• YAKHAK HOEJI
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• v.55 no.4
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• pp.324-331
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• 2011

Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specifications in Korean Pharmaceutical Codex (KPC). Among those commercially available, Piracetam Tablets and Fenoterol hydrobromide Tablets were selected to develop the dissolution testing method. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korea Food & Drug Administration (KFDA). The dissolution test for Piracetam Tablets was carried out under sink condition with distilled water as dissolution medium, paddle rotation speed at 50 rpm and medium volume of 900 ml. More than 80% of its label claim was released within 30 min. In case of Fenoterol hydrobromide Tablets, distilled water was also found to be suitable to ensure sink condition. The rotation speed of 50 rpm and 900 ml of dissolution medium were used to evaluate the dissolution profile. The dissolution rate of fenoterol hydrobromide was over 90% in 15 min. The HPLC analysis methods were validated in terms of accuracy, precision, specificity, linearity, quantitation limit and range. The results suggested that the analytical methods used are simple and suitable to measure the dissolution rate of piracetam and fenoterol hydrobromide. Therefore, the analysis methods could be utilized in setting dissolution specifications of Piracetam Tablets and Fenoterol hydrobromide Tablets in the revised version of KPC.

• YAKHAK HOEJI
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• v.47 no.6
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• pp.352-355
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• 2003

Voglibose is a new antidiabetic agent currently being devoloped by the research and development division of Takeda chemical industries Ltd. in japan. Basic research for the determination of voglibose in pharmaceutical preparation by gas chromatography. This method utilizes voglibose to give its acyl compound with acetyl anhydride in pyridine solution. The calibration curve for voglibose was linear over the concentration range of 0.08∼0.32 $\mu\textrm{g}$/${mu}ell$ with correlation coefficient of 0.996. The detection limit for voglibose was 0.016 $\mu\textrm{g}$/${mu}ell$ and the result of recovery test was 101.6% with relative standard deviation of 2.0% by standard addition method.

• YAKHAK HOEJI
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• v.54 no.5
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• pp.348-353
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• 2010

The dissolution test method and an analytical procedure by HPLC were developed and validated for viquidil hydrochloride capsules and alibendol tablets. These drugs were not yet characterized by the dissolution specifications in Korean Pharmaceutical Codex. So, with each reference and test drugs, we did the preliminary and standard experiments based on the Korean Pharmacopeia Guideline of dissolution testing for solid oral dosage forms. The dissolution test for viquidil hydrochloride capsules was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 50 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 30 min in this method. Also the dissolution test for alibendol tablets was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 100 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 45 min in this method. The dissolution samples were analyzed with a precise and accurate HPLC method. The developed dissolution test showed specificity, linearity, precision and accuracy within the acceptable range. The dissolution testing method described above was adequate for the purpose and may be proposed as a pharmacopeial standard to assess the performance of viquidil hydrochloride capsules and alibendol tablets.

• Food Science of Animal Resources
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• v.33 no.2
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• pp.239-243
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• 2013

Salmonella Enteritidis is responsible for causing foodborne diseases upon consumption of egg products. While cases of S. Enteritidis isolation from eggs have been reported in other countries, no such cases have previously been reported in Korea. In this study, we report the first isolation and identification of S. Enteritidis from domestically distributed eggs in Korea. Eggs were collected from eight countrywide grocery stores during different seasons between 2011 and 2012. Egg contents and washing solution of egg shells were incubated in buffered peptone water, and the enriched broth was further enriched in tetrathionate broth and Rappaport-Vassiliadis. The secondary enriched broth was streaked on xylose lysine desoxycholate agar. The suspected colonies were confirmed to S. Enteritidis by a biochemical test, serotyping, and PCR test. Genetic relatedness among the isolates was analyzed using Diversilab Salmonella kit. Three strains of S. Enteritidis were isolated from egg contents and egg shells collected from grocery stores of the Eumseong-city in the fall of 2011. All three stains showed resistance to chloramphenicol, streptomycin, nalidixic acid, and ampicillin by the disk diffusion method. In addition, the isolates showed more than 99% DNA homology, indicating that they were presumably identical strains. Therefore, there is a requirement to monitor and control against S. Enteritidis from eggs in Korea.

• Proceedings of the PSK Conference
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• 2003.10b
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• pp.218.2-218.2
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• 2003

An efficient method is described for the enantioseparation of urinary amino acids to determine their absolute configurations. It involves two-phase extractive ethoxycarbonylation in alkaline aqueous solution with subsequent extraction after acidification. The resulting derivatives of amino acids are converted to volatile diastereomeric esters or amides for the direct analysis by gas chromatography (GC) on achiral dual-columns with different polarities. The present method was applied to urine specimens from patients with inherited metabolic disorders. In this study, the usefulness for the chiral separation of diagnostic amino acids will be discussed.

• YAKHAK HOEJI
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• v.54 no.5
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• pp.362-369
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• 2010

Despite the fact that the dissolution test can serve as an effective tool for drug quality control and prediction of in vivo drug performance, there are a number of drugs with no established dissolution specifications because they were developed quite a long time ago. Under this circumstances, KFDA started the new project that establishes dissolution method and specifications for drugs with no dissolution specifications listed in the Korea Pharmaceutical Codex (KPC). This project aims for promoting the appropriate management of oral solid dosage forms. Seoul regional KFDA selected 2 items, Nicametate citrate tablet and Norfloxacin capsule, for establishing dissolution specifications. We went through the following procedures to develop the dissolution method and specifications: (1) Validation of dissolution test equipment, (2) Purchase of test drugs, (3) Preliminary test with one of the test products (1 lot), (4) Validation of analysis methods (3 lots), (5) Final tests and cross tests among other laboratory to establish dissolution specifications, (6) Additional test with the other test drugs. The outcome of this study will be reflected in revision of the KPC. It is believed that the quality control and evaluation of oral solid dosage forms listed in KPC will be advanced with the revision which adds additional dissolution test and specifications for the drugs with no established dissolution specifications.

• Journal of Pharmaceutical Investigation
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• v.41 no.4
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• pp.233-238
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• 2011

DEET, N,N'-diethyl-m-toluamide, is the most commonly used mosquito repellent. However, it can easily permeate through skin leading to toxic effects. A recent study showed that the ortho analogue of DEET showed enhanced repellency with reduced permeation compared to the commercially used meta analogue. Thus, in order to understand the differences in properties and effectiveness among the m-, o- and p-analogues of DEET, an HPLC-UV method was developed for separately analyzing the three analogues. Moreover, stability profiles at temperatures ranging from $30^{\circ}C$ to $70^{\circ}C$ as well as pH ranging from pH 3 to pH 9 have been determined. All three analogues were stable with no degradation observed during the 5 day period. o-DEET therefore could be further developed into a safer and more effective mosquito repellent.

• Journal of Korean Society for Quality Management
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• v.50 no.3
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• pp.373-386
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• 2022

Purpose: This study proposes the application of Six Sigma management innovation method for more systematically enhanced execution of Quality by Design (QbD) activities. QbD requires a deeper understanding of the product and process at the design and development stage of the drug, and it is very important to ensure that no fault is fundamentally generated through thorough process control. Methods: Analyzing the background and specific procedures of quality improvement based on the drug design basis, and analyzing the key contents of each step, we have differentated and common points from the 6 Sigma methodology. We propose a new model of Six Sigma management innovation method suitable for pharmaceutical industry. Results: Regulatory agencies are demanding results from statistical analysis as a scientific basis in developing medicines to treat human life through quality improvement activities based on drug design. By utilizing the education system to improve the statistical analysis capacity in the Six Sigma activities and operating the 6 Sigma Belt system in conjunction, it helped systematically strengthen the execution power of quality improvement activities based on pharmaceutical design based on the members of the pharmaceutical industry. Conclusion: By using QbD Six Sigma, which combines quality enhancement based on pharmaceutical design basis and Six Sigma methodology suitable for pharmaceutical industry, it is possible to obtain satisfactory results both by pharmaceutical companies and regulators by using appropriate statistical analysis methods for preparing scientific evidence data required by regulatory.

• YAKHAK HOEJI
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• v.56 no.5
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• pp.288-292
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• 2012

The aim of the paper is to ameliorate old research methods of Korean Pharmaceutical Codex to adjust the newest scientistic level which is necessary to maintain quality of medical supplies effectively. After reviewing result of Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph, there are two items chosen for the methods - Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph which KFDA researched in 2010, arranged new measuring standard by having an experiment to set measuring method after obtaining each item. According to the result, The experiment includes a measuring method of two items; Nafronyl Oxalate Capsules, and Ticlopidine Hydrochloride Tablets. The research is ameliorated by research methods through several experiments such as High Performance Liquid Chromatography validation, preparing items, implement of trial-experiment and authentic experiment, and experiment on measuring method of regulations of Korea Pharmaceutical Codex. The experiments are taken opinions of experts in KFDA into consideration and wrote out a report of the new measuring method on each last item. The report is combined as each two experiment sections of analyzing method to maintain the quality on the basis of the research in 2010 on setting of dissolution specifications for oral solid dosage forms. The result of measuring method of medical supplies through modernizing trial method of oral solid dosage forms is available to be accurate. In conclusion, this study could contribute to promotion of public health by organizing a basis for safe and high quality of medical supplies in domestic market.

• YAKHAK HOEJI
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• v.34 no.3
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• pp.161-165
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• 1990

An automated, simple, and reliable method was developed for determining in vitro drug release rate from transdermal delivery dosage forms. The patch is held in position in the heating block by sandwiching it between the middle plate and the bottom plate of diffusion cell. The dissolution profile of the commercially available transdermal scopolamine patch was determined over a 72-h period, and the results were compared with those obtained with other methods; paddle-over-disk method, reciprocating method, and diffusion cell method. It was demonstrated that the flow-through method is equivalent in terms of release rate profile and accumulated released drug amount over the lifetime of the dosage form tested. Also this method is simple, reliable and reproducible. Therefore, this technique can be used in a quality control for assuring product uniformity.