Document Detail

Development of a colon delivery capsule and the pharmacological activity of recombinant human granulocyte colony-stimulating factor (rhG-CSF) in beagle dogs.
MedLine Citation:
PMID:  7545751     Owner:  NLM     Status:  MEDLINE    
A peroral dosage form was examined to deliver recombinant human granulocyte colony-stimulating factor (rhG-CSF) to the colon in beagle dogs. A new gelatin capsule with its inside surface coated with ethylcellulose was prepared for this purpose. RhG-CSF was dissolved with propylene glycol and was filled in the capsule. Several kinds of ethylcellulose-gelatin capsules with an ethylcellulose layer of thickness 46 to 221 mm were used. The capsule was filled with propylene glycol solution containing fluorescein as an absorption marker, castor oil derivative and citric acid. The hardness of the capsule was tested after the gelatin layer was dissolved using a hardness tester and was dependent on the thickness of the ethylcellulose layer of the capsule. The time, Tmax, at which plasma fluorescein level reaches its maximum following oral administration of ethylcellulose capsules was used as a parameter for the in-vivo disintegration time of the ethylcellulose capsule into the colon. Capsules of thickness 84 mm with a Tmax of 4-6 h were filled with rhG-CSF solution containing fluorescein and were administered to dogs. After administration, blood samples were collected for 96 h and the blood total leucocyte (BTL) counts were measured as a pharmacological index of rhG-CSF. The maximum BTL count appeared at 10 h then gradually decreased and returned to its normal level at 48 h. These results suggest the usefulness of ethylcellulose capsules for the delivery of rhG-CSF to the colon and the possibility of a new oral rhG-CSF dosage form has been elucidated.
T Takaya; C Ikeda; N Imagawa; K Niwa; K Takada
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of pharmacy and pharmacology     Volume:  47     ISSN:  0022-3573     ISO Abbreviation:  J. Pharm. Pharmacol.     Publication Date:  1995 Jun 
Date Detail:
Created Date:  1995-10-18     Completed Date:  1995-10-18     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  0376363     Medline TA:  J Pharm Pharmacol     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  474-8     Citation Subset:  IM    
Department of Pharmaceutics and Pharmacokinetics, Kyoto Pharmaceutical University, Japan.
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MeSH Terms
Cellulose / analogs & derivatives
Chemistry, Physical
Colon / metabolism*
Granulocyte Colony-Stimulating Factor / administration & dosage*,  pharmacokinetics*
Leukocyte Count
Physicochemical Phenomena
Recombinant Proteins / administration & dosage
Sulfapyridine / blood
Reg. No./Substance:
0/Capsules; 0/Fluoresceins; 0/Recombinant Proteins; 0/Solutions; 143011-72-7/Granulocyte Colony-Stimulating Factor; 144-83-2/Sulfapyridine; 2321-07-5/Fluorescein; 9000-70-8/Gelatin; 9004-34-6/Cellulose; 9004-57-3/ethyl cellulose

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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