Co esponding au ho : P achi Nandkuma Padwal
Copy igh © 2025 Au ho (s) e ain he copy igh o his a icle. This a icle is published unde he e ms o he C ea i e Commons A ibu ion License 4.0.
Fo mula ion, De elopmen and e alua ion o Ni o u an oin able s d ug deli e y
sys ems
P achi Nandkuma Padwal 1, *, Akanksha Da a ay Kho e 2, Reema Chand akan Londhe 1, Madha i Baban
Ahe 2, Mujeba Rajjak Pa han 2 and Payal Heman Padwal 2
1 Assis an P o esso , Depa men o Quali y Assu ance Technique, Sama h Ins i u e o Pha macy, Belhe, Pune,
Maha ash a.
2 S uden , Sama h Ins i u e o Pha macy, Belhe, Pune, Maha ash a.
Wo ld Jou nal o Biology Pha macy and Heal h Sciences, 2025, 24(02), 054-058
Publica ion his o y: Recei ed on 21 Sep embe 2025; e ised on 01 No embe 2025; accep ed on 03 No embe 2025
A icle DOI: h ps://doi.o g/10.30574/wjbphs.2025.24.2.0940
Abs ac
Ni o u an oin is a syn he ic ni o u an de i a i e widely used o he ea men and p e en ion o u ina y ac
in ec ions (UTIs). I exhibi s bo h bac e ios a ic and bac e icidal p ope ies depending on i s concen a ion. The
o mula ion o Ni o u an oin able s aims o achie e op imum bioa ailabili y, s abili y, and pa ien compliance. This
e iew summa izes a ious app oaches o he o mula ion and e alua ion o Ni o u an oin able s, ocusing on
excipien selec ion, manu ac u ing me hods, quali y con ol pa ame e s, and ecen ad ances in sus ained o con olled
elease sys ems.
Keywo ds: Ni o u an oin; Hyd oxyl P opyl Me hyl Cellulose (HPMC K4M; HPMC K100M); Xan han Gum; Sus ained
Release
1. In oduc ion
The o al ou e is conside ed o be he mos con enien o adminis a ion o d ugs o pa ien s. O al adminis a ion o
con en ional dosage o ms no mally dissol es in he s omach luid o in es inal luid and abso p ion om hese egions
o gas o-in es inal ac (GIT) depends upon he physicochemical p ope ies o he d ug. I is a se ious d awback in
condi ions whe e localized deli e y o he d ugs in he u ina y ac is equi ed o in condi ions whe e a d ug needs o
be p o ec ed om he hos ile en i onmen o uppe GIT. Dosage o ms ha deli e d ugs in o he u ina y ac o colon
a he han uppe GIT p e e s numbe o ad an ages. A adi ional o al sus ained elease o mula ion eleases mos o
he d ug, a e he dosage o m pass om he s omach. Hence, he d ug should ha e abso p ion window ei he in he
duodenum o in es ine o u ina y ac [1]. The main goal o sus ained d ug deli e y sys ems is o imp o e he
e ec i eness o d ug he apies [2]. Sus ained elease d ug sys em is “any d ug o dosage o m modi ica ion ha
p olongs he he apeu ic ac i i y o he d ug”. Ideally a sus ained elease o al dosage o m is designed o elease apidly
some p e-de e mined ac ion o he o al dose in o GI ac . This ac ion (loading dose) is an amoun o d ug, which
will p oduce he desi ed pha macological esponse as p omp ly as possible and he emaining ac ion o he o al dose
(main enance dose) is hen elease a a cons an a e. Ni o u an oin is a u ina y ac an ibio ic [3]. The sho biological
hal -li e (0.3 o 1 hou ) and dosing equency mo e han one pe day make Ni o u an oin an ideal candida e o
sus ained elease [4]. To educe he equency o adminis a ion om ou imes daily o wo imes daily, o minimize
he side e ec s o nausea and emesis and o imp o e pa ien compliance.
Wo ld Jou nal o Biology Pha macy and Heal h Sciences, 2025, 24(02), 054-058
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2. Ma e ial and me hods
Ma e ial: Ni o u an oin was ob ained om QMED P . l d Bhak apu , Nepal and he excipien s p esen in he SR
g anules a e: hyd oxyp opyl me hylcellulose-K4M, HPMC K100M, Xan han gum, Anhyd ous Lac ose, Magnesium
s ea a e, Talc we e ob ained om Am ech Med. P . L d. Ka aha i-4, Mo ang as a gi . All he chemicals used we e o
analy ical g ade and pu chased om an au ho ized deale .
D ug-D ug and D ug-Excipien Compa ibili y D ug- D ug and D ug-Excipien Compa ibili y was assu ed by FT-IR
spec oscopy. P epa a ion o sus ained elease ma ix able o ni o u an oin able s we e p epa ed by di ec
comp ession me hod. Speci ied quan i y o ni o u an oin, polyme s such as HPMC K4M, HPMC K100M, xan han gum,
o he excipien s like lac ose, magnesium s ea a e and alc weighed acco dingly o he o mula gi en in able no.1. All
he ma e ials excep magnesium s ea a e and alc we e ans e ed in a mo a and pes le and mixed ho oughly. This
powde was passed h ough sie e no #80. To his add weighed quan i y o magnesium s ea a e and alc. Each ba ch
o mula ion powde blend was weighed o accu a e single o al able weigh (710mg). Table was comp essed wi h
Single head o a y able comp ession machine.
Table 1 Ma e ial and Supplied By
Ni o u an oin
QMED PVT ITD Bhak apu , Nepal
HPMC K4M
Ya ow chem PVT ITD, Mumbai
HPMC K100M
Ya ow chem PVT ITD, Mumbai
Xan han gum
Ya ow chem PVT ITD, Mumbai
Anhyd ous Lac ose
Meh a chemicals, Bangalo e
Magnesium s ea a e
Signe Chemical Co po a ion Mumbai
Talc
Ka na aka Fine Chem, Bangalo e
Table 2 Equipmen Used
S . No
Equipmen
1
Fou ie T ans o m In a ed Spec opho ome e
(IR. The moscien i ic Nicole is 10)
2
UV/VIS Spec opho ome e
(up Jasco 2016) No: Qc.cp-057
3
pH Me e
H12216 pH/ ORP/ISE Me e
4
Ul a-sonic
5
Elec onic Balance
Sa o ius No: Oc-Cp.059
6
Ha dness Tes e
Rimek- India. No: cp.010.
7
Disin eg a ion Tes e
(disin eg a ion es e -bj-3)
8
HPIC 2020
9
Dissolu ion Tes e
(Rc-80C) No: Qc-cp-071
10
Table Machine
Wo ld Jou nal o Biology Pha macy and Heal h Sciences, 2025, 24(02), 054-058
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Ro a y able s p ess machine Zp-7
11
F iabili y Tes e
(Cjy-300D Table s iabili y es e )
12
Thickness Tes e
Ve nie (S ainless ha dened)
13
O en Incuba o )
Accele a e S abili y S udy Champe
2.1. Fo mula ion And E alua ion o Ni o u an oin
Table 3 Fo mula ion Table
Ing edien in mg
F1
F2
F3
F4
F5
Ni o u an oin
200
200
200
200
200
Xan hine gum
300
_
_
_
150
HPMC K4M
_
300
_
150
150
HPMC K100M
_
_
300
150
_
Anhyd ous lac ose
200
200
200
200
200
Magnesium s a s
7
7
7
7
7
Talc
3
3
3
3
3
To al weigh
710
710
710
710
710
2.2. E alua ion o Ni o u an oin
• E alua ion o p e-comp ession low p ope ies o powde blend
• O ganolep ic p ope ies -O ganolep ic p ope ies o API like colo , odo and s abili y
• we e obse ed a eco ded. Solubili y was obse ed in
• me hanol and sodium hyd oxide.
• Bulk Densi y -Bulk densi y was measu ed using bulk densi y appa a us. Fixed weigh o powde was pou ed in
he measu ing cylinde and olume was eco ded.
• Bulk densi y = Bulk weigh /Bulk olume Tapped Densi y -Fixed weigh o powde was pou ed in he measu ing
cylinde and apped 50 cycles mul iple imes. Volume was eco ded a e each 50 apping cycles un il ixed
(concu en ) eading was ob ained. The apped densi y was ob ained by using ollowing equa ion: Tapped
Densi y = Bulk weigh /Tapped olume.
• Weigh a ia ion- The weigh a ia ion es would be sa is ac o y me hod o de e mining he d ug con en
uni o mi y. Twen y able s andomly we e aken om each ba ch and weigh ed indi idually, calcula ing he
a e age weigh , and compa ing he indi idual able weigh s o he a e age. The a e age weigh o one able
was calcula ed.
• Diame e es -The diame e es one o es s which used o de e mina ion o he able s size, i is done by
aking i e able s om each ba ch andomly. Diame e may ob ain by using sui able mic ome e .
• Thickness es -The hickness es o i e able s was picked om each ba ch andomly and hickness was
measu ed indi idually using “Ve nie - calipe ” (Elec onic Digi al Calipe ). I is exp essed in millime e and
a e age was calcula ed.
• Ha dness es -The ha dness es o able c ushing s eng h. The o ce equi ed o b eak a able in a diame ic
comp ession was measu ed using digi al able ha dness es e . I is exp essed in kg/cm. Fi e able s we e
andomly selec ed om each ba ch and ha dness o able s was de e mined by using digi al ha dness es e .
The mean alues and s anda d de ia ion o each ba ch we e calcula ed.
• F iabili y es -The iabili y es is pe o med o assess he e ec o ic ion and shocks, which may o en cause
able o chip, cap o b eak. Roche yola o was used o he pu pose. P e-weighed sample o i e able s om
each ba ch we e placed in he yola o , which was hen ope a ed o 100 e olu ions. A e 100 e olu ions
he able s we e dus ed and eweighed. Comp essed able s should no lose mo e han 1% o hei weighed.
Wo ld Jou nal o Biology Pha macy and Heal h Sciences, 2025, 24(02), 054-058
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• In- i o disin eg a ion ime- The in- i o disin eg a ion ime was de e mined using disin eg a ion es
appa a us. A able was placed in each o he six ubes o he appa a us and one disc was added o each ube.
The ime in seconds aken o comple e disin eg a ion o he able wi h no pala able mass emaining in he
appa a us was measu ed in seconds.
3. Resul and discussion
Table 4 E alua ion pa ame e s o Ni o u an oin
Fo mula ion Code
Ha dness
Thickness
F iabili y%
A e age Weigh
D ug Con en
F1
7.5 ± 0
5.5
0.74
710.3
98.29 ± 0.05
F2
6.66
5.5
0.47
710.17
99.54 ± 0.64
F3
6.5 ±0
5.4
0.72
710.42
99.05 ± 0.4
F4
6±0
5.48
0.70
709.36
100.35 ± 0.16
F5
7.33 ± 0.288
5.01
0.50
709.4
101.76 ±0.52
F6
6.5 ±0
5.02
0.83
710.5
100.63 ± 0.09
4. Conclusion
Ma ix able o ni o u an oin was success ully p epa ed by di ec comp ession me hod, using di e en ypes o
ma ixes o ming polyme s like HPMC K4M, HPMC K100M, Xan han gum. Ma ix able s a e easy o p epa e. They a e
cos e ec i e and exhibi p edic able elease beha io . So, he ul ima e aim o he p esen s udy was o p epa e wice
daily sus ained elease ma ix able s o Ni o u an oin o imp o ed pa ien compliance, be e he apeu ic e icacy,
less side e ec s and educed dosage egimen wi h less oxici y o ea men o u ina y ac in ec ion. In con en ional
dosage o m i unde goes Fi s pass me abolism, ha is way i shows poo bioa ailabili y o 45-56%. So, due o his
disad an age o imp o e bioa ailabili y sus ained elease ma ix able was o mula ed. Following conclusions ha e
been d awn om he p esen s udy. Ø Compa ibili y o d ug and polyme was con i med by FTIR s udies.
Ø he o mula ion blend was subjec ed o p e-comp essional e alua ions such as angle o epose, bulk and apped
densi y, comp essibili y index and Hausne ’s a io and was ound o be in he speci ied limi .
Ø he e alua ion da a o p ope ies such as ha dness, hickness, iabili y, weigh a ia ion, d ug con en indica ed ha
he p epa ed ma ix able was wi hin he speci ied s anda ds.
Compliance wi h e hical s anda ds
Acknowledgmen s
We since ely acknowledge he con inuous guidance, mo i a ion, and cons uc i e eedback p o ided by ou men o , Ms.
P achi Nandkuma Padwal Thei expe ise and pa ience ha e been ins umen al in shaping his e iew pape . We also
ex end ou g a i ude o Sama h Ins i u e o Pha macy, Belhe o p o iding he necessa y academic en i onmen and
esou ces ha suppo ed his wo k.
Disclosu e o con lic o in e es
No con lic o in e es o be disclosed.
Re e ences
[1] Sus ained-Release Ma ix Table s o Ni o u an oin: Fo mula ion and Op imiza ion. (2013) — using HPMC K-100
LV P emium and o he excipien s in we g anula ion echnique.
[2] Fo mula ion and in i o e alua ion o ni o u an oin loa ing ma ix able s.” — ocused on gas ic- esidence
ime p olonga ion
Wo ld Jou nal o Biology Pha macy and Heal h Sciences, 2025, 24(02), 054-058
58
[3] No el o ally adminis able o mula ion o ni o u an oin and a me hod o p epa ing said o mula ion.
US20050202079A1.
[4] Sus ained – elease ma ix able s o Ni o u an oin: o mula ione alua ion by Bha N,Goyal S. In J chem Tech
Res,2013:5(1):491-501.
[5] Me ck and Co, Inc. The Me ck index. 13 h ed. Whi ehouse S a ion: Me ck and Co. Inc., 2001
h ps://www.d ugbank.ca>Ni o u an oin
[6] No el D ug Deli e y Sys em. 2nd edi ionby Chein YW Ma cel Decke Inc., New Yo k, 2005;
[7] Aul on, M.E. Eds. Pha maceu ics: The science o dosage o m design. 2nd edn., Chu chill
[8] Indian Pha macopoeia. Minis y o Heal h and Family Wel a e, Go e nmen o India, Published by he Con olle
o Publica ions, New Delhi, 2007; A-89.Li ings one, New Yo k, 2002; 487- 495.3.
[9] The Uni ed S a es Pha macopoeia 24, NF 19. Uni ed S a es Pha macopoeial Con en ion, Rock ille, M.D. Asian
edi ion, 1462-1465 1913-14, 1941-1944, 2000.
[10] Indian Pha macopoeia, New Delhi: Minis y o Heal h and Family Wel a e, Go e nmen o India, Con olle o
Publica ions, ol. II,2014;2344-45.
[11] Indian Pha macopoeia 2010, Go e nmen o India Minis y o heal h and amily Wel a e, 6 h edi ion-2010,
olume I, 187-193.
[12] Sus ained-Release Ma ix Table s o Ni o u an oin: Fo mula ion and Op imiza ion. (2013) — using HPMC K-100
LV P emium and o he excipien s in we g anula ion echnique.
[13] Fo mula ion and in i o e alua ion o ni o u an oin loa ing ma ix able s.” — ocused on gas ic- esidence
ime p olonga ion
[14] No el o ally adminis able o mula ion o ni o u an oin and a me hod o p epa ing said o mula ion.
US20050202079A1.
