???????????????(wako100?wako10?wako500?903?Sacchachitosan)???????????????????????????????????acetaminophen?????????,?????????,????,Heckel plot ????????????????????

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???????????????(wako100?wako10?wako500?903?Sacchachitosan)???????????????????????????????????acetaminophen?????????,?????????,????,Heckel plot ????????????????????

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Title: ???????????????(wako100?wako10?wako500?903?Sacchachitosan)???????????????????????????????????acetaminophen?????????,?????????,????,Heckel plot ????????????????????

1
????????????????????????

??????????????????????,???????????????????????????
??????????????????????????????,???????????????????
????????????????????????,?????????????????????????
???
???????????????(wako100?wako10?wako500?903?Sacchac
hitosan)???????????????????????????????????acetami
nophen?????????,?????????,????,Heckel plot
???????????????????? (????,??????????)???????Sacch
achitosan?????????,???????????????????????????????
????????????????????Heckel plot???????????????????
?????????wako100?wako10??wako500?903??????????????
?wako10?wako100???????????
??wako 10?wako100?acetaminophen???????????????????
??????????????????????????????????????????????????
????????????????????,???????????70???????
???????????????????Acetaminophen??????????????????
???,wako10????30,wako100??10????????,???????????
???????????,??????????????????????????????????????
??????,????????(pH6.8)?,?????24???????,??????????
????????????????????,?????????????????????????????
????????,????????,??????????????????????

2
Physical and tabletting characterization of
chitosan obtained from various sources

Chitosan is a biodegradable and biocompatible
biopolymer leading to draw many researchs
interests. It has been investigated as an
excipient in the pharmaceutical field to be used
in direct compression, as a disintegrant for the
improvement of drug dissolution, as a matrix
material for the production of controlled release
solid dosage forms. The physical properties of
chitosan is mainly characterized by two
parameters degree of acetylation and molecular
weight. In this study, the possible use of
chitosan from two different sources with
variation in these two parameters as directly
compressible excipient for modification of drug
release were examined.
Five different chitosan products (wako10,
wako100, wako500, and 903 from shell chitin, and
sacchachitosan from sacchachitin) varied in
physical properties were selected for evaluation
of main factors influencing the success of direct
compression. Powder only and a series ratio of
binary mixture with acetaminophen were prepared
for characterization with the measurement of
powder rheology, compaction profiles, heckel plot
analysis, and drug dissolution in three different
conditions (simulated gastric fluid, pH-changing
medium, and simulated intestinal fluid).
Preliminary results demonstrated that the
compressibility of sacchachitosan was so poor to
form tablet even increasing compression force to
a higher value. Compaction profiles showed that
there was insignificant difference in profiling
parameters including effective work and ejection
force for all chitosan products compared. Yield
pressure calculated from Heckel plot for each
product also demonstrated to be insignificantly
different. However, the tensile strength of
tablets prepared with wako100 and wako10 was much
higher than that with wako500 and 903. Degree of
elastic recovery might be used to explain why
wako100 and wako10 could make tablets stronger.
The compressibility for a series of binary
mixture of acetaminophen and chitosan of wako100
and wako10 were determined. There also shows
insignificant difference in degree of elastic
recovery and effective work. With increasing the
percentage of chitosan in the formulation, the
ejection force of tablets decreased and the
tensile strength of tablets increased
correspondingly. The yield pressure of tablets
decreased with increasing percentage up to 70 of
chitosan in tablet formulation as well for all
types of chitosan examined, and then increased
afterward with increasing the percentage of
chitosan.
The drug release of acetaminophen from binary
mixture of acetaminophen and wako100 (or wako10)
was examined in three different media. The drug
release follows a sustained manner in simulated
gastric fluid (pH1.2) when the percentage of
chitosan in tablet formulation is greater than
30 for wako10 and 10 for wako100. This is
expectedly due to the gelling effect of chitosan
in contact with acidic environment. Since that,
the higher viscosity of chitosan is used, the
less amount of chitosan is needed to achieve the
sustained effect. Dissolution under pH-changing
medium, the sustainability of drug release is
even extended to be longer than 24 hours after
changing to simulated intestinal fluid (pH6.8).
This might be ascribed to the insolubility of
chitosan in neutral pH leading to the formation
on the tablet surface of gel barrier with higher
resistance than that formed in acidic medium.
However, the dissolution of these tablets in the
simulated intestinal fluid was faster as a result
of disintegration effect of chitosan. This
disintegration effect of chitosan might be
explainable by its insolubility in neutral medium.