ABSTRACT
In this study a novel High Performance Liquid Chromatography for the assay of nystatin in oral and vaginal tablets were optimized and validated using Box-Behnken experimental design. The method was performed in the isocratic mode on a RP-18 column [30 [degree]C] using a mobile phase consisting of ammonium acetate 0.05 M buffer/ Methanol mixture [30:70] and a flow-rate of 1.0 mL/min. The specificity, linearity, precision, accuracy, LOD and LOQ of the method were validated. The method was linear over the range of 5-500 microg/mL with an acceptable correlation coefficient [r[2] = 0.9996]. The method's limit of detection [LOD] and quantification [LOQ] were 0.01 and 0.025 microg/mL respectively. The results indicate that this validated method can be used as an alternative method for assay of nystatin
Subject(s)
Chromatography, High Pressure Liquid , Pharmaceutical PreparationsABSTRACT
The aim of this study was to evaluate the antibacterial effects of Thymus vulgaris, Thymus caramanicus Zataria multiflora, Zizphora clinopodioides and Zizphora tenuior against four foodborne and four other bacteria including Staphylococcus aureus, Shigella dysenteriae, Salmonella typhimurium, Escherichia coli Staphylococcus epidermidis, Bacillus subtilis, MRSA and Pseiidomona aeruginosa and measuring the amount of total phenolics of the plants. The extracts were prepared by maceration method. Pre-evaluation of the antimicrobial effect was utilized by cup-plate technique and then Minimum Inhibitory Concentration was determined by agar dilution method according to NCCLS. The total phenolics as a possible cause of antibacterial effect, was measured by Folin-Ciocalteucolorimetry. The results showed that T. caramanicus and Z. multiflora were the most effective ones with MIC values between 0.78-3.125 mg/mL against all of the Bactria and Z. tenuior and Z. clinopodioides had the minimum antimicrobial activity. Total phenolic contents of these five plants were different and followed the general pattern of the antimicrobial effect. The antibacterial effects and the total phenolic content of T. caramanicus and Z. multiflora were remarkable and should be investigated more in future studies
ABSTRACT
Iodine and Iodophore have been longley used as antiseptic to prevent infections with good efficacy and safety. The aim of this study was to formulate new povidone iodine 7.5% antiseptic foam and evaluate its antibacterial effect. In this experimental study, in the first step, the effects of the foaming agents including Sodium Lauryl Ether Sulfate [SLES], Sodium Lauryl Sulfate [SLS] and Nonoxynol 9 were studied and then the effect of pH and different buffer formulations including citrate, phosphate citrate and phosphate buffers on the organoleptic properties and the amount of the free iodine were evaluated according to the USP 32 criteria. The effects of the emollient such as glycerin and glycerox HE were evaluated and the accelerated stability test was taken for optimum formulations. Finally, the antimicrobial effect of the proper formulation was evaluated. SLES 3% in Citrate buffer with the pH 3.5 showed the best results for the quality of the foam and glycerin 1% was selected as proper emollient agent in presence of poloxamer 407 as foam stabilizer. The stability test was done on the superior formula and it proved its antiseptic properties. The foam formulation contained povidone iodine 7.5%, SLES 3%, Poloxamer [407] 2%, citrate buffer and glycerin 1% has passed stability as well as and antimicrobial effects tests; therefore, it can be used as a new antiseptic product and an appropriate detergent to prevent spreading of infectious disease
Subject(s)
Anti-Infective Agents, Local , Anti-Infective Agents , Chemistry, PharmaceuticalABSTRACT
Determination of streptokinase activity is usually accomplished through two assay methods: a] Clot lysis, b] Chromogenic substrate assay. In this study the biological activity of two streptokinase products, namely Streptase[registered], which is a native product and Heberkinasa[registered], which is a recombinant product, was determined against the third international reference standard using the two forementioned assay methods. The results indicated that whilst the activity of Streptase[registered] was found to be 101 +/- 4% and 97 +/- 5% of the label claim with Clot lysis and Chromogenic substrate assay respectively, for Heberkinasa[registered] the potency values obtained were 42 +/- 5% and 92.5 +/- 2% of the label claim respectively. To shed some light on the reason for this finding, the n-terminal sequence of the streptokinase molecules present in the two products was determined. The results showed slight differences in the amino acid sequence of the recombinant product in comparison to the native one at the amino terminus. This finding supports those of other workers who found that n-terminal sequence of the streptokinase molecule can have significant effect on the activity of this protein
Subject(s)
Fibrin Clot Lysis Time , Chromogenic Compounds , Streptokinase/pharmacokineticsABSTRACT
Thimerosal, which is approximately 50% mercury by weight is a preservative widely used in vaccines since the 1930's. It meets the requirements for a preservative as set forth by Pharmacopeia challenge test and has been shown to be effective against a broad spectrum of pathogens. In July 1999, the Public Health Service agencies and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure but, due to the lack of appropriate alternative, it is still extensively used in multiple dose formulations of vaccines such as hepatitis-B in developing countries. In this study the effect of the removal of thimerosal in two formulations of hepatitis B vaccines containing either aluminum hydroxide or aluminum phosphate were evaluated in Balb/c mice. These formulations were administered interperitoneally and the titer of antibody was determined by ELISA technique after 28 days. The geometric mean of antibody titer [GMT], seroconversion and seroprotection rates, ED50 and relative potency of different formulations were determined. The ED50 of thimerosal-free formulations were reduced by more than 35% in both preparations. In addition, GMT of antibody titer, seroconversion and seroprotection indicated significantly higher immunogenicity for thimerosal free formulations for both aluminum phosphate and hydroxide adjuvants
ABSTRACT
Several adjuvants have been evaluated for vaccine formulations but aluminum salts will continue to be used for many years due to their safety, low cost and adjuvanticity with different antigens. Two commonly used aluminum adjuvants, aluminum hydroxide and aluminum phosphate have different adjuvanticity properties. Commercial recombinant protein hepatitis B vaccines containing aluminum hydroxide is facing low induction of immunity in some sections of the vaccinated population. In this study, to follow the current global efforts in finding more potent hepatitis B vaccine formulations, adjuvanticity of aluminum phosphate, aluminum hydroxide and their combinations has been evaluated. The formulated vaccines were administered intra-peritoneally [i.p.] to BALB/c mice and the titer of antibody was determined after 28 days using ELISA technique. The geometric mean of antibody titer [GMT, mIU/ml], seroconversion and seroprotection rates, ED50 [ng] and relative potency [micro g/dose] of different formulations were determined. GMT of antibody titer, seroconversion and seroprotection rates showed significantly higher adjuvanticity for aluminum phosphate than other formulations. The ED50 of aluminum phosphate was approximately two fold less than other formulations. Aluminum phosphate showed more adjuvanticity than aluminum hydroxide and their combinations in hepatitis B protein vaccine. The use of aluminum phosphate as adjuvant leads to higher immunity which may result in more protective response in vaccinated groups