Formulation and Evaluation of Benzoyl Peroxide Injection

Objective: The present research has been undertaken for the formulation and evaluation of Benzoyl Peroxide Injection. It is used for Antiacne activity. Methods: Benzoyl peroxide is used as Antiacne. Methyl paraben, Propyl paraben and benzalkoniumchloride were used as preservatives. Water for injection is used as a vehicle. The following parameters were evaluated such as clarity test, leakage test, chearity test, assay and Sterility test. Results: The clearity test shows clear solution. Drug chearity test shows no chear in the vials. Leakage test shows no leakage in the vials. pH and drug content show the F1 batch was better the other batches. IR confirmed that all functional groups are same as benzoyl Peroxide. Conclusion: It was concluded that F1 batch is the good than the other batches. So F1 batch is good for the Parenteral use.

Formulasi dan evaluasi karakter fisik sediaan gel ekstrak etanol daun salam (Syzygium polyanthum)

Abstrak: Bay leaves (Syzygium polyanthum) are known to have antioxidant effects that can neutralize free radicals found in the skin. The objectives of this research are to formulate the ethanol extract of bay leaves into gel formulation and evaluate the physical properties of gel formulation. Ethanol extract of bay leaves was obtained through the maceration method with 70 % ethanol as a solvent. The thick ethanol extract of bay leaves was formulated into gel formulation with CMC – Na as a gelling agent, glycerin as a humectant, methyl paraben as a preservative, and aquadest as a solvent. After the freeze-thaw test was done, there was no change found in organoleptic but there were changes in pH, spreadability, and adhesion. The pH of gel preparation before being in storage was 5 and after being in storage was 6. In the spreadability, gel formulation spread 5,5 cm before being in the storage, and 5,1 cm after being in the storage. Gel adhesion has a sticky time of 8.35 seconds before in being storage and 8.45 seconds after being in storage.

Using Pressure-Driven Membrane Processes to Remove Emerging Pollutants from Aqueous Solutions

Currently, there is great concern about global water pollution. Wastewater generally contains substances called emerging pollutants, and if the removal of these pollutants is not given sufficient attention, the pollutants can enter into the water cycle and reach the water supply for domestic use, causing adverse effects on the well-being of people. In order to avoid this menace, a multitude of techniques to reduce the high concentration levels of these substances dissolved in water are being researched and developed. One of the most-used techniques for this goal is the physical-chemical separation of contaminants in water through membrane technology. In this study, different membranes were tested with the objective of investigating the removal of three emerging pollutants: caffeine, metformin, and methyl-paraben. Initially, a nanofiltration (NF) membrane was selected, and the influence of pressure was evaluated in the rejection coefficients and permeate fluxes. Next, a screening of three new membranes to remove methyl paraben was completed. The influence of the operating variables, working pressure, and methyl paraben-feed concentration was checked. Finally, the solution-diffusion model was applied to predict the behavior of the different membranes in the removal of methyl paraben. A good correlation between experimental and calculated values of permeate flux and methyl paraben concentration was obtained.

HPLC method development/validation and skin diffusion study of caffeine, methyl paraben and butyl paraben as skin–diffusing model drugs

The focus of this research was to develop and validate a suitable HPLC method, which allows simultaneous determination of three proposed skin model penetrants to investigate the percutaneous diffusion behavior of their combination: caffeine, methyl paraben and butyl paraben. These penetrants were selected because they represent a wide range of lipophilicities. This model highlights the effect of combining penetrants of different molecular properties on their diffusion behavior through skin. The proposed method employed a gradient system that was systematically optimized for separation and quantification of the penetrants. The effect of the stationary phase (C18, C4 and cyano (CN)) was assessed with CN proven to be superior in terms of peak shape, retentivity and dynamic linear range. Significant differences in retention time, peak broadening, and quantifiability between different stationary phases could be demonstrated. The method was validated as per ICH guidelines Q2 (R1) with a satisfactory outcome. The method was successfully applied for real diffusion experiments, and revealed notable differences between the individual penetrants and their ternary mixture on transdermal permeation. The method could potentially be extended to determine these analytes in other related skin permeation investigations.

Application of grouping and read-across for the evaluation of parabens of different chain lengths with a particular focus on endocrine properties

This article presents the outcomes of higher-tier repeated-dose toxicity studies and developmental and reproductive toxicity (DART) studies using Wistar rats requested for methyl paraben and propyl paraben under the European Union chemicals legislation. All studies revealed no-observed adverse effects (NOAELs) at 1000 mg/kg body weight/day. These findings (absence of effects) were then used to interpolate the hazard profile for ethyl paraben, further considering available data for butyl paraben. The underlying read-across hypothesis (all shorter-chained linear n-alkyl parabens are a ‘category’ based on very high structural similarity and are transformed to a common compound) was confirmed by similarity calculations and comparative in vivo toxicokinetics screening studies for methyl paraben, ethyl paraben, propyl paraben and butyl paraben. All four parabens were rapidly taken up systemically following oral gavage administration to rats, metabolised to p-hydroxybenzoic acid, and rapidly eliminated (parabens within one hour; p-hydroxybenzoic acid within 4–8 h). Accordingly, for ethyl paraben, the NOAELs for repeated-dose toxicity and DART were interpolated to be 1000 mg/kg body weight/day. Finally, all evidence was evaluated to address concerns expressed in the literature that parabens might be endocrine disruptors. This evaluation showed that the higher-tier studies do not provide any indication for any endocrine disrupting property. This is the first time that a comprehensive dataset from higher-tier in vivo studies following internationally agreed test protocols has become available for shorter-chained linear n-alkyl parabens. Consistently, the dataset shows that these parabens are devoid of repeated-dose toxicity and do not possess any DART or endocrine disrupting properties.

A new gas chromatographic method development and validation for the simultaneous determination of ibuprofen and caffeine in bulk and pharmaceutical dosage form

Background Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties. Caffeine is one of the most common adjuvant analgesic drugs which is combined with ibuprofen in commercially available formulations. Combining analgesics offers the possibility of increasing effectiveness without increasing dose and therefore risk. Prescribing ibuprofen and caffeine together is common in clinical practice. This is the first work reporting a new and validated gas chromatographic method for the simultaneous determination of ibuprofen and caffeine in bulk and pharmaceutical dosage form. The separation was performed on a TRB-17 column (30.00 m in length, 0.25-mm ID, and 0.25-μm df). Detection was carried out using a flame ionization detector (FID). Methyl paraben was used as an internal standard. The injection volume was 1 μL with 1:50 split ratio using nitrogen as a carrier gas at a flow rate of 1 mL/min. The oven temperature was programmed at 150 °C for 0.5 min, with a rise of 10 °C/min up to 250 °C. The injector temperature was 280 °C, and the detector temperature was 300 °C. The validation of the method including linearity, range, detection limit (DL), quantitation limit (QL), accuracy, precision, specificity, system suitability, and robustness was carried out utilizing International Conference on Harmonization (ICH) guidelines. Results The retention times of methyl paraben, ibuprofen, and caffeine were 1.687, 2.594, and 4.031 min, respectively. The method was linear in the range of 1000–7000 μg/mL for ibuprofen and 162.5–1137.5 μg/mL for caffeine with a correlation coefficient of 0.9999 for both drugs. The DL was found to be 131.68 μg/mL and 15.74 μg/mL for ibuprofen and caffeine, respectively, whereas QL was found to be 399.02 μg/mL for ibuprofen and 47.68 μg/mL for caffeine. The accuracy of the method was validated by mean percentage recovery, which was found to be in the acceptable range. The precision study results of the new method were less than the maximum allowable limit percentage of relative standard deviation %RSD ≤ 2.0. The specificity was evaluated by the standard edition method, and the results of the recovery data showed that excipients do not affect the accuracy of the proposed method. The results of system suitability and robustness tests were also within the acceptable limits. Conclusion The first reported method for simultaneous determination of ibuprofen and caffeine by gas chromatography in bulk and combined dosage form was carried out in this work. The developed method gave a good separation of the drugs and internal standard. The analytical performance of the method was statistically validated as per ICH guidelines, and satisfactory results were obtained. The proposed method can be easily adopted for the routine analysis of ibuprofen and caffeine.