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Article ; Online: Potent antibacterial activity in surgical wounds with local administration of D-PLEX

Emanuel, Noam / Kozloski, Goldi A / Nedvetzki, Shlomo / Rosenfeld, Sefi

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences

2023 Volume 188, Page(s) 106504

Abstract: Despite significant advances in infection control guidelines and practices, surgical site infections remain a substantial cause of morbidity, prolonged hospitalization, and mortality. The most effective component of SSI reduction strategies is the ... ...

Abstract	Despite significant advances in infection control guidelines and practices, surgical site infections remain a substantial cause of morbidity, prolonged hospitalization, and mortality. The most effective component of SSI reduction strategies is the preoperative administration of intravenous antibiotics; however, systemic antibiotics drug exposure diminishes rapidly and may result in insufficient prophylactic activity against susceptible and resistant SSI pathogens at the wound. D-PLEX
Language	English
Publishing date	2023-06-22
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1154366-8
ISSN	1879-0720 ; 0928-0987
ISSN (online)	1879-0720
ISSN	0928-0987
DOI	10.1016/j.ejps.2023.106504
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Article ; Online: Preclinical In-Vivo Safety and Toxicokinetics of D-PLEX100 in an Abdominal Surgery Incision Model in Juvenile Miniature Swine.

Ramot, Yuval / Nyska, Abraham / Dvir, Meidan / Nedvetzki, Shlomo / Rosenfeld, Sefi / Emanuel, Noam

International journal of toxicology

2023 Volume 43, Issue 1, Page(s) 19–26

Abstract: D-PLEX100 (D-PLEX) is a novel product candidate made of a polymer-lipid-based matrix (PLEX platform) which contains doxycycline that is being released at a constant rate for 30 days. D-PLEX was developed to prevent surgical site infections, which are a ... ...

Abstract	D-PLEX100 (D-PLEX) is a novel product candidate made of a polymer-lipid-based matrix (PLEX platform) which contains doxycycline that is being released at a constant rate for 30 days. D-PLEX was developed to prevent surgical site infections, which are a major global health challenge. Previous studies have shown its safety in adult humans, adult swine, and adult rabbits. The aim of this study was to assess the toxicity and safety of D-PLEX also in juvenile animals to support future clinical trials in pediatric patients. Yucatan miniature swine were selected as a model, primarily due to their relatively larger mass. D-PLEX or placebo (formulation without doxycycline) was administered locally to abdominal incisions, and the animal's safety parameters were followed for 9 months and compared to sham-control swine. There was no evidence of any systemic safety concern or local toxicity at the incision site in D-PLEX-treated animals. D-PLEX was detected after 1 month and was fully resorbed at the 3-month time point. The surgical incision sites were fully healed at the 6-month time point in all D-PLEX-treated animals. Toxicokinetic (TK) assessments revealed that doxycycline exhibited low C
MeSH term(s)	Animals ; Doxycycline/adverse effects ; Swine, Miniature ; Toxicokinetics
Chemical Substances	Doxycycline (N12000U13O)
Language	English
Publishing date	2023-10-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	1379845-5
ISSN	1092-874X ; 1091-5818
ISSN (online)	1092-874X
ISSN	1091-5818
DOI	10.1177/10915818231205222
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Article ; Online: D-PLEX500: a local biodegradable prolonged release doxycycline-formulated bone graft for the treatment for peri-implantitis. A randomized controlled clinical study.

Emanuel, Noam / Machtei, Eli E / Reichart, Malka / Shapira, Lior

Quintessence international (Berlin, Germany : 1985)

2020 Volume 51, Issue 7, Page(s) 546–553

Abstract: Objectives: In the present pilot, multicenter, randomized, single-blinded, controlled study, surgical treatment with or without the administration of D-PLEX500 (a biodegradable prolonged release local doxycycline formulated with β-tricalcium phosphate ... ...

Abstract	Objectives: In the present pilot, multicenter, randomized, single-blinded, controlled study, surgical treatment with or without the administration of D-PLEX500 (a biodegradable prolonged release local doxycycline formulated with β-tricalcium phosphate bone graft) was accessed for the treatment of peri-implantitis. Method and materials: Subjects undergoing surgical treatment for intrabony peri-implantitis defects after flap elevation were randomly assigned, to adjunct D-PLEX500 placement group or to control group. Clinical and radiographic parameters were measured at 6 and 12 months. Results: Twenty-seven subjects (average age: 64.81 ± 7.61 years) were enrolled; 14 patients (18 implants) were randomized to the test group and 13 (14 implants) to the control group. There was no difference in plaque scores between the groups. There was no difference in the changes of mean periodontal probing depth between the test and control groups between baseline and the 6-month follow-up, whereas statistically significant difference was observed after 12 months' follow-up when analyzed for all sites averaged. There was a statistically significant difference in the changes of clinical attachment levels and radiographic bone levels between the groups between baseline and 12 months. These improvements were demonstrated when analyzed at both implant and subject levels. Only D-PLEX500 treatment led to improved bone levels at both time points. The improvement in bone levels was significant in the D-PLEX500 treatment group already after 6 months, and further improved over the 12-month follow-up. Implants were lost only in the control group (14%). Conclusions: D-PLEX500 sustained release local antibiotic formulated with bone filler showed promising results in enabling healing of peri-implantitis lesions. The antibacterial component of the bone graft material might create favorable conditions that enable implant surface decontamination and soft and hard tissue healing over a prolonged period.
MeSH term(s)	Aged ; Alveolar Bone Loss ; Anti-Bacterial Agents ; Bone Transplantation ; Dental Implants ; Doxycycline ; Humans ; Middle Aged ; Peri-Implantitis ; Treatment Outcome
Chemical Substances	Anti-Bacterial Agents ; Dental Implants ; Doxycycline (N12000U13O)
Language	English
Publishing date	2020-06-04
Publishing country	Germany
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	7436-6
ISSN	1936-7163 ; 0033-6572
ISSN (online)	1936-7163
ISSN	0033-6572
DOI	10.3290/j.qi.a44629
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Article ; Online: Toxicity and Safety Study of D-PLEX

Ramot, Yuval / Nedvetzki, Shlomo / Rosenfeld, Sefi / Emanuel, Noam / Nyska, Abraham

Toxicologic pathology

2019 Volume 47, Issue 4, Page(s) 504–514

Abstract: Bacterial infections are a common complication after surgical procedures. Therefore, local delivery of antibiotics has been developed, including the use of biodegradable polymers. A newly developed product for prevention of surgical site infections is a ... ...

Abstract	Bacterial infections are a common complication after surgical procedures. Therefore, local delivery of antibiotics has been developed, including the use of biodegradable polymers. A newly developed product for prevention of surgical site infections is a polymer-lipid encapsulation matrix loaded with doxycycline, named D-PLEX
MeSH term(s)	Animals ; Anti-Bacterial Agents/blood ; Anti-Bacterial Agents/chemistry ; Anti-Bacterial Agents/therapeutic use ; Anti-Bacterial Agents/toxicity ; Delayed-Action Preparations ; Dose-Response Relationship, Drug ; Doxycycline/blood ; Doxycycline/chemistry ; Doxycycline/therapeutic use ; Doxycycline/toxicity ; Drug Carriers/chemistry ; Female ; Male ; Rabbits ; Sternum/pathology ; Sternum/surgery ; Surgical Wound Infection/drug therapy ; Surgical Wound Infection/pathology ; Survival Analysis ; Tensile Strength ; Toxicokinetics
Chemical Substances	Anti-Bacterial Agents ; Delayed-Action Preparations ; Drug Carriers ; Doxycycline (N12000U13O)
Language	English
Publishing date	2019-04-11
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	841009-4
ISSN	1533-1601 ; 0192-6233
ISSN (online)	1533-1601
ISSN	0192-6233
DOI	10.1177/0192623319837887
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Article ; Online: D-PLEX

Ramot, Yuval / Nedvetzki, Shlomo / Rosenfeld, Sefi / Rousselle, Serge D / Nyska, Abraham / Emanuel, Noam

Toxicologic pathology

2020 Volume 48, Issue 5, Page(s) 677–685

Abstract: Surgical site infections (SSIs) are a common surgical-related complication. To avoid these complications, a new biodegradable polymer-lipid encapsulation matrix that provides controlled release of doxycycline (doxycycline/polymer-lipid encapsulation ... ...

Abstract	Surgical site infections (SSIs) are a common surgical-related complication. To avoid these complications, a new biodegradable polymer-lipid encapsulation matrix that provides controlled release of doxycycline (doxycycline/polymer-lipid encapsulation matrix [D-PLEX]) has been developed. The aim of this comprehensive study was to evaluate the potential safety of D-PLEX
MeSH term(s)	Animals ; Doxycycline/administration & dosage ; Drug Delivery Systems ; Humans ; Models, Animal ; Surgical Wound Infection ; Swine ; Swine, Miniature
Chemical Substances	Doxycycline (N12000U13O)
Language	English
Publishing date	2020-06-11
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	841009-4
ISSN	1533-1601 ; 0192-6233
ISSN (online)	1533-1601
ISSN	0192-6233
DOI	10.1177/0192623320928902
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Article ; Online: Reduction in surgical site infections by localized administration with D-PLEX

Senagore, Anthony J / Stark, Yafit / Belotserkovsky, Olga / Reichert, Malka / Wasserberg, Nir / Tulchinsky, Hagit / Segev, Lior / Zmora, Oded / Kozloski, Goldi A / Emanuel, Noam

American journal of surgery

2022 Volume 225, Issue 3, Page(s) 485–488

Abstract: Background: D-PLEX: Patients and methods: A post-hoc analysis of a previously reported prospective randomized trial assessing D-PLEX: Results: The overall incidence of SSI was significantly lower for the D-PLEX: Conclusions: D- ... ...

Abstract	Background: D-PLEX Patients and methods: A post-hoc analysis of a previously reported prospective randomized trial assessing D-PLEX Results: The overall incidence of SSI was significantly lower for the D-PLEX Conclusions: D-PLEX
MeSH term(s)	Humans ; Surgical Wound Infection/epidemiology ; Surgical Wound Infection/prevention & control ; Surgical Wound Infection/etiology ; Anti-Bacterial Agents/therapeutic use ; Prospective Studies ; Colorectal Surgery/adverse effects ; Risk Factors ; Antibiotic Prophylaxis
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2022-11-23
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	2953-1
ISSN	1879-1883 ; 0002-9610
ISSN (online)	1879-1883
ISSN	0002-9610
DOI	10.1016/j.amjsurg.2022.11.021
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Article ; Online: Local prolonged release of antibiotic for prevention of sternal wound infections postcardiac surgery-A novel technology.

Kachel, Erez / Moshkovitz, Yaron / Sternik, Leonid / Sahar, Gideon / Grosman-Rimon, Liza / Belotserkovsky, Olga / Reichart, Malka / Stark, Yafit / Emanuel, Noam

Journal of cardiac surgery

2020 Volume 35, Issue 10, Page(s) 2695–2703

Abstract: Introduction: Sternal wound infection (SWI) is a devastating postcardiac surgical complication. D-PLEX: Method: Eighty-one patients were enrolled in a prospective single-blind randomized controlled multicenter study. Sixty patients were treated with ... ...

Abstract	Introduction: Sternal wound infection (SWI) is a devastating postcardiac surgical complication. D-PLEX Method: Eighty-one patients were enrolled in a prospective single-blind randomized controlled multicenter study. Sixty patients were treated with both D-PLEX and standard of care (SOC) and 21 with SOC alone. Both groups were followed 6 months for safety endpoints. SWI was assessed at 90 days. Results: No SWI-related serious adverse events (SAEs) occurred in either group. The mean plasma C Conclusion: D-PLEX was found to be safe for use in cardiac surgery patients. By providing localized prophylactic prolonged release of broad-spectrum antibiotics, D-PLEX has the potential to prevent SWI postcardiac surgery and long-term postoperative hospitalization, reducing high-treatment costs, morbidity, and mortality.
MeSH term(s)	Aged ; Anti-Bacterial Agents/administration & dosage ; Anti-Bacterial Agents/pharmacokinetics ; Antibiotic Prophylaxis ; Cardiac Surgical Procedures/adverse effects ; Delayed-Action Preparations/therapeutic use ; Drug Liberation ; Female ; Humans ; Male ; Middle Aged ; Prospective Studies ; Single-Blind Method ; Sternotomy/adverse effects ; Sternum ; Surgical Wound Infection/prevention & control
Chemical Substances	Anti-Bacterial Agents ; Delayed-Action Preparations
Language	English
Publishing date	2020-08-02
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	639059-6
ISSN	1540-8191 ; 0886-0440
ISSN (online)	1540-8191
ISSN	0886-0440
DOI	10.1111/jocs.14890
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Article: Real-time monitoring of E. coli O157 and Salmonella enterica serovar Typhimurium in water using ultrasound and latex-based immunoassay

Bavli, Danny / Emanuel, Noam / Barenholz, Yechezkel

Analytical methods. 2013 Dec. 19, v. 6, no. 2

2013

Abstract: This study aimed at evaluating real-time, low-cost detection and quantification of bacteria, exemplified by E. coli O157 and Salmonella enterica serovar Typhimurium in aqueous systems. The approach takes advantage of the well-established latex-based ... ...

Abstract	This study aimed at evaluating real-time, low-cost detection and quantification of bacteria, exemplified by E. coli O157 and Salmonella enterica serovar Typhimurium in aqueous systems. The approach takes advantage of the well-established latex-based immunoassay (LBI) and combines it with bacteria trapping and measuring using ultrasound. The results obtained demonstrate the utility of combining ultrasound standing waves of mean energy density 10 W cm−2, acoustic amplitude 100 kPa, and a laminar flow rate of the medium of 60 μl min−1 to trap selectively E. coli O157 or Salmonella enterica serovar Typhimurium (S. typhimurium) bacteria attached to 300–400 nm-antibody-coated latex particles. The ultrasound velocity measurements enabled a sensitivity down to 1.6 × 104 colony-forming units (CFU) ml−1 for E. coli O157 and 4.0 × 104 CFU ml−1 for S. typhimurium, compared to a sensitivity of 8.36 × 105 CFU ml−1 for E. coli O157 and 6.4 × 106 CFU ml−1 for S. typhimurium obtained by the standard LBI. The assay sensitivity can be further improved by use of various fluorescence methodologies.
Keywords	Escherichia coli O157 ; Salmonella Typhimurium ; acoustics ; analytical methods ; bacteria ; energy density ; fluorescence ; immunoassays ; laminar flow ; latex ; monitoring ; ultrasonics
Language	English
Dates of publication	2013-1219
Size	p. 395-403.
Publishing place	The Royal Society of Chemistry
Document type	Article
ZDB-ID	2515210-5
ISSN	1759-9679 ; 1759-9660
ISSN (online)	1759-9679
ISSN	1759-9660
DOI	10.1039/c3ay41135d
Database	NAL-Catalogue (AGRICOLA)

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Article: A lipid-and-polymer-based novel local drug delivery system—BonyPid™: From physicochemical aspects to therapy of bacterially infected bones

Emanuel, Noam / Rosenfeld, Yosef / Cohen, Or / Applbaum, Yaakov H / Segal, David / Barenholz, Yechezkel

Journal of controlled release. 2012 June 10, v. 160, no. 2

2012

Abstract: Bacterial infection of bone may result in bone destruction and is difficult to cure due to poor accessibility to bone of systemically-administrated antibiotic and poor performance of currently available local antibacterial treatments. We developed a ... ...

Abstract	Bacterial infection of bone may result in bone destruction and is difficult to cure due to poor accessibility to bone of systemically-administrated antibiotic and poor performance of currently available local antibacterial treatments. We developed a novel local drug delivery system based on self-assembly of specific familiar lipids and polymers that encapsulate the desired drug (exemplified by doxycycline). The entrapped doxycycline present in the anhydrous environment of the formulation is fully protected from long-term water-exposure-related degradation. The fine coating of the tricalcium phosphate bone filler by this doxycycline-containing formulation (BonyPid™) is capable of releasing intact and active drug at a steady, zero-order rate for a predetermined period of up to 30days and in amount sufficient to achieve therapy potentially capable of eliminating the contaminating bacteria. Therefore a clinical evaluation is proposed for testing the efficacy and toxicity of BonyPid for therapy of bacterial bone infections.
Keywords	bacteria ; bacterial infections ; bones ; coatings ; doxycycline ; drug delivery systems ; drugs ; lipids ; physicochemical properties ; polymers ; toxicity ; tricalcium phosphate
Language	English
Dates of publication	2012-0610
Size	p. 353-361.
Publishing place	Elsevier B.V.
Document type	Article
ZDB-ID	632533-6
ISSN	1873-4995 ; 0168-3659
ISSN (online)	1873-4995
ISSN	0168-3659
DOI	10.1016/j.jconrel.2012.03.027
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Article ; Online: A lipid-and-polymer-based novel local drug delivery system--BonyPid™: from physicochemical aspects to therapy of bacterially infected bones.

Emanuel, Noam / Rosenfeld, Yosef / Cohen, Or / Applbaum, Yaakov H / Segal, David / Barenholz, Yechezkel

Journal of controlled release : official journal of the Controlled Release Society

2012 Volume 160, Issue 2, Page(s) 353–361

Abstract	Bacterial infection of bone may result in bone destruction and is difficult to cure due to poor accessibility to bone of systemically-administrated antibiotic and poor performance of currently available local antibacterial treatments. We developed a novel local drug delivery system based on self-assembly of specific familiar lipids and polymers that encapsulate the desired drug (exemplified by doxycycline). The entrapped doxycycline present in the anhydrous environment of the formulation is fully protected from long-term water-exposure-related degradation. The fine coating of the tricalcium phosphate bone filler by this doxycycline-containing formulation (BonyPid™) is capable of releasing intact and active drug at a steady, zero-order rate for a predetermined period of up to 30 days and in amount sufficient to achieve therapy potentially capable of eliminating the contaminating bacteria. Therefore a clinical evaluation is proposed for testing the efficacy and toxicity of BonyPid for therapy of bacterial bone infections.
MeSH term(s)	Animals ; Anti-Bacterial Agents/administration & dosage ; Anti-Bacterial Agents/therapeutic use ; Calcium Phosphates/chemistry ; Chemical Phenomena ; Coated Materials, Biocompatible ; Delayed-Action Preparations ; Doxycycline/administration & dosage ; Doxycycline/therapeutic use ; Drug Compounding ; Drug Delivery Systems ; Drug Stability ; Female ; Lactic Acid/chemistry ; Microbial Sensitivity Tests ; Osteomyelitis/diagnostic imaging ; Osteomyelitis/drug therapy ; Osteomyelitis/microbiology ; Phosphatidylcholines/chemistry ; Polyglycolic Acid/chemistry ; Rabbits ; Radiography ; Staphylococcal Infections/diagnostic imaging ; Staphylococcal Infections/drug therapy ; Staphylococcal Infections/microbiology ; Staphylococcus aureus/drug effects
Chemical Substances	Anti-Bacterial Agents ; Calcium Phosphates ; Coated Materials, Biocompatible ; Delayed-Action Preparations ; Phosphatidylcholines ; polylactic acid-polyglycolic acid copolymer ; Polyglycolic Acid (26009-03-0) ; Lactic Acid (33X04XA5AT) ; tricalcium phosphate (K4C08XP666) ; Doxycycline (N12000U13O)
Language	English
Publishing date	2012-06-10
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	632533-6
ISSN	1873-4995 ; 0168-3659
ISSN (online)	1873-4995
ISSN	0168-3659
DOI	10.1016/j.jconrel.2012.03.027
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