002] This application claims the benefit of priority to U.S. Application Serial No. 17 / 004,753, filed August 27, 2020, which claims priority to U.S. Provisional Application Serial No. 62 / 894,113, filed August 30, 2019, said U.S. Each of the Provisional Applications is hereby incorporated by reference in its entirety. technical field [0003] The present application generally relates to systems, devices, and methods for injecting or implanting drug delivery platforms that can deliver one or more active therapeutic agents to ear, nose, and throat ("ENT") targets organize. Systems, devices, and methods employ a bioabsorbable platform of a size and form factor suitable for implantation into a target tissue, wherein the platform is embedded, coated, and / or infused with a therapeutic agent, such as a drug or biologic or its combination. Upon insertion of the platform into the target tissue, a clinically meaningful dose of the therapeutic agent is lo...

Claims

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Application Information

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IPC IPC(8): A61M31/00A61L31/14A61L31/16A61K9/70A61K31/58A61K47/34
CPCA61K31/58A61M37/0069A61K9/0024A61K9/0043A61K9/70A61F2/18A61F9/0017A61F2250/0068A61M31/00A61M2210/0618A61M2210/0662A61M2210/0668A61K9/7007A61M2210/1028A61M2210/065A61M2210/1032A61M2210/105A61M2210/0675A61M2210/0656A61M2210/0681A61K47/34A61M2210/1046A61M2205/02
Inventor 约翰·约瑟夫·斯坦库斯詹姆斯·苏安东尼·J·阿巴特图·杜克·恩戈迭戈·贾维尔·加尼卡
Owner INTERSECT ENT INC
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