Document Detail

Novel approach to DPI carrier lactose with mechanofusion process with additives and evaluation by IGC.
MedLine Citation:
PMID:  17077547     Owner:  NLM     Status:  MEDLINE    
The effect of lactose carrier surface property on the inhalation profile of dry powder inhaler (DPI) was evaluated using a micronized drug (Compound A) by inverse gas chromatography (IGC). Mechanofusion with magnesium stearate (Mg-St) or sucrose stearate increased the fine particle fraction (FPF), considered to be due to decrease in the interaction between Compound A and the lactose carrier. The effect of Compound A concentration on FPF was smaller in mechanofusion-processed lactose compared to intact lactose, especially when processed with Mg-St. The relationship between the IGC parameters of the lactose and FPF was also investigated. FPF increased as both the dispersive component of the surface energy and acidity similarity between the lactose carriers and Compound A increased. Although further investigation is necessary, it could be suggested that acidity similarity decreases the interaction between Compound A and lactose, thus contributing to the increase in the FPF. In conclusion, (1) mechanofusion with Mg-St or sucrose stearate could be an effective method to improve FPF of a DPI drug formulation; (2) IGC would be a valuable method to investigate the interaction between a drug and the DPI carrier; and (3) a relationship between surface acidity and inhalation profile was suggested.
Michiko Kumon; Masahiko Suzuki; Akira Kusai; Etsuo Yonemochi; Katsuhide Terada
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Publication Detail:
Type:  Evaluation Studies; Journal Article    
Journal Detail:
Title:  Chemical & pharmaceutical bulletin     Volume:  54     ISSN:  0009-2363     ISO Abbreviation:  Chem. Pharm. Bull.     Publication Date:  2006 Nov 
Date Detail:
Created Date:  2006-11-01     Completed Date:  2007-02-08     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0377775     Medline TA:  Chem Pharm Bull (Tokyo)     Country:  Japan    
Other Details:
Languages:  eng     Pagination:  1508-14     Citation Subset:  IM    
Pharmaceutical Development Laboratories, Sankyo Co., Ltd., Hiratsuka, Kanagawa, Japan.
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MeSH Terms
Chromatography, Gas / instrumentation,  methods
Drug Carriers / chemistry*
Drug Delivery Systems
Equipment Design
Ethers / chemistry*
Hydrocarbons, Fluorinated / chemistry*
Lactose / chemistry*
Microscopy, Electron, Scanning / methods
Particle Size
Sensitivity and Specificity
Surface Properties
Reg. No./Substance:
0/Drug Carriers; 0/Ethers; 0/Hydrocarbons, Fluorinated; 0/Powders; 58109-34-5/fluoromethyl 2,2-difluoro-1-(trifluoromethyl)vinyl ether; 63-42-3/Lactose

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