Intrasite administration and dosing methods and pharmaceuticals for use therein

A drug and biological technology, applied in chemical instruments and methods, separation methods, drug delivery, etc., can solve problems such as insecurity

Inactive Publication Date: 2020-04-10
HKL MEDICAL LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Targeted drug delivery to wounds could also allow the safe use of chemicals as drugs that would be unsafe when administered via traditional means

Method used

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  • Intrasite administration and dosing methods and pharmaceuticals for use therein
  • Intrasite administration and dosing methods and pharmaceuticals for use therein
  • Intrasite administration and dosing methods and pharmaceuticals for use therein

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0170] In-site vancomycin pharmacodynamics test. A single-dose cohort (cohort) pharmacodynamic study was conducted under FDA IND #117494, the first FDA IND approved for intrasite vancomycin. This dose cohort involved the administration of low doses of intrasite lyophilized vancomycin to complex instrumented spinal surgery wounds in adult subjects. Vancomycin and endotoxin levels were measured in the bloodstream and in wound effusion fluid (through wound drains) at specific time points after surgery. Endotoxin levels in the blood stream and effusion fluid were also measured at the same time points after surgery. During administration of IS vancomycin, certified N-90 respirators were required to be worn by all present to prevent inhalation of aerosolized vancomycin powder, a known safety risk for pulmonary fibrosis.

[0171] Intrasite administration of vancomycin. Intrasite administration is based on the surface area of ​​the wound (tissue within the spinal wound deep below t...

Embodiment 2

[0186] Endotoxin is removed from vancomycin and / or other IS drugs by ultrapurification. To render a drug suitable for IS administration, various purification methods can be used alone or in series to achieve the desired reduction in endotoxin levels of approximately 10-fold over those found in current vancomycin formulations. Various embodiments of these methods are described herein. To achieve industrial-scale production of endotoxin-depleted vancomycin, vancomycin-rifaximin, or any other IS drug that requires this process, a series of cost-effective and scalable experiments were performed to determine which process or Process combinations are best suited for industrial production / commercial scale production of specific drug products. This scale-up process uses sub-batch confirmatory batch testing to determine endotoxin levels and other impurities based on the methods disclosed herein. Commercial-scale production methods for endotoxin-removed vancomycin, vancomycin-rifaximi...

Embodiment 3

[0188] Testing for endotoxin levels in ultrapure pharmaceuticals. A number of methods exist for the quantitative measurement of endotoxin presence. The most commonly used is the Quantitative Limulus Amebocyte Lysate (qLAL) test, but newer and potentially more accurate and precise methods exist, including gas chromatography / mass spectrometry (GC / MS), high-pressure liquid chromatography / tandem mass spectrometry (HPLC / MS / MS) and human endothelial cell E-selectin binding assay. We compared the accuracy, precision and assay reliability of these methods against standard positive and negative controls on (purified) drug samples to detect endotoxin concentrations down to 0.01 EU / mL. A test method capable of performing accurate and precise down to 0.01EU / mL (indicating the most cost-effectiveness) was used to test our drug samples for endotoxin levels in the future.

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Abstract

A new method of targeted intrasite drug administration to wounds offers advantages in treatment efficacy and safety over traditional routes of administration. A novel method of dosing intrasite medications based on wound surface area provides the parameters for safe and effective dosing, a necessary advance for any FDA approval. Large intrasite doses increase risk of toxicity from impurities allowed in drugs given by other routes. Pharmacodynamic parameters make certain drugs advantageous as intrasite agents, including slow trans-wound surface diffusion, protein binding, and limited local tissue toxicity. Vancomycin is a prototypical drug with these features and is therefore very useful as an intrasite medication. Other drugs, including but not limited to rifaximin, possess similar pharmacodynamics and may be useful intrasite pharmaceuticals, delivered alone or in combination with other drugs, carriers, or materials. All of these attributes are advantages over traditional administration methods.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to U.S. Provisional Application No. 62 / 456,639, filed February 8, 2017, and U.S. Provisional Application No. 62 / 456,642, filed February 8, 2017. The entire contents of both applications are incorporated herein by reference. technical field [0003] The present disclosure relates to the use of active pharmaceutical ingredients for direct application in wounds (surgical and / or traumatic) in order to prevent, suppress and / or treat disease, promote and / or improve health. More particularly, embodiments may have antimicrobial, antithrombotic, prothrombotic, antinecrotic, antiapoptotic, antineoplastic, chemotherapeutic, osteogenic, osteolytic, antiinflammatory, analgesic, antispasmodic, paralytic activities, Prevent or promote wound healing, and / or act as a growth factor or growth inhibitor, among other effects. Background technique [0004] Traditional methods of drug administration such a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/00A61L26/00A61L15/00
CPCA61K9/0014A61K9/06A61K9/12A61K9/19A61K9/7007A61K31/437A61K38/14A61K47/10A61K47/24A61M27/00A61M35/00A61M11/007A61P31/04B01D3/14B01D15/361B01D15/3804A61K9/0019A61K9/7015A61K47/12A61K47/14A61K47/36A61K47/38A61L27/54A61L2300/406A61M11/02A61M11/06B01D61/145
Inventor T·F·霍尔坎普M·P·凯利L·G·伦科
Owner HKL MEDICAL LLC
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