• Title/Summary/Keyword: excipient

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Effect of the Viscosity of (Hydroxypropyl)methyl Cellulose on Dissolution Rate of Alfuzosin-HCl Granule Tablet (HPMC의 점도에 따른 염산 알푸조신 과립정제의 용출률 조절)

  • Kim, Won;Song, Byung-Joo;Kim, Dae-Sung;Kim, Su-Jin;Lee, Seon-Kyoung;Kim, Hye-Lin;Lee, Dong-Won;Khang, Gil-Son
    • Polymer(Korea)
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    • v.34 no.3
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    • pp.269-273
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    • 2010
  • The primary objective of this work is to find the optimal condition for the granule tablet formulation of alfuzosin-HCl that aims to achieve a sustained drug release. (Hydroxypropyl)methyl cellulose (HPMC) is one of the most widely used polymer as a drug formulation and therefore has been utilized in this study as an excipient. Alfuzosin-HCl granule tablet was developed using the various viscosities of HPMC and the effects of viscosity on drug release was investigated. Fourier transform-infrared (FTIR) and X-ray diffraction (XRD) were employed to investigate the chemical structure and crystallization of alfuzosin-HCl in the formulation. We prepared the granule tablet by a direct compression method and studied the release profile in the stimulated intestinal fluid (pH 6.8). As the viscosity of HPMC increased the release of alfuzosin-HCl decreased, demonstrating that controlled release of alfuzosin-HCl can be achieved by varying the viscosity of HPMC.

Study of four week repeated dose toxic test of Sweet Bee Venom in Beagle Dogs (Sweet Bee Venom의 비글견을 이용한 4주 반복 근육시술 독성시험)

  • Park, Jae-Seuk;Lee, Kwang-Ho;Kwon, Ki-Rok
    • Journal of Pharmacopuncture
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    • v.13 no.4
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    • pp.5-41
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    • 2010
  • Objectives: This study was performed to analyse four week repeated dose toxicity of Sweet Bee Venom(Sweet BV) extracted from the bee venom in Beagle dogs. Methods: All experiments were conducted under the regulations of Good Laboratory Practice (GLP) at Biotoxtech Company, a non-clinical study authorized institution. Male and female Beagle dogs of 5-6 months old were chosen for the pilot study of four week repeated dose toxicity of Sweet BV which was administered at the level of 0.56mg/kg body weight which is eighty times higher than the clinical application dosage as the high dosage, followed by 0.28 and 0.14mg/kg as midium and low dosage, respectively. Equal amount of excipient(normal saline) to the Sweet BV experiment groups was administered as the control group every day for four weeks. Results: 1. No mortality was witnessed in all of the experiment groups. 2. All experiment groups were appealed pain sense in the treating time compared to the control group, and hyperemia and movement disorder were observed around the area of administration in all experiment groups, and higher occurrence in the higher dosage treatment. 3. For weight measurement, Neither male nor female groups showed significant changes. 4. In the urine analysis, CBC and biochemistry didn't show any significant changes in the experiment groups compared with control group. 5. For weight measurement of organs, experiment groups didn't show any significant changes compared with control group. 6. To verify abnormalities of organs and tissues, thigh muscle which treated with Sweet BV, cerebrum, liver, lung, kidney, and spinal cords were removed and conducted histologocal observation with H-E staining. In the histologocal observation of thigh muscle, cell infiltration, inflammatory, degeneration, necrosis of muscle fiber, and fibrosis were found in both thigh tissue. And the changes were depend on the dose of Sweet BV. But another organs were not detected in any abnormalities. 7. The proper high dosage of Sweet BV for the thirteen week repeated test in Beagle dogs may be 0.28mg/kg in one time. Conclusion: Above findings suggest that Sweet BV is relatively safe treatment medium. Further studies on the subject should be conducted to yield more concrete evidences.

A Study of Dexibuprofen Loaded Solid Dispersion Using Rotary Hot-melt Granulation (회전식 고온용융과립법을 이용한 덱시부프로펜 함유 고체분산체 연구)

  • Kim, Dong-Wook
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.2
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    • pp.595-600
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    • 2020
  • The purpose of this paper was to prepare and evaluate solid dispersions (SD) that can increase the dissolution rate of dexibuprofen as a model drug with low solubility in water using saccharides and sugar alcohols as dispersion materials. DSC, XRD, content and content uniformity test, dissolution test, and disintegration test were conducted for physicochemical evaluation of the prepared SD. For the results, it was confirmed using differential scanning calorimetry that fructose, which has a melting point around 120 ℃ of the device operating temperature range, is a suitable excipient for the preparation of SD by the rotary hot-melt granulation (RHMG) method. X-ray diffraction analysis was conducted to confirm that the crystallinity of dexibuprofen was reduced. Disintegration test of the prepared tablet using SD-containing dexibuprofen and fructose confirmed a very fast disintegration time within 1~2 seconds and also showed that the dissolution rate was about 20% faster than that of the dexibuprofen raw material. Dexibuprofen with reduced crystallinity by SD confirmed through the RHMG method can be used to increase the dissolution rate of the drug and increase the disintegration time of the tablet. Thus, it can be used in the manufacturing of various solid preparations.

Dissolution Profile Analysis of Hydroxypropyl Methylcellulose-based Vitamin C Tablets (Hydroxypropyl methylcellulose를 활용한 비타민 C 지속성 정제의 용출 특성 분석)

  • Cha, Ja-Hyun;Hong, Jun-Kee;Lee, Sung-Wan;Cha, Jae-Uk;Ko, Won-Hwa;Baek, Hyon-Ho;Park, Hyun-Jin
    • Korean Journal of Food Science and Technology
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    • v.44 no.3
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    • pp.274-279
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    • 2012
  • The objective of this study was to develop oral matrix tablets for the sustained release of vitamin C. In this study hydroxypropyl methylcellulose (HPMC) has been utilized as an excipient, as it is one of the most widely used polymers, for use during long periods of time in formations. The vitamin C tablet formulation depends on the molecular weight and concentration of sustained-delivery in HPMC. Anti-oxidants have been added as a dissolution medium in order to prevent vitamin C degradation in water. The dissolution test was carried out in a distilled water medium, and the release model equation was applied to analyze the vitamin C release pattern. The results demonstrated that the release and lasting power of vitamin C tablets, containing HPMC, lasted for more than 12 h.

Preparation and Dissolution Properties of Oral Controlled Release Formulation Containing Carvedilol (카르베딜롤을 함유하는 경구제어 방출형 제제의 제조 및 용출특성)

  • Choi, Won-Sik;Kim, Yong-Nam;Nam, Seok-Woo;Yang, Jin-Ah
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.11 no.7
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    • pp.2451-2458
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    • 2010
  • We prepared sustained release matrix system which contains carvedilol with Compritol 888 ATO used as lipophilic sustained release excipient and hydroxypropyl methyl cellulose (HPMC) or polyethylene oxide (PEO) used as hydrophilic sustained release polymer. Wet granulation compressed method was used for preparing carvedilol sustained release matrix tablets. When carvedilol sustained release matrix tablets were prepared, we evaluated the drug release kinetics which is affected by Compritol 888 ATO ratio, a kind of hydrophilic polymer (HPMC, PEO) and hot melt coating coagglutination (HMCC) process was done. The drug release kinetics was measured for 24 hours in pH 1.2 simulated gastric fluid and pH 6.8 simulated intestinal fluid, using a dissolution tester at $37.5^{\circ}C$ in 50 rpm. Dissolution rate of controlled release matrix tablets of carvedilol was evaluated by paddle method. We confirmed that HMCC process was very effective to controlled release of drugs. The rate of Compritol 888 ATO, as a lipidic material, can control the drug release pattern about the elution rate of 95% and 24 hours delay than that of the normal tablet.