• Title/Summary/Keyword: Pharmaceuticals

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Retention Analysis of Binary Mixture Injected into a Four-Zone Simulated Moving Bed at Steady-State (정상상태의 4 구역 SMB 공정에 유입된 이성분계 물질의 체류 분석)

  • Yang, Jinhyo;Kim, Jin-Il;Koo, Yoon-Mo
    • Korean Chemical Engineering Research
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    • v.46 no.4
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    • pp.732-738
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    • 2008
  • Simulated moving bed (SMB) process is a continuous chromatographic technology used to separate a large amount of petrochemicals, fine chemicals, pharmaceuticals, and so on, drawing a great attraction of related industries. With the recent development of biotechnology, the SMB process has been adopted for the separation of various useful bio-products. Attempts to understand the separation mechanism of the SMB process in many aspects are reported in many publications. These researches have dealt with the improvement of SMB for easier operation and solving problem in process. The feed mixture fed into the SMB process may be of different concentration batch by batch rather than in uniform concentration. Retention behaviors of feed (psicose (A) and fructose (B) mixture) existing in the SMB unit in dynamic steady-state and feed (psicose (C) and fructose (D) mixture) newly injected into the SMB were analyzed. It was observed that the existing components, (A) and (B), were eluted relatively faster as the injection time of new feed was earlier during the port-switching period. In addition, the components (C) and (D) were eluted earlier as fresh feed was injected earlier in a port-switching time.

Development of Dissolution Testing Method for Piracetam Tablets and Fenoterol Hydrobromide Tablets in Korean Pharmaceutical Codex (고시 수재 의약품 중 피라세탐 정 및 브롬화수소산페노테롤 정의 용출시험법 개발)

  • Kim, Eun-Jung;Lee, Jin-Ha;Park, Chan-Ho;Sohn, Kyung-Hee;Kim, In-Kyu;Kim, Dong-Sup;Sah, Hong-Kee;Choi, Hoo-Kyun
    • 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.

Preparation of Liquid Crystalline with Gemini Surfactant (제미니형 계면활성제를 사용한 액정기술의 제조방법)

  • Zhoh Choon-Koo;Kim In-Young;Han Chang-Giu
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.30 no.3 s.47
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    • pp.369-375
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    • 2004
  • In this study, liquid crystalline (LC) is formed using Gemini surfactant (GS) type and moisturizing effect in vivo is measured. $3.0\;wt\%$ of sodium dicocoyl ethylene diamine (PEG)-15 sulfate (SCD-PEG-15S) is used as GS and $4.0\;wt\%$ of hydrogenated dimer acid esters (HDAE) as booster. For stabilizers, $2.0\;wt\%$ of behenyl alcohol (BA) and $1.0\;wt\%$ of Iyso-lecithin (LyL) are utilized. It is stabilized in pH from 4.0 to 10.5 and the best condition is in pH 6.5. The value of viscosity is $8,000\pm500$ cP. The most excellent particles are formed within the range of 4.0 to 15.5 um. Formed LC is observed around LC particles using polarization microscope. It is also observed that lamellar gel network structure is formed around LC particles. Moisturizing effect is improved by $13.6\%$ (P<0.05) compared to control when measured 30 min later after coating samples. After 1 h, moisturizing effect is improved by 1$12.6\%$ (P<0.05) than control while showing $28.3\%$ (P<0.05) of improvement after 4 h. These results may be caused from that manufactured LC forms lamellar structure so that it has better water-holding ability and absorbance of oil increases. This formula could be utilized by delivery system (DS) on skin so that this technology can be applied for manufactuing pharmaceuticals and cosmetics.

A Study on the Improvement Case of Cosmetic Packaging Process Using ARENA Simulation (아레나 시뮬레이션을 활용한 화장품 포장공정의 개선사례 연구)

  • Lee, Nam-Su;Lee, Jae-Yong;Jo, Eun-Hyeon;Lee, Dong-Hyung
    • Journal of Korean Society of Industrial and Systems Engineering
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    • v.43 no.2
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    • pp.72-78
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    • 2020
  • Demand for cosmetics with functionality and eco-friendliness has increased dramatically due to recent aging, well-being trends, and increased interest in beauty. Cosmetics production in 2014 was 8,970.4 billion won, an increase of about 50% compared to 6,014.6 billion won in 2010. In the midst of this, similar companies in intense competition are pursuing differentiated strategies and innovation activities to solve quality, price and delivery problems. In particular, cosmetics packaging work is getting more difficult due to the increasing bill of materials (BOM) and difficult assembly methods. Therefore, in this study, the following problems were identified and suggestions for the improvement of the packaging Many research laboratories such as biotechnology, chemistry, and pharmaceuticals, which are undergoing various studies, are equipped with ready-made laboratory safety equipments such as bio-safety workbenches, aseptic bases, and exhaust workbenches. However, most researchers are disadvantaged in using existing safety equipment. This is because existing safety equipment can not take into account all of the unique characteristics of the research. For this reason, researchers are demanding the development of customized safety equipment that is well suited to their research needs. process of Company C, which is facing difficult situation to respond to the customer 's delivery due to the 52 - hour work week. First, we used the stopwatch to find the difficulty process in the packaging process and show ways to improve it. Second, to improve the efficiency of line balancing in the packaging process, we integrate processes, improve work methods, and perform simple automation. As a result, the prepare loss for replacement was reduced by 1 minute from 5 minutes, resulting in a 23% increase in productivity from 112 ea./hour to 137ea./ hour per person. At this time, the LOB of the packaging process was improved from 70% to 82% by operating one more production line through one person per line, total 9 people saving.

Establishment of Dissolution Specifications for Generic Drugs in Korea Pharmaceutical Codex Monograph - Nicametate Citrate Tablet, Norfloxacin Capsule (고시 수재 의약품의 용출규격 설정 - 구연산니카메테이트 정, 노르플록사신 캡슐)

  • Kim, Hee-Yun;Choi, Seon-Hee;Bang, Su-Jin;Han, Kyung-Jin;Choi, Sung-Hee;Baek, Ji-Yun;Kim, Dong-Sup;Kim, Young-Ok;Sohn, Kyung-Hee;Song, Young-Me;Sah, Hong-Kee;Choi, Hoo-Kyun
    • 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.

Formation and Crystallization of Calcium Carbonate in $C_2H_5OH-Ca(OH)_2-CO_2$ System by Ceramic Bubble Plate Reactor. (Ceramic Bubble Plate를 이용한 $C_2H_5OH-Ca(OH)_2-CO_2$계의 탄산칼슘 생성 및 결정화 연구)

  • Ahn, Ji-Whan;Park, Chan-Hoon
    • Resources Recycling
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    • v.5 no.3
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    • pp.56-64
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    • 1996
  • C,H,OH system is widely used for producing synthetic beverages and pharmaceuticals. Calcium hydroxide suspension was used to callhol the morphology of calcium carbonate, and the charactenstics of the formahan and crystsllizatian of calcium cilrbonate by adding ethylenc glycol were determined A reaclor was made with attaching a ceramic bubble plate, and lhe eleclrical conductivity was continously monitored during the rcaction with CO, gas. A part of the suspension was separated and powdered at the transition point. XRD and electron microscopic observation showed that the intermedmte and final products were vilterite, ;~r;lganite and calcite. In this study, the volumc of the ethylene glycol added to CH,OH was fixed a1 10 vol\ulcornerh. The valumc of the suspension was 500 ml, and the changes oi characteristics were shdied along with variims cnntents(l0-50 g) of calcium hydroxide. Except m the case of 10 g of calcium hydroxide at the crystallization stagc, all of products showed gelation. Tne marc the calcium hydroxide the shorter the formation time. Alsa. the farmalion of spherical valcrile ivas obsemcd when 30 g Ca(OH), was added. Tne vaterite(a compound material) can bc synthesised under alnbienl pressure and lempcmhre m a C,H,OH system by morphology control. Even though the vateritc was meta-stable phasc and could bc changed to calcitc easily, the stable and spherical vateritc was observed by using G5 glass fillers and vacuum dricrs.

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Self Assembly and Formation of Bi-continuous Cubic Liquid Crystalline Phase (바이컨티니어스 큐빅상 액정의 생성과 자기조직화)

  • Kim, In-Young;Choi, Hwa-Sook;Lee, So-Ra;Choi, Seong-Ho
    • Journal of the Korean Applied Science and Technology
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    • v.31 no.3
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    • pp.478-485
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    • 2014
  • This study is to form the self assembly of cubic crystalline phase to penetrate into the skin epidermis. The various performance synthesized diglyceryl phytylacetate (DGPA) having hydroxyl group (-OH) and 4 methyl chains with phytyl group was carried out as an amphoteric lipid such as emulsifying power, self assembly. Emulsifying activity of DGPA was very stabilized on only 1% of small content, it could make a W/O emulsion containing high internal phase incorporated with water. Cubic liquid crystal structure with DGPA on three-phase diagram was formed, when mixed DGPA, dimethicone (2CS), and water. Through three-phase diagram forming the cubic liquid crystal area, hexagonal structure zone, and mixing water phase and hexagonal structure area, reversed micelle area were respectively certified. Its structure was proved by the SAXS (small angled x-ray scattering) analysis. As an application, formation of cubosome containing 10% of magnesium ascorbylphosphate and 5% of pyridoxine tris-hexyldecanoate was encapsulated. Occlusive effect of cubosome had above 1.7 times better than reversed micelle. From using poloxamer of dispersing agent, phase structure recovered from W/O emulsion to cubic liquid crystal phase when storage in $33^{\circ}C$ incubator. Therefore, our this study is expected to be as epidermal-dermal skin absorbers in skin care cosmetics and pharmaceuticals industries as raw materials to form a cubic crystal phase through a more in-depth research to DGPA having amphoteric lipid property.

Optimal Processing Parameters of Low Molecular Weight Carrageenan by Ultrasound (초음파에 의한 carrageenan 저분자화의 최적 조건)

  • KIM Sang-Moo;PARK Seong-Min;CHOI Hyeon-Mee;LEE Keun-Tai
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.32 no.4
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    • pp.495-500
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    • 1999
  • The carrageenans are linear, sulfated Polysaccharides extracted from various species of the Rhodophyta (marine red algae). The carrageenan backbone is based on a repeating disaccharide sequence of $\beta$-D-galactopyranose residues linked glycosidically through position 1 and 3, and $\alpha$-D-galactopyranose residues linked glycosidically through position 1 and 4. Carrageenans are typical food polysaccharides in that food applications overwhelmingly dominate their end uses. Other applications, hewer, including cosmetics, pharmaceuticals, industrial suspensions and paints are also of importance But because of its high degree of gelling and viscosity with low solubility, carrageenan is limited to use beyond $0.03\%$ as food additives. Response Surface Methodology was applied for optimizing the processing parameters of ultrasound treatment in order to produce low-molecular-weight carrageenan. The use of ultrasound significantly reduced viscosity of $\lambda$-carrageenan solutions. Optimal parameters for ultrasound reduction of carrageenan molecular weight were: temperature, $10^{\circ}C$; ultrasound intensity, 121.64 $W/cm^2$ ; tarrageenan concentration, $2\%$; treatment time, 40 min. As the gel permeation chromatogram of dextran standards (M.W.= 500,000 ; 260,000 ; 167,000 ; 71,400 ; 42,000) and ultrsound treated carrageenan, the molecular weight of ultrasound treated carrageenan were approximately 200,000 (peak 1) and 60,000 (peak 2), respectively.

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An Empirical Study on the Influence of the Selection Factors of the Cold Chain Third Party Logistics Companies on Satisfaction (의약품 콜드체인 3자 물류업체의 선정요인이 만족도에 미치는 영향에 관한 실증연구)

  • Sun, Il-Suck;Ahn, Sung-Jin
    • Journal of Korea Port Economic Association
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    • v.34 no.3
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    • pp.1-16
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    • 2018
  • The demand for biopharmaceuticals is on the rise spurred by the fourth industrial revolution and an aging society in Korea. Consequently, the scale of the biopharmaceutical industry is continuously increasing globally, thereby leading to an increase in the distribution of biopharmaceuticals. However, the relative inferiority of the domestic drug distribution structure, when compared to the advanced countries, and strict logistics regulations concerning the handling of biopharmaceuticals have raised the need for systematic management. Essentially, the significance of third-party logistics companies in the cold chain for pharmaceutical cold chain has increased with an intense management environment for pharmaceuticals. The purpose of this study is to investigate the selection factors of drug cold chain's third-party logistics companies and to examine the influence of selection factors on satisfaction. A multiple regression analysis was conducted to investigate how cold chain third-party logistics factors affect the satisfaction of third-party logistics in cold chain. The results of analysis showed that expertise, facility, and linkage are factors affect customer satisfaction. The managerial capacity was derived not as an influential factor. These findings suggest that the future cold chain industry will be equipped to provide direction and strategic implications.

Bioequivalence Test of Fexofenadine Hydrochloride 120 mg Tablets (염산펙소페나딘 120밀리그람 정제의 생물학적동등성시험)

  • Cho, Hea-Young;Kang, Hyun-Ah;Kim, Se-Mi;Lee, Yong-Bok
    • YAKHAK HOEJI
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    • v.52 no.3
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    • pp.188-194
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    • 2008
  • Fexofenadine, ($\pm$)-4-1-hydroxy-4-{4-(hydroxydiphenylmethyl)-1-piperidinyl}-butyl-a,a-dimethyl benzeneacetic acid, is a selective histamine $H_1$ receptor antagonist, and is clinically effective in the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria as a first-line therapeutic agent. The purpose of the present study was to evaluate the bioequivalence of two fexofenadine hydrochloride tablets, $Allegra^{(R)}$ (Handok Pharmaceuticals Co., Ltd.) and Alecort (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of fexofenadine from the two fexofenadine hydrochloride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media. Twenty six healthy male subjects, 25.62$\pm$3.35 years in age and 70.05$\pm$11.71 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After a single tablet containing 120 mg as fexofenadine hydrochloride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of fexofenadine in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The harmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Allegra^{(R)}$, were -1.37, 5.22 and 16.50% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.83$\sim$log 1.08 and log 0.81$\sim$log 1.03 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Alecort tablet was bioequivalent to $Allegra^{(R)}$ tablet.