Thai Food and Drug Journal

Editorial

2024-04-25T10:02:12+07:00

Utilizing of Nanopore Technology for Species Identification and Safety Evaluation of Probiotics

2024-04-25T10:07:10+07:00

Situation analysis of safety monitoring program of new drugs in the hospital

2024-04-25T10:24:53+07:00

Background: The Thai FDA announced the new guideline of the risk-based approach of a safety monitoring program in 2017, which required a different approach to safety monitoring for drugs with different risk levels. Currently, there are no new drug guidelines under the Safety Monitoring Program (SMP) for collaboration between hospitals and entreprenures.

Objectives: The study was to investigate the current situation of the Safety Monitoring Programme of new drugs (SMP) and explore the collaboration activities between marketing authorisation holders and hospitals for new drugs with SMP conditions.

Methods: It was qualitative research by selecting public hospitals in Bangkok and its vicinity with a capacity of not less than 400 beds that have been used under SMP conditions in the hospital's drug inventory for the past two years. Then, it collected data between 1-31 September 2022 through in-depth interviews as using a semi-structured questionnaire. Six or more hospital pharmacists were interviewed; participants were invited until we had no new information.

Results: Six participants participated in the study, it is found that all of them Report Adverse Events (AEs) in a similar working process to each other. The hospital pharmacists assessed the causal relationship that covered new drugs and SMP-decommissioned drugs, then recorded it in the hospital database system and reported it to the Health Product Vigilance Center (HPVC). There was one hospital that only referred serious adverse events due to its heavy workload. When asked about the feasibility of operators participating in monitoring the safety of new drugs together with hospitals, it was found that most of them pointed it out as possible but were unable to provide support due to concerns about the Personal Data Protection Act and that collaboration would require permission from the hospital director or hospital board.

Conclusion: The safety monitoring program of new drugs among hospital samples has similar approach but may differ in practice. Hospital pharmacists need important safety data of new drugs and all new information updated whenever available from entrepreneurs.

Developing The Capabilities of Laboratories and Creating a Network to Enhance The Efficiency of Monitoring The Quality of Cannabis and Hemp Products in Thailand

2024-04-25T10:46:02+07:00

Background: Surveillance and control of the quality of cannabis foods for consumer protection required laboratory analysis, and the analysis method was an important issue that directly affected the efficiency of surveillance.

Objectives: To enhance the laboratory capacity of the Bureau of Quality and Safety of Food, Department of Medical Sciences, and regional laboratories in four regions of Thailand

methods: Developing the analytical methods for cannabinoids in foods according to the laws, establishing the project to enhance the capacity of regional laboratories, evaluating by providing the sample for interlaboratory comparison, and onsite visiting.

Result: In 2021, the analytical method for cannabinoids in foods was developed to support the Ministry of Public Health Announcement No. 425, covering all 11 types of food, and other methods were continuously developed in response to the Ministry of Public Health Announcement No. 427, 428, 429, 437, 438, and 439. Eventually, in 2022, the laboratory was accredited according to ISO/IEC 17025: 2017 for the analysis methods of ready-to-eat food, beverage (with and without cannabis ingredient), and cannabis plant (fresh and dried plant, excluding cannabis flower), which was the first laboratory in Thailand. Then, in 2022-2023, there has been a project to develop the regional network laboratories, enhancing laboratory capacity in all 4 regions of Thailand. The scope of analytes was complied with the related laws for the surveillance and registration of the local products. In 2023, there has been an evaluation of the analytical method of regional laboratories by interlaboratory testing, and the results of THC and CBD testing were satisfied for 92.9% and 92.3%, respectively. Finally, the project has continuously supported the regional laboratories by onsite visiting, advising, and solving the challenges.

Conclusion: The outcome of this project can be beneficial for both public and private sectors, extend the capacity to monitor the quality and safety of foods for the regional laboratories, be able to handle the local products, provide more service areas for the customers, and acquired the analytical results as a big data that could be used to plan the food safety surveillance, continuously and systematically. Also, the data could be communicated to the related agencies for further use.

Efficiency of turmeric germs elimination in the traditional Thai medicine production process with ozone

2024-04-25T11:03:22+07:00

Background: Herbal medicinal products are accepted in modern medicine circles as alternatives that are increasingly being used to treat disease. It is important to control the quality of raw materials to control the growth of germs in drug production, such as by baking them with low heat at a temperature of 50 degrees Celsius and sending them for irradiation before being sold, which takes time and costs. Therefore, large quantities must be sent in order to cover the operating costs. However, it is found that currently there are studies that use ozone to control the growth of germs in herbal products and the food industry, but no studies have been found on turmeric. This research therefore proposes a method for eliminating germs in herbs and increasing efficiency in the production of herbal medicines with ozone as an alternative to producing standardized Thai traditional medicines.

Objectives: To study the process of germs eliminating by drying the traditional method, we created a turmeric germs elimination device using ozone that does not affect the important substances in the herb for Thai traditional medicine production and studied to compare the amount of the important substance curcumin and the efficiency of germs eliminating in the decontamination process by drying and using ozone.

Methods: Turmeric powder (200 g) was treated with ozone with a production capacity of 60 g/h for a period of 120 minutes in a closed system. Samples of Turmeric powder that was disinfected using ozone were analyzed for the amount of microorganisms (FDA BAM online 2001 (Chapter 3)), yeasts and mold (FDA BAM online 2001 (Chapter 18)). Thin -layer Chromatography was used to indicate the curcumin level with silica gel GF254 for stationary phase and Toluene: chloroform: ethanol (49:49:2) for mobile phase. The curcumin level was investigated in normal light, UV 254 nm, UV 366 nm and Vanillin-sulfuric acid test solution.

Results: Results show that the turmeric powder that has been eliminated by heat treatment (conventional method) found that Microbial levels were at 4.3x102 CFU/g, yeast and mold levels were at 1.4x102 CFU/g, respectively, while turmeric powder that was treated with ozone for 120 minutes was found to have microbial levels at <250EAPC. CFU/g, levels of yeast and mold were <10 CFU/g, respectively. The thin-layer chromatography results were confirmed that ozone treatment in turmeric did not affect the curcumin level.

Conclusions: Ozone treatment is effective to eliminate germs in turmeric powder and does not affect the important substance curcumin in turmeric that will be used in the Thai traditional medicine production.

Specific Toxicity Testing of Residual Pertussis Toxin in Acellular Pertussis Vaccine Using Chinese Hamster Ovary Cells

2024-04-25T12:37:03+07:00

Background: Pertussis is prevented by a combined acellular pertussis vaccine that contains Pertussis Toxoid (PTs) and Filamentous Haemagglutinin (FHA) as the main constituents. PTd is an inactivated Pertussis toxin (PT). The specific toxicity test of residual PT remaining in the vaccine must be controlled in order to meet the standard requirements to ensure the safety of vaccines. Some traditional methods were tested toxicity in mice which caused animal suffering. Therefore, the alternative CHO cell assay was developed for replacement of animal testing by In vitro assay following 3Rs concept. CHO–K1 cells had a specific response to PT. Then, the exposure of residual PT caused CHO–K1 cells morphological changes to rosette their shapes.

Objectives: To develop and use this as the alternative method for the determination of specific toxicity of PT in the combined vaccine which contains acellular pertussis by Chinese Hamster Ovary (CHO) cell assay by monitoring residual PT in finished product.

Methods: A validation method study of specific toxicity of PT in combined vaccine which contains acellular pertussis by CHO cell assay was conducted. The qualitative assay was examined in two parameters of specificity and limits of detection which was based on the international ICH guideline. One sample of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis combined vaccine (Tdap) was used to study optimal conditions and examined the validity of the method.

Results: The results of validation with pertussis toxin (JNIH–5, NIBSC) were proved that the methods were specific to pertussis toxin that showed rosette-shaped clusters of CHO cells. The lowest limit of detection of pertussis toxin was 0.0015 IU/mL. One sample of Diphtheria -Tetanus - acellular Pertussis Vaccine combined vaccine was removed adjuvant and was tested by CHO cell assay. The negative presented results indicated that the vaccine sample absented residual pertussis toxin.

Conclusion: This assay was appropriate to be adapted as a standard method for specific toxicity based on residual pertussis toxin in a combined vaccine containing acellular pertussis in both local and imported vaccine products.

Method Development and Validation of Identity Test for Meningococcal Conjugate Vaccine by Indirect ELISA

2024-04-25T12:49:19+07:00

Background: An identity test is an important test that is performed on the meningococcal vaccine to verify its identity for quality control of the vaccine. The meningococcal conjugate vaccine consists of purified polysaccharides from Neisseria meningitidis, and each serogroup of meningococcal polysaccharide conjugates with a diphtheria toxoid carrier protein that corresponds to the registration dossier, so that vaccine recipients can be confident in the quality of the vaccine according to the product's standards. Therefore, the agency has expanded its ability to validate the identity of meningococcal vaccines. This testing has not been previously available for the quality control service of meningococcal conjugate vaccines.

Objective: To develop and validate method of the identity test of the meningococcal conjugate vaccine for use as standard methods in the laboratory.

Methods: The optimum conditions were determined by the specific reaction between the antigen and the antibody that was suitable for testing. In addition, the method validation was verified for two parameters, including specificity and intermediate precision.

Results: The results of the optimum conditions of the identity test for meningococcal conjugate vaccine by indirect ELISA showed that the optimum dilution level of each antibody has a specified dilution factor. The N. meningitidis antiserum group A was diluted at 1:10,000, while the N. meningitidis antiserum C, Y, and W135 groups were diluted at 1:5,000, respectively. In addition, this assay must be tested according to the designated plate templates so that it can be a valid analysis because each type of antigen has a specific antibody. Moreover, the result of the validation method was found that this method was highly specific to the reaction between antigen and antibody. These were calculated from the ratio values of each type of antigen, which presented the ratio values in the range of 17.69 - 40.78, while there were no specific reactions between antigen and antibody; the ratio values were very low, in the range of -0.02 - 4.95. Thus, the identity of each antigen can be determined, and there was no cross-reaction among the serogroups. The OD_{450 nm}value of the blank was less than 0.1, which met the acceptance criteria. The results of intermediate precision by two independent analysts showed that the results of both analysts met the criteria, and the average ratios of standard substances and vaccine samples were not significantly different between the two analysts at the 95% confidence interval.

Conclusions: The results of the study revealed that the identity test for the meningococcal conjugate vaccine using the indirect ELISA technique met the requirements for validation. Therefore, it is suitable for use as a standard method for submitting the registration of the meningococcal vaccine in Thailand.