Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Received on 19 March 2014; received in revised form, 19 May 2014; accepted, 09 July 2014; published 01 October 2014
identical therapeutic effect. An identical effect stirred with a glass rod to disperse starch until no
would occur only if the released quantity of the lumps were observed. Then the above dry mixture
active ingredient were identical within an was granulated with binder solution and dried in
equivalent period. Tablet disintegration is one part the tray drier at the temperature of 40-500 ºC until
of the complex process of the release of the active the moisture reduces down to NMT-2%. The dried
ingredient from the dosage form. granules were passed through mesh no. 30. Then
Mannitol (pearlitol200) was passed through mesh
MATERIALS AND METHODS no. 30, Sodium saccharine, Carmofine, and
Materials: Albendazole, Sodium starch glycolate, pineapple flavor were passed through mesh no.
lactose, starch, Mannitol, and all other ingredients 100. All these were then added to the dried
were obtained from S D fine Chem. Ltd. granules and blended for ten minutes. Finally, the
above blend was lubricated with Magnesium
Types of equipment used were Compression
stearate, Talc, Aerosil for two minutes.
machine of Create company Pvt Ltd, veriner
callipers of Edison, Roche friabilator, Direct Compression: All the ingredients were
Disintegration apparatus and Dissolution apparatus separately weighed and sifted using mesh no. 40.
of DBK instruments, Electronic balance of Citizen Albendazole, Lactose monohydrate, Starch, and
scales and UV spectrophotometer of ELICO SL Sodium starch glycolate Mannitol (pearlitol200)
244. were passed through mesh no. 30. Sodium
saccharine, Carmofine color, and pineapple flavor
Methods: We employed three methods for the
were passed through 100 mesh, and required
preparation of granules, and the amounts of all
quantities were blended for ten minutes in poly
ingredients required for the tablets are shown in
bag. Finally, the above blend was lubricated with
Table 1.
Magnesium Stearate, Talc, and Aerosil for two
Nonaqueous Granulation: All the ingredients minutes.
were separately weighed and sifted using mesh no.
Finally, the preparation of tablets using the above
40. Albendazole, Lactose monohydrate, Starch, and
three methods with the suitable ingredients by
Sodium Starch Glycolate was mixed in a polybag
weighing of each tablet of 785mg and the powder
for ten minutes. For the preparation of binder
blend was evaluated for flow properties such as
dispersion, isopropyl alcohol was taken in a beaker,
bulk density, tapped density, compressibility index,
stirred with a glass rod to disperse starch until no
Hausner’s ratio, angle of repose and results are
lumps were observed. Then the above dry mixture
presented in Table 2.
was granulated with binder solution and dried in
the tray drier at the temperature of 40-50 ºC until Evaluation of Granules: 8-9
the moisture reduces down to NMT-2%. Bulk Density: 10 An accurately weighed quantity
of powder, which was previously passed through
The dried granules were passed through mesh no.
sieve # 40 [USP] was carefully poured into the
30, Mannitol (Perlitol200) through mesh no. 30.
graduated cylinder. Then after pouring the powder
Sodium Saccharine, Carmofine color, and
into the graduated cylinder, the powder bed was
pineapple flavor were passed through mesh no.
made uniform without disturbing. Then the volume
100. All these were finally added to the dried
was measured directly from the graduation marks
granules and blended for ten minutes. The above
on the cylinder as ml. The volume measured was
blend was lubricated with Magnesium stearate,
called as the bulk volume, and the bulk density is
Talc, Aerosil for two minutes.
calculated by the following formula;
Aqueous Granulation: All the ingredients were Bulk density = Weight of powder / Bulk volume
separately weighed and sifted using mesh no. 40.
Albendazole, Lactose monohydrate, Starch, and Tapped Density: 10 The same measuring cylinder
Sodium starch glycolate were mixed in a polybag which was used for the bulk volume was set into
for ten minutes. For the Preparation of binder tap density apparatus. The tap density apparatus
dispersion, purified water was taken in a beaker, was set to 300 taps drop per min and operated for
500 taps. Volume was noted as (Va) and again tapped volume. The tapped density is calculated by
tapped for 750 times, and volume was noted as the following formula.
(Vb). If the difference between Va and Vb not
Tapped density = Weight of powder / Tapped volume
greater than 2% then Vb is considered as final
TABLE 1: COMPOSITION OF ALBENDAZOLE TABLETS FORMULATION
S. no. Ingredients NAQ AQ DC
1 Albendazole 410 mg 410 mg 410 mg
2 Lactose 120 mg 120 mg 120 mg
3 Starch 60 mg 43 mg 86 mg
4 Sodium starch glycolate 49 mg 49 mg 49 mg
5 Starch 25 mg 41.2 mg -
6 Isopropyl alcohol q.s - -
7 Mannitol 100 mg 100 mg 100 mg
8 Sodium saccharide 10 mg 10 mg 10 mg
9 Magnesium stearate 6 mg 6 mg 6 mg
10 Talc 6 mg 6 mg 6 mg
11 Purified Water - q.s -
Total 785 mg 785 mg 785 mg
AQ = Aqueous granulation; NAQ = non aqueous granulation; DC = direct compression
Carr’s Index and Hausner’s Ratio: 10 The hardness of the tablet was determined and
volume of a known quantity of the granules from expressed in kg/cm2.
each batch was obtained before and after tapping.
The volume before tapping was used to determine Thickness: 14 The thickness of the tablets was
the bulk density while the volume after tapping was measured using manual Vernier Calliper and
employed to determine the tap density expressed in mm.
mathematically. Furthermore, Hausner’s quotient
Friability: 15 It is a measure of the mechanical
and Carr’s compressibility index used to determine
strength of tablets. The friability of the tablet was
the flow and compressibility properties of granules
determined using Roche Friabilator. It is expressed
were obtained from the equations:
in percentage (%). 10 tablets were initially weighed
Carr’s index = (Tapped density – Bulk density / Tapped (W0) and transferred into the friabilator.
density) × 100
The friabilator was operated at 25 rpm for four
Hausner’s Ratio = Tapped density / Bulk density mins. The tablets were weighed again (W). The
percentage friability was then calculated by
Angle of Repose: 11-12 The angle of repose of
powder was determined by the funnel method. The % F = {(W – W0)/W0} × 100
accurately weighed powder was taken in a funnel.
The height of funnel (h) was adjusted in such a way Disintegration: 15 The in-vitro disintegration time
that the tip of the funnel just touches the apex of was determined using the disintegration test
the heap of the powder. The powder was allowed to apparatus. A tablet was placed in each of the six
flow through the funnel freely on to the surface. tubes of the apparatus, and one disc was added to
each tube. The time in seconds taken for complete
Evaluation of Tablets: The mechanical strength of disintegration of the tablet with no palpable mass
the formulated and prepared tablets of albendazole remaining in the apparatus was measured in
were evaluated the parameters such as hardness, seconds. The in-vitro disintegration of the tablets
weight variation, thickness, friability, and was found to be within 15 mins.
disintegration time.
Dissolution: 16 Dissolution of core tablets of
13
Tablet Hardness: Hardness is the crushing albendazole formulation was studied using USP II
strength of tablet, which determines the ease of dissolution rate test apparatus employing paddle
handling and rigors of the transportation. For each stirrer. 900 ml of 0.1N HCL was used as
formulation, 3 tablets were used for the study. The dissolution medium. A 410mg tablet was used for
the test. The stirrer was adjusted to rotate at 50 CONCLUSION: The present research study
rpm, and a temperature of 37 ± 0.5 ºC was concludes that the non-aqueous granulation method
maintained throughout the experiment. 10 ml of shows the better dissolution rate compared to
samples were withdrawn at various time intervals aqueous granulation method, direct compression
and analyzed by measuring the absorbance at 309.0 method and also to the marketed drug. The in-vitro
nm. The volume withdrawn at various intervals was drug release of the albendazole chewable tablets
immediately replaced with a fresh quantity of are immediately prepared by the non-aqueous
dissolution medium. The above results are given in granulation method, the granules and tablets were
Fig. 1. found satisfactory in terms of physical parameters,
dissolution time as well as the drug release profiles
from the tablets prepared from different granulation
techniques.
ACKNOWLEDGEMENT: The Authors are
thankful to SSJ College of Pharmacy management
for providing all the necessary facilities during this
research work.
16. United States Pharmacopeia (USP 29-NF 24), The Official Asian Edition; 60-62, 2006: 2007: 2675, 2505.
Compendia of Standards Twin Brook Parkway, Rockvillle.
This article can be downloaded to ANDROID OS based mobile. Scan QR Code using Code/Bar Scanner from your mobile. (Scanners are available on Google
Playstore)