Abstract：
:A swellable matrix tablet is described which is partially coated with cellulose acetate (CA) to obtain a film having the shape of a cup, whose permeability to water and solutes was altered by mixing increasing amounts of poly(ethylene glycol) 400 (PEG). The drug-release mechanism from such systems was assessed by carrying out drug-release experiments both in water and saline solutions. Drug permeability through the polymeric cup and SEM analysis on the films were also performed. It was found that the systems exhibited drug-release kinetics very close to linearity. The mechanisms governing drug release were (i) drug diffusion through the uncoated gel layer, (ii) drug transport through the gel layer due to the osmotic pressure difference, and (iii) drug diffusion through the cup pores. The relative importance of each contribution depended on the amount of PEG in the film. The systems with a cup containing 1%, 13%, and 33% PEG w/w behaved in part as osmotic systems, whereas the system having a permeable cup behaved as a hybrid reservoir system. These modifications of the coating permeability introduce a further possibility of modulating drug-release kinetics and lead to a reduced dependence of swellable matrix tablet release on environmental conditions.
journal_name
J Pharm Scijournal_title
Journal of pharmaceutical sciencesauthors
Catellani PL,Colombo P,Peppas NA,Santi P,Bettini Rdoi
10.1021/js9800026subject
Has Abstractpub_date
1998-06-01 00:00:00pages
726-31issue
6eissn
0022-3549issn
1520-6017pii
S0022-3549(15)50584-4journal_volume
87pub_type
杂志文章abstract：:This study examined the safety, pharmacodynamic and pharmacokinetic similarity of the human recombinant filgrastim products ior®LeukoCIM and Neupogen® following a 28-day repeated subcutaneous dose administration in male and female Sprague-Dawley rats with a 14-day recovery period. Safety profiling was based on clinica...
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abstract：:Currently, the EMEA, FDA, and WHO as regulatory authorities accept rapidly dissolving (>85% dissolved in 30 min) biopharmaceutics classification system (BCS) I drug products for biowaiver candidates. In the draft EMEA guideline the requirement has been set tighter, that is, the drug product should be very rapidly diss...
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