• Journal of Pharmaceutical Investigation
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• 제34권1호
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• pp.73-79
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• 2004

The union of information-technology and biology presents great possibilities to both applications of bio-information and development of science and technology. Also, meaningful analysis of bio-information brings about a new innovation in the field of bio-market with the advent and growth of bioinformatics. Hence, bioinformatics is the most import aspect for establishing a science-technology-oriented society in the $21^{st}$ century. This article provides trends in current state of bioinformatics. Technological development of bioinformatics for the rapid growth of bio-industry means that using bioinformatics, a biologist can process and store enormous amount of data such as current Human Genome Project and future data in the field of biology. We have manly looked at the tends of bio-information, databases and mining tools that are generally used, and strategies and directions for the future.

• Journal of Pharmaceutical Investigation
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• 제37권2호
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• pp.119-126
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• 2007

Tablet splitting is used in pharmacy practice to adjust the dose to be administered. However, it also causes several problems such as undesirable effect for sustained release or enteric-coated dosage form, inaccuracy of dose, and pharmacist's safety by splitting hazardous drugs. This study investigated the current status of oral dosage form splitting for patients older than 19 years by analyzing Korea National Health Insurance Claims Database. Out of oral solid drugs prescribed (N=1,486,584) 9.8% of them included tablets (or capsules) split. There were some splitting cases even in sustained release (4.9%), enteric-coated forms (1.3%) and hazardous drugs (2.7%) that were selected by NIOSH (The National Institute for Occupational Safety and Health). The most frequently split drugs were antihistamines, neuropsychotics and steroids. In case of digoxin and warfarin, unit doses in a domestic market were not diverse compared to foreign markets. Guidelines for splitting oral solid dosage forms, approval of diverse doses and conducting dose-response studies for the commonly splitting ingredients on Korean people are needed for the saff and effective use of oral solid drugs.

• Journal of Pharmaceutical Investigation
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• 제36권6호
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• pp.421-435
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• 2006

The objective of this report is to introduce the European Union's variation rules governing medicinal products that are subject to post-approval changes. The EMEA outlines a variety of changes occurring to approved medicinal products. It also recommends a marketing authorisation holder to follow specific post-approval applications in various situations. For instance, the Commission Regulation(EC) No. 1085/2003 explains variation types and suggests post-authorisation procedures with which an applicant should comply. In all cases of minor and major variations the applicant has to investigate and validate whether or not the intended changes would have impact on the safety, efficacy and quality of a drug product. The applicant should then submit to the EMEA a variation application with adequate documentation in support of the notified changes. This procedure is implemented to ensure that changes to the approved medicinal product do not cause my public health concerns. In fact, the post-authorisation guidance categorizes post-approval changes into type IA/IB variations, type II variations, and extension applications. Such classifications determine administrative procedures to be followed in an efficient manner. Based on the type of a variation, the regulatory agency opts to reduce or extend the evaluation time-frame. The thrust of the EU's post-authorisation guidance is introduced in text with appropriate explanation. All these information will be likely to be helpful in updating a Korean regulatory guidance that could better deal with post-approval changes to generic drugs available in the market.

• Bulletin of the Korean Chemical Society
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• 제35권7호
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• pp.1939-1943
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• 2014

Solid dispersion (SD) system of everolimus (EVR) with Gelucire 50/13 (Stearoyl polyoxyl-32 glycerides) was prepared using melt granulation technique with the aim of improving the physicochemical properties and dissolution rate. The solid state characterization using scanning electron microscopy and X-ray powder diffraction, indicated that the drug was homogeneously distributed in the surfactant carrier in a stable amorphous form. The dissolution rate of EVR from the optimized SD composed of the drug, Gelucire 50/13 and microcrystalline cellulose in a weight ratio of 1:5:10, was markedly rapid and higher than that from the drug powder and the market product (Afinitor$^{(R)}$, Novartis Pharmaceuticals) in all dissolution mediums tested from pH 3.0 to pH 6.8. The results of this study suggest that formulation of SD with Gelucire 50/13 using melt granulation procedure may be a simple and promising approach for improving the dissolution rate and oral absorption of the anti-cancer agent without the need for using an organic solvent.

• 한국자원식물학회지
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• 제6권1호
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• pp.33-44
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• 1993

The medicinal plants used traditional medicines are classified into two groups. The first group is formulary medicine which have been recorded on authorized books, for example, kampo drug in Japan. The second group is the fork medicines. These medicinal plants production is 165 billion yen(about 1.5 billion dollar) and which rate to to total pharmaceutical production is about 3% in 1990. The number of important medicinal plants treated in the market is 124 herbs from the total 364 herbs for kampo durgs(210 preparations kampo durgs) and other propritetary drugs (agents for common cold, laxatives, gastrointestional and so on). The production of the Ginseng and Bupleurum Root are increased about ten times in last twelve years(1976 or 1988). The 80% of these medicinal plants are imported from China, Korea and Southern Asian countries. Then the Pharmaceutical Affairs Bureau of Ministry of Health and Welfare published "The Guideline of Medicinal Plant for Cultivation" for a quality control and a stabilization supply of 80 herbs. The first part(1992) of the guideline reported 5 herbs; Coptis Rhizome, Rehmannia Root, Bupleur, Root, Japanese Angelica Root and Rhubarb, The next part will be published following 5herbs; Cnidium Rhizome, Safflower, Coix seed and Fruiet, Platicodon Root and Zedoary.

• Journal of Microbiology and Biotechnology
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• 제23권6호
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• pp.802-810
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• 2013

This work aims at investigating the production of yellow, orange, and red natural colorants in a submerged culture of Penicillium purpurogenum DPUA 1275. For this purpose, different experimental conditions evaluating the effect of incubation time, type and size of inoculum, and different carbon and nitrogen sources were performed. Furthermore, the growth kinetics were obtained in the conditions of $10^8$ spores/ml and 5 mycelia agar discs during 360 h. These experiments showed that 5 mycelia agar discs and 336 h promoted the highest yellow (3.08 $UA_{400nm}$), orange (1.44 $UA_{470nm}$), and red (2.27 $UA_{490nm}$) colorants production. Moreover, sucrose and yeast extract were the most suitable carbon and nitrogen sources for natural colorants production. Thus, the present study shows a new source of natural colorants, which can be used as an alternative to others available in the market after toxicological studies.

• Journal of Pharmaceutical Investigation
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• 제20권3호
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• pp.115-119
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• 1990

The reaction rates, duration times and neutralizing capacities of the antacids which are frequently used in Korean market and three different commercial combination products were evaluated in vitro by Fuchs method and Johnson-duncan method, respectively. In vivo tests of combination products were determined in the fasted state of rat by Aspiration method. Comparing the result of in vitro test with that of in vivo test, the maximal pH was lowered by 2-3 value and the durational time increased by two folds in vivo test. Each antacid composition and combination products from three phamaceutical companies (A, B, and C) were studied, respectively. The duration times measured by Fuchs method were double compared to those by Johnson-Duncan method. A and C preparation maintained the pH range from 3 to 7 for 60 min by Fuchs method. In vovo test, maximum pH of A, B and C preparation was 6.50, 3.65, 2.65 and duration time of those was 200, 500, 0 min, respectively.

• Journal of Pharmaceutical Investigation
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• 제30권2호
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• pp.119-125
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• 2000

In an attempt to develop a non-aqueous liquid formulation of practically insoluble biphenyl dimethyl dicarboxylate (DDB), dissolution and permeation studies were performed. Various non-aqueous DDB solutions were formulated and filled into empty hard capsules. Dissolution rates of a new formulation were compared with those of commercially available DDB preparations using one and eight dose units. Dissolution rates after 2 hr of DDB tablets (DDB 25 mg), hard capsules (DDB 7.5 mg) and soft capsules (DDB 7.5 mg) on market and new formulation (DDB 7.5 mg) were 6.3, 15.0, 84.5 and 98.0%, respectively. Higher doses (8 units) resulted in a supersaturation within one hr of dissolution, and dissolved amounts were reduced markedly. Due to the saturation and precipitation, a directly proportional dose-dissolution relationship was not observed. The addition of copolyvidone and/or glycyrrhizic acid ammonium salt to DDB solution in polyethylene glycol 300 and 400 inhibited the formation of precipitates during dissolution and markedly enhanced the rabbit duodenal permeation of DDB. From the site-specific gastrointestinal permeation studies, it was found that permeation rates of DDB after mixing of non-aqueous DDB solutions with aqueous buffered solutions were faster in the order of $rectal\;<\;colonic\;{\risingdotseq}\;ileal\;{\risingdotseq}\;duodenal\;<\;jejunal\;<\;gastric$.

• Journal of Pharmaceutical Investigation
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• 제20권4호
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• pp.209-215
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• 1990

The activities of s-amylase, ${\alpha}-amylase$ and protease of three combination products containing digestive enzymes, antacids and herbal drugs on the Korean market were estimated. The effects of antacids and herbal drugs on the activities of digestive enzymes were investigated. Starch-saccarifying activity of s-amylase, starch-dextrinizing activity of ${\alpha}-amylase$ and protein-peptic activity of protease were estimated by Somogy, Mc'Credy, and Casein-Folin method, respectivley. The optimal pH of s-amylase, ${\alpha}-amylase$ and protease were pH 5.0, 4.8 and 7.0, rcspectively. The digestive activities at optimal pH continued about eight hours. The digestive activities of individual enzymes were reduced to 40-90% by antacids and were affected somewhat positively or negatively by herbal drugs. Enzyme activities of the combination products were also affected by pH and reaction time.

• 유통과학연구
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• 제17권7호
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• pp.99-109
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• 2019

Purpose - The purpose of this development the business model of the healthcare sector in order to promote patents satisfaction towards medical sector services improvement for the medical business model innovation to possess a competitive advantage in the medical and pharmaceutical industry. Research design, data, and methodology - Safety standard protocol from existing multidisciplinary literature is a process of theorization, which uses grounded theory methodology rather than a description of the data and the targeted phenomenon by using Jabareen (2009). The first task is to map the spectrum of food safety literature regarding the phenomenon in safety management. This process includes developing the implementation factors and other sources such as existing business models and practices into the protocol design. Results - The study suggests the conceptual framework to improve the safety management for patients' environmental sustainability performance. Conclusion - The business model may support the beneficial aspect to healthcare government's policymakers, hospital employees, and medical specialist who can apply the practical perspective of its value regarding an educational protocol. Originality/value - This study contributes to and extends our understanding of environmental sustainability performance, identifying the rationale for safety standards performance in the healthcare industry with suggested hybrid safety standards market consumer interconnector.