Engelhard Arzneimittel GmbH and Co KG

Niederdorfelden, Germany

Engelhard Arzneimittel GmbH and Co KG

Niederdorfelden, Germany
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Lang C.,Engelhard Arzneimittel GmbH and Co KG | Staiger C.,Engelhard Arzneimittel GmbH and Co KG
Pharmazie | Year: 2016

The antimicrobial agent tyrothricin is a representative of the group of antimicrobial peptides (AMP). It is produced by Bacillus brevis and consists of tyrocidines and gramicidins. The compound mixture shows activity against bacteria, fungi and some viruses. A very interesting feature of AMPs is the fact, that even in vitro it is almost impossible to induce resistances. Therefore, this class of molecules is discussed as one group that could serve as next generation antibiotics and overcome the increasing problem of bacterial resistances. In daily practice, the application of tyrothricin containing formulations is relatively limited: It is used in sore throat medications and in agents for the healing of infected superficial and small-area wounds. However, due to the broad spectrum antimicrobial activity and the low risk of resistance development it is worth to consider further fields of application.

Schaefer A.,Medizentrum Essen Borbeck | Kehr M.S.,Engelhard Arzneimittel GmbH and Co. KG | Giannetti B.M.,Clinsearch GmbH | Bulitta M.,CRM Biometrics GmbH | Staiger C.,Engelhard Arzneimittel GmbH and Co. KG
Pharmazie | Year: 2016

This randomized, placebo-controlled, double-blind trial was conducted to assess the efficacy and safety of ivy leaves cough liquid in the treatment of acute cough. A total of 181 adult patients with acute cough were treated with either ivy leaves cough liquid containing EA 575® or with placebo three times a day for one week. The primary efficacy outcome was cough severity (CS) assessed by Visual Analogue Scale (VAS) over the whole treatment period (area-under-the-curve (AUC0-168 h) over 7 days (visit (V)1, V2, V3, V4, and V5). The secondary endpoints were defined as the CS assessed by VAS over the whole observation period (V1 - V6) and by Bronchitis Severity Score (BSS) and Verbal Category Descriptive (VCD) score. The evaluation of the VAS, BSS and VCD score revealed that subjects treated with ivy leaves cough liquid showed statistically significant and clinically relevant reductions in CS, severity of symptoms associated with cough and bronchitis compared to the placebo group. Furthermore, a remarkable early onset of efficacy was observed as significant reductions of cough severity were detected within 48 hours after the first drug intake. At all following visits and even 7 days after the end of treatment (V6) this significant treatment advantage was detected in comparison to placebo. All adverse events (AEs) in this clinical trial were non-serious, mild or of moderate severity and not drug-related. This clinical trial proved consistent superiority of the ivy leaves cough liquid treatment versus placebo and confirmed the EA 575® preparation to be a safe and efficacious option for the treatment of acute cough. © 2016, Govi-Verlag Pharmazeutischer Verlag GmbH. All rights reserved.

Stauss-Grabo M.,Engelhard Arzneimittel GmbH and Co. KG | Atiye S.,Engelhard Arzneimittel GmbH and Co. KG | Warnke A.,SocraTec RandD GmbH | Wedemeyer R.S.,SocraTec RandD GmbH | And 2 more authors.
Phytomedicine | Year: 2011

The only saponin drug currently prescribed in any significant amount in monotherapy medicines is ivy. This post-marketing surveillance study (PMSS) aimed at investigating the tolerability and safety of film-coated tablets containing ivy leaves dry extract (extracting medium: ethanol 30%, DER 5-7.5:1 [Prospan® Cough Tablets]) under practice conditions. Adults and children aged 11-85 years of both genders were included. A total of 330 patients suffering from colds accompanied by coughing or from chronic, inflammatory bronchial diseases were scheduled to undergo treatment for a period of at least seven days. The tolerability of the tablets was rated by means of questionnaires. The results of this PMSS reflect the good to very good tolerability of the tablets in the global assessment by both, the practitioner (98.5%) and by the patient (96.4%). This is one of the reasons for the high acceptance and compliance (rated as 'good' in 98.8% of all cases). The safety not only regarding the administration form but also regarding the active substance is thus underlined once again. © 2010 Elsevier GmbH. All rights reserved.

Lang C.,Engelhard Arzneimittel GmbH and Co. KG | Staiger C.,Engelhard Arzneimittel GmbH and Co. KG | Wegener T.,Engelhard Arzneimittel GmbH and Co. KG
Zeitschrift fur Phytotherapie | Year: 2015

Ivy in everyday paediatric use: Administration of EA 575®to schoolchildren for the treatment of acute bronchitis The efficacy and tolerability of five different administration forms containing the special ivy extract EA 575®were investigated in a non-interventional study involving over 1000 schoolchildren (aged 6 to 12) suffering from acute bronchitis. Efficacy was recorded by means of an assessment of the findings on the part of the physicians, an assessment of the patients involving questioning of their typical symptoms as well as by means of a diary. There was a clear improvement in all findings and symptoms over the course of the 7-day treatment. What is more, the administration forms proved to be very well tolerated and the patients exhibited a high level of compliance. All five investigated EA 575®administration forms thus constitute an effective and reliable form of treatment for acute bronchitis amongst the examined group of schoolchildren, and, consequently, confirm the many years of EA 575®use.

Korting H.C.,Ludwig Maximilians University of Munich | Schlolmann C.,Ludwig Maximilians University of Munich | Stauss-Grabo M.,Engelhard Arzneimittel GmbH and Co KG | Schafer-Korting M.,Free University of Berlin
Skin Pharmacology and Physiology | Year: 2012

Antimicrobial peptides (AMPs) are small, cationic, amphiphilic peptides with broad-spectrum microbicidal activity against both bacteria and fungi. In mammals, AMPs form the first line of host defense against infections and generally play an important role as effector agents of the innate immune system. The AMP era was born more than 6 decades ago when the first cationic cyclic peptide antibiotics, namely polymyxins and tyrothricin, found their way into clinical use. Due to the good clinical experience in the treatment of, for example, infections of mucus membranes as well as the subsequent understanding of mode of action, AMPs are now considered for treatment of inflammatory skin diseases and for improving healing of infected wounds. Based on the preclinical findings, including pathobiochemistry and molecular medicine, targeted therapy strategies are developed and first results indicate that AMPs influence processes of diseased skin. Importantly, in contrast to other antibiotics, AMPs do not seem to propagate the development of antibiotic-resistant micro-organisms. Therefore, AMPs should be tested in clinical trials for their efficacy and tolerability in inflammatory skin diseases and chronic wounds. Apart from possible fields of application, these peptides appear suited as an example of the paradigm of translational medicine for skin diseases which is today seen as a 'two-way road' - from bench to bedside and backwards from bedside to bench. Copyright © 2012 S. Karger AG, Basel.

Lang C.,Engelhard Arzneimittel GmbH and Co. KG | Rottger-Luer P.,Engelhard Arzneimittel GmbH and Co. KG | Staiger C.,Engelhard Arzneimittel GmbH and Co. KG
Planta Medica | Year: 2015

Preparations from ivy leaves (Hederae helicis folium, Hedera helix) dry extracts are well established in the treatment of different respiratory diseases. Until today, the efficacy and safety of ivy leaf preparations has been demonstrated in a variety of controlled clinical studies and non-interventional studies. These results were nearly exclusively obtained using the commercial ivy leaves dry extract EA 575®. This paper will provide information on the clinical data obtained with this special extract, showing the importance of those preparations as a valuable therapeutic option for the treatment of acute and chronic respiratory diseases. Overall, 18 publications covering clinical trials and non-interventional studies of, in total, 65383 patients suffering from acute as well as chronic respiratory diseases were included. © 2015 Georg Thieme Verlag KG Stuttgart . New York .

Wigger-Alberti W.,Bioskin GmbH | Stauss-Grabo M.,Engelhard Arzneimittel GmbH and Co. KG | Grigo K.,Bioskin GmbH | Atiye S.,Engelhard Arzneimittel GmbH and Co. KG | And 2 more authors.
Skin Pharmacology and Physiology | Year: 2013

Background: Topical preparations are a common treatment for superficial acute wounds, which at the least do not interfere with healing and ideally result in enhanced wound healing irrespective of microbial colonization. Objective: To examine the effects of a topical antimicrobial gel and its vehicle on the wound healing of standardized, superficial abrasions. Methods: Thirty-three healthy volunteers were enrolled in a double-blinded, randomized, intraindividual comparison study. Three standardized, superficial abrasions were induced on their forearms. A tyrothricin 0.1% gel (Tyrosur® gel; Engelhard Arzneimittel GmbH & Co. KG, Niederdorfelden, Germany) and its vehicle were randomly applied to two of the test areas, and one lesion remained untreated. Results: A significant improvement of wound healing was seen with both tyrothricin 0.1% gel and its corresponding vehicle in the clinical assessment. The mean area under the curve (AUC) of wound healing scores was the same for both preparations and the mean reepithelization scores were comparable at all test points over the entire 12 days. A lower mean AUC representing less reepithelization was found for the untreated test fields. Conclusion: The use of tyrothricin 0.1% gel and its corresponding vehicle resulted in statistically significant improved wound healing with an earlier onset of healing in particular. Based on these results obtained using an abrasive wound model, it can be concluded that the addition of tyrothricin 0.1% to the gel vehicle did not interfere with the improved wound healing seen with the vehicle alone. Copyright © 2012 S. Karger AG, Basel.

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