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Compositions and methods for the treatment and prophylaxis of surgical site infections

a surgical site infection and composition technology, applied in the field of sustained release compositions, can solve the problems of increased economic burden on healthcare systems, increased postoperative hospital duration and costs, yeast species and viral pathogens also pose a risk, etc., and achieve the effect of suppressing or preventing surgical site infections

Inactive Publication Date: 2017-08-31
POLYPID
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The invention is a substrate that can be used during surgical procedures to prevent and treat infections. It is coated with a matrix composition that includes a biocompatible polymer, a sterol, a phospholipid, and optionally an antiobiotic, antiseptic, anti-inflammatory, or anti-fungal agent. The coated substrate can release the drug at the surgical site for a period of time, reducing the risk of infection and eradicating existing biofilm. Overall, the invention provides a useful tool to prevent and treat surgical infections.

Problems solved by technology

SSIs are responsible for an increased economic burden to healthcare systems, including additional postoperative hospital duration and costs.
Methicillin-resistant S. aureus (MRSA) is an increasingly important pathogen that causes more than 50% of S. aureus hospital-acquired infections in the US and Europe, and presents challenges to treatment due to multiple antibiotic resistance.
Yeast species and viral pathogens also pose a risk.
Surgical site infections present a significant clinical problem in orthopedic surgeries, spinal surgeries, operation of the digestive system, cardiac surgeries, breast operations and many other clinical procedures involving skin incision.
Patients with Sternal wound infection require longer hospital stay, repeated surgical interventions, long-term antibiotic treatment, a substantial damage to the quality of life, and great suffering to the patient.
Indeed, in recent years, despite the development of new surgical techniques, new antibiotics, new technologies for postoperative infection diagnosis, and wound care technologies, the occurrence of surgical site infections has not been reduced.
Surgical site infections are still a major problem of the health care system.

Method used

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  • Compositions and methods for the treatment and prophylaxis of surgical site infections
  • Compositions and methods for the treatment and prophylaxis of surgical site infections
  • Compositions and methods for the treatment and prophylaxis of surgical site infections

Examples

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example 1

or the Preparation of a Substrate (e.g. Tri-Calcium Phosphate Particles, Poly Vinyl Alcohol Particles) Coated / Impregnated with a Doxycycline Containing Matrix Composition According to Certain Embodiments of the Invention (for the Treatment and Prevention of Surgical Site Infections)

[0126]Overview: To produce lipid-saturated polymer matrices, two mixtures are created.

[0127]1. A biodegradable polymer and a first lipid component (e.g. sterol) are mixed with a volatile organic solvent, which is mixed to yield a solution or suspension of lipid-saturated polymer matrix, as measured by its differential scanning calorimetric (DSC) profile.

[0128]2. The active agent and a second lipid component (e.g. at least one phospholipid) are mixed with a second volatile organic solvent to yield a second solution or suspension.

[0129]3. The two solutions or suspensions are combined and mixed until equilibrium is reached.

[0130]4. A substrate (e.g. gelatin sponge, collagen foam, mineral substrate) is then m...

example 2

ase from PVA Particles Impregnated / Coated with the Sustained Release Formulation of the Invention

[0148]Coated / impregnated PVA particles were prepared as described above in Example 1. Following hydration (5% serum at 37° C.) the release of doxycycline from the PVA particles impregnated / coated with the matrix composition was detected and quantified by HPLC. The release profile is presented in FIG. 2.

[0149]As can be seen in FIG. 2, the first hour release reached about 45% of the doxycycline in the coating matrix. Further investigation the first hour release revealed that when the collected sample was centrifuged (spin-down) and further sieved (45 um filter) or vice versa (sieved and further centrifuged), the amount of the doxycycline released within the first hour and detected by HPLC was lower by at least 50% (e.g. ˜20%). Without being bound by theory or mechanism of action, it is estimated that the collected sample (before centrifuging and / or filtering the collected sample) includes ...

example 3

ase from Absorbable Gelatin Sponge Containing the Sustained Release Formulation of the Invention

[0154]A 1 cm*1 cm piece of collagen sponge was placed in a 20 ml vial. 0.4 ml of solution AB (as described above in Example 1) were added to the vial and the vial was left closed at room temperature for 10 min. The piece of collagen sponge impregnated with solution AB was transferred to a 4 ml vial for evaporation of the solvents followed by vacuum overnight. This collagen piece was put to release experiment.

[0155]Following hydration (5% serum at 37° C.) the release of doxycycline from the gelatin sponge piece impregnated with the matrix composition into the surrounding was detected and quantified by HPLC.

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Abstract

The present invention provides methods for preventing, inhibiting or treating a surgical site infection associated with a surgical operation comprising the step of applying to the surgical site a biocompatible, biodegradable substrate being impregnated and / or having its surface coated fully or partially with a matrix composition which provides local controlled and prolonged release of at least one pharmaceutically active agent at the surgical site.

Description

[0001]This application claims the benefit of U.S. provisional application No. 62 / 058,809, filed Oct. 2, 2014 and entitled “COMPOSITIONS AND METHODS FOR THE TREATMENT AND PROPHYLAXIS OF SURGICAL SITE INFECTIONS”, the contents of which are incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention generally relates to sustained release compositions and uses thereof for the prevention and treatment of surgical site infections.BACKGROUND OF THE INVENTION[0003]Surgical site infection (SSI), an infection at or near surgical incisions within 30 days of an operative procedure, is a commonly-occurring healthcare-associated infection, accounting for 15% of all nosocomial infections and, among surgical patients, represents the most common nosocomial infection. Increased morbidity and mortality are associated with SSI, ranging from wound discharge associated with superficial skin infection to life-threatening conditions such as severe sepsis. SSIs are responsible for an ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/16A61K31/685A61K31/575A61K31/65
CPCA61K9/1676A61K31/65A61K31/575A61K9/1635A61K31/685A61K9/1611A61K45/06A61K9/0024A61K9/146A61K9/148A61K9/1682A61K9/70A61P31/00A61P31/02A61P31/04A61P41/00A61K6/849
Inventor EMANUEL, NOAM
Owner POLYPID
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