1998 Fiscal Year Final Research Report Summary
Development of pulmonary drug delivery system with dry powder and aqueous suspension aerosols
| Project/Area Number |
08457595
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| Research Category |
Grant-in-Aid for Scientific Research (B)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Physical pharmacy
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| Research Institution | GIFU PHARMACEUTICAL UNIVERSITY |
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Principal Investigator |
KAWASHIMA Yoshiaki Gifu Pharmaceutical University, Pharmacy, Professor, 薬学部, 教授 (30082978)
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| Co-Investigator(Kenkyū-buntansha) |
YAMAMOTO Hiromitsu Gifu Pharmaceutical University, Pharmacy, Assistant, 薬学部, 助手 (30275094)
HINO Tomoaki Gifu Pharmaceutical University, Pharmacy, Assistant (Present, Tokushima Universi, 薬学部, 助教授 (90208778)
TAKEUCHI Hirofumi Gifu Pharmaceutical University, Pharmacy, Associate Professor, 薬学部, 助教授 (50171616)
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| Project Period (FY) |
1996 – 1998
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| Keywords | dry powder inhalation / pulmonary delivery / aerosolized aqueous suspension / nanocapsule / lactide / glycolide copolymer / nebulizer / insulin / surface modification |
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| Research Abstract |
The evaluation methods for the dry powder inhalation dosage forms (DPI) were developed by using cascade impactor and twinimpinger, which have been utilizing to evaluate for metered dose inhalation dosage forms. The in vivo evaluation system for DPI with aerosol generator, dispersing chamber, respirator and particle concentration monitoring system was successfully established. The in vivo evaluation system for the nebulized aqueous suspension was also designed consisting with nebulizer, spacer and respirator.
Dry powder inhalation dosage forms (DPI) with fine dispersibility into the air were successfully developed by modifying particle surface. Pranlukast hydrate (antiasthmatic drug) was used as a model drug particle. Colloidal hydrophilic light anhydrous silicic acid (AEROSIL 200) or hydroxypropylmethylcellulose phthalate (HP-55) nanosphere was used as surface modifying agent. Particle surfaces were modified with AEROSIL 200 and HP-55 by high-speed elliptical-rotor type mixer and freeze
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-dry or spray dry method, respectively. The inhalation characteristics of pranlukast hydrate were improved significantly with the surface modification. The pharmacological activity of surface modified drug after pulmonary administration to guinea pig was also enhanced compared with unmodified particle. The ED5O of pulmonaryly administered drug was smaller than that of intravenous administration.
DL-lactide/glycolide copolymer nanocapsules with insulin were developed by the emulsion solvent diffusion method in water. The nebulized PLGA nanospheres by a sieve type ultrasonic nebulizer were administered by using a respirator into the trachea of the fasted guinea pig. After the administration of insulin encapsulated in the PLGA nanospheres, the blood glucose level reduced significantly and the hypoglycemia prolonged over 48hrs, compared to the nebulized aqueous solution of insulin as a reference (8 hrs). This result could be attributed to the sustained releasing of insulin from the nanospheres deposited widely on the whole lung. It might be possible to develop a new non-parenteral dosage form of peptide drug by using the present system developed. Less
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