\ w - "/_.-
Roll No. ......................
\.:21:t"-
Total No. of Questions : 06]
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[1btal No. of Pirgcs : 02
M. Pharmacy (Sem.
_ 1.')
(pharmaceutics)
Dosage Forms Dcsign, Dcvclopmcut and proccss Valiclation
SUB.IECT CODE :PI{CEU-Sl3
Paoe{ ID : [E021.t]
lNo(. : pleasc
n[
surrjc.t code .nd
pip.r ID
Time:03 Ilours
Insllllclion to
1)
2)
-o
Ol)
Ca
oD
Otfll]
llaximum Marks
: 80
ndidrrcs:
Atterrpt any Fivc questions.
All
questions
caly
equal marks.
a'; What is mcant by preformulation studies? Euruneratc the type of
invcstigations-caried out dururg this phase.
eive a br.ief account of.the
approaches that can be applied for successfully formulating a BCS class
.
IV drug into an oral dosagc
fomt.
Q2)
+-
b)
Wirat is the rnechanism ofgaseous sterilization? Discuss the validation
of gascous sterilization process.
a)
Discuss thc significance ol partition coefficient with respect to
physiological pI{ in ilfluencing oral drug absorption. Enumeiate the
methods used for modilyihg the partilion coeflicient ofa drug.
*,
b) Whar are polymorphs and how this knowledge can bc applied to dosage
form design? Cotmert on the methods used for detecting polynorpllsm
of drrrg candidaics
Q3)
a)
Give examplcs of different types of cyclodextrins and mention their
applications in drug delivery.
b) Give examples of biodegradable poly,rners ald distinguish them from
bioerodable polymers. Mention their advantages and limitations. Briefly
explain thc rnethods used for explaining the m ha4li.sm of drug release
\aNcE5-\\
from thcsc polyrneric vehicles.
R-300
PT,O.
O4).
""
a)
"'
b
P5J
'-'
IQ OQandPQ
between
Meution the differenccs
{illing process'
validared lor a ascptic
MentiolFeters
;;l;
)
Exp
Ia i
n
r
hi x ot ro
py
""
I,:"[]T:X:X"JJ, ::,'ffi:'J
ProPcnies with
modilicr in matnx tablels'
resPect
#H
rJ":';
Writc short notes on
pH-independent drugrelec'
criteria of polymers for
release intra
"i"
of pollmers for sustained
,i"t'"n
h)
"'
Rheological ton'id"'ution
lomulation
*u,"uti
'j"ttable
a)
96)
b)
'rlelines? Briefly comment on these guidelines
sTnS-T'lf
whar
needed to be suttnxned'
the tlpe c d"ra rhat is
$erilization
"n*"tuting
protocol for validating filfation
idation
val
the
BrieflY describe
process'
*t
III
2
R-300