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Applicotion<br />

I Disotcet@ appti:Slion<br />

oeg<br />

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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


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'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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.q<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 />

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l:,<br />

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