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Applicotion<br />
I Disotcet@ appti:Slion<br />
oeg<br />
()o{}<br />
Disolcer@ can provide excerent properties in majority of formurations. The use<br />
levers are between 0.5 to 3.0% onry. Disorcer@ u. r""J i" ur'iuf,",,ng process<br />
including direct compression and wet granulation. """<br />
In wet granulation, oi"ir"uio<br />
be used intra- or extra_granular or equally divided between the two. ""n<br />
Disolcel@ has been used in pharmaceuticat tablets, capsules and granules to aid in<br />
disintegration of dosage form and drug dissolution.<br />
Disorcer@<br />
arso used in industriar apprications as an absorbent in diapers or<br />
detergents tablet in laundrv.<br />
Specificqtion<br />
l<br />
Basic specification<br />
Appearance<br />
Color<br />
ldentification tests<br />
pH (19 in 100mt)<br />
Loss on drying, 70<br />
Sodium chloride & sodium glycolate, %<br />
Residue on ignition(sulfated ash), %<br />
Heavy metals, ppm<br />
Degree of substitution<br />
Content of water-soluble material, yo<br />
Settling volume, ml<br />
Residual solvents<br />
Free-flowing fibrous powder<br />
White to off-white<br />
Conforms<br />
5.0 - 7.0<br />
< 10.0<br />
< 0.50<br />
14.O - 2A.O<br />
Effects of Disotcel@ on ioblef<br />
disintegrotion time in o model drug formulotion<br />
llTable 1.<br />
Formulation of Hydrochlorothiazide 75mg Tablets<br />
lngredients<br />
Percentage<br />
Hydrochlorothiazide<br />
15.Oo/o<br />
Dicalciumphosphatedihydrate 41.75"/o<br />
Lactose<br />
41.7 sok<br />
Disintegrant 0.50 %<br />
Magnesium Stearate<br />
1.O"/.<br />
Disintegrant<br />
Disolcel@(ccs)<br />
Low-substituted NaCMC (L-CMC)<br />
Sodium starch glycolate(SSG)<br />
Crospovidone(CP)<br />
Pregelatinized starch(PGS)<br />
Disintegration (sec)<br />
27<br />
38<br />
51<br />
470<br />
> 120 min<br />
Hyd roch lorothiazide dissolved, T60% (min)<br />
Disintegrants o-25 ok o.5o '/o 1-o %<br />
Disorcel@(ccs) 13 8 8<br />
a,m<br />
E<br />
Low substitlted<br />
NacMc (L-cMC)<br />
CP<br />
SSG<br />
PGS<br />
Blan k<br />
19 10 9<br />
23<br />
5a<br />
13 11<br />
105 87 21<br />
> 120<br />
Time (mn)<br />
-a- ccs ---.- ssc L.CMC<br />
+ cP ---ra- PGS
.&,r<br />
'4.iilF-<br />
Table 2.<br />
Phenacetin Model System (Direct Gompression)<br />
Ingredients<br />
Phenacetin<br />
Lactose<br />
Disolcel@(ccS)<br />
Magnesium Stearate<br />
Dicalcium Phosphate Dihydrate<br />
Percentage<br />
10.0%<br />
43.750k<br />
0,2.O %<br />
0.5 %<br />
qs 100%<br />
Disolcet@ level<br />
Tablet Hardness(kg)<br />
Disintegration<br />
o% (Blank) 2o/o<br />
5 15 4 86<br />
>72 min 22 sec<br />
'72 mir| 51 sec<br />
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c
llTable 3.<br />
Aluminum Acetylsalicylate Model System (Wet granulation)<br />
Ingredients<br />
Alu minum Acetylsalicylate<br />
PVP<br />
Disolcel-(CCS)<br />
Magnesium Stearate<br />
Lactose<br />
Percentage<br />
50%<br />
3.2"/"<br />
0, 0.5,1.0%<br />
1.O %<br />
qs 100%<br />
Disolcel@ level (%)<br />
0<br />
0.5<br />
1.0<br />
Tablet Hardness (kg) Disintegration (sec)<br />
5.40<br />
>2400<br />
5.38<br />
zv<br />
4 ',.7<br />
18
Different bronds of<br />
Croscqrmellose Sodium comporison<br />
Comporison of Toblet properties using different bronds of<br />
Croscormellose Sodium (Disolcel@ ond other bronds) os disintegront,<br />
$ Utodel Formulation Containing API<br />
(Hydrochlorothiazide 75mg per tablet)<br />
-a-<br />
--_|-<br />
Time (min)
o-,*lf*;<br />
l'<br />
I<br />
l:,<br />
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