• Title/Summary/Keyword: Dissolution test

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Development of Dissolution Test Method for Buflomedil Hydrochloride Tablets and Ticlopidine Hydrochloride Tablets (염산부플로메딜 정과 염산티클로피딘 정의 용출시험법 개발)

  • Lee, Ryun-Kyung;Jeong, Gyeong-Rok;Oh, Hyun-Sook;Shim, Jee-Youn;Suh, Sang-Chul;Lee, Hyo-Jung;Kim, Min-A;Park, Seong-Min;Lee, Kyu-Ha;Sohn, Kyung-Hee;Kim, In-Kyu;Sah, Hong-Kee;Choi, Hoo-Kyun;Cho, Tae-Yong;Hong, Choong-Man
    • YAKHAK HOEJI
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    • v.56 no.4
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    • pp.211-216
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    • 2012
  • Drug dissolution test has been used for the purpose of both quality control of solid oral dosage forms and predicting in vivo drug release profiles. In this study, the dissolution profiles of buflomedil hydrochloride tablets and ticlopidine hydrochloride tablets were investigated according to the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korean Pharmacopoeia (KP). The analytical method using HPLC was validated. The validation was performed in terms of specificity, linearity, accuracy, precision and limit of quantitation.

Development of 13C-urea-containing capsule for diagnosis of H. pylori (헬리코박터 파이로리 균 진단용 13C-요소 캅셀의 개발)

  • Yong, Chul-Soon;Kim, Yong-Il;Kim, Chi-Man;Kang, Sung-Hoon;Quan, Qi-Zhe;Rhee, Jong-Dal;Kim, Chong-Kook;Sah, Hong-Kee;Choi, Han-Gon
    • Journal of Pharmaceutical Investigation
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    • v.32 no.1
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    • pp.7-11
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    • 2002
  • The purpose of this study was to develop a new $^{l3}C-urea-containing$ capsule for diagnosis of H. pylori. The urea-containing capsules were prepared with various diluents such as polyethylene glycol (PEG), microcrystalline cellulose, sodium lauryl sulfate and citric acid. The dissolution test, $^{l3}C-urea$ breath test and stability test were then performed on the capsules. Microcrystalline cellulose and sodium lauryl sulfate retarded the initial dissolution rates of urea. However, PEG increased the initial dissolution rates of urea. Furthermore, two formulae composed of PEG, [$^{l3}C-urea/PEG$ (38/1.9 mg/cap)] and [$^{l3}C-urea/PEG/citric$ acid (38/1.9/1.9 mg/cap)] had the maximum DOB value, about 16 at 20 mim, while the formula composed of only 38 mg $^{l3}C-urea$ had the maximum DOB value at 30 min. The results indicated that PEG improved the, sensitivity of $^{l3}C-urea$ in the human volunteers. The capsule [$^{l3}C-urea/PEG$ (38/1.9 mg/cap)] was stable for at least six months in 25 and $37^{\circ}C$. Thus, a PEG-containing capsule, [$^{l3}C-urea/PEG$ (38/1.9 mg/cap)] would be a more economical, sensitive and stable preparation for diagnosis of H. pylori.

Control of Uniformity in the Drug Industry By focusing on solid dosage forms for internal use

  • Lee, Seung-Woo
    • Proceedings of the PSK Conference
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    • 2003.10a
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    • pp.40-41
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    • 2003
  • The present topic in pharmaceutical industry is to establish Quality Assurance System for medicinal product Therefore, the most important and urgent subject to be solved in the field of the manufacturing industry is to establish, implement and maintain the control system for ensuring uniformity of medicinal product. In case of solid dosage forms for internal use, its quality was controlled by disintegration test, etc but at present bioavailability could be predicted with dissolution test and so the assurance of its uniformity should be prerequistie to preserve suitable dissolution of the manufactured medicinal product. (omitted)

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Dissolution Properties for the Inorganic Pollutants in Soils (토양 중 무기 오염물질의 용출 특성)

  • Chung, Kang-Sup;Choi, Byung-In;Kim, Sang-Yeon;Song, Duk-Young;Kim, Kun-Han;Seong, Hak-Je
    • Analytical Science and Technology
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    • v.12 no.1
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    • pp.53-60
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    • 1999
  • Dissolution properties for the 6 inorganic pollutants (As, Cd, Cu, Pb, Zn, Cr) in soils have been studied. These 6 inorganic pollutants were spiked to 3 kinds of fresh soils which were sand, clay, and loam. The dissolution properties of the prepared samples were investigated under the various extracting conditions such as extracting time, acid concentration, particle size, etc. in order to obtain basic information about the process of extraction test and improvement of related analytical methods. As the results, dissolution properties were affected mainly by acid concentration in extracting procedure and mineral composition of soils. On the other hand, extracting time, sort of acids and particle size of soils had a little influence on the dissolution properties. Cd revealed very high dissolving efficiency and As was very low in whole extracting test.

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Dissolution Characteristics of Biphenyl Dimethyl Dicarboxylate from Solid Dispersions and Permeation through Rabbit Deuodenal Mucosa (고체분산체로부터 비페닐디메칠디카르복실레이트의 용출 특성 및 토끼의 십이지장 점막 투과)

  • Hyun, Jean;Chun, In-Koo
    • Journal of Pharmaceutical Investigation
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    • v.24 no.2
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    • pp.57-65
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    • 1994
  • To increase the dissolution rate of practically insoluble biphenyl dimethyl dicarboxylate (DDB), various solid dispersions were prepared with water soluble carriers, such as povidone (PVP K-30), poloxamer 407, sodium deoxycholate (SDC) and polyethylene glycol (PEG) 6000, at drug to carrier ratios of 1:3, 1:5 and 1:10 (w/w) by solvent or fusion method. Dissolution test was performed by the paddle method. The dissolution rate of DDB tablets (25 mg) on market was found to be very low (11.44, 9.02 and 6.42% at pH 1.2, 4.0 and 6.5 after 120 min, respectively). However, dissolution rates of DDB from various solid dispersions were very fast and reached supersaturation within 10 min. DDB-PEG 6000 solid dispersion appeared to be better in enhancing the in vitro dissolution rate than others. Furthermore, the incorporation of DDB and phosphatidylcholine (PC) into ${\beta}-cyclodextrin$ at ratios of 1:2:20, 1:5:20 and 1:10:20 resulted in a 4.9-, 11.2- and 19.6-fold increase in DDB dissolution after 120 min as compared with the pure drug, respectively. This might be attributed to the formation of lipid vesicles which entrapped a certain concentration of DDB during dissolution. On the other hand, the permeation of DDB through rabbit duodenal mucosa was examined using some enhancers such as SDC, sod. glycocholate (SGC) and glycyrrhizic acid ammonium salt (GAA). Only trace amounts of DDB were found to permeate through deuodenal mucosa in the absence of enhancer. SDC was found to markedly decrease the permeation flux of DDB, however, SGC and GAA (5 mM) enhanced the flux of DDB 1.6 and 2.4 times higher as compared with no additive, respectively.

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Comparative Study of Dissolution Properties of Immediate-release and Controlled-release Type Vitamin C Tablets (속방형 및 용출조절형 비타민 C 정제의 용출 특성 비교 분석)

  • Yang, Hyo-Jin;Ryu, Na-Hee;Yang, Joo-Hong;Hong, Sun-Ho;Lee, Yeonkyung;Cho, Yang-Hee
    • Journal of Food Hygiene and Safety
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    • v.37 no.2
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    • pp.114-120
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    • 2022
  • In this study, a comparative dissolution experiment was conducted between an immediate-release and a controlled-release vitamin C tablet applied with a technology to control the dissolution of vitamin C to maintain the vitamin C level in the human body. In order to confirm the dissolution rate (%) of vitamin C tablets, HPLC determination was conducted based on the dissolution test methods in the 'Korean Pharmacopoeia (No. 2020-88),' 'Guidelines on Specifications of Dissolution Tests for Oral dosage Forms,' and 'Standard and Specifications for Health Functional Foods (No. 2020-63)' from Ministry of Food and Drug Safety (MFDS). In addition, the dissolution pattern between the immediate-release tablet and the controlled-release tablet was comparatively analyzed. The analysis result confirmed that the immediate-release vitamin C tablet was 100% dissolved after 45 minutes, while the controlled-release vitamin C tablet was 100% dissolved after 480 minutes (8 hours). Furthermore, the dissolution rate (%) at 60 minutes was slower than that of the immediate-release vitamin C tablet. Based on these results, this study confirmed that the dissolution rate (%) test and development of controlled-release tablets containing vitamin C as the main component a re possible.

Formulation of sustained-release matrix tablets of nifedipine (니페디핀 서방성 정제의 제제설계)

  • Cui, Yu;Kim, Seung-Su;Park, Eun-Seok;Chi, Sang-Cheol
    • Journal of Pharmaceutical Investigation
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    • v.32 no.2
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    • pp.95-101
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    • 2002
  • Matrix tablets of nifedipine (NP) were prepared with Eudragit, diluent (lactose or Ca. phosphate) and Mg. stearate employing two different preparation methods (wet granulation and direct compression) to develop its sustained-release dosage forms. The effects of various formulation factors on the dissolution rate of the drug were investigated. Dissolution test was studied in pH 6.8 phosphate buffer containing 1% sodium lauryl sulfate using the paddle method. Formulation factors were the type and content of Eudragit, the type of diluent and the tablet preparation method. The optimum formula of NP matrix tablet, which resulted in a similar dissolution profile to that from Adalat Oros used as a reference, was 30 mg NP, 10% Eudragit RS, 2% Mg. stearate and an adequate quantity of lactose to yield 500 mg weight using the wet granulation method.

In vitro/In vivo Correlation of Sustained Release Diltiazem (딜티아젬서방정을 이용한 In vitro/In vivo 상관성)

  • Choi, Myoeng-Sin;Kang, Chan-Soon;Choi, Bo-Kyung;Hong, Chong-Hui;Kim, Kil-Soo
    • Journal of Pharmaceutical Investigation
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    • v.32 no.4
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    • pp.321-325
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    • 2002
  • IVIVC (In vitro/in vivo correlation) is useful for predicting in vivo results from in vitro data. The aim of this study was to develop IVIVC of sustained release diltiazem. For this purpose, three types of diltiazem tablets with different in vitro dissolution rates were prepared. An in vitro dissolution testing method comprising of paddle apparatus, 50 rpm, water as dissolution medium was developed. Under these condition, we demonstrated that AUCinf could be predicted by evaluating $d_{70%}$ (time dissolved 70%) in vitro since the in vivo AUCinf was correlated with the in vitro $d_{70%}$ (r=-0.9981).

Preparation of Hydroxyapatite Powder Derived from Tuna Bone and Its Sintering Property (참치 뼈로부터 수산화아파타이트 분말의 제조 및 소결 특성)

  • Seo, Dong-Seok;Kim, Young-Gook;Hwang, Kyu-Hong;Lee, Jong-Kook
    • Journal of the Korean Ceramic Society
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    • v.45 no.10
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    • pp.594-599
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    • 2008
  • Hydroxyapatite(HA) was prepared from waste tuna bone, and its sintering property and dissolution behavior were investigated. Tuna bone derived-HA powder consisted of mainly HA and small amount of MgO. Porous HA ceramics with sintered density of 79% was obtained by pressureless sintering at $1200^{\circ}C$. Meanwhile, HA ceramics prepared by hot pressing at $1000^{\circ}C$ showed dense microstructure with sintered density of 95%. Immersion test revealed that both porous and dense HA ceramics were stable in liquid environment without distinct evidence of surface dissolution. It may be assumed that the presence of Mg in tuna bone-derived HA may improve dissolution resistance of HA.