• 제목/요약/키워드: Dosage forms

검색결과 160건 처리시간 0.023초

A Goneral Procedure for Testing Equivalence

  • Sung Nae Kyung
    • Communications for Statistical Applications and Methods
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    • 제5권2호
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    • pp.491-501
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    • 1998
  • Motivated by bioequivalence studies which involve comparisons of pharmaceutically equivalent dosage forms, we propose a more general decision rule for showing equivalence simultaneously between multiple means and a control mean. Namely, this testing procedure is concerned with the situation in that one must make decisions as to the bioequivalence of an original drug product and several generic formulations of that drug. This general test is developed by considering a spherical confidence region, which is a direct extension of the usual t-based confidence interval rule formally approved by the U.S. Food and Drug Administration. We characterize the test by the probability of rejection curves and assess its performance via Monte-Carlo simulation. Since the manufacturer's main concern is the proper choice of sample sizes, we provide optimal sample sizes from the Monte-Carlo simulation results. We also consider an application of the generalized equivalence test to a repeated measures design.

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의약품첨가물과 규격관리 (The Quality Regulation of Drug Excipients)

  • 최명신;홍정희;장성재;강찬순
    • Journal of Pharmaceutical Investigation
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    • 제33권1호
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    • pp.67-71
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    • 2003
  • Drug excipients are material used in the formulation of pharmacologically active drugs. They have a variety of roles including dilutents/fillers/bulking agents, binders/adhesives, propellant, disintegrants, lubricants/dlidants, colors, flavors, coating agents, polising agents, fragrance, sweeteening agent, polymers and waxes. Excipient should be inert or inactive and does not interfere with the test. Nowadays within industry there has been a recent surge of interest in novel excipient for novel dosage forms. The purpose of the review is to introduce the administration systems of drug excipient about kinds, matters to be attended to change of excipients.

분말성제제(粉末性製劑)의 안정성(安定性)에 관(關)한 연구(硏究) -제제중(製劑中)의 Ascorbic Acid의 분해(分解)에 미치는 Talc의 영향(影響)- (Study on the Effect of Talc on the Degredation of Ascorbic Acid in its Diluted Preparation)

  • 정기화;이민화;우종학;김신근
    • Journal of Pharmaceutical Investigation
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    • 제2권1호
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    • pp.52-57
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    • 1972
  • There are many reports on the stability of drugs in powders and various dosage forms. The author studied on the stability of ascorbic acid mixed with talcs. From the result of this experiment, it was considered that talcs markedly accelerated oxidative degredation of ascorbic acid in powders and the acceleration rate depends on the varieties of crude talcs. Iron salts seem to be the principal factor influencing the degradation of ascorbic acid Degradation rate of ascorbic acid mixed with purified talc is significantly slower than that with the crnde talcs. The more the concetration of ascorbic acid is diluted, the faster the degradation rate and degredation rate of Ascorbic acid is the function of tme.

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An overview on recent new nano-anti-parasitological findings and application

  • Farhoudi, Ramin
    • Advances in nano research
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    • 제5권1호
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    • pp.49-59
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    • 2017
  • Till now nanotechnology based anti-parasite pharmaceutical dosage forms development and application is being vastly developed worldwide. The field of nanotechnology involves an array of different areas of expertise with the application of innovative products in Medicine, Engineering, and to a less extent to Veterinary Medicine. In our conclusion, enriched experimental analysis is required, to announce the state of the art outputs to remove negative problems. Animals or human may benefit from nanotechnological products respectively, like vaccines, target recombinant peptides, or novel pharmaceutical alternatives. As a result, it would be desirable to give some energy for thought to drive nanomedical scientific introductions. To create more safe medium to animals and or humans. In this review all aspects of nanoparticles applications in parasitology will be carefully discussed depending on particle charge and size as well as kind of nanoparticles. Perspectives and prospective of nanoparticles in human parasitology will be predicted as well.

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

  • 최옥;김승수;박은석;지상철
    • Journal of Pharmaceutical Investigation
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    • 제32권2호
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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.

Pharmacokinetic and Pharmacodynamic Characteristics of Cyclosporin A in Rats and Rabbits

  • Lee, Yong-Bok
    • 대한약학회:학술대회논문집
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    • 대한약학회 2002년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
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    • pp.214-217
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    • 2002
  • Cyclosporin A (CSA) is a poorly water-soluble cyclic peptide comprising 11 amino acids. It inhibits T-lymphocyte function that plays an important role in the induction of immune response. The potent immunosuppressive activity of CSA has been used for the prevention of rejection following transplantation of liver, kidney and bone marrow, etc. The use of CSA has been often limited by several disadvantages including low bioavailability, narrow therapeutic window, nephrotoxicity, hepatotoxicity and neurotoxicity. Moreover, CSA injection is limited to patients who are unable to take the oral preparations, because it has a risk of anaphylactic shock and nephrotoxicity due to Cremophor EL$\textregistered$, a solubilizing agent used in the commercial intravenous formulation. Owing to above mentioned disadvantages of commercial products, there is a great interest in the development of the alternative dosage forms. (omitted)

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인제거를 위한 흡착제로써 분변토 재활용 (Recycling of Casts as an Adsorbent for Phosphorous Removal)

  • 손희정;김은호;이용희
    • 환경위생공학
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    • 제13권2호
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    • pp.76-81
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    • 1998
  • The technology of removing phosphorous, considered as one of the most important control nutrients causing eutrophication in various water bodies, have been investigated by many researchers. In this study, casts which can be obtained from the vermicomposting of mixing sewage sludge and cow manure, were used as an adsorbent, and their effects of several physical/chemical factors on the efficiencies of phosphorous adsorption were examined by batch tests. Generally, it could be showed that the efficiencies of phosphorous adsorption were very influenced by cast dosage, temperature and agitation speed. If we reflected the adsorption capacity(k) and adsorption intensity(1/n) of Freundlich isotherm, we couldn't consider casts as a good adsorbent for removing phosphorous. But, because casts were relatively excellent in cation exchange, in point of waste recycling, we could know that they were capable of removing phosphorous. The SEM observation revealed that the evident variations were hardly seen, but particle sizes of cast were relatively bigger and showed forms of smaller plate than before.

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사상의학에서의 탕제 복용법에 관한 문헌적 고찰 (A Literature Review on Methods of Taking Decoction in Sasang Constitutional Medicine)

  • 박세원;박성식
    • 사상체질의학회지
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    • 제29권2호
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    • pp.73-82
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    • 2017
  • Objective The purpose of this study was to provide appropriate methods of taking decoction in Sasang Constitutional Medicine. Methods We investigated the methods of taking decoction written in Lee Je-ma's writings such as "Donguisusebowon(東醫壽世保元)", "Donguisusebowon-Sasangchobongwon(東醫壽世保元四象草本卷)", "Dongmuyoogo(東武遺稿)" and several papers which related to methods of taking decoction. Results and Conclusions The effects of decoction can be affected by the methods of taking decoction. Therefore, when administering decoction of Sasang Constitutional Medicine to the patient, we should consider the stages of disease and condition of patient. This paper shows the appropriate methods of taking decoction in Sasang Constitutional Medicine. Further studies should be needed to find out the appropriate administration methods of various dosage forms.

Studies of Complex Formation between the Bromophenol Blue and some Important Aminoquinoline Antimalarials

  • Saadia-Mohamed-El-Ashry;Aly, Fatma-Ahmed;Amina-Mohamed-El-Brashy
    • Archives of Pharmacal Research
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    • 제17권6호
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    • pp.415-419
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    • 1994
  • A simple nad rapid colorimetric method for the assay of amodiaquine hydrochloride, chloroquine phosphate and primaquine phosphate is described. The method is based on the interaction of the drug base with bromophenol blue to give a ion-pair complex. The spectra of the complex shows a maxima at 415-420 nm with high apparent molar absorptivities. Beer's law was obeyed in the concentration range 1-8, 2-10 and $2-12{\;}{\mu}{\cdot}ml^{-1}$ for amodiaquine hydrochloride, primaquine phosphate and chloroquine phosphate respectively. The proposed method was applied to the determination of these drugs in certain formulations and the results were favourably comparable to the official methods.

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서방출성 플루르비프로펜 정제의 제제설계 (Formulation of Sustained-Release Tablets of Flurbiprofen)

  • 이상철;박은석;지상철
    • 약학회지
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    • 제39권2호
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    • pp.185-192
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    • 1995
  • Flurbiprofen, one of potent nonsteroidal antiinflammatory drugs, has several systemic side effects due to dose dumping effect following oral administration of its conventional solid dosage forms. To reduce these side effects and to sustain therapeutic concentration of the drug, matrix tablets of flurbiprofen were prepared and evaluated for sustained release from the tablets. The matrix tablets of flurbiprofen were prepared with Eudragit, Pluronic, (anhydrous) lactose and colloidal silicon dioxide employing two different preparation methods, wet granulation and direct compression. The dissolution rates of the tablets were evaluated using KP 2 method. Formulation factors that affected dissolution rates of flurbiprofen were the type and content of Eudragit, the type and content of Pluronic, and the tablet preparation method. Several formulations of the matrix tablets showed dissolution patterns close to the simulated profile using pharmacokinetic parameters of flurbiprofen.

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