• Title/Summary/Keyword: dissolution

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Implementation of Biopharmaceutics Classification System Concepts in Developing Dissolution Tests (용출규격 설정을 위한 생물약제학적분류체계 개념 활용)

  • Sah, Hong-Kee;Lee, Kyung-Sin;Baek, Min-Sun
    • Journal of Pharmaceutical Investigation
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    • v.36 no.3
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    • pp.161-167
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    • 2006
  • The objective of this study was to investigate the dissolution patterns of variety of orally administered drug products available on the market. It aimed to understand their dissolution behaviors on the basis of the biopharmaceutics classification system (BCS) concept. On the tenets of BCS, several active pharmaceutical ingredients were selected: fluoxetine hydrochloride (class I), naproxen sodium (class ll), pyridostigmine bromide (class III), furosemide (class IV) and simvastatin (class IV). Typical dissolution media used in this study were pH 1.2, pH 4 & 6.8 phosphate buffers, and water. In cases, particular dissolution media specified in the KP and/or USP were used. Dissolution patterns of fluoxetine hydrochloride and pyridostigmine bromide products were characterized by their rapid release In addition, their dissolution characteristics were relatively unaffected by the type of a dissolution medium. Similar dissolution patterns were observed with pH 1.2, pH 4 & 6.8 phosphate buffers and water. By sharp contrast, poor dissolution patterns were noticed with naproxen sodium products, when pH 1.2 and pH 4 phosphate buffer were used. Improvements in its dissolution were achieved by switching the dissolution media to pH 6.8 phosphate buffer or water. Unsatisfactory dissolution data also were observed with a simvastatin product, when it was subject to dissolution tests by use of a surfactant-free pH 1.2, pH 4 & 6.8 phosphate buffers and water. All the release patterns reported in this study were best understood when BCS concepts were implemented. Our results demonstrated that a BCS-based drug classification should be considered first to choose a dissolution test/method and set up dissolution specification.

Relationship Between Dissolution Patterns of Carbamazepine Tablet and Dissolution Medium Composition (카르바마제핀 정제 용출패턴과 용출액 조성과의 상관성)

  • Lee, Hyeon-Tae;Kim, Jeong-Ho;Kim, Hyun-Joo;Sah, Hong-Kee
    • Journal of Pharmaceutical Investigation
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    • v.34 no.3
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    • pp.185-192
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    • 2004
  • The objective of this study was to evaluate the effects of surfactant type and concentration upon dissolution rates of carbamazepine from an immediate-release tablet. The dissolution media used in this study were aqueous solutions containing 0.1-2% sodium lauryl sulfate, cetyltrimethylammonium bromide, or polysorbate 80. The solubility of carbamazepine in the dissolution media was determined at first. A dissolution study was then conducted by using the USP dissolution apparatus II (paddle method) with an agitation rate of 75 rpm. Aliquots of the dissolution media were taken at predetermined time intervals, and the amount of carbamazepine dissolved was measured spectrophotometrically at 285 nm. The dissolution data obtained were fitted into a biphasic exponential equation with four parameters. Excellent correlations were observed between the experimental data and the theoretical ones predicted by the equation. This equation permitted the calculation of $T_{50%}$ (the time required for dissolving 50% of carbamazepine) under various experimental conditions. Differentiation of the equation also led to the attainment of dissolution rates at dissolution time points. The addition of a surfactant to an aqueous solution led to increasing the solubility of carbamazepine by 3- to 12-folds, depending upon its type and concentration. This event also resulted in enhancing the magnitude of a sink condition during the dissolution study. As a result, the dissolution rate of carbamazepine was affected by the aqueous surfactant concentration in a proportional manner. Subsequently, $T_{50%}$ values declined rapidly, as the surfactant concentration increased. Such effects were observed in decreasing order of sodium lauryl sulfate, cetyltirmethylammonium bromide, and polysorbate 80. These results clearly demonstrated that it was possible to tailor a dissolution rate and $T_{50%}$ of carbamazepine by manipulating the type and concentration of a surfactant. Relevant information would be beneficial to setting up dissolution specifications for poorly water-soluble drug products.

A Textbook Analysis and Teaching Practices on Dissolution in Elementary School (용해 현상에 대한 초등학교 과학 교과서의 내용 분석 및 지도 실태)

  • Kang, Dae-Hun;Paik, Seoung-Hey
    • Journal of Korean Elementary Science Education
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    • v.22 no.2
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    • pp.138-148
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    • 2003
  • This study was to analyze how elementary school science textbooks explain dissolution and to examine the patterns of elementary school teachers' conceptions on dissolution and the teaching practices on dissolution of elementary school teachers. According to the result of the textbook analysis, the textbooks based on the 7th curriculum didn't explain dissolution very differently from those based on the 6th curriculum. The contents dealing with dissolution in the textbooks of 7th curriculum became difficult gradually as the year went up, but the connected organization of the contents made students learn it easily. For example, in order to learn dissolution introduced first in the 3rd year 2nd semester textbook, students would tell soluble substance in water from insoluble substance in water as they put powdered substance in water. In the 5th year 1st semester textbook students were supposed to acquire the knowledge related to dissolution through the designed activities such as comparing solubility produced by different solvents and defining a solvent, a solute, dissolution, and a solution. In addition, teachers' guide for 5th year 1st semester textbook elucidated the principle of dissolution using attraction concept that was scientific. The result of the survey on teachers showed that 90% of elementary school teachers understood the dissolution of salt in water just as millet particles' filling the space between bean particles and they responded that they demonstrated millet particles' filling the space between been particles when they taught the dissolution of salt in water. When it comes to teachers who had the right idea on dissolution as the attraction conception, understanding was one thing and teaching was another, because they often instructed dissolution as the space conception in the real teaching.

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Effects of dissolution temperature on the rheological properties of polyvinyl alchol solutions in dimethyl sulfoxide

  • Cho, Yong-Han;Dan, Kyung-Sik;Kim, Byoung-Chul
    • Korea-Australia Rheology Journal
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    • v.20 no.2
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    • pp.73-77
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    • 2008
  • The rheological properties of polar solutions are very sensitive to preparative methods as well as measuring conditions. The effects of dissolution temperature on the rheological properties of the solutions of polyvinyl alcohol (PVA) in dimethyl sulfoxide were investigated over the range of dissolution temperatures $70-130^{\circ}C$. Viscosity was increased as dissolution temperature was increased. PVA solutions prepared at 120 and $130^{\circ}C$ showed Bingham behavior, which became less noticeable with decreasing dissolution temperature. The modified Cole-Cole plot of the solutions gave slope less than 2, suggesting the solutions were a heterogeneous system irrespective of optical transparency. Further, the slope was decreased with increasing dissolution temperature, indicating that the solid character got more prominent as dissolution temperature was increased. However, the relaxation time of the solutions was little dependent on dissolution temperature.

Surfactant Effects upon Dissolution Patterns of Carbamazepine Immediate Release Tablet

  • Lee Hyeontae;Park Sang-Ae;Sah Hongkee
    • Archives of Pharmacal Research
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    • v.28 no.1
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    • pp.120-126
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    • 2005
  • The objective of this study was to investigate the effects of sodium lauryl sulfate upon the saturation solubility of carbamazepine, its dissolution kinetics, and $T_{50\%}$ defined as the time required for dissolving $50\%$ of carbamazepine. Water, 0.1N-HCI, and phosphate buffers at pH 4.0 and 6.8 containing 0.1, 0.5, 1, and $2\%$ sodium lauryl sulfate were used as dissolution media. The dissolution study was conducted by using the USP dissolution apparatus II with an agitation rate of 75 rpm. Samples of the dissolution media were taken in 7, 15, 30, 45, 60, 75, and 90 min, and the amounts of carbamazepine were determined spectrophotometrically at 285 nm. All dissolution data were fitted well into a four-parameter exponential equation: $Q\;=\;a(1\;-\;e^{-bxt})\;+\;c(1\;-\;e^{-dxt})$. In this equation Q represented $\%$ carbamazepine dissolved at a time t, and a, b, c, and d were constants. This equation led to the calculation of dissolution rates at various time points and $T_{50\%}$. It was found that the dissolution rate of carbamazepine was directly proportional to the aqueous concentration of sodium lauryl sulfate. In addition, under our experimental conditions $T_{50%}$ values ranged from 37.8 to 4.9 min. It was interesting to note that $T_{50\%}$ declined rapidly as the surfactant concentration increased from 0.1 to $0.5\%$, whereas it declined more slowly at concentrations greater than $1\%$. These results clearly demonstrated that the dissolution rate of carbamazepine and duration of its dissolution test could be tailored by optimizing the amount of sodium lauryl sulfate in a dissolution medium.

$7^{th}-12^{th}$ Grade Students, Pre-service Teachers and Science Teachers' Views on the Dissolution of Salt in a Liquid

  • Won, Jeong-Ae;Kang, Dae-Hun;Paik, Seoung-Hey
    • Journal of The Korean Association For Science Education
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    • v.28 no.3
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    • pp.187-196
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    • 2008
  • In this study, a survey was conducted of students in grades 7 through 12, student teachers enrolled in their senior year at teachers' colleges, and science teachers. Subjects were surveyed on their conceptions of phenomenon related with dissolution, saturation, and extraction. The models and analogies used by student teachers and science teachers to explain dissolution were sought. The highest percentage of students thought of dissolution as a phenomenon in which particles broke into the spaces between other particles. The models or analogies used by the highest percentage of science teachers were similar. They generally conceived of dissolution phenomenon through what we call the 'space conception'. A conception of dissolution phenomenon as 'hydration through attraction of solvent and solute' was held by more student teachers than science teachers; there were some differences, however, according to their academic background. The percentage of teachers professing this view decreased when they attempted to explain the process of extraction of matter in a solution after other matter had dissolved or after the solution was cooled, indicating that the 'hydration' conception was not firmly established in the student teachers' cognition. Therefore, it can be inferred that the conceptions of dissolution as 'hydration' were transformed into the conceptions of dissolution as 'space' after teaching dissolution phenomenon as practicing teachers. This finding should be considered in teacher-training courses.

Polymorphism of Sulpiride and Its Pharmaceutical Applications ( III ) -Dissolution Kinetics of Sulpiride Polymorphs- (Sulpiride의 Polymorphism 및 그 약제학적(藥劑學的) 연구(硏究) (제3보)(第三報) -Polymorph에 따른 용출속도(溶出速度)-)

  • Lee, Min-Hwa;Kim, Kil-Soo
    • Journal of Pharmaceutical Investigation
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    • v.12 no.3
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    • pp.55-63
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    • 1982
  • The dissolution kinetics for polymorphs of sulpiride, the effect of polyethylene glycol 4000 on the dissolution kinetics of sulpiride polymorphs and the dissolution rate difference between the tablets of polymorph form I and form II were investigated. The results could be summerized as followings: 1. The dissolution rates of two polymorphs of sulpiride were significantly different and the thermodynamic parameters calculated from dissolution kinetics were as follows; transition temperature $98^{\circ}C$, enthalpy change, -2.108 kcal/mole, free energy change, -783 cal/mole $(31.0^{\circ}C)$. 2. The dissolution rates of the two polymorphs of sulpiride containing polyethylene glycol 4000 were significantly diefferent in 0.01N HCl but the effect of polyethylene glycol on the dissolution rates of two polymorphs was not significant at low concentration of polyethylene glycol 4000. The study on the effect by stirring speed showed that at lower stirring speed the promotion rate of dissolution of polymorph form I is greater than that of form II. 3. In the case of tablets the dissolution rates of polymorph form I of sulpiride was two fold as compared with the results obtained from form II.

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Studies on Dissolution of Lorazepam Preparation (Lorazepam 제제(製劑)의 용출(溶出)에 관한 연구(硏究))

  • Yang, Jae-Heon
    • Journal of Pharmaceutical Investigation
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    • v.14 no.4
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    • pp.161-169
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    • 1984
  • The tests of dissolution and bioavailability of six formulas of lorazepam tablet under various binders were performed. Lorazepam can be seperated in pharmaceutical preparation and biological plasma by high performance liquid chromatograph. Dissolution process of lorazepam tablet was largely influenced by binder and the dissolution rate was increased by sodium starch glycolate and microcrystalline cellulose, the slower dissolution rate in starch. Bioavailability of lorazepam tablet got relationship with dissolution rate, because tablets containing sodium starch glycolate and microcrystalline cellulose as binder maintained higher plasma level than other binders.

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Dissolution of North Korean Magnesite by using Hydrochloric Acid

  • Baek, Ui-Hyun;Park, Hyungkyu;Lee, Jin-Young;Kang, Jungshin
    • Korean Chemical Engineering Research
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    • v.55 no.5
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    • pp.711-717
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    • 2017
  • A fundamental study was conducted on the dissolution of North Korean magnesite using hydrochloric acid to understand the dissolution behavior of the magnesium and impurities. The influence of the acid concentration, particle size of the magnesite, reaction temperature, and pulp density on the dissolution of magnesium, iron, calcium, aluminum, and silicon dioxide was studied. The experimental results showed that 98.5% of magnesium, 86.9% of iron, 87.3% of calcium, 23.6% of aluminum, and 20.4% of silicon dioxide were dissolved when magnesite particle sizes within the range of $75{\sim}105{\mu}m$ were reacted using 3 M HCl solution under 6% pulp density at 363 K for 3 h. The residues that remained after the dissolution were silicon dioxide, talc, and clinochlore.

A clean technology development using the iron(Fe) dissolution reaction with hydrogen peroxide (과산화수소를 이용한 철(Fe)선 용해반응에 따른 청정기술 개발에 관한 연구)

  • 김재우
    • Journal of environmental and Sanitary engineering
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    • v.16 no.4
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    • pp.62-68
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    • 2001
  • The advantages of hydrogen peroxide dissolution method were no discharge of noxious matter when dissolution of iron wire which used as the center supporter, reactions occur in room temperature and easy to recover dissolved iron. This study was aimed at gathering the basic data of iron wire dissolution- recovery process and proposes the reaction condition of iron wire dissolution- recovery process rind the factors influencing those reactions. The results were as follows : 1 . Hydrogen peroxide dissolution method used hydrochloric acid as the catalyst. 1. In the dissolution of iron wire(1.668 g), the condition of reaction was E1702(30 ml), HCI(20 ml) and $H_2O$(200 ml) ; time of the reaction was 18 min. P.W.(Piece weight) was 7.75 mg, and C.R. was $2.34{\;}{\Omega}$ 2. In the dissolution of iron wire(1.529 g), the condition of reaction was H7O2(30 ml), HCI(20 ml) and $H_2O$(200 ml), time of the reaction was 21 min., P.W.(Piece weight) was 7.73 mg, and C.R. was $2.35{\;}{\Omega}$. Hydrogen peroxide dissolution method used sulfuric acid as the catalyst. 1. In the dissolution of iron wire(0.834 g), the condition of reaction was $H_2O$(65 ml), $H_2SO_4$(5 ml) and 1702(5 ml) ; time of the reaction was 5 min.30 sec, P.W.(Piece weight) was 7.74 mg, and C.R. was $2.33{\;}{\Omega}$ 2. In the dissolution of iron wire(1.112 g), the condition of reaction was $H_2O$(65 ml), $H_2SO_4$(5 ml) and $H_2O_2$(5 ml) ; time of the reaction was 4 min.30 sec, P.W.(Piece weight) was 7.75 mg, and C.R. was $2.33{\;}{\Omega}$. Hydrogen peroxide dissolution method used hydrochloric acid and sulfuric acid as the catalyst confirmed a clean technology, because there were not occurred a pollutant discharged in the existing method.

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