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Acide fusidique betamethasone. Fusidic acid
Acide fusidique betamethasone. Fusidic acid in dermatology
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The recovery rates for each impurity lay between The recovery rates of both APIs were evaluated in the same fashion and over the same range, with values of Solution stability was determined by preparation of standard and sample solutions and analyses of these solutions at 4 hourly intervals over a period of 48 h. The active substance BV proved to be stable over the measurement period with the content values of relevant degradation products remaining unchanged.
The FA samples showed a slight increase of 0. This increase was considered negligible. The content values of all other known impurities remained unchanged.
No new unknown impurities were observed for either of the APIs. Some of the conditions tested, e. As a result, a visual examination of the resolution between critical peak pairs has been adopted as a system suitability requirement before sample measurement. The limits of detection and quantitation were defined as 3 times and 10 times the signal-to-noise ratio and were calculated using a mixed standard solution containing the available impurities at a suitably low concentration level ca.
For impurities which were not available for purchase, the respective active substances were used as a surrogate. This is a standard approach used in analytical chemistry. The response factors for the available impurities betamethasone, betamethasonevalerate and 3-didehydrofusidic acid were calculated by preparing solutions of equal concentration of each of the impurities together with their respective APIs and comparing the resulting peak areas.
For the remaining known impurities of FA, which were not available for purchase, the prescribed response factors were taken directly from the EP monograph for fusidic acid 7. In cases where no response factor was available, the impurities were presumed to have the same response as the API, i. The approach taken is justified since the impurities cannot be purchased as pure substances and the purity of the cream preparation is being measured at the same wavelength as prescribed in the EP monograph for the API.
The relevant response factors are provided in Table III. Thirty-eight trial batches of topical cream were analyzed with the above-detailed purity procedure during formulation development.
It was observed that betamethasonevalerate was isomerizing rapidly to its corresponding valerate isomer in some of the formulations and that this process was both temperature and pH dependent. Furthermore, the isomerization rate was also shown to be significantly influenced by the concentration of the primary emulsifier in the cream formulation.
At higher concentrations of emulsifier, e. Reducing the emulsifier concentration to an appropriate level lead to a significant reduction of the isomerization rate, with only 0. In the final cream product only betamethasonevalerate is observed. Fusidic acid proved stable in all of the development formulations tested.
Of these impurities epideacetylfusidic acid and epideacetylfusidic acid,lactone appear to be the major degradation products of fusidic acid as demonstrated by Figures 2 and 3. The results of the accelerated stability studies are presented in Table III. The product shows significant degradation after 6 months storage.
This further underlines the stability-indicating nature of the procedure for the topical cream. The sample demonstrated a significant degradation. Peak 3 was not present in this particular sample. An RP-HPLC method was developed for the simultaneous quantitation of impurities of betamethasonevalerate and fusidic acid in a topical cream preparation. The method was validated according to current ICH guidelines and was demonstrated to be selective, linear, precise, accurate, robust and sufficiently sensitive within the validated range.
The mass-balance values of degraded samples are acceptable, demonstrating the stability-indicating power of the procedure for the topical cream.
The method is suitable for employment in the analysis of trial formulations, release batches as well as during ICH stability testing. Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances. ICH , Q6A , Impurities in New Drug Products. Irwin W. Yip Y. Google Scholar. Vladimirov S. Fiser Z. Agbaba D. Zivanov-Stakic D. Al-Shaalan N. Shaikh S. Muneera M. Thusleem O. Tahir M. Kondaguli A. European Pharmacopoeia 7.
Godtfredsen W. Jahnsen S. Lorck H. Roholt K. Tybring L. Draft Monograph Fusidic acid monohydrate. Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. If you forget to put the drops in, do it as soon as you remember.
Then continue to use the drops at the usual time. If you accidentally put too many fusidic acid eye drops in your eye, or if you swallow the eye drops, it's unlikely to harm you.
Page last reviewed: 30 November Next review due: 30 November How and when to use fusidic acid. Using cream or ointment The main difference between fusidic acid cream and ointment is how it feels — the ointment is greasier.
Dosage for fusidic acid cream or ointment You'll usually put on fusidic acid cream or ointment 3 or 4 times a day. How to use fusidic acid cream or ointment Remove the cap. Check the seal is not broken before you first use the cream or ointment. There is a small spike in the top of the cap — push this spike through the seal on the tube.
Always wash your hands before using fusidic acid cream or ointment. Unless you're using the cream or ointment to treat your hands, always wash your hands afterwards, too. Put a thin layer of cream or ointment onto the infected area and gently rub it in. Be careful to avoid your eyes if you use it on your face.
Fire warning Fusidic acid cream or ointment applied to the skin can dry onto your clothes and bedding. Finishing your course of fusidic acid cream or ointment Carry on using this medicine until you have finished the course, even if you feel better. If you stop your treatment early, the infection could come back. Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you. Dated July Two weeks ago this itchy rash appeared on my upper back.
It is extremely itchy. It is located only in this specific area of my back with no rash or itching anywhere else. I have not changed washing Disclaimer: This article is for information only and should not be used for the diagnosis or treatment of medical conditions. Egton Medical Information Systems Limited has used all reasonable care in compiling the information but make no warranty as to its accuracy. Consult a doctor or other health care professional for diagnosis and treatment of medical conditions.
For details see our conditions. Apply the cream or ointment three or four times a day, unless you have been told otherwise.
If you have any questions about this medicine ask your pharmacist. Are you protected against flu?
Fusidic acid is a steroidal antibiotic, derived from the fungus Fusidium coccineum. It was developed by Leo Pharma in Ballerup, Denmark, and then commercialized in the s. Fusidic acid has good in vitro activity against staphylococci, including strains sensitive and resistant to methicillin. It is used to treat bacterial infections, such as skin infections, including cellulitis and impetigo, and eye infections, including conjunctivitis.
It comes as a cream, ointment, or eye drops Fusidic acid eye drops are called by the brand name Fucithalmic. Fusidic acid cream or ointment is called by the brand name Fucidin.
Note : It is also given by injection, as a liquid to swallow, or as tablets, but these are usually only used in hospital.
Fusidic acid is prescribed mainly for skin infections caused by staphylococci also for infections with streptococci and Corynebacterium minutissimum. These infections include impetigo, infected cuts and abrasions, infected dermatitis, dermatophytic skin infection, eczematous rash, eczematous rash.
According to the latest recommendations, HAStopical fusidic acid is now restricted as a second-line treatment in cases of intolerance or resistance to mupirocin. Fusidic acid monotherapy, particularly topical preparations, has been strongly associated with the emergence of resistance to fusidic acid in both methicillin-resistant Staphylococcus aureus MRSA and S. A variety of antibiotics have been used in conjunction with fusidic acid therapy, including rifampin, novobiocin, and beta-lactams, although rifampin plus fusidic acid regimens are the most common.
Fusidic acid is a monocarboxylic acid. It is a colorless, crystalline compound sparingly soluble in water. The sodium fusidate used in therapy is water-soluble and liposoluble, which gives it good tissue distribution. Fusidic acid acts by inhibiting the protein synthesis of the bacteria by blocking the ribosome by binding to "factor G", responsible for the translocation of the peptide chain during protein synthesis.
Fusidic acid is active in vitro against Staphylococcus aureus, most coagulase positive staphylococci, beta-hemolytic streptococci, Corynebacterium species and most Clostridium species. It is active in vitro and clinically against Mycobacterium leprae but has only marginal activity against Mycobacterium tuberculosis. Fusidic acid has good in vitro activity against staphylococciincluding strains sensitive and resistant to methicillin. It also has useful activity against Neisseria spp, Bordetella pertussis, Corynebacterium spp and Gram-positive anaerobes such as Clostridium difficile and C.
Home Bacteria Infections Laboratory Contacts. Sulfamides Trimethoprime et association. Overview Fusidic acid is a steroidal antibiotic, derived from the fungus Fusidium coccineum. Fusidic acid uses Fusidic acid is prescribed mainly for skin infections caused by staphylococci also for infections with streptococci and Corynebacterium minutissimum. Fusidic acid.
Structure of fusidic acid.
WOA1 - Crème médicinale d'acide fusidique faite au moyen de fusidate de sodium et incorporant un biopolymère et de la bétaméthasone, et procédé de. Fucicort Cream contains betamethasone, a high potency anti-inflammatory corticosteroid, combined with fusidic acid, a topical antibiotic. Betamethasone in. Abstract. A topical pharmaceutical cream containing the active pharmaceutical ingredients (APIs) betamethasonevalerate and fusidic acid. NHS medicines information on fusidic acid – what it's used for, side effects, dosage and who can take it. Also called, Brand names: Fucidin®; Fucidin® H (fusidic acid with hydrocortisone); Fucibet®, Xemacort® (fusidic acid with betamethasone). Kondaguli A. The structures of the above-mentioned impurities are provided in Figure 1 a. The analysis of both APIs with the aid of a single HPLC run would significantly simplify laboratory analysis, thus saving time and reducing costs.A topical pharmaceutical cream containing the active pharmaceutical ingredients APIs betamethasonevalerate and fusidic acid has been developed for the treatment of inflammatory skin conditions and associated secondary infections. A gradient programme was employed at a flow rate of 0. The method has been validated according to current International Conference on Harmonisation ICH guidelines and applied during formulation development and stability studies.
The procedure has been shown to be stability-indicating for the topical cream. Dermatological disorders, such as eczema and psoriasis, can have a debilitating effect on the quality of life of affected patients due to their very obvious symptoms, including severe inflammation, itching, bleeding and excess skin growth.
Further complications often arise due to secondary infections of open wounds caused by picking or scratching of the affected areas by the patient. A common treatment for these disorders is the use of topical glucocorticoids, such as hydrocortisone and betamethasone, together with antibiotic agents including fusidic acid FA and gentamicin sulfate. For this purpose a topical pharmaceutical preparation containing the active pharmaceutical ingredients APIs betamethasonevalerate BV and fusidic acid Figure 1 has been developed.
Current international guidelines 1 , 2 require that degradation products of APIs in finished pharmaceutical products are quantified at release and also during the shelf-life of the product. This is to guarantee an acceptable level of quality by ensuring that 1 the APIs do not degrade to such an extent that the efficacy of the product is diminished and 2 the levels of potentially toxic impurities, arising through degradation of these APIs, are maintained below well-defined limits.
To minimize degradation, the APIs should be formulated in a suitably stable vehicle. This is the goal of formulation development and this process requires the employment of a stability-indicating analytical procedure.
None of the analytical methods reported in the literature are suitable for the simultaneous analysis of impurities of both BV and FA in a single chromatographic run.
There are methods available for the analysis of the single APIs in topical formulations, e. Po et al. The available methods, however, are not suitable for the present analysis since they are not selective for all relevant impurities.
With regard to FA, the vast majority of published methods are only suitable for the analysis of the main component, i. Furthermore, many of the published procedures are often poorly selective, being based on methods such as UV-Vis spectrophotometry 4 or atomic absorption spectrometry 5 which are not stability-indicating.
Shaikh et al. This method is capable of separating and quantifying the impurity 3-didehydrofusidic acid 3-ketofusidic acid , which is one of the main impurities of FA. However, 14 other impurities related to FA have been described, many of which are potential degradation products 7. These impurities have not been considered in any of the peer-reviewed literature methods found. Consequently, it was necessary to develop a new procedure for the selective analysis of impurities of both active substances.
The analysis of both APIs with the aid of a single HPLC run would significantly simplify laboratory analysis, thus saving time and reducing costs. In this paper the development of a novel stability-indicating RP-HPLC method for the simultaneous quantitation of impurities of both BV and FA in a single chromatographic run is reported. The method has been validated according to current International Conference on Harmonisation ICH guidelines and applied to development formulations and stability samples of cream.
Both APIs were of Ph. Purified water was obtained from the in-house purification system at mibe GmbH Arzneimittel Brehna, Germany. Betamethasone was purchased from Sigma-Aldrich.
The increased temperature allows for complete suspension of the cream by facilitating the melting of the fatty components, e. Thorough mixing was ensured with the help of a vortexing machine. The mixture was allowed to cool to room temperature before being made up to volume with acetonitrile.
A portion of the cold suspension was then centrifuged at rpm for 5 min. The resulting supernatant was removed and allowed to warm to room temperature before dilution. This served to further aid the precipitation of unwanted matrix components and also to improve peak symmetry by reducing sample solvent strength.
Finally, the solution was filtered through a 0. The concentrations of the APIs were The impurities were quantified against a 0. The impurities of FA were quantified against the 0. Fusidic acid hemihydrate has a single carboxylic acid functional group with a p K a of 5. Consequently, the retention time of FA will be influenced by the pH of the mobile phase.
A suitable mobile phase should have a pH of 2 units below the p K a of the acidic group, in order to ensure that the molecule remains completely protonated in solution. For this reason a mobile phase acidified with phosphoric acid was chosen. BA, on the other hand, is a neutral compound and its retention on the analytical column will not be affected by pH.
The initial flow rate was 1. However, several impurities were still not satisfactorily separated. In order to achieve an acceptable separation the gradient programme, flow-rate and mobile phase composition were altered.
Fifty microliters were also the maximum possible injection volume of the system. The available impurities of BV were identified by dissolving an appropriate quantity of each compound in the sample solvent and injecting them into the HPLC. Their respective retention times and relative retention times were recorded and compared with the peaks in the sample solution.
See Figure 2 for an example chromatogram of a cream sample. Chromatogram of cream sample measured shortly after manufacture. Peak assignment as follows: 1. Fusidic acid. Deacetylfusidic acid,lactone. U, unknown impurity. These samples were therefore considered to be worst case. Stress tests as well as accelerated stability studies had shown that the impurities betamethasone and betamethasonevalerate are the predominant degradation products of BV which are formed in the cream under normal storage conditions.
The degradation scheme of BV is described in Figure 1 b. The data also showed that the impurities epideacetylfusidic acid, epideacetylfusidic acid,lactone, 3-didehydrofusidic acid and hydroxyfusidic acid are the main degradants of FA observed.
It is generated by hydrolysis of the acetyl group at position C Further reaction of the resulting free hydroxyl group with the neighboring carboxyl group at C21 forms the cyclic-lactone epideacetylfusidic acid,lactone, the second most abundant degradant of FA observed.
The structures of the above-mentioned impurities are provided in Figure 1 a. The purity of the main API peaks and relevant impurities was evaluated using a photodiode array scan from to nm, whereby spectra were recorded and compared across the entire peak. The peaks were found to be pure with this method. No interferences from solvent or placebo components were observed. The linearity of the detector response for betamethasone, betamethasonevalerate, BV, 3-didehydrofusidic acid and FA was checked using a point calibration over a suitable range as detailed in Table II.
These substances were chosen because they were the only impurities which were commercially available as pure substances. This is common practice in analytical chemistry. The residual values demonstrated no particular trend.
The repeatability reproducibility of the analytical procedure was checked by preparation and measurement of six sample solutions by Analyst A using HPLC Machine A on Day 1. The accuracy of the analytical procedure was determined by preparation and measurement of nine solutions comprising of placebo which had been spiked with each of the available impurities over the range 0.
The recovery rates for each impurity lay between The recovery rates of both APIs were evaluated in the same fashion and over the same range, with values of Solution stability was determined by preparation of standard and sample solutions and analyses of these solutions at 4 hourly intervals over a period of 48 h.
The active substance BV proved to be stable over the measurement period with the content values of relevant degradation products remaining unchanged.
The FA samples showed a slight increase of 0. This increase was considered negligible. The content values of all other known impurities remained unchanged.
No new unknown impurities were observed for either of the APIs. Some of the conditions tested, e. As a result, a visual examination of the resolution between critical peak pairs has been adopted as a system suitability requirement before sample measurement.
The limits of detection and quantitation were defined as 3 times and 10 times the signal-to-noise ratio and were calculated using a mixed standard solution containing the available impurities at a suitably low concentration level ca. For impurities which were not available for purchase, the respective active substances were used as a surrogate.
This is a standard approach used in analytical chemistry. The response factors for the available impurities betamethasone, betamethasonevalerate and 3-didehydrofusidic acid were calculated by preparing solutions of equal concentration of each of the impurities together with their respective APIs and comparing the resulting peak areas.
For the remaining known impurities of FA, which were not available for purchase, the prescribed response factors were taken directly from the EP monograph for fusidic acid 7. In cases where no response factor was available, the impurities were presumed to have the same response as the API, i. The approach taken is justified since the impurities cannot be purchased as pure substances and the purity of the cream preparation is being measured at the same wavelength as prescribed in the EP monograph for the API.
The relevant response factors are provided in Table III. Thirty-eight trial batches of topical cream were analyzed with the above-detailed purity procedure during formulation development. It was observed that betamethasonevalerate was isomerizing rapidly to its corresponding valerate isomer in some of the formulations and that this process was both temperature and pH dependent.
Furthermore, the isomerization rate was also shown to be significantly influenced by the concentration of the primary emulsifier in the cream formulation. At higher concentrations of emulsifier, e. Reducing the emulsifier concentration to an appropriate level lead to a significant reduction of the isomerization rate, with only 0. In the final cream product only betamethasonevalerate is observed.
Fusidic acid proved stable in all of the development formulations tested. Of these impurities epideacetylfusidic acid and epideacetylfusidic acid,lactone appear to be the major degradation products of fusidic acid as demonstrated by Figures 2 and 3. The results of the accelerated stability studies are presented in Table III.
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