Formulation and Evaluation of Anthelmintic Chewable Tablets: ISSN 2231-5896 ©2012 IPS

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INTERNATIONALE PHARMACEUTICA SCIENCIA

| Jan-March 2012 | Vol. 2 | Issue 1 |


Available online http://www.ipharmsciencia.com
ISSN 2231-5896
©2012 IPS
RESEARCH ARTICLE

Formulation and evaluation of Anthelmintic Chewable Tablets


ABSTRACT Deepak Prashar*1, Sanjay Saklani2
Today in the world of pharmacy, evaluation parameters play a vital and 1Department of Pharmaceutical
critical role in deciding the best method for the preparation of various Sciences, Vinayaka College of
dosages forms. The R & D department is responsible for carrying out Pharmacy, Kullu (H.P.), India
various researches and later deciding the most appropriate among the all. 2Department of Economics, Govt.

The process should be economical and at the most rationalized to be College Dharampur, Mandi (H.P.),
considered as the process of choice. India

Keywords: anthelmintic, preformulation, flow properties, in vitro, post Date of Submission: 12-11-2011
Date of Acceptance: 31-12-2011
formulation
Conflict of interest: Nil
Source of support: None

INTRODUCTION powder flow and compact mechanical properties of


Over 90% of the tablets manufactured today are sucrose and three high-intensity sweeteners used in
ingested orally1.The administration of drugs through chewable tablets. Al-Suwayeh et al6 studied the
oral route is the most common and the easiest way of bioavailability of two different formulations of
administering a drug. However, pediatric, geriatric and Diclofenac sodium containing chewable tablets. Suzuki
bedridden patient shows inconvenience swallowing et al7 worked on the Acetaminophen containing
conventional tablets or capsules due to difficulties in chewable tablets with suppressed bitterness and
swallowing with lesser amounts of water with the improved oral feeling. Kathiresan et al8 worked on the
medication, unable to tolerate the taste of many drugs formulation and evaluation of loratadine chewable
when formulated as liquid dosage forms, resulting in tablets. Jagdale et al9 studied the formulation and
poor patient compliance2. The rationalized approach evaluation of chewable tablet of levamisole. The
in case of medication leads to the development of chewable tablets of levamisole were prepared by using
chewable tablets. These are formulated and lactose or mannitol along with sodium starch glycolate
manufactured so that they may be chewed, producing a in concentration ratios especially for pediatric use.
pleasant tasting residue in the oral cavity that is easily In the present research paper anthelmintic drug
swallowed and does not leave a bitter or unpleasant albendazole is prepared by three different techniques
taste. Chewable tablets are prepared by utilizing and evaluated for the best method available among
various excipients including binders, fillers, colors and these. The preformulation and post formulation
flavors to enhance their appearance and taste3. As far parameters are also utilized to strengthen the effect.
as the literature goes the number of evidence can be
spotted for the formulation and evaluation of chewable MATERIAL AND METHODS
tablets of various categories. Suzuki et al4 studied the The various materials along with their pharmaceutical
development of oral acetaminophen chewable tablets categories used in the formulation of the albendazole
with inhibited bitter taste. Mullarney et al5 studied the chewable tablets are listed in Table 1. These formulated
Address for correspondence tablets and raw materials are being evaluated for their
pre and post formulation parameters using various
Deepak Prashar
Email: prashardeepak99@yahoo.in pharmaceutical and analytical tools and equipments

13 Internationale Pharmaceutica Sciencia Jan-Mar 2012 Vol 2 Issue 1


Deepak Prashar, et al: Formulation and evaluation of Anthelmintic Chewable Tablets

listed in Table 2. All chemicals used were of analytical c) Preparation of Chewable Tablets by Direct
grade and were used as received. Compression
All these methods utilize different excipients and
Table1: Details of the drug, excipients and chemicals
additives as enlisted in Table 3. In non-aqueous
used for formulation development
granulation method and in direct compression purified
S. Drug /
Manufacturer Category water is not used, whereas in case of aqueous
No. Excipients
Arandy Laboratiries granulation method isopropyl alcohol was used as a
1 Albendazole Anthelmintic
Ltd.
2 Starch Maruti chemicals Binder granulating fluid. A minimum of 50 tablets were

3
Lactose Viswaat Chemicals,
Diluent
prepared for each batch and evaluated using various
monohydrate Mumbai
Finar Chemicals preformulation and post formulations parameters.
4 S.S.G Disintegrant
ltd.
5 Starch Maruti chemicals Disintegrant Table 3: Ingredients used in different formulation
6 Mannitol Maruti chemicals Diluent techniques
Sodium Finar Chemicals
7 Sweetener Non
Saccharine ltd. Aqueous Direct
S. Ingredients Aqueous
Carmofine No. Name Granulation
Granulation Compression
8 Ferro corporation Coloring agent (mg/tablet) (mg/tablet)
colour (mg/tablet)
Granulating 1. Albendazole 410 410 410
9 I.P.A. Finar Chemicals ltd
Fluid Lactose
2. 120 120 120
Pineapple Flavoring mono.
10 Ferro corporation 3. Starch 60 43.2 86.4
Flavour agent
Magnesium 4. S.S.G 29.34 29.34 29.34
11 Ferro corporation Lubricant 5. Starch 25 43.2 -----
stearate
Gangotri 6. I.P.A q.s. ----- -----
12 Talc Glidant Purified
Enterprises 7.
water
----- q.s. -----
8. Mannitol 100 100 100
Table 2: Equipments used for evaluation of raw and Sodium
9. 10 10 10
formulated preparations saccharine
Carmofine
10. 0.5 0.5 0.5
color
S.
Name of Equipments Source 11.
Pineapple
5 5 5
No. flavor
USP XXI Dissolution Rate Magnesium
1. Electrolab India 12. 6 6 6
Apparatus stearate
Water Bath Incubator 13. Talc 6 6 6
2. Navyug India 14. Aerosil 12 12 12
Shaker
UV-Visible
3. Systronics
Spectrophotometer Evaluation of Chewable Tablets:
4. Electric balance Melter AJ 100
a) Evaluation of Flow Properties of Granules
Monsanto Hardness
5. Tablet hardness tester The flow properties of the granules are being evaluated
Tester
6. Digital vernier caliper M & W ltd for preformulation studies. Angle of repose (θ), Bulk
7. Friability tester Pharmatest
density (BD), Tapped density (TD), Carr’s Index and
8. Disintegration tester Lab India
Hausner Ratio are evaluated as per specified in
9. PH meter Systronics
10. Vacuum oven Navyug India
monographs. The evaluation carried out by these
First medicine parameters helps to specify the best granules which
11. Single punch tablet press
machinery ltd
Best instrument and
can be further cross-checked by post formulation
12. Sieves (ASTM standard)
sieves evaluation.

Methods of Preparation of Chewable Tablets: b) Evaluation of formulated chewable tablets

The albendazole chewable tablets are being prepared Formulated tablets were evaluated by carrying out

by the following techniques tests for weight variation, uniformity of tablet,

a) Preparation of Chewable Tablets by Non- thickness and diameter, friability, hardness,

aqueous Granulation disintegration, dissolution, and content uniformity.

b) Preparation of Chewable Tablets by Aqueous These parameters help us to predict the best technique

Granulation available for the preparation of albendazole chewable


tablets out of the three available techniques.
Internationale Pharmaceutica Sciencia Jan-Mar 2012 Vol 2 Issue 1 14
Deepak Prashar, et al: Formulation and evaluation of Anthelmintic Chewable Tablets

RESULTS AND DISCUSSION The results of the Table 5 shows acceptable flow
a) Preformulation study properties value in comparison to that of the standard
Table 4: Identification and characterization of drug values.

S.
Parameter Standard value Observed value Table 5: Study parameters for powdered material
No.
Slightly soluble in Slightly soluble in
ethanol, chloroform, ethanol, chloroform, Angle Bulk Taped
1. Solubility S. Methods of Carr’s Hausner
practically insoluble in practically insoluble in of density density
water. water. No. preparation index ratio
repose (g/cm3) (g/cm3)
Amorphous in nature Amorphous in nature Non aqueous
and color was white to and color was white to 1. 26.06 0.48 0.55 12.88 1.14
2. Appearance granulation
off-white powder. off-white powder. Aqueous
2. 24.67 0.38 0.44 12.89 1.14
granulation
Melting Direct
3. 208-2100c 2070c 3. 25.55 0.58 0.66 12.63 1.14
point compression
Percentage
4. 90-110% 99.75%
purity
C) Post-formulation evaluation of chewable
Table 4 clearly represents that the active ingredient tablets
albendazole shows characteristics in accordance with All the prepared chewable tablets formulations exhibit
the pharmacopeial standard. The percentage purity of acceptable friability Table 6. The percent loss did not
the sample is 99.5 % which clearly indicates that the exceed 1% of the tablet weight and none of the
sample is of higher purity order. The general formulated tablets were broken or deformed. The
appearance, solubility and melting point of the sample chewable tablets formulations had hardness in the
further strengthen the sample choice. range 5.1-5.5 kg/cm2.Also the batches passed the USP
weight variation test. All the prepared batches had
b) Flow properties of powdered materials disintegration time in range 3.5-5.0 min.

Table 6: Study parameters for prepared tablets formulations

S. Methods of Hardness Thickness Friability Weight variation Disintegration time Drug


No. preparation (kg/cm2) (mm) (%) (mg± %) (min.) content (%)
Non aqueous
1. 5.2±0.25 5.67±0.08 0.65 785±3.0 5.0 99.50
granulation
2. Aqueous granulation 5.1±0.10 5.64±0.05 0.55 785±4.5 4.0 99.20
3. Direct compression 5.5±0.09 5.5±0.03 0.25 785±2.5 3.5 99.70

Table 7: Comparative evaluation of In vitro drug In vitro dissolution study revealed that chewable
release of chewable tablets prepared by different
tablets formulations prepared by direct compression
technique and marketed preparation
method has higher dissolution rates as compared to
Time %CDR (%)
S. No. the marketed formulation and others chewable tablets
(min.) N.A.G. A.G. D.C. Marketed prep.
1. 5 42.7 41.6 47.2 45.0
2. 10 51.7 50.6 57.3 56.2
prepared by different methods such as non aqueous
3. 15 58.5 58.0 65.2 63.0 and aqueous granulation. The dissolution rate of all
4. 20 66.3 65.5 74.2 72.0
5. 25 73.1 73.0 81.0 79.8 chewable tablets formulations prepared by different
6. 30 81.0 80.5 88.8 85.5
methods has the following order, direct compression
(88.8%) > non aqueous granulation (81.0%)>
aqueous granulation (80.5%) after 30 min.

CONCLUSION
From the ongoining studies and evaluation of the
albendazole tablets it could be concluded that direct
compression method proves to be the best among all.
Moreover, the other techniques too are available and
Figure 1: Graphical representation of in vitro drug
release still further testing is required before reaching on
15 Internationale Pharmaceutica Sciencia Jan-Mar 2012 Vol 2 Issue 1
Deepak Prashar, et al: Formulation and evaluation of Anthelmintic Chewable Tablets

some fixed conclusion. Various parameters apart from


above prove to be effective in future for deciding the
best among the available techniques.

REFERENCES
1) Lachman L, Lieberman HA, Kanig JL. The theory
and practice of industrial pharmacy. 3rd edition,
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2) Michele T, Knorr B, Vada E, Reiss T. Safety of
chewable tablets for children. J Asthma 2002;
39: 28-35.
3) Herbert L, Lachman L, Schwartz BJ. Chewable tablet
Pharmaceutical dosage forms: Tablets 2,
1989, 711-715.
4) Suzuki H, Onishi H, Takahashi Y, Iwata M, Machida
Y. Development of oral acetaminophen
chewable tablets with inhibited bitter taste. Int J
Pharm 2003; 252: 123- 132.
5) Mullarney MP, Hancock BC, Carlson GT, Ladipo DD,
Langdon BA. The powder flow and compact
mechanical properties of sucrose and three high-
intensity sweeteners used in chewable tablets. Int J
Pharm 2003; 257: 227–236.
6) Al-Suwayeh SA, Al-Omran MF, Saleh SI.
Bioavailability Assessment of Diclofenac
sodium chewable tablets. Saudi Pharm J 2003; 11:
32-36.
7) Suzuki H, Onishi H, Hisamatsua S, Masudaa
K, Takahashia Y, Iwatab M, Machidaa Y
Acetaminophen-containing chewable tablets with
suppressed bitterness and improved oral feeling.
Int J Pharm 2004; 278: 51-61.
8) Kathiresan K, Vijin P, Moorthi C, Manavalan R.
Formulation and Evaluation of loratadine
Chewable tablets. Res J Pharm Bio Chem Sci 2010;
2: 763-774.
9) Jagdale S, Gattani m, Bhavsar D, Kuchekar B,
Chabukswar A. Formulation and Evaluation of
Chewable Tablets of Levamisole. Int J Res Pharm Sci
2010; 1: 282-289.

Internationale Pharmaceutica Sciencia Jan-Mar 2012 Vol 2 Issue 1 16

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