Double-blind, randomised clinical study comparing efficacy and safety of Clindamycin/Tretinoin Gel (10 mg/g + 0.25 mg/g) (Test) vs. Acnatac(R) 10 mg/g + 0.25 mg/g Gel (Reference) vs. Vehicle in patients with papulopustular acne - 23-01/ClindaTret-G

Start Date03 Jun 2024

Sponsor / Collaborator

Dermapharm AG

CTIS2024-511390-30-00 / Recruiting

Double-blind, randomised clinical study comparing efficacy and safety of Methylprednisolone Aceponate 0.1% Cream (Test) vs. Advantan(R) 0.1% Cream (Reference) vs. Vehicle in patients with mild to moderate atopic dermatitis - 22-01/MPA-C

Start Date17 Aug 2023

Sponsor / Collaborator

Dermapharm AG

DRKS00030411 / CompletedNot Applicable

Studies on the influence of thiomersal in a vaccine on in vitro immune responses in whole blood samples from volunteers - SU 5.9

Start Date23 Nov 2022

Sponsor / Collaborator

Strathmann GmbH & Co. KG

100 Clinical Results associated with Dermapharm AG

0 Patents (Medical) associated with Dermapharm AG

Literatures (Medical) associated with Dermapharm AG

01 Jul 2017·European Journal of Hospital PharmacyQ4 · MEDICINE

A stability study of amphotericin B, colistin and tobramycin in a hydrophilic suspension commonly used for selective decontamination of the digestive tract by HPLC and in vitro potency measurements

Q4 · MEDICINE

Article

Author: Remane, Yvonne ; Fassauer, Georg ; Vogel, Jan ; Noll, Sylvia ; Frontini, Roberto ; Reinhardt, Robert ; Gerecke, Hagen ; Pfeifer, Corina ; Jira, Thomas

OBJECTIVESA suspension for oral use which consists of three non-absorbable antibiotics (amphotericin B, colistin and tobramycin) is often used in clinical practice for the selective decontamination of the digestive tract (SDD) of patients in intensive care. Such a therapy is a preventive tool to minimise the risk of pneumonia and bacteraemia in intubated patients. The administration and the treatment results are controversially discussed. One limiting factor for a unique SDD treatment in the hospitals is a lack of adequate data regarding batch formula and stability for such a formulation. Since no detailed procedures, specifications or stability data are available for manufacturing this formulation there may be discrepancies regarding formulation and stability of suspensions prepared in different pharmacies. The aim of this research was to collect the physicochemical and microbiological stability data of a developed, stable standard formulation under defined storage conditions. The effectiveness of the SDD suspension should be preferably proven over a long period. This would help guarantee that all patients receive the same preparation, therefore, ensuring similar efficacy and improved safety.METHODSAn adequate formulation composed of the registered, marketed medicinal product Ampho-Moronal suspension (Dermapharm AG, Germany) and a buffered, preserved aqueous solution of colistin and tobramycin both as sulfates has been developed. A stability study has been performed on two batches of the formulation. During the storage, samples were taken and compatibility was verified by physicochemical and microbiological testing in stability-indicating terms of colour, odour, flavour, pH, chemical and microbiological purity as well as in vitro potency. The test methods were built and tailored to be suitable, reliable and precise for the test needs.RESULTSThe results show the physicochemical and microbiological stability of the described formulation for defined storage conditions.CONCLUSIONSA standardised formulation with a proven stability for at least 6 months under fridge (5°C±3°C) conditions for the SDD of patients in intensive care was established.

19 May 2017·Pharmaceutical Development and TechnologyQ4 · MEDICINE

Formulation factors affecting the isomerization rate of betamethasone-17-valerate in a developmental hydrophilic cream – a HPLC and microscopy based stability study

Q4 · MEDICINE

Article

Author: Wyraz, Anke ; Velasco-Torrijos, Trinidad ; Reinhardt, Robert ; Byrne, Jonathan

The formulation of betamethasone-17-valerate (BV) into topical medicines presents a significant challenge for the formulation chemist. The substance is susceptible to acid and base catalyzed isomerization in aqueous environments, which results in valerate transesterification from carbon 17 to carbon 21 of the steroid ring system. This acyl migration process is of significant clinical importance since the 21-valerate ester possesses only a fraction of the potency of the 17-valerate parent compound. Isomerization of BV should therefore be reduced to a minimum through design of a suitable drug vehicle. In this study, the effect of varying the concentration of several excipient components on the isomerization rate of betamethasone valerate in a model hydrophilic cream has been investigated. These excipients include the emulsifier macrogolstearylether-20/21, the co-emulsifier cetylstearyl alcohol and the thickening agent hydroxyl propyl methylcellulose. Additionally, the influence of pH, the presence of the antioxidant, alpha-tocopherol, as well as the chelating agent, disodium edetate, on the stability of the formulation have been investigated. Trial drug product formulations, which were designed to investigate the influence of the above-mentioned components/parameters were manufactured and their stability was tested according to current ICH Guidelines. The content, purity and crystalline structure of the active substance in these formulations was analyzed by a combination of HPLC and microscopy techniques. The study demonstrates that the rate of isomerization of betamethasone valerate depends significantly on the concentration of emulsifier used in the cream formulation. At higher concentrations of emulsifier the isomerization proceeds rapidly with significant degradation over a period of weeks, whereas at lower concentrations significant degradation may not be observed, even after several years' storage. The influence of the emulsifier has been shown to be independent of the pH value of the aqueous phase of the cream. These findings have not been reported in previous literature reports on this topic, which have tended to focus on the influence of pH. The results are likely to be of interest to pharmaceutical chemists working on the formulation of glucocorticoids as well as to local- and hospital pharmacists who carry out the practice of dilution of proprietary corticoid preparations, where the choice of diluent is likely to be critical for ensuring the stability of the diluted product.

01 Jan 2017·Journal of Analytical Methods in ChemistryQ4 · CHEMISTRY

Polymorphism in Commercial Sources of Fusidic Acid: A Comparative Study of the In Vitro Release Characteristics of Forms I and III from a Marketed Pharmaceutical Cream

Q4 · CHEMISTRY

ArticleOA

Author: Reinhardt, Robert ; Velasco-Torrijos, Trinidad ; Byrne, Jonathan

A comparison of the polymorphic forms of 3 commercial sources of fusidic acid using FTIR and XRPD techniques has been performed in this study. It has been demonstrated that polymorphic Forms I and III are currently available on the commercial market. The influence of the observed polymorphism on the stability of the drug substance in bulk form has been investigated through stability and stress testing according to current ICH guidelines. Significant differences were detected between commercial sources with regard to the stability of the bulk substance under photolytic and humidity stress conditions. When properly packaged in an inert atmosphere, fusidic acid from all 3 manufacturers showed a comparable stability. The effects of the observed polymorphic differences on the intrinsic dissolution rate of the drug substance and its in vitro release from the marketed drug product Fusicutan® plus Betamethasone cream have been investigated. Results indicated that the release rate of the drug substance is similar for polymorphic Forms I and III, allowing both forms to be used during manufacture without affecting the safety or efficacy of the drug product.

100 Deals associated with Dermapharm AG

100 Translational Medicine associated with Dermapharm AG

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