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.

The Ethylene Oxide Product Test of Sterility: Limitations and Interpretation of Results

The ethylene oxide (EO) product test of sterility (ToS) can be conducted to comply with ANSI/AAMI/ISO 11135:2014 for the generation of data to demonstrate the appropriateness of the biological indicator (BI) that is used to develop and qualify the EO sterilization process. Clause D.8.6 of 11135 provides an option to perform a sublethal EO process, followed by conducting a product ToS, performing sterility testing of BIs from the process challenge device, and comparing the test results. Certain limitations for the EO product ToS should be considered when conducting studies that feature the use of this test, in order to support compliance with this requirement. Limitations for any sterility test include sample size, testing frequency, detection sensitivity, and/or the potential for false-positive/false-negative results, each of which must be recognized and well understood in order to support compliance with the standard. In addition, the experimental design of any study featuring the use of a sterility test should be carefully developed to ensure the generation of scientifically sound results and conclusions to support the study objective.

Development of next-generation sequencing-based sterility test

The sterility testing methods described in pharmacopoeias require an incubation period of 14 days to obtain analysis results. An alternative method that can significantly shorten the detection time and improve the accuracy is in urgent need to meet the sterility testing requirements of regenerative medicine products with a short shelf life. In this study, we developed the next-generation sequencing-based sterility test (NGSST) based on sequencing and multiple displacement amplification. The NGSST can be finished within 48 hours with five steps including whole genome amplification, sequencing, alignment, sterility testing report, and microorganism identification. We use RPKM ratio to minorize the influence of environmental bacteria and determine its cutoff based AUC curve. The NGSST showed high sensitivity in reporting contaminates at 0.1 CFU in supernatant of biological product or 1 CFU in cell suspension. Furthermore, we identified microorganisms in 5 primary umbilical cord mesenchymal stem cell samples that were tested positive by BacT/ALERTR 3D. Overall, the NGSST can serve as a promising alternative for sterility testing of biological products.

Removal of bacterial growth inhibition of anticancer drugs by using complexation materials

In the context of batch production of cytotoxic drugs in hospital pharmacies with the need of sterility testing, the objective was to validate the use of Rapid Microbiological Method (RMM), and to develop adequate neutralization method in case of inhibition of bacterial growth. The potential microbiological growth inhibitory effect of three anticancer drugs (5 fluorouracil, irinotecan and oxaliplatin) selected for batch production was assessed on BacT/ALERT® system. Among cytotoxic drugs, only 5FU exhibited inhibitory effect on microbiological growth using rapid microbiological method. To counteract this effect our purpose was to use neutralizing agents complexing the drug i. e. activated carbon or ion exchange resins. The microbiological bactericidal concentration of 5FU was very low (1.10–4 mg/mL) indicating the absolute need to neutralize the whole drug before sterility test. The complexation was validated by High Performance Liquid Chromatography control of the residual 5FU concentration in solution after the use of neutralizing agents. Only activated carbon was able to fully capture 5FU when previously diluted at 5 mg/mL. Conversely, the resins, in the condition of the study, were not able to fully capture 5FU whatever the dilution. The microbiological growth on BacT/ALERT® system after active carbon treatment was successfully confirmed with Staphylococcus aureus. Based on this validation results a method was then developed to routinely be able to perform sterility test of the batches produced and was confirmed on five microbiological species (i. e. S. aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans, Aspergillus brasiliensis). Our work gives a new insight for considering sterility testing by rapid microbiological method even for drugs exhibiting inhibitory effect on microbiological growth.

General Considerations on Antimicrobial Tests and Conditions Applicable in Textile Industry

Due to the globally increasing need for utilizing antimicrobial materials, it is necessary to improve and develop newer methods and techniques for determining the antimicrobial properties of these materials qualitatively and quantitatively, especially in the medical field. Recently there has been a debate among scientists between the difference between antimicrobial test and sterility test. For antimicrobial and microbial resistance, the test is limited to the standard methods to determine the effect of the sample as an antimicrobial without paying attention to the fact that the sample is sterile or not, unless the sample was taken into sterile atmosphere and isolated with a protective suitable sterile package cover after treatment with the antimicrobial agent because the external atmosphere contains a lot of scattered types of bacterial and fungal microorganisms. In case of sterility test, the sample to be examined should be prepared, isolated and coated from the outside atmosphere, where the presence of microbes on the surface of the sample by standard methods is detected and in some sterilization tests it is prohibited to include an antimicrobial substance to the sample to be tested to avoid the interference with the test. In both cases the tests should be implemented in a sterilized room and conditions according to the recognized scientific principles. In conclusions, the antimicrobial test is used to make sure that the specimen is attained antimicrobial properties or not and the sterilization test is done by ensuring that the sample is free of contaminated microorganisms. This review poses on some factor and conditions affecting antimicrobial action and some standard test methods for determination of antimicrobial and sterility potential of materials.