Basic Evaluation Techniques in Pharmaceutical Formulation Study

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  • KANEKO Hideo
    Daiichi Pharmaceutical Co., LTD Pharmaceutical Technology Research LaboratoriesTokyo Pharmaceutical Research Center
  • TSUGE Hideya
    Daiichi Pharmaceutical Co., LTD. Pharmaceutical Technology Research Laboratories Osaka Pharmaceutical Research Center
  • SHIMABAYASHI Saburo
    The University of Tokushima Faculty of Pharmaceutical Sciences Division of Physical Pharmacy

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Other Title
  • 最近の製剤研究にみる評価技術
  • サイキン ノ セイザイ ケンキュウ ニ ミル ヒョウカ ギジュツ

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Abstract

“Oleoscience” is very useful and important in formulation research and development, and the associated technologies are now often employed during the pharmaceutical formulation development stage. In this review, some “Oleoscience” based methods used in recent pharmaceutical formulation development studies are illustrated and evaluated. The following experiments are described : measuring the degree of self-assembly between the molecules of a drug by using the physicochemical method; analyzing the relationship between orally administered dose in human and capacity factor determined from liposome chromatography; estimating the physicochemical stability of liposomes by osmometry; determination of the thickness of the hydration layer around liposomes by measuring zeta-potentials; estimating the degree of aggregation in water/oil emulsions using dielectric relaxation measurement; particle size determination of perfluorocarbon/water emulsions by phase doppler particle analysis; analysis of an immuno-reaction between drug-antibody complex and antigen expressed by tumor cells using surface plasmon resonance method; molecular weight determination of macromolecular drugs by using light-scattering, and so on. The number of poorly or less water-soluble and macromolecular drugs is increasing, providing fresh challenges for pharmaceutical formulation research. New drug delivery technology is expected to provide novel solutions to some of the problems often encountered when developing suitable formulations for these new types of products. The methods described in this review demonstrate some of the basic and important technologies for drug delivery, which are required to support this rapidly growing area of pharmaceutical research.

Journal

  • Oleoscience

    Oleoscience 1 (7), 725-733,722, 2001

    Japan Oil Chemists' Society

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