• 제목/요약/키워드: Product Release

검색결과 393건 처리시간 0.026초

국소치료용 구강점막패취의 제제설계 및 약제학적 특성 (Formulation and Pharmaceutical Properties of Local Mucoadhesive-Patch Preparation)

  • 이계주;서현주;이덕근;박종범;신광현;황성주
    • 약학회지
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    • 제42권2호
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    • pp.187-195
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    • 1998
  • In order to ameliorate disadvantages of buccal ointments and mucoadhesive tablets used for the treatment of aphthosis, a thin mucoadhesive patch containing triamcinolone acetoni de was designed and evaluated for the pharmaceutical properties. The adhesive gel layer consisting of Noveon AA-1, hydroxypropylcellulose-M and ethylcellulose N 100, and the protective gel layer of ethylcellulose N 100, Eudragit RSPO and castor oil have been formulated and various properties such as viscosity of drug gel layer, thickness, in vitro adhesion time, adhesive strength, surface pH, content uniformity and drug release are tested. The mean viscosity of drug-containing gel layer was found to increase with increasing amount of Noveon OAA-1 or hydroxypropylcellulose-M. The optimum formulation showed the thickness of 171 ${\mu}$m, surface pH of 4.6, in vitro adhesion time of 8 hours and adhesive strength of 272.7g/sheet. The drug content of each patch was relatively homogeneous with the value of 273${\pm}$6.77g. Drug release study showed that compared to mucoadhesive tablet, the patch showed a faster drug release. Drug release was delayed by hydroxypropylcellulose-M, but not by ethylcellulose N 100. The patches prepared were nonirritant and the muco adhesion was better than the commercial product (AftachR) on the market. Based on these results, this mucoadhesive patch is expected to be an effective dosage form for the treatment of aphthosis.

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Comparative Study of the Dissolution Profiles of a Commercial Theophylline Product after Storage

  • Negro, S.;Herrero-Vanrell, R.;Barcia, E.;Villegas, S.
    • Archives of Pharmacal Research
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    • 제24권6호
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    • pp.568-571
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    • 2001
  • The purpose of this work was to study the effect of storage time and temperature on the in vitro release kinetics of a commercial sustained-release dosage form of theophylline, at different pHs of the dissolution medium. The formulation was stored at $35^{\circ}C$ for 16 months and at $45^{\circ}C$ for 8 months, with a relative humidity of 60%. The in vitro release tests were performed at pHs 2, 4, 6 and 7.4. The mean values of the transport coefficient n, were close to 0.5 in all the conditions tested, which indicates that the transport system is not modified after storage of the formulation at $35^{\circ}C$ and $45^{\circ}C$. The mean values of the dissolution rate constant ranged from 0.036 to 0.043 $min^{-n}$, under all the conditions tested. Significant differences (${\alpha}=0.05$) were found between pHs 2, 4 and 6, 7.4 for all the model-independent parameters studied. When the formulation was kept at $35^{\circ}C$ for 16 months, the mean percentage of drug dissolved at 8 hours was 25.61% (pHs 2, 4) and, 36.12% (pHs 6, 7.4), representing a 26% and 24% reduction, respectively. Simitar results were obtained after storing the formulation at $45^{\circ}C$ for 8 months, corresponding to 33.3% (pHs 2, 4) and, 22.5% (pHs 6, 7.4) diminution, respectively. The values of the similarity factory $f_2$, obtained were lower than 50, which indicates the lack of similarity among the dissolution profiles, after storing the formulation under the experimental Conditions tested.

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Study on the effect of long-term high temperature irradiation on TRISO fuel

  • Shaimerdenov, Asset;Gizatulin, Shamil;Dyussambayev, Daulet;Askerbekov, Saulet;Ueta, Shohei;Aihara, Jun;Shibata, Taiju;Sakaba, Nariaki
    • Nuclear Engineering and Technology
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    • 제54권8호
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    • pp.2792-2800
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    • 2022
  • In the core of the WWR-K reactor, a long-term irradiation of tristructural isotopic (TRISO)-coated fuel particles (CFPs) with a UO2 kernel was carried out under high-temperature gas-cooled reactor (HTGR)-like operating conditions. The temperature of this TRISO fuel during irradiation varied in the range of 950-1100 ℃. A fission per initial metal atom (FIMA) of uranium burnup of 9.9% was reached. The release of gaseous fission products was measured in-pile. The release-to-birth ratio (R/B) for the fission product isotopes was calculated. Aspects of fuel safety while achieving deep fuel burnup are important and relevant, including maintaining the integrity of the fuel coatings. The main mechanisms of fuel failure are kernel migration, silicon carbide corrosion by palladium, and gas pressure increase inside the CFP. The formation of gaseous fission products and carbon monoxide leads to an increase in the internal pressure in the CFP, which is a dominant failure mechanism of the coatings under this level of burnup. Irradiated fuel compacts were subjected to electric dissociation to isolate the CFPs from the fuel compacts. In addition, nondestructive methods, such as X-ray radiography and gamma spectrometry, were used. The predicted R/B ratio was evaluated using the fission gas release model developed in the high-temperature test reactor (HTTR) project. In the model, both the through-coatings of failed CFPs and as-fabricated uranium contamination were assumed to be sources of the fission gas. The obtained R/B ratio for gaseous fission products allows the finalization and validation of the model for the release of fission products from the CFPs and fuel compacts. The success of the integrity of TRISO fuel irradiated at approximately 9.9% FIMA was demonstrated. A low fuel failure fraction and R/B ratios indicated good performance and reliability of the studied TRISO fuel.

고연소도 경수로 사용후핵연료의 열처리에 따른 세슘 방출거동 (Cesium Release Behavior during the Thermal Treatment of High Bum-up Spent PWR Fuel)

  • 박근일;조광훈;이정원;박장진;양명승;송기찬
    • 방사성폐기물학회지
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    • 제5권1호
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    • pp.53-64
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    • 2007
  • 고연소도 경수로사용후핵연료를 이용하여 voloxidation 및 소결 열처리 공정으로부터 세슘의 시간에 따른 방출 거동을 실험적으로 평가하였다. 사용후핵연료 voloxidation 공정에서는 fragment 형태의 시편을 사용하여 최대 $1,500^{\circ}C$의 산화 및 환원 분위기에 따른 세슘 방출 거동을 상호 비교하였으며, 소결 공정에서는 압분체를 이용하여 4% H2/Ar 환원분위기 에서 열처리 온도 변화에 따른 세슘방출 특성 변화를 분석하였다. 산화 분위기에서 fragment 형태의 사용후핵연료로부터 세슘 방출 온도 구간은 $800{\circ}C{\sim}1,200^{\circ}C$였으며, 환원 분위기에서 압분체로부터 방출 온도 구간은 $1,100{\circ}C{\sim}1,400^{\circ}C$로서, 산화에 의한 사용후핵 연료의 분말화가 세슘 방출 거동에 영향을 미치는 것으로 나타났다. 아울러 사용후핵 연료로부터 세슘 방출 거동에 영향을 미치는 주요 인자는 사용후핵 연료내 세슘 화합물의 화학적 형태뿐만 아니라 결정립 및 핵연료 표면으로의 확산 속도에 지배를 받음을 알 수 있었다.

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Inhibitory Effects of Self-Fermented Pine Needle Extract on Catecholamine Release in the Rat Adrenal Medulla

  • Choi, Mee-Sung;Seo, Young-Hwan;Cheong, Hyeon-Sook;Lim, Dong-Yoon
    • Natural Product Sciences
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    • 제19권1호
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    • pp.36-48
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    • 2013
  • The aim of the present study was to investigate the effects of several fractions obtained from methylene chloride ($CH_2Cl_2$) extract of self-fermented pine needle (SFPNE) on the acetylcholine (ACh)-evoked CA release from the isolated perfused model of the rat adrenal medulla and to establish the mechanism of the most active fraction (Fr.)-induced inhibitory action on the CA release. We obtained 6 fractions from $CH_2Cl_2$ extract of self-fermented pine needle. For the ACh (5.32 mM)-evoked CA release, the following rank order of inhibitory potency was obtained: Fr.4-5 > Fr.8-11 ${\gg}$ Fr.3 > Fr.6 = Fr.7 > Fr.1-2. Fr. 4 - 5 (60 ${\mu}g/mL$) perfused into an adrenal vein for 90 min produced relatively time-dependent inhibition of the CA secretory responses to ACh (5.32 mM), DMPP (100 ${\mu}M$), McN-A-343 (100 ${\mu}M$) and high $K^+$ (56 mM). Fr. 4 - 5 itself did not affect basal CA secretion. Also, in the presence of Fr. 4 - 5 (60 ${\mu}g/mL$), the CA secretory responses to angiotensin II (AngII, 0.1 ${\mu}M$), veratridine (50 ${\mu}M$), Bay-K-8644 (10 ${\mu}M$), and cyclopiazonic acid (10 ${\mu}M$) were significantly reduced, respectively. In the simultaneous presence of Fr. 4 - 5 (60 ${\mu}g/mL$) and L-NAME (30 ${\mu}M$), the inhibitory responses of Fr. 4 - 5 on the CA secretion evoked by ACh, DMPP, high $K^+$, AngII, Bay-K-8644 and veratridine were considerably recovered to the extent of the corresponding control secretion compared with that of Fr. 4 - 5-treatment alone. The level of NO released from adrenal medulla after the treatment of Fr. 4 - 5 (60 ${\mu}g/mL$) was greatly elevated compared with the basal level. Taken together, these results demonstrate that Fr. 4 - 5 inhibits the CA secretion from the isolated perfused rat adrenal medulla evoked by stimulation of cholinergic receptors as well as by direct membrane-depolarization. It seems that this inhibitory effect of Fr. 4 - 5 is mediated by blocking the influx of $Ca^{2+}$ and $Na^+$ into the adrenomedullary chromaffin cells as well as by inhibition of $Ca^{2+}$ release from the cytoplasmic calcium store, which is evoked at least partly through the increased NO production due to the activation of NO synthase. Based on these results, it is also thought that Fr. 4 - 5 isolated from $CH_2Cl_2$ extract of pine needle may contain beneficial antihypertensive components to prevent or treat hypertension.

Suppressive Impact of Ginsenoside-Rg2 on Catecholamine Secretion from the Rat Adrenal Medulla

  • Ha, Kang-Su;Kim, Ki-Hwan;Lim, Hyo-Jeong;Ki, Young-Jae;Koh, Young-Youp;Lim, Dong-Yoon
    • Natural Product Sciences
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    • 제27권2호
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    • pp.86-98
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    • 2021
  • This study was designed to characterize the effect of ginsenoside-Rg2 (Rg2), one of panaxatriol saponins isolated from Korean ginseng root, on the release of catecholamines (CA) in the perfused model of the rat adrenal medulla, and also to establish its mechanism of action. Rg2 (3~30 µM), administered into an adrenal vein for 90 min, depressed acetylcholine (ACh)-induced CA secretion in a dose- and time-dependent manner. Rg2 also time-dependently inhibited the CA secretion induced by 3-(m-chloro-phenyl-carbamoyl-oxy)-2-butynyltrimethyl ammonium chloride (McN-A-343), 1.1-dimethyl-4-phenyl piperazinium iodide (DMPP), and angiotensin II (Ang II). Also, during perfusion of Rg2, the CA secretion induced by high K+, veratridine, cyclopiazonic acid, methyl-1,4-dihydro-2,6-dimethyl-3-nitro-4-(2-trifluoro-methyl-phenyl)-pyridine-5-carboxylate (Bay-K-8644) depressed, respectively. In the simultaneous presence of Rg2 and Nω-nitro-L-arginine methyl ester hydrochloride ʟ-NAME), the CA secretion induced by ACh, Ang II, Bay-K-8644 and veratridine was restored nearly to the extent of their corresponding control level, respectively, compared to those of inhibitory effects of Rg2-treatment alone. Virtually, NO release in adrenal medulla following perfusion of Rg2 was significantly enhanced in comparison to the corresponding spontaneous release. Also, in the coexistence of Rg2 and fimasartan, ACh-induced CA secretion was markedly diminished compared to the inhibitory effect of fimasartan-treated alone. Collectively, these results demonstrated that Rg2 suppressed the CA secretion induced by activation of cholinergic as well as angiotensinergic receptors from the perfused model of the rat adrenal gland. This Rg2-induced inhibitory effect seems to be exerted by reducing both influx of Na+ and Ca2+ through their ionic channels into the adrenomedullary cells as well as by suppressing Ca2+ release from the cytoplasmic calcium store, at least through the elevated NO release by activation of NO synthase, which is associated to the blockade of neuronal cholinergic and AT1-receptors. Based on these results, the ingestion of Rg2 may be helpful to alleviate or prevent the cardiovascular diseases, via reduction of CA release in adrenal medulla and consequent decreased CA level in circulation.

의약품 제조공정에서의 전사적 품질혁신을 위한 공정분석기술 개발 (Development of Process Analytical Technology (PAT) for Total Quality Innovation on Pharmaceutical Processes)

  • 신상문;박경진;최용선;이상길;최광진;권병수
    • Journal of Pharmaceutical Investigation
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    • 제37권6호
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    • pp.329-338
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    • 2007
  • The quality assurance issue of drug products is more important than the general product because it is highly related to the human health and life. In this reason, the regulatory guide lines have continuously been intensified all around the world. In order to achieve effective quality assurance and real-time product release (RTPR) of drug products, process analytical technology (PAT), which can analyze and control a manufacturing process, has been proposed from the United States. With the PAT process, we can obtain significant process features of materials, quality characteristics and product capabilities from a raw material to the final product in the real-time procedure. PAT can also be utilized to process validation using information system that can analyze the risk of drug products through out an entire product life-cycle. In this paper, we first offered a new concept for the off-line process design methods to prepare the improved quality assurance restrictions and a real-time control method by establishing an information system. We also introduced an automatic inspection system by obtaining surrogate variables based on drug product formulations. Finally, we proposed an advanced PAT concept using validation and feedback principles through out the entire life-cycle of drug product manufacturing processes.

스마트폰 보안 기술 분석 (The Study on the security of Smartphone)

  • 이영숙;김지연
    • 디지털산업정보학회논문지
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    • 제6권2호
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    • pp.91-105
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    • 2010
  • With the release Apple's iPhone, smartphone is enjoying a tremendous popularity. Security experts pointed the smartphone security risks and KCC(Korea Communications Commission) published safety rules for smartphone users. In this paper we surveyed market and product trends of smartphone and analyzed the security technology of smartphoen OS including Symbian, iPhone OS, Windows Mobile and Android.

중소제조업을 위한 생산관리시스템의 개발 (Development of Production Management System for Medium and Small Companies)

  • 임수경;오근태
    • 산업경영시스템학회지
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    • 제18권36호
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    • pp.193-203
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    • 1995
  • The production management system software which can be applied In the medium and small companies is developed. Since the medium and small companies hesitate to install the computer system for production management owing to the lack of funds and the complexities of operation, the system is made to be used in PC and only requires minimum input data. This system is composed of interrelated modules for receive/order release, inventory management MRP, new product registration, document management and production scheduling. In this paper the architecture of the system, functions of each module, and information processing procedures of each funtion are discussed.

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In vitro and in vivo evaluation of meloxicam capsule

  • Park, Sei-Yeon;Park, Young-Joon;Kang, Dae-Sik;Lee, Ho-Chan;Kang, Heui-Il
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-2
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    • pp.232.1-232.1
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    • 2003
  • Purpose. To develop a hard gelatine capsule containing meloxicam (Yuhan Meloxam capsule$\^$TM/), in vitro dissolution characteristics and bioavailability in beagle dog were compared with commercial product (Mobic capsule$\^$TM/). Methods. Meloxicam capsule$\^$TM/ was prepared by powder filling method using meloxicam, lactose, magnesium stearate, and others. The release of Meloxicam capsule$\^$TM/ and Mobic capsule$\^$Tm/ were monitored by USP dissolution method under various dissolution donditions - dissolution medium (pH 1.2, 4.0, 6.8 and water). (omitted)

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