• Title/Summary/Keyword: Changes to drug products

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Analysis of Best-selling Over-the-counter (OTC) Drug Trends in Korea by Decades Since 1950s and Evaluation of Their Overall Significance (근·현대사 이후 한국인의 최다 선호 일반의약품의 추이에 대한 연대별 분석 및 종합적 의의에 대한 평가)

  • Lee, Yun Jeong;Kang, Tae Jin;Lim, Sung Cil
    • YAKHAK HOEJI
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    • v.60 no.3
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    • pp.146-153
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    • 2016
  • Over-the-counter (OTC) drugs refer to medicines that are generally safe when used according to the product label. We aimed to assess and reflect upon changes in perception of health and health-related demands by decades in Korea according to the consumption and sales trends of OTC drugs. This study was conducted by literature search on the production and sale rankings of OTC drug market in Korea. Changes in the OTC drug market were analyzed and organized by decades to evaluate changes in drug demands and the influence of national and societal factors. There was a specific trend in the most popular drugs by decades. In the 1950s, drugs of top necessity were antibiotics and helminthics. In the 1960s, the pharmaceutical industry quickly grew and invigorators, such as Bacchus$^{(R)}$, Alps$^{(R)}$, Aronamin$^{(R)}$, were top manufactured drugs. Popularity of these invigorating drinks and vitamin products continued until the 1990s. In 1990s, sales of topical nonsteroidal anti-inflammatory drugs (Ketotop Plaster$^{(R)}$, Trast Patch$^{(R)}$), and in 2000s, gum disease medicine (Insadol$^{(R)}$) and liver and intestine supplement (Ursa$^{(R)}$) were prominent. However, after the separation of prescribing and dispensing in 2000, the sales of OTC drugs decreased dramatically from 58.7% of the total market share in 1990s to 39.6% in 2000 and this trend has continued. In 2012, thirteen OTC drugs were allowed to be sold in convenience stores, and as the sales of health functional foods have been expanding beyond pharmacies, sales of invigorators and nutritional supplements in pharmacies have continued to decrease. As government's drug expenditure will continue to grow, reclassification of OTC drugs based on established safety information and deliberate team efforts on continued development of OTC drugs to meet the health demands of Koreans are required by the healthcare professionals, pharmaceutical industries, and the government.

Investigation of the Lactic Acid Bacteria Content of Probiotic and Lactic Acid Bacteria Products: a Study on Changes in the Preservation Method of Probiotic Products (프로바이오틱스와 유산균 제품의 균수 함량과 보존방법에 따른 변화 연구)

  • Kim, Young-Su;Hwang, Sun-Il;Kim, Sang-Tae;Han, Na-Eun;Kim, Hye-Young;Kim, Hyun-Soo;Park, Kwang-Hee;Yoon, Mi-Hye
    • Journal of Food Hygiene and Safety
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    • v.33 no.6
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    • pp.474-482
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    • 2018
  • The aim of this study was to determine and analyze probiotic contents, pH, and acidity of 120 samples of health functional and processed foods containing lactic acid bacteria distributed in 2017. The changes due to the preservation methods were also determined and analyzed in five probiotic products. Two samples of the 85 health functional food products had lactic acid bacteria at lower levels than the marked amount required to meet Korean food standards, whereas the 35 processed products were all suitable for distribution. The averages for probiotic contents, pH, and acidity were $1.2{\times}10^{10}CFU/g$, 5.35, and 1.29%, respectively. The average count of lactic acid bacteria in the 17 samples with marked amount among the 35 processed foods was $5.8{\times}10^8CFU/g$. The effects of preservation temperature ($-20^{\circ}C$, $4^{\circ}C$, $20^{\circ}C$, and $40^{\circ}C$) and storage period (1, 3, and 6 months) on probiotic content, pH, and acidity were determined for 5 probiotic products. After 1 to 6 months, the average reduction in probiotic content was by 59%; the lowest reduction occurred at $4^{\circ}C$ and the highest reduction occurred at $40^{\circ}C$. In addition, 3 of the 5 products showed a rapid decrease in probiotic content by more than 70% at $40^{\circ}C$ after a storage period of 1 to 3 months. Therefore, from this study results, it is recommended that products containing lactic acid bacteria should be refrigerated and consumed shortly after purchase.

The Impact of Moving Pharmaceutical Products from Prescription Only to Over-the-Counter Status on Consumer Exposure to Advertising

  • Yang, Hae-Kyung
    • International Journal of Human Ecology
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    • v.12 no.2
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    • pp.1-12
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    • 2011
  • Many pharmaceutical products are available through prescription (Rx) only status. As a result, access to physicians and insurance coverage play a key role in the use of these products, and therefore may affect the population to whom advertising is targeted at. The movement of pharmaceutical products from prescription (Rx) to Over-the-Counter (OTC), or Rx-to-OTC switch changes the cost of acquiring the drug and therefore may change the incentives manufacturers have at targeting particular population segments. This study examines whether Rx-to-OTC switch changes the frequency and the distribution of who is exposed to pharmaceutical advertising. Using an archive of pharmaceutical advertisements and National Consumer Survey, this study examines how individuals with particular demographic characteristics are exposed to pharmaceutical advertisements before and after drugs are moved from Rx to OTC. The results provide evidence that individual's advertising exposure increases after Rx-to-OTC switch. Moreover, the increase in advertising exposure is greater for the low socioeconomic status (SES) consumers which implies they may get more information about the disease, treatment and product after the Rx-to-OTC switch through advertising. If low SES consumers have more exposure to the advertising after products switched to OTC, then FDA policies regulating this switch should recognize the potential role of advertising providing access to health-related information.

AMPK Activators from Natural Products: A Patent Review

  • Uddin, Mohammad Nasir;Sharma, Govinda;Choi, Hong Seok;Lim, Seong-Il;Oh, Won Keun
    • Natural Product Sciences
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    • v.19 no.1
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    • pp.1-7
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    • 2013
  • AMP-activated protein kinase (AMPK) is a major cellular energy sensor and master regulator of metabolic homeostasis. On activation, this cellular fuel sensing enzyme induces a series of metabolic changes to balance energy consumption via multiple downstream signaling pathways controlling nutrient uptake and energy metabolism. This pivotal role of AMPK has led to the development of numerous AMPK activators which might be used as novel drug candidates in the treatment of AMPK related disorders, diabetes, obesity, and other metabolic diseases. Consequently, a number of patents have been published on AMPK activators from natural products and other sources. This review covers the patented AMPK activators from natural products and their therapeutic potential in treatment or prevention of metabolic diseases including diabetes and obesity.

Evaluation of the Microbiological Status of Raw Beef in Korea: Considering the Suitability of Aerobic Plate Count Guidelines

  • Kim, Hye-Jin;Kim, Dongwook;Kim, Hee-Jin;Song, Sung-Ok;Song, Young-Han;Jang, Aera
    • Food Science of Animal Resources
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    • v.38 no.1
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    • pp.43-51
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    • 2018
  • This study was conducted to analyze the microbiological contamination status of raw beef distributed in Korea, and evaluate the suitability of current aerobic plate count (APC) guidelines. We analyzed five years (2010-2014) of microbiological monitoring data obtained from the Ministry of Food and Drug Safety and investigated the microbiological status of raw beef collected from meat packing centers and meat shops in the Seoul/Gyeonggi, Gangwon, and Chungcheong regions in August 2015. From 2010-2014, most raw beef (>94%) displayed APC levels of < $1.0{\times}10^6CFU/g$. However, raw beef samples collected from all three regions in August 2015 had comparatively higher APC levels than those reported in previous years. To evaluate the relationship between the APC level and quality, changes in beef loin were evaluated during cold storage for 15 days at $4^{\circ}C$. On day 11, the mean APC level ($4.7{\times}10^6CFU/g$) conformed to current guidelines in Korea ($1.0{\times}10^7CFU/g$) and the pH value was 5.82. However, the sensory evaluation score for color and overall acceptability was under 3.0, meaning that the beef loin was not acceptable for eating. These results suggest that current APC guideline for raw beef should be lowered to $1.0{\times}10^6CFU/g$ to improve both the microbiological safety and palatability of raw beef.

The History of Korean GMP (우리나라 GMP 변천사)

  • Paik, Woo-Hyun
    • YAKHAK HOEJI
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    • v.59 no.1
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    • pp.40-46
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    • 2015
  • The term "GMP" firstly came on the 1962 amendment of the Federal Food, Drug and Cosmetic (FD&C) Act and the US FDA established and officially announced the Good Manufacturing Practice Regulation for the first time in the world in 1963. In 1969, the World Health Organization published the GMP regulation and recommended that member states adopt the GMP regulation and implement the "GMP Certification Scheme" for international commerce of finished pharmaceutical products. As a result, GMP requirements have become important ones that have to be complied with in the manufacture of pharmaceutical products. The Korean GMP regulation was announced as the official notification by the Ministry of Health and Social Affairs in 1977. The KGMP regulation was voluntarily adopted by pharmaceutical companies at the early stage, but it had become mandatory. In addition, various kinds of GMP regulations have been established to cover active pharmaceutical ingredients, biological products and others, in addition to finished pharmaceutical products. Taking account of technological development and changes in the pharmaceutical environments, the KGMP regulation was fully amended and harmonized with GMP requirements of developed countries. In this way, the KGMP has developed to keep up with international trends and standards, leading to accession to the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

A Comparative Study of Radiation and Gas Sterilization. (방사선항균법과 개스항균법의 비교연구)

  • 정해원;유영수
    • Journal of Environmental Health Sciences
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    • v.8 no.1
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    • pp.81-97
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    • 1982
  • Ethylene oxide gas has been used as a cold sterilant for heat-sensitive medical equipments and as a fumigant for food for more than 30 years, and it is used more widely than radiation although radiation sterilization has made significant inroads in recent years. But according to recent studies of toxicities such as mutagenicity, haemolytic effect and possible carcinogenicity of Ethylene oxide (ETO) and its two main reaction products, Ethylene chlorohydrin (ETCH) and Ethylene glycol (ETG), Environmental Protection Agency in U.S.A. has suggested some regulations on residual gas in drug products and medical devices for human use. The mutagenic activity of ETO compared with that of X-ray has an equivalency of 1 ppm/hr for ETO as compared to 20 mrad for X-ray, and one could suggest the present maximum allowable concentration for ETO (50 ppm) should be 400 times lower than the radiation standard (2.5 mrad/hr). Although radiation sterilization has advantages of simplicity of operation and complete reliability, changes of physico-chemical properties with possible formation of toxic substances may occur. It is therefore necessary to make some regulations of our own for residual toxicities orginated from each sterilization method.

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Antidepressant-like Effects of Schisandra chinensis Baillon Water Extract on Animal Model Induced by Chronic Mild Stress (만성스트레스로 유발된 우울증 동물모델에서 오미자 물 추출물의 항우울 효과)

  • Kang, Min Gu;Kim, Young Hwa;Im, A Rang;Nam, Byung Soo;Chae, Sung Wook;Lee, Mi Young
    • Korean Journal of Medicinal Crop Science
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    • v.22 no.3
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    • pp.196-202
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    • 2014
  • Depression is one of the most common neuropsychiatric disorders and has been associated with the neuroendocrine system and alterations in behavior. Schisandra chinensis Baillon is one of major medicinal plants used as a Korea medicine and food sources, and has been processed in the fields of various food products and medicinal herbs. The chronic mild stress (CMS) protocol is widely used to evoke depressive-like behaviors in laboratory mice or rat. The CMS procedure induced some behavioral changes that are compatible with the common expectations, i.e. 'anhedonic' behavior and can affect corticosterone level. The present study, Schisandra chinensis extract administration by daily gavage from the 3 weeks exhibited an antidepressant-like effect on CMS-induced depression in mice. Schisandra chinensis extract administration at dose of 200mg/kg significantly increased the sucrose consumption, and decreased the immobility durations in forced swim test and tail suspension test. Furthermore the corticosterone level decreased than control group. In conclusion, Schisandra chinensis extract showed antidepressant-like effects on sucrose preference test, forced swimming test and tail suspension test based on CMS model.

An Extract from Hydrolyzed Normal Human Urine which Induces Drug Binding Defects (정상인뇨의 가수분해에 의한 의약품결합 저해유도인자의 추출)

  • 장판섭
    • YAKHAK HOEJI
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    • v.26 no.4
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    • pp.223-229
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    • 1982
  • Uremia is associated with defective protein binding of weakly acidic drugs, whereas the protein binding of basic drugs tends to be normal. The exact chemical nature of compound(s) and mechanism for these changes as yet is unknown, and has not been defined. Organic solvent extraction of pooled normal human urine following hydrolysis by hydrochloric acid produced an extract, which when added to normal human serum, was capable of inducing binding defects similar to those in uremia. Binding defects were observed with the weakly acidic drugs such as nafcillin, salicylate, sulfamethoxazole and phenytoin while the binding of the basic drugs such as trimethoprim and quinidine were unaffected. The binding defects induced by the hydrolyzed urine extract could readily be corrected by same organic solvent extraction of acidified serum and the defects could be transferred to the normal human serum using the organic solvent layer at the physiologic pH (7.4). Followed by reacidification ind extraction of the binding defects induced serum with the same solvent, separated several fractions were obtained on thin-layer chromatography. One of these fractions could reinduce the binding defects and this factor(s) is apparently weakly acidic compounds and tightly bound to serum at physiologic pH, but extractable at acidic pH, and its molecular weight range is approximately 500 or less similar to those seen in uremia. These findings strongly support the hypothesis that the drug binding defect in uremia is due to the accumulation of endogenous metabolic products which arc normally excreted by the kidneys but accumulate in renal failure.

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SAL 10-6 and Cytotoxicity of Sanitary Aid Products Utilizing Gamma Sterilization Technology (감마선 멸균기술을 이용한 의약외품의 무균보증수준(SAL 10-6) 확보 및 세포독성 평가)

  • Kim, Kwang Hoon;Eom, Yong Woon;Lee, Hoo Chul;Park, Sung Hyun;Kim, Soo Jin;Kim, Kwan Soo;Park, Soon Youn;Jeong, Ill Yun
    • Journal of Radiation Industry
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    • v.8 no.2
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    • pp.133-140
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    • 2014
  • The sterilization of health care products is widely used to choose conventional Ethylene Oxide gas sterilization in South Korea. But the method has brought serious issues because of the toxic residual gas and global warming of $CO_2$ evacuation after the sterilization process. This study is carried out to confirm the application possibility of gamma sterilization instead of Ethylene Oxide in sanitary aid products. Four kinds of products (gauze, menstrual pad, bandage, menstrual tampon) were treated with gamma irradiation of 15 kGy, then analyzed the achievement of the sterility assurance level (SAL) $10^{-6}$ through BI test. The cytotoxicity of accelerated samples of 6 months elapse evaluated by means of colony forming rate at various concentration of the extracts. pH and UV measurements at extract concentrations were tested according to the MFDS (Ministry of food & drug safety) guideline to verify a stability & safety of product sterilized. The results revealed that the extracts did not show any significant changes in cytoxicity assay as well as pH and UV values by gamma sterilization. All extract concentration was observed high cell viability, pH and UV values were calculated within the acceptable range prescribed by the guideline. It indicates that gamma sterilization could effectively substitute for conventional sterilization such as Ethylene Oxide sterilization in the sanitary aid products.