A simple, fast, precise, accurate and rugged stability indicating high performance liquid chromatography (HPLC) method has been developed for simultaneous estimation of Amoxicillin and Clavulanic acid from injectable ...A simple, fast, precise, accurate and rugged stability indicating high performance liquid chromatography (HPLC) method has been developed for simultaneous estimation of Amoxicillin and Clavulanic acid from injectable dosage form. The stability indicating capability of the method was proven by subjecting the drugs to stress conditions as per ICH recommended test conditions such as alkaline and acid hydrolysis, oxidation, photolysis, thermal degradation and resolution of the degradation products formed therein. The separation was obtained using a mobile phase composition at a ratio of 95:5 (v/v) of pH 5.0 buffer and methanol on Inertsil C18 column (250 × 4.0 mm, 4 μm) with UV detection at 220 nm at a flow rate of 1 ml/minute. The photodiode array detector was used for stress studies. The order of elution of peaks was Clavulanic acid followed by Amoxicillin. The linear calibration range was found to be 79.51 to 315.32 μg/ml for Amoxicillin and 17.82 to 67.90 μg/ml for Clavulanic acid. The Amoxicillin and Clavulanic acid were found to be stable in solution up to 24 hours. The method validation data showed excellent results for precision, linearity, specificity, limit of detection, limit of quantification and robustness. The present method can be successfully used for routine quality control and stability studies.展开更多
Real-world evidence (RWE) is clinical evidence on a medical product’s safety and efficacy that is generated using real-world data (RWD) resulting from routine healthcare delivery. This study evaluates the clinical ef...Real-world evidence (RWE) is clinical evidence on a medical product’s safety and efficacy that is generated using real-world data (RWD) resulting from routine healthcare delivery. This study evaluates the clinical efficacy of amoxicillin + clavulanic acid in children with pharyngitis, acute otitis, or acute rhinosinusitis with suspected bacterial origin under normal office and home conditions. Methods: This was a real-life, prospective, observational, pharmacovigilance study. It included children of both sexes between 2 and 12 years old, with a diagnosis of Rhinopharyngitis (tonsillitis), Acute Otitis Media and Rhinosinusitis. The main effectiveness variable evaluated was reduction and time to resolution of symptoms. All patients received Amoxicillin/Clavulanic Acid suspension 600 mg/42.9 mg/5 mL at a dose of 90 mg/Kg/day in two doses, every 12 hours for 7 days. The evaluations were carried out at the beginning, at 72 hours (3rd day) and at 7 days. All patients underwent culture and antibiogram. Results: The majority of cultures were negative for pathogenic germs, suspecting unidentifiable germs, or viral etiology despite the rigorous selection of subjects following validated scores. The most frequently isolated germ was Staphylococcus aureus;growth of gram-negative bacteria was reported in 33.33% of the cultures. There was a significant improvement in symptoms in children with tonsillitis and rhinosinusitis from the first 72 hours of treatment, persisting until the 7 days. In the otitis media group, returning to normal by the tenth day. During the conduction of this investigation, no adverse effects associated with the prescribed therapy were reported.展开更多
Objective: To explore the genotoxic potential and histopathological changes induced in liver, kidney, testis, brain and heart after using the antibiotic drug amoxicillin/clavulanic acid(4:1).Methods: The study include...Objective: To explore the genotoxic potential and histopathological changes induced in liver, kidney, testis, brain and heart after using the antibiotic drug amoxicillin/clavulanic acid(4:1).Methods: The study included chromosomal aberration analysis in bone-marrow and mouse spermatocytes, induction of sperm morphological abnormalities and histopathological changes in different body organs. The drug was administrated orally at a dose of81 mg/kg body weight twice daily(Total = 162 mg/kg/day) for various periods of time equivalent to 625 mg/men(twice daily).Results: The results revealed non-significant chromosomal aberrations induced after treatment with amoxicillin/clavulanic acid(AC) in both bone marrow and mouse spermatocytes after 7 and 10 days treatment. On the other hand, statistically significant percentages of sperm morphological abnormalities were recorded. Such percentage reached 8.10 ± 0.55, 9.86 ± 0.63 and 12.12 ± 0.58 at the three time intervals tested(7, 14 and 35 days after the 1 st treatment respectively)(treatment performed for 5 successive days) compared with 2.78 ± 0.48 for the control. The results also revealed histopathological changes in different body organs after AC treatment which increased with the prolongation of the period of therapy. Congestion of central vain, liver hemorrhage and hydropic changes in hepatocytes were noticed in the liver. Degenerative changes were found in kidney glomerulus and tubules while testis showed atrophy of seminiferous tubules, and reduction of spermatogenesis. AC also induced neurotoxicity and altered brain neurotransmitter levels. Hemorrhage in the myocardium, disruption of cardiac muscle fibers and pyknotic nuclei in cardiomyocytes were recorded as side effects of AC in heart tissue.Conclusions: The results concluded that AC treatment induced sperm morphological abnormalities and histopathological changes in different body organs. Clinicians must be aware of such results while describing the drug.展开更多
Aim: To assess the quality and in vitro efficacy of five brands of amoxicillin/clavulanic acid tablet, suspension and injectable preparations selected from pharmacies in the Central Region of Ghana. Method: Using a St...Aim: To assess the quality and in vitro efficacy of five brands of amoxicillin/clavulanic acid tablet, suspension and injectable preparations selected from pharmacies in the Central Region of Ghana. Method: Using a Stratified Representation Sampling method, forty preparations (tablets, suspensions and injectable powders) containing amoxicillin and clavulanic acid were sampled from nine different locations within the Central Region of Ghana. To determine drug quality, several procedures, namely, content assay, disintegration and dissolution testing were employed. In vitro drug efficacy was determined by comparing the Minimum Inhibitory Concentrations (MIC’s) obtained with published values. Results: All tablets passed the disintegration test, with disintegration time ranging between six (6) and fifteen (15) minutes. Analyses of all the tablets for drug content showed 100% failure (14 out of 14) for amoxicillin and 14% failure (2 out of 14) for clavulanic acid. Injectable formulations showed similar results. All four (4) samples analyzed for content failed the amoxicillin content assay (0 out of 4) but all passed clavulanic acid assay (4 out of 4). For tablet dissolution tests, there was a 93% (13 out of 14) pass rate for both amoxicillin and clavulanic acid. Content analysis of all suspension formulations involved twenty-two (22) samples from five (5) brands. Only 41% (9 out of 22) passed for both amoxicillin and clavulanic acid. All the other samples failed for either amoxicillin, clavulanic acid or both. Results obtained from drug quality tests were confirmed by in vitro efficacy tests against selected microorganisms. Conclusion: The samples were therefore not of good quality, since content assay is the most crucial test. It is hypothesized that this is due to poor storage conditions, and recommendations, such as air conditioning and more structured procedures along the supply chain, are put forward to counteract this.展开更多
文摘A simple, fast, precise, accurate and rugged stability indicating high performance liquid chromatography (HPLC) method has been developed for simultaneous estimation of Amoxicillin and Clavulanic acid from injectable dosage form. The stability indicating capability of the method was proven by subjecting the drugs to stress conditions as per ICH recommended test conditions such as alkaline and acid hydrolysis, oxidation, photolysis, thermal degradation and resolution of the degradation products formed therein. The separation was obtained using a mobile phase composition at a ratio of 95:5 (v/v) of pH 5.0 buffer and methanol on Inertsil C18 column (250 × 4.0 mm, 4 μm) with UV detection at 220 nm at a flow rate of 1 ml/minute. The photodiode array detector was used for stress studies. The order of elution of peaks was Clavulanic acid followed by Amoxicillin. The linear calibration range was found to be 79.51 to 315.32 μg/ml for Amoxicillin and 17.82 to 67.90 μg/ml for Clavulanic acid. The Amoxicillin and Clavulanic acid were found to be stable in solution up to 24 hours. The method validation data showed excellent results for precision, linearity, specificity, limit of detection, limit of quantification and robustness. The present method can be successfully used for routine quality control and stability studies.
文摘Real-world evidence (RWE) is clinical evidence on a medical product’s safety and efficacy that is generated using real-world data (RWD) resulting from routine healthcare delivery. This study evaluates the clinical efficacy of amoxicillin + clavulanic acid in children with pharyngitis, acute otitis, or acute rhinosinusitis with suspected bacterial origin under normal office and home conditions. Methods: This was a real-life, prospective, observational, pharmacovigilance study. It included children of both sexes between 2 and 12 years old, with a diagnosis of Rhinopharyngitis (tonsillitis), Acute Otitis Media and Rhinosinusitis. The main effectiveness variable evaluated was reduction and time to resolution of symptoms. All patients received Amoxicillin/Clavulanic Acid suspension 600 mg/42.9 mg/5 mL at a dose of 90 mg/Kg/day in two doses, every 12 hours for 7 days. The evaluations were carried out at the beginning, at 72 hours (3rd day) and at 7 days. All patients underwent culture and antibiogram. Results: The majority of cultures were negative for pathogenic germs, suspecting unidentifiable germs, or viral etiology despite the rigorous selection of subjects following validated scores. The most frequently isolated germ was Staphylococcus aureus;growth of gram-negative bacteria was reported in 33.33% of the cultures. There was a significant improvement in symptoms in children with tonsillitis and rhinosinusitis from the first 72 hours of treatment, persisting until the 7 days. In the otitis media group, returning to normal by the tenth day. During the conduction of this investigation, no adverse effects associated with the prescribed therapy were reported.
基金supported by the project in National Research Centre under grant number: 10090013, Cairo, Egypt
文摘Objective: To explore the genotoxic potential and histopathological changes induced in liver, kidney, testis, brain and heart after using the antibiotic drug amoxicillin/clavulanic acid(4:1).Methods: The study included chromosomal aberration analysis in bone-marrow and mouse spermatocytes, induction of sperm morphological abnormalities and histopathological changes in different body organs. The drug was administrated orally at a dose of81 mg/kg body weight twice daily(Total = 162 mg/kg/day) for various periods of time equivalent to 625 mg/men(twice daily).Results: The results revealed non-significant chromosomal aberrations induced after treatment with amoxicillin/clavulanic acid(AC) in both bone marrow and mouse spermatocytes after 7 and 10 days treatment. On the other hand, statistically significant percentages of sperm morphological abnormalities were recorded. Such percentage reached 8.10 ± 0.55, 9.86 ± 0.63 and 12.12 ± 0.58 at the three time intervals tested(7, 14 and 35 days after the 1 st treatment respectively)(treatment performed for 5 successive days) compared with 2.78 ± 0.48 for the control. The results also revealed histopathological changes in different body organs after AC treatment which increased with the prolongation of the period of therapy. Congestion of central vain, liver hemorrhage and hydropic changes in hepatocytes were noticed in the liver. Degenerative changes were found in kidney glomerulus and tubules while testis showed atrophy of seminiferous tubules, and reduction of spermatogenesis. AC also induced neurotoxicity and altered brain neurotransmitter levels. Hemorrhage in the myocardium, disruption of cardiac muscle fibers and pyknotic nuclei in cardiomyocytes were recorded as side effects of AC in heart tissue.Conclusions: The results concluded that AC treatment induced sperm morphological abnormalities and histopathological changes in different body organs. Clinicians must be aware of such results while describing the drug.
文摘Aim: To assess the quality and in vitro efficacy of five brands of amoxicillin/clavulanic acid tablet, suspension and injectable preparations selected from pharmacies in the Central Region of Ghana. Method: Using a Stratified Representation Sampling method, forty preparations (tablets, suspensions and injectable powders) containing amoxicillin and clavulanic acid were sampled from nine different locations within the Central Region of Ghana. To determine drug quality, several procedures, namely, content assay, disintegration and dissolution testing were employed. In vitro drug efficacy was determined by comparing the Minimum Inhibitory Concentrations (MIC’s) obtained with published values. Results: All tablets passed the disintegration test, with disintegration time ranging between six (6) and fifteen (15) minutes. Analyses of all the tablets for drug content showed 100% failure (14 out of 14) for amoxicillin and 14% failure (2 out of 14) for clavulanic acid. Injectable formulations showed similar results. All four (4) samples analyzed for content failed the amoxicillin content assay (0 out of 4) but all passed clavulanic acid assay (4 out of 4). For tablet dissolution tests, there was a 93% (13 out of 14) pass rate for both amoxicillin and clavulanic acid. Content analysis of all suspension formulations involved twenty-two (22) samples from five (5) brands. Only 41% (9 out of 22) passed for both amoxicillin and clavulanic acid. All the other samples failed for either amoxicillin, clavulanic acid or both. Results obtained from drug quality tests were confirmed by in vitro efficacy tests against selected microorganisms. Conclusion: The samples were therefore not of good quality, since content assay is the most crucial test. It is hypothesized that this is due to poor storage conditions, and recommendations, such as air conditioning and more structured procedures along the supply chain, are put forward to counteract this.
