Document Detail

Release of hydrocortisone from a cream matrix: dependency of release on suspension concentration and measurement of solubility and diffusivity.
MedLine Citation:
PMID:  11485179     Owner:  NLM     Status:  MEDLINE    
The principal object of the present research was to investigate the sensitivity of drug release from a semisolid system to the manner of its preparation and to the concentration of drug placed within it. Established theory indicated that release should be concentration dependent, with the specific dependency determined by whether the drug in the system is fully in solution or is present substantially as suspended matter. To purposefully explore these relatively untested performance expectations, the total amount of drug in the formula was varied from a low concentration of 0.25% to a high concentration of 3%. Conditions were established such that drug release conformed to release from a semi-infinite medium into a receptor sink. At every concentration, release profiles were well reproduced in replicate samples and, where multiple lots of a kind were employed, from lot to identical lot. In all cases square root of time release kinetics were observed. Moreover and without exception, the square root of time release rate from run to run was directly proportional to the square root of the total concentration of hydrocortisone placed in the formulations. The amount released per square root of time per square root of total concentration was nearly identical from run to run irrespective of total concentration. The overall behavior fit theoretical expectations for suspensions having only a small fraction of the drug they contain in solution. That this condition prevailed even at the lowest 0.25% hydrocortisone strength was proven by independently measuring hydrocortisone's solubility (0.02%). Measurement of solubility permitted estimation of the effective diffusivity of the drug through the cream (2 x 10(-7) cm2/s).
R Pillai; V Shah; L Abriola; P Caetano; G L Flynn
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Validation Studies    
Journal Detail:
Title:  Pharmaceutical development and technology     Volume:  6     ISSN:  1083-7450     ISO Abbreviation:  Pharm Dev Technol     Publication Date:  2001 Aug 
Date Detail:
Created Date:  2001-08-03     Completed Date:  2002-01-22     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9610932     Medline TA:  Pharm Dev Technol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  373-84     Citation Subset:  IM    
DPT Laboratories, San Antonio, TX 78215, USA.
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MeSH Terms
Administration, Cutaneous
Administration, Topical
Anti-Inflammatory Agents / chemical synthesis,  chemistry*
Chemistry, Pharmaceutical
Delayed-Action Preparations / chemical synthesis,  chemistry
Therapeutic Equivalency
Reg. No./Substance:
0/Anti-Inflammatory Agents; 0/Delayed-Action Preparations; 0/Emulsions; 50-23-7/Hydrocortisone

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

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