• 제목/요약/키워드: Pharmaceutical Product

검색결과 821건 처리시간 0.025초

Biopharmaceutical Evaluation of a Solid Dispersion System Containing Sibutramine Freebase

  • Lee, Min-Suk;Chang, Hee-Chul;Kim, Taewan;Park, Jung-Hwa;Lee, Bong-Sang;Kim, Sung-Hee;Kim, Do-Hwan;Kim, Bo-Gyun;Oh, Seong-Tae;Kang, Myung-Joo;Park, Jong-Hyeok;Lee, Jaehwi;Choi, Young-Wook
    • Bulletin of the Korean Chemical Society
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    • 제29권4호
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    • pp.749-754
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    • 2008
  • To increase the solubility of sibutramine freebase, the solid dispersion was prepared using a fluid-bed granulator. The solid dispersion containing sibutramine freebase was characterized by differential scanning calorimetry (DSC) and powder X-ray diffraction (XRD). After filling the sibutramine solid dispersion in the gelatin hard capsule, we performed in vitro dissolution test, the stability test under accelerated conditions and pharmacokinetic study in beagle dogs. The DSC and XRD data showed that sibutramine solid dispersion would be amorphous state. The dissolution rate of sibutramine solid dispersion was significantly increased about 70% than sibutramine freebase. The stability of sibutramine solid dispersion capsules was equivalent or above to commercial product of sibutramine. In beagle dogs, the sibutramine solid dispersion showed equivalent pharmacokinetic behavior with commercial product of sibutramine hydrochloride. In conclusion, the solid dispersion system provided a possible way to overcome the low solubility of sibutramine freebase, and the sibutramine solid dispersion can be a bioequivalent with the commercial product in humans.

Anti-inflammatory and Antimicrobial activities of Petroleum ether and Ethanol extracts of Scutia myrtina (Rhamnaceae)

  • Kritheka, N;Kumar, R Sambath;Kumar, S Suresh;Murthy, N Venkateswara;Sundram, R Shanmuga;Perumal, P
    • Advances in Traditional Medicine
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    • 제8권4호
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    • pp.400-407
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    • 2008
  • The aim of the present study is to investigate the anti-inflammatory and antimicrobial activity of petroleum ether and ethanol extracts of Scutia myrtina (Family: Rhamnaceae). In anti-inflammatory activity carrageenan and histamine induced paw oedema and cotton pellet induced granuloma for acute and chronic inflammatory models were studied in Wister albino rats. Based on the results of the present study it can be concluded that petroleum ether and ethanol extract of Scutia myrtina at 400 mg/kg has potential anti-inflammatory effect and they act in a dose dependent manner. Both extracts of Scutia myrtina showed antimicrobial activity against all bacterial and fungal strains tested at the concentration of $100\;{\mu}g$/ml. From the result, it can be concluded that the Scutia myrtina contain antibacterial and antifungal principle. Further more, besides the confirmation of the popular use; the obtained results demonstrate this herbal drug to represent a new source of antimicrobial and anti-inflammatory agent.

Validation of aseptic processes for pharmaceuticals

  • Joseph, Lincy;George, Mathew;Jain, Saurabh Kumar
    • Advances in Traditional Medicine
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    • 제10권4호
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    • pp.231-238
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    • 2010
  • Sterile Products may be broadly classified into two main categories, according to the manner in which they are produced: those which are sterilized after the product has been filled and sealed in the final container(s) ("terminally sterilized" products) and those where the sterilization stage (or stages) takes place is it before or after the bulk product filled in to final container. In this latter instance, all subsequent processing (typically, the filling and sealing operations) must be conducted aseptically in order to prevent recontamination of the sterilized product. The two most common pharmaceutical applications of aseptic processing methods are (a) the filling of liquid products following sterilization by filtration and (b) the filling of previously sterilized bulk powder products. An aseptic processing operation should be tested using a microbiological growth medium (media fill) during lyophilized injection formulation, filling, loading, lyophilisation, stoppering, and unloading activities.

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

  • Lee, Seung-Woo
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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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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Antioxidant potential of aerial part of Asclepias curassavica. Linn (Family-Asclepiadaceae)

  • Raja, S;Ahamed, KFH Nazeer;Kumar, V;Mukherjee, Kakali;Bandyopadhyay, Arun;Mukherjee, Pulok K
    • Advances in Traditional Medicine
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    • 제5권2호
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    • pp.92-99
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    • 2005
  • Asclepias curassavica. Linn, an erect, simple (or) much branched perennial herb with a somewhat woody base, belonging to the family Asclepiadaceae. It has been reported to have multiple pharmacological effect of anti-inflammatory, cardiotonic, anticancer, anthelmintic and to treat piles and gonorrhoea. It is to be expected that several activities might be related to a possible antioxidant action from this plant. The hydro alcoholic extract of Asclepias curassavica was tested in vitro for its antioxidant activities, such as DPPH radical, nitric oxide radical, superoxide anion radical, lipid peroxidation assay, hydroxyl radical, reducing power, and total phenol content. The extract exhibited scavenging potential with $IC_{50}$ value of $8.7\;{\mu}g/ml,\;198.4\;{\mu}g/ml\;and\;21.7\;{\mu}g/ml$ for DPPH, nitric oxide and superoxide anion radicals. The values were found to higher than those of Vitamin-C, rutin, and curcumin, as standards. The extract showed 50% protection at the dose of $134.2\;{\mu}g/ml\;and\;41.4\;{\mu}g/ml$ in lipid peroxidation as well as deoxyribose degradation, those values more to that of standard, vitamin E $(IC50\;values,\;119.2\;{\mu}g/ml\;and\;32.5\;{\mu}g/ml,\;respectively)$. The reducing power of the extract depends on the concentration and amount of extract. Since a significant amount of polyphenol could be detected by the equivalent to $0.0495\;{\mu}g$ of pyrocatechol from 1 mg of extract. It can be concluded that hydro alcoholic extract of aerial part of Asclepias curassavica could be considered as potent antioxidant, which makes it suitable for the prevention of human disease.

Antioxidant potentials of Hypericum hookerianum (Family: Hypericaceae) on CCl4 induced hepatotoxicity in rats

  • Wahile, Atul;Mukherjee, Kakali;Kumar, Venkatesan;Saha, Bishnu Pada;Mukherjee, Pulok K
    • Advances in Traditional Medicine
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    • 제7권1호
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    • pp.85-93
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    • 2007
  • Free radicals are known to play important role in pathophysiology of hepatic disorders and antioxidants are employed along with other chemotherapeutic agents in treatment of such diseases. In search of natural antioxidant, successive extracts of Hypericum (H.) hookerianum (Family: Hypericaceae) were evaluated by in vitro and in vivo methods. Extracts of aerial parts of H. hookerianum were subjected for 1,1-diphenyl 2-picryl hydrazyl radical scavenging activity (DPPH assay), nitric oxide radicals scavenging assay and thiobarbituric acid reactive substances (TBARS) assay. Methanolic extract was found to be more active than other extracts in DPPH and in vitro TBARS assay with $IC_{50}$ at 5.82 ${\pm}$ 1.33 ${\mu}g/ml$ and 49.78 ${\pm}$ 3.79 ${\mu}g/ml$ respectively. While petroleum ether extract showed more potentials in scavenging the nitric oxide radicals with $IC_{50}$ 220.97 ${\pm}$ 2.69 ${\mu}g/ml$. The administration of $CCl_{4}$ to the control animals caused decrease in the level of catalase and superoxide dismutase, together with significant increase in the level of TBARS in liver and kidney. Reversal of these changes towards normal group was observed by administration of H. hookerianum methanolic extract at 50 and 100 mg/kg body weight, while other extracts were found to be less active.

조영제부작용에 대한 제조물책임의 한계 (The Frontiers of Product Liability for Adverse Reactions to the Contrast Medium)

  • 임창선
    • 한국산학기술학회논문지
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    • 제9권5호
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    • pp.1386-1391
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    • 2008
  • 제조물책임법에 의하면 조영제 제조업자는 조영제결함으로 인한 조영제부작용에 대해 환자에게 손해배상책임이 있다. 그러나 환자 측에서 조영제부작용이 조영제의 결함에 의한 것이라는 것을 증명하기 어려울 것이며, 그에 따라 조영제부작용을 제조물책임으로 묻기 어려울 것이다. 또한 조영제 제조회사에 제조물책임이 있다고 하여 조영제 부작용에 대한 의료기관이나 조영검사자의 법적 책임을 덜 수도 없을 것이다. 오히려 조영검사를 위해 조영제 농도를 조정하는 조제행위가 이루어지는 경우에 이에 관여한 의사방사선사도 조제조영제에 대한 제조물책임의 주체가 되어 제조물책임을 져야 하는 문제가 발생할 수 있게 된다. 그러므로 조영제부작용을 제조물책임으로 묻는 데는 신중해야 하며 조영검사자와 환자 측 양방을 보호할 수 있는 합리적인 새로운 법리가 모색되어야 할 것이다.