Document Detail


Effects of pharmaceutical processing on pepsin activity during the formulation of solid dosage forms.
MedLine Citation:
PMID:  23216083     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
The main aim of this study was to investigate the effects of pharmaceutical technological methods on pepsin activity during the formulation of solid dosage forms. The circumstances of direct compression and wet granulation were modeled. During direct compression, the heat and the compression force must be taken into consideration. The effects of these parameters were investigated in three materials (pure pepsin, and 1:1 (w/w) pepsin-tartaric acid and 1:1 (w/w) pepsin-citric acid powder mixtures). It was concluded that direct compression is appropriate for the formulation of solid dosage forms containing pepsin through application without acids or with acids at low compression force. The effects of wet granulation were investigated with a factorial design for the same three materials. The factors were time, temperature and moisture content. There was no significant effect of the factors when acids were not applied. Temperature was a significant factor when acids were applied. The negative effect was significantly higher for citric acid than for tartaric acid. It was found that wet granulation can be utilized for the processing of pepsin into solid dosage forms under well-controlled circumstances. The application of citric acid is not recommended during the formulation of solid dosage forms through wet granulation. A mathematically based optimization may be necessary for preformulation studies of the preparation of dosage forms containing sensitive enzymes.
Authors:
Katalin Kristó; Klára Pintye-Hódi
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Pharmaceutical development and technology     Volume:  18     ISSN:  1097-9867     ISO Abbreviation:  Pharm Dev Technol     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2012-12-11     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9610932     Medline TA:  Pharm Dev Technol     Country:  England    
Other Details:
Languages:  eng     Pagination:  17-21     Citation Subset:  IM    
Affiliation:
Department of Pharmaceutical Technology, University of Szeged , Szeged , Hungary.
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