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Effect of pharmaceutical additives on physicochemical properties of pharmaceutical preparations.

Research Project

Project/Area Number 08672491
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeSingle-year Grants
Section一般
Research Field Physical pharmacy
Research InstitutionKobe Pharmaceutical University

Principal Investigator

MATSUDA Yoshihsa  Kobe Pharmaceutical University, Professor, 薬学部, 教授 (30068332)

Co-Investigator(Kenkyū-buntansha) OTSUKA Makoto  Kobe Pharmaceutical University, Associate Professor, 薬学部, 助教授 (90160548)
Project Period (FY) 1996 – 1997
Project Status Completed (Fiscal Year 1997)
Budget Amount *help
¥2,200,000 (Direct Cost: ¥2,200,000)
Fiscal Year 1997: ¥800,000 (Direct Cost: ¥800,000)
Fiscal Year 1996: ¥1,400,000 (Direct Cost: ¥1,400,000)
KeywordsPolymorphism / additives / international harmonization / excipients / reaction rate / powder characteristics / pharmaceutical properties / kinetics
Research Abstract

In order to harmonize the regulation of pharmaceutical products, the tests for physicochemical properties of pharmaceutical preparations are important. The physicochemical properties of expicients affect their bioavailability of the preparations through effects on the dissolution rate, disintegration time, tabelt hardness. Thus, the design of pharmaceutical preparations, specially the interaction between the pharmaceutical additives and bulk drug powders which are practically insoluble in water affects on the bioavailability of the preparations, and the stability during storage period. However, there is no evaluation method concerning the effect of pharamceutical additives on the preparations in Pharmacopoeia in countries throughout the world. Therefore, we investigate the relationship between the physicochemical properties of pharmaceutical products and the effect of additives during storage period.
1)Effect of solvents on polymorphic transformation of piretanide, etc during granulation process were investigated.
2)Effect of mixing mode on the coloration of compound isoniazid sodium methanesulfonate and pyridoxal calcium phospate was investigeted.
3)In order to improvement of the photostability (Vitamin K1) in model infusion fluids, Effect of addition of fat-soluble vitamine on the photodegradation of phytonadione was investigated by kinetics methods.
4)Effect of excipients on polymorphic transformation of carbamazepine during tabletting compression was investigated.

Report

(3 results)
  • 1997 Annual Research Report   Final Research Report Summary
  • 1996 Annual Research Report
  • Research Products

    (23 results)

All Other

All Publications (23 results)

  • [Publications] M.Otsuka and Y.Matsuda: "Comparative Evaluation of Mean Particle Size of Bulk Drug Powder in Pharmaceutical Preparations by Fourier-Transformed Powder Diffuse Reflectance Infrared Spectroscopy" J.Pharm.Sci.85 (1). 112-116 (1996)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1997 Final Research Report Summary
  • [Publications] 寺岡麗子、大塚 誠、ら: "イドアジドスルホン酸ナトリウム・リン酸ピリドキサールカルシウム散の着色変化に及ぼす混合様式の影響" 病院薬学. 22 (2). 198-205 (1996)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1997 Final Research Report Summary
  • [Publications] Y.Chikaraishi, M.Otsuka et al.: "Preparation of Piretanide Amorphous and Polymorphs and their Physicochemical Properties and Solubilities." Chem.Pharm.Bull.,. 44 (8). 1614-1617 (1996)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1997 Final Research Report Summary
  • [Publications] 寺岡麗子, 松田芳久 ら: "フィトナジオン輸液の光安定化設計:脂溶性ビタミンの添加により光分解抑制効果." 病院薬学. 22 (5). 449-456 (1996)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1997 Final Research Report Summary
  • [Publications] Y.Chikaraishi, M.Otsuka et al.,: "Dissolution Phenomena of the Piretanide Amorphous Form Involving Phase Change" Chem.Pharm.Bull.,. 44 (11). 2111-2115 (1996)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1997 Final Research Report Summary
  • [Publications] 松田 芳久ら: "安定性試験法の国際調和に関する研究" 医薬品規制ハ-モナイゼーション推進国際共同研究 平成七年度研究業績報告書. 31-34 (1996)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      1997 Final Research Report Summary
  • [Publications] M.OTSUKA and Y.MATSUDA: "Comparative Evaluation of Mean Particle Size of Bulk Drug Powder in Pharmaceutical Preparations by Fourier-Transformed Powder Diffuse Reflectance Infrared Spectroscopy" J.Pharm.Sci.85(1). 112-116 (1996)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1997 Final Research Report Summary
  • [Publications] R.TERAOKA,M.OTSUKA,et al.: "Effect of mixing mode on the coloration of compound isoniazid sodium methanesulfonate and pyridoxal calcium phospate" Jpn.J.Hosp.Pharm.22(2). 198-205 (1996)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1997 Final Research Report Summary
  • [Publications] Y.CHIKARAISHI,M.OTSUKA et al.: "Preparation of Piretanide Amorphous and Polymorphs and theri Physicochemical Properties and Solubilities" Chem.Pharm.Bull.44(8). 1614-1617 (1996)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1997 Final Research Report Summary
  • [Publications] R.TERAOKA,Y.MATSUDA,et al.: "Improvement of the photostability of phytonadione (Vitamin K1) in model infusion fluids : Effect of addition of fat-soluble vitamine on the photodegradation of phytonadione" Jpn.J.Hosp.Pharm.22(5). 449-456 (1996)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1997 Final Research Report Summary
  • [Publications] Y.CHIKARAISHI,M.OTSUKA et al.: "Disslution Phenomena of the Piretanide Amorphous Form Involving Phase Change" Chem.Pharm.Bull.44(11). 2111-2115 (1996)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1997 Final Research Report Summary
  • [Publications] Y.MATSUDA,et al: "Study on the international hamodization of stability testing method" Annula Report on the Joint International Research for Promotion of ICH. (1995)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      1997 Final Research Report Summary
  • [Publications] M.Otsuka and Y.Matsuda: "Comparative Evaluation of Mean Particle Size of Bulk Drug Powder in Pharmaceutical Preparations by Fourier-Transformed Powder Diffuse Reflectance Infrared Spectroscopy and Dissolution Kinetics," J.Pharm.Sci.,. 85(1),. 112-116 (1996)

    • Related Report
      1997 Annual Research Report
  • [Publications] 寺岡麗子、大塚 誠、ら: "イドアジドスルホン酸ナトリウム・リン酸ピリドキサールカルシウム散の着色変化に及ぼす混合様式の影響," 病院薬学,. 22(2). 198-205 (1996)

    • Related Report
      1997 Annual Research Report
  • [Publications] Y.Chikaraishi,M.Otsuka et al.,: "Preparation of Piretanide Amorphous and Polymorphs and theri Physicochemical Properties and Solubilities," Chem. Pharm. Bull.,. 44(8). 1614-1617 (1996)

    • Related Report
      1997 Annual Research Report
  • [Publications] 寺岡麗子、松田芳久ら,: "フィトナジオン輸液の光安定化設計:脂溶性ビタミンの添加により光分解抑制効果," 病院薬学,. 22(5). 449-456 (1996)

    • Related Report
      1997 Annual Research Report
  • [Publications] Y.Chikaraishi,M.Otsuka et al.,: "Disslution Phenomena of the Piretanide Amorphous Form Involving Phase Change," Chem. Pharm. Bull.,. 44(11),. 2111-2115 (1996)

    • Related Report
      1997 Annual Research Report
  • [Publications] 松田 芳久: "安定性試験法の国際調和に関する研究" 医薬品規制ハ-モナイゼーション推進国際共同研究 平成七年度研究業績報告書. 31-34 (1996)

    • Related Report
      1997 Annual Research Report
  • [Publications] M.Otsuka et al.: "Comparative Evaluation of Mean Particle Size of Bulk Drug Powder in Pharmaceutical Preparations by Fourier-Transformed Powder Diffuse Reflectance Infrared Spectroscopy and Dissolution Kinetics." J.Pharm.Sci.85. 112-116 (1996)

    • Related Report
      1996 Annual Research Report
  • [Publications] 寺岡 麗子、他: "イドアジドスルホン酸ナトリウム・リン酸ピリドキサールカルシウム酸の着色変化に及ぼす混合様式の影響." 病院薬学.22. 198-205 (1996)

    • Related Report
      1996 Annual Research Report
  • [Publications] Y.Chikaraishi,et al.: "Preparation of Piretanide Amorphous and Polymorphs and theri Physicochemical Properties and Solubilities." Chem.Pharm.Bull.44. 1614-1617 (1996)

    • Related Report
      1996 Annual Research Report
  • [Publications] 寺岡 麗子、他: "フィトナジオン輸液の光安定化設計:脂溶性ビタミンの添加により光分解抑制効果。" 病院薬学.22. 449-456 (1996)

    • Related Report
      1996 Annual Research Report
  • [Publications] Y.Chikaraishi,et al.: "Disslution Phenomena of the Piretanide Amorphous Form Involving Phase Change." Chem.Pharm.Bull.44. 2111-2115 (1996)

    • Related Report
      1996 Annual Research Report

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Published: 1996-04-01   Modified: 2016-04-21  

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