Evaluation of Additives Required for Periodontal Disease Formulation Using Basic Fibroblast Growth Factor

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  • Sato Yasuhiko
    Drug Formulation Department, Central Research Laboratories, Kaken Pharmaceutical Co., Ltd.
  • Oba Takuma
    Drug Formulation Department, Central Research Laboratories, Kaken Pharmaceutical Co., Ltd.
  • Natori Nobuyuki
    Drug Formulation Department, Central Research Laboratories, Kaken Pharmaceutical Co., Ltd.
  • Danjo Kazumi
    Faculty of Pharmacy, Meijo University

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To design a suitable periodontal disease formulation using basic fibroblast growth factor (bFGF), legally available thickeners were evaluated focusing on their viscosity, extrusive force from a syringe, flow property and inertness to bFGF. Thirteen candidate thickeners showed appropriate viscosity (about 1×104 mPa·s), and further evaluations were conducted on them. Flow property was evaluated by the tilting test tube method. As a result, most thickener solutions with the optimum viscosity showed appropriate flow time (about 100 s) and the flow time did not depend on thickener concentration, whereas the extrusive force from a syringe depended on thickener concentration despite the thickener type and grade. Thickener solutions of 2—3% showed ideal result (10—20 N) and thickener solutions prepared outside of the concentration range (2—3%) were found to show unsuitable extrusive force. Consequently, to obtain required properties for a dental drug formulation, thickener solutions needed to show adequate viscosity (about 1×104 mPa·s) at 2—3% thickener concentration. In addition, several types of cellulose derivatives showed inertness to the bFGF because of their structure, without strong ionic dissociable groups, and neutral pH. Overall, the present work demonstrates that some water-soluble cellulose derivatives, such as hydroxypropylcellulose (HPC) and hydroxyethylcellulose (HEC), were suggested to have required properties for a dental drug formulation including bFGF.

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