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Rajesh et.al.
Pre-formulation studies
Preparation of mixed blend of drug and excipients:
All the Ingredients were passed through mesh 60.
Required quantity of each ingredient was taken for each
specified formulation and all the ingredients were cog
rind in a mortar and pestle. The powder blend was
evaluated for flow properties such as Bulk density,
Tapped density, Compressibility index, Hausner ratio
and angle of repose.
Volume 1(4)
July-August 2013
Page 565
ISSN: 2321-5674(Print)
ISSN: 2320 3471(Online)
Indian Journal of Research in Pharmacy and Biotechnology
Rajesh et.al.
Test
Description:
Colour
Odour
Form
Taste
Solubility
F6
150
10
14
-
Results
Complies
Complies
Identification:
IR-Spectrum of the test sample should match
Complies
IR-Spectrum
with the IR-Spectrum of the working standard.
Assay
99% w/w
99.0% to 101.0% w/w
All the Identity parameters of the API are found to be within the limits
Table: 3 Physical parameters of API in Preformulation studies
parameters
Tapped density
Bulk density
Compressibility Index
Hausner Ratio
Angle of repose
Result
0.728 gm/ml
0.521 gm/ml
28.40 %
1.397
350311
Range
1788
3192
1631
1028
July-August 2013
Page 566
ISSN: 2321-5674(Print)
ISSN: 2320 3471(Online)
Indian Journal of Research in Pharmacy and Biotechnology
Rajesh et.al.
Volume 1(4)
July-August 2013
Page 567
ISSN: 2321-5674(Print)
ISSN: 2320 3471(Online)
Indian Journal of Research in Pharmacy and Biotechnology
Rajesh et.al.
15 Sec
30Sec
45 Sec
55 Sec
Fig 6: Disintegration time at the end of Various time interval
July-August 2013
Page 568
Rajesh et.al.
ISSN: 2321-5674(Print)
ISSN: 2320 3471(Online)
Indian Journal of Research in Pharmacy and Biotechnology
CONCLUSION
The demand for orally disintegrating tablets
has enormously increased during the last decade,
particularly for geriatric and pediatric patients who feel
difficulty in swallowing conventional tablets and
capsules. Fast dissolving or fast disintegrating dosage
form is advantageous for such patients. Fast dissolvable
or fast disintegrating dosage forms are meant to
disintegrate immediately upon contact with the saliva
leading to faster release of drug in the oral cavity. By
administrating the fast disintegrating dosage forms,
absorption of the drugs occurs through buccal mucosa
and it may reduce the first pass metabolism leading to
better efficacy of the drug. In my present work an
attempt was made to develop mouth dissolving tablets of
naproxen by direct compression method and by using
cross povidone, cross carmellose sodium and sodium
starch glycolate as superdisintegrants. In the
preformulation studies it has been proved that there is no
interaction between the drug and the excipients. The
blends of varying super disintegrants were formulated
into 6 formulations ranging from F1 to F6, and the blends
were evaluated for the pre and post comparison
parameters and In vitro drug release is also studied. All
the pre compression parameters angle of repose, Cars
index, Hausners ratio, tapped and bulk density and is
within the limits. The results shown that the
formulations containing the Cross povidone have the
good flow properties and the good compactability when
compared with the other formulations. The post
compression parameters include the Weight variation,
Hardness, friability, Thickness, wetting time, In vitro
disintegration and In vitro dispersion time and the water
absorption ratio. The results shown maximum for the
formulation (F4) that containing the cross povidone as
superdisintegrant. The In vitro drug release of
formulation F4 had shown that maximum drug release
99.4 0.54 when compared with the other formulations.
So F4 was choosen as the best formulation which
Volume 1(4)
July-August 2013
Page 569