vol - 4, issue - 4, supl – 1, sept 2013 issn: 0976-7908 tiwari et al
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Vol - 4, Issue - 4, Supl – 1, Sept 2013 ISSN: 0976-7908 Tiwari et al
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PHARMA SCIENCE MONITOR
AN INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES
FORMULATION AND EVALUATION OF CEFADROXIL DISPRSIBLE
TABLET
Tiwari Bhupendra R.*, Rane Bhushan R., Pawar Sunil P.
P.S.G.V.P.M.’S College Of Pharmacy Department Of Pharmaceutics Shahada, Dist. Nandurbar, Maharashtra
ABSTRACT The demand for fast dissolving tablets has been growing during the last decade especially for the geriatric and pediatric patients. The main objective of this study was to formulate and evaluate the fast dissolving tablets of Cefadroxil using natural and synthetic superdisintegrants in different concentration. Various formulations were prepared by direct compression using different concentration of superdisintegrant i.e. croscarmellose,isolated Aloe vera powder , sago starch to achieve optimum release profile, disintegration time and hardness. Dibasic calcium phosphate was used as diluent/disintegrent and starch as binding agent. The initial compatibility studies between the drug and excipients were carried out using FTIR spectroscopy. The tablets were evaluated for weight variation, hardness, friability, in-vitro disintegration time, dispersiontime, percentage of drug release and Assay characteristics . Hardness indicated good mechanical strength around 5-7 kg/cm2 for all the batches. The results of in-vitro disintegration time indicated that the tablets dispersed rapidly in mouth within 50 secs. It was concluded that superdisintegrants addition technique is a useful method for preparing orally disintegrating tablets by direct compression method. Key words: Fast dissolving tablet, direct compression method, croscarmellose, isolated Aloe vera powder,Sago starch.
INTRODUCTION
An ideal dosage regimen in drug therapy of disease is the one which immediately attains
the desired therapeutic effect of drug in plasma and maintain it constant for entire
duration of treatment [1].
The drug may be administered by variety of routes of dosage forms. The oral route of
drug administration is most widely held and has been successfully used for conventional
delivery of drugs. It offers the advantage of convenience, ease of administration, greater
flexibility in dosage forms design, ease of production and cheap [1,30]. Hence it is adopted
wherever possible. It is probable that at least 90 % of all drug is used to produce systemic
effects are administered by oral route. [1, 12]
Cefadroxil is broad spectrum antibiotic having bacteriocidal activity against gram
positive as well as gram negative bacteria. It is white to off white powder, sparingly
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soluble in water. It is reported to have biological half-life of 3 to 5 hour. So aim of the
present work is to enhance dissolution of the drug by formulating its fast disintegrating
tablets.[11]
Tablets
Tablets may be defined as solid pharmaceutical dosage forms containing drug substance
with or without suitable diluents and prepared by either direct compression or moulding
methods [1, 7].
Advantages of tablets
They are a unit dosage form and offer the greatest dose precision and the least content
variability.
Their cost is lowest of all oral dosage forms.
They are lightest and most compact of all oral dosage forms.
They are in general the easiest and cheapest to package and shipment of all oral
dosage forms.
They may provide the greatest ease of swallowing with the least tendency for “hang-
up” above the stomach. Especially when coated, provided that tablet disintegration is
not excessively rapid.
They lend themselves to certain special release profile products such as enteric or
delayed release products.
They are better suited to large scale production than other unit oral forms.
Tablets have the best combined properties of chemical, mechanical and
microbiological stability.[4,7]
Disadvantages of tablets
The major drawback for a tablet dosage form is that they are large in size.
Some drugs resist compression into dense compacts owing to their amorphous nature
or flocculent low density character.
Drugs with poor wetting, slow dissolution properties, intermediate to large dosage or
any combination of these features may be difficult or impossible to formulate and
manufacture as a tablet that will still provide adequate or full delay bioavailability.
Difficult for pediatric and geriatric patient swallow.[3,5]
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Characteristics of an Dispersible tablets
Taste of medicament
As most of drugs are unpleasant, Dispersible drug delivery system usually contain the
medicament in the taste masked. Delivery systems dissolve or disintegrate in the
patient mouth, thus relaxing the active ingredients which come in contact with the
taste buds and hence taste masking of drug becomes critical for patient compliance.
Hygroscopicity
Several Dispersible Dosage forms are hygroscopic and cannot maintain physical
integrity under normal conditions of temperature and humidity which calls for
specialized product packaging.
Friability
In order to allow Dispersible tablets to dissolve or disintegrate in oral cavity they are
made of either porous or compressed into tablets with very low compression force,
which makes the tablet friable which are difficult to handle, often requiring
specialized peel-off blister packing.[13]
Desired criteria for Dispersible Tablets (DT)
Dispersible Tablets should
Not require water to swallow but it should dissolve or disintegrate in the mouth in
matter of seconds.
Be portable without fragility concern
Have pleasing mouth feel
Leave minimal or no residue in the mouth after oral administration
Exhibit low sensitivity to environmental conditions as humidity and Temperature
Allow the manufacture of tablet using conventional processing and packaging
equipment as low cost.[3,14]
Mechanism of drug release
The drug release from Dispersible tablet (DT) due to the action of super disintegrating
like croscarmellose sodium, Sago Starch, Alovera Powder in the formulation[8].
Superdisintegrants provides quick disintegration due to combined effect of swelling and
water absorption by the formulation as an effect of swelling of super disintegrates. The
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wetted surface of the carrier increases, and promotes the wettability, dispersability of the
system and there by enhance the disintegration and dissolution [8].
Material and method :-
Cefadroxil should be gift sample from Lupinwith an analytical grade, crosscarmellose is
collected from Rosswell industry and other polymers are also analytical grade collected
[10, 16].
CHARACTERIZATION OF DRUG
UV spectrophotometric study
The stock solution of pure drug was prepared in distil water the solution was further
diluted (10µg/ml) and scanned between 263 nm by UV-visible spectrophotometer [10].
Preparation of calibration curve of cefadroxil
(i) Preparation of standard stock solution: Cefadroxil (10 mg) was first dissolved in of
distilled water (10 ml) (IP, 2007). This solution (10 ml) was then transferred to a 10 ml
volumetric flask. The volume of solution was made up by using the water to give a
solution of concentration 100 µg/ml [10].
(ii) Working stock solution: The standard stock solution was then appropriately diluted
with distilled water to obtain a series ofcefadroxil solution in the concentration range of
10-50µg/ml. The absorbance of all the solutions was measured against blank at 263 nm
using Single beam spectrophotometer. A standard plot of absorbance v/s concentration of
drug was plotted. This graph was used for the estimation of drug concentration in the fast
dissolving tablets for in-vitro drug release studies [10, 16].
Infrared spectrum
The Infrared absorption spectral analysis of drug was carried out by IR
spectrophotometer. Drug was mixed with IR grade KBr in 1:1 proportion and spectrum
was recorded. It was compared with the reference IR spectrum of cefadroxil [11].
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PREFORMULATION STUDIES
Table 1:General Composition and Application of CefadroxilFast Dissolving Tablets
during Initial Studies.
Ingredients Concentration (%) Application Cefadroxil 250mg Active Pharmaceutical Ingredient Crosscarmillose 10-20 Super disintegrant Alovera powder 10-20 Super disintegrant Sago starch 10-20 Super disintegrant Dibasic calcium phosphate
2-40 Disintegrant
Starch 5-40 Binder, Disintegrant Magnesium stearate <1 Glidant Aerosil <1 Lubricant Flavour <0.1 Flavour
During preliminary studies, different formulations were prepared using various
concentrations of Superdisintegrants. This was done to aid in choosing the limits for
ingredients for further evaluation [6, 13]. Pre-optimized investigation containing different
concentration of superdisintegrants keeping the total tablet weight constant, are enlisted
in Table No. 2
Table 2:Different Concentration of Superdisintegrants employed during Initial Studies
for Tablets.
ING F1 F2 F3 F4 F5 F6 cefadroxil (mg) 250 250 250 250 250 250 Crosscarmellose 6% 12% Sago starch 6% 12% Aloe vera powder 6% 12% DCP 32% 26% 32% 26% 32% 26% Starch 11.2% 11.2% 11.2% 11.2% 11.2% 11.2% Mg. stearate 1mg 1mg 1mg 1mg 1mg 1mg Aerosil 1mg 1mg 1mg 1mg 1mg 1mg Pineapple flavor 0.1mg 0.1mg 0.1mg 0.1mg 0.1mg 0.1mg Total(mg) 375 375 375 375 375 375
*All ingredients are in mg.
EVALUATION OF POWDER BLEND
The blend was evaluated for following parameters.
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Angle of repose
Angle of repose is defined as the maximum angle possible between the surface of pile of
powder and horizontal plane. The angle of repose was determined by the funnel method.
The accurately weighed powder was taken in a funnel. The height of the funnel was
adjusted in such a way that the tip of the funnel just touched the apex of the heap of the
powder. The powder was allowed to flow through the funnel freely onto the surface. The
diameter of the powder cone was measured. The angle of repose was calculated by
substituting the values of the base radius ‘r’ and pile height ‘h’ in the following equation
[5, 16]:
Therefore,
Where, = Angle of Repose
h = Pile height
r = Radius of pile
Table 3: Relationship between Angle of Repose () and Flowability
Angle of repose
() Flowability
< 20 Excellent
20-30 Good
30-34 Acceptable
> 40 Very poor
Bulk density
The powder sample, 25 g was accurately weighed and filled in a 100 ml graduated
cylinder and the powder was leveled and the unsettled volume was noted. The bulk
density was calculated by the formula [16]:
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Tapped density
The tapped density was determined by mechanically tapping the measuring cylinder and
the volume was noted [5, 16]:
Compressibility Index
Percent compressibility can be determined from the formula [16]:
Table 4: Relationship between % Compressibility and Flowability.
% Compressibility Flowability
5-15 Excellent
12-16 Good
18-21 Fairly acceptable
23-35 Poor
33-38 Very poor
< 40 Very very poor
Hausner’s ratio
It provides an indication of degree densification which could result from vibration of feed
hopper. [16]
Lower Hausner’s ratio (<1.25) = Better flowability
Higher Hausner’s ratio (>1.25) = Poor flowability
PREPARATION OF FAST DISSOLVING TABLET
Fast dissolving tablets of Cefadroxilwere prepared using direct compression method
incorporating superdisintegrants. The Cefadroxil is passed through sieve no.80# & all
excipients are passed through sieve no.60# the Cefadroxilequivalent to 4 mg, &
excipients were mixed thoroughly in glass mortar using a pestle. Superdisintegrants, taste
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masker & other excipients were incorporated in the powder mixture according to each
formulation in the table and finally magnesium stearate was added as lubricant. The
whole mixture is then passed through sieve no.60 twice. Tablets were prepared using 6.35
mm circular flat-beveled edge punch of the rotary tablet machine [CIP-
Machine12station]. Compression force was kept constant for all formulations & thickness
of the tablet was kept in 4.11±0.3mm. [10,15]
Table 5:Preparation of Final Formulation
ING
F1 F2 F3 F4 F5 F6
cefadroxil (mg) 250 250 250 250 250 250
Crosscarmellose 15 30
Aloe vera powder 15 30
Sago starch 15 30
DCP 80 65 80 65 80 65
Starch 28 28 28 28 28 28
Mg. stearate 1 1 1 1 1 1
Aerosil 1 1 1 1 1 1
Pineapple flavor 0.1. 0.1 0.1 0.1 0.1 0.1
Total(mg) 375 375 375 375 375 375
*All ingredients are in mg
EVALUATION OF TABLETS
Physical Evaluation of Tablets
I Dimension
The thickness and diameter of the tablets was determined using a Vernier caliper. Five
tablets from each type of formulation were used and average values were calculated [16].
II Hardness
Hardness was measured using the Monsanto hardness tester and measured the pressure
required to break diametrically placed matrix tablet, by a coiled spring.[13, 16]
III Friability
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Roche Friabilator was used for the purpose, 10 tablets were weighed and placed in the
Roche friabilator test apparatus, the tablets were exposed to rolling and repeated shocks,
resulting from free falls within the apparatus. After 100 evolutions the tablet were de-
dusted and weighted again. The friability was determined as the percentage loss in weight
of tablets.[3, 16]
IV Weight variation test
According to method given in IP, weight variation test is done by 20 tablets were selected
randomly. By weighing tablets individually; calculating the average weight and
comparing the individual tablet weight to average weight variation tolerance. [4, 16]
Table 6: Specifications for Tablets as per IP
Sr No. Average Weight of Tablet % Deviation
1 80 mg or less 10
2 More than 80 mg but less that 250 mg 7.5
3 250 more 5
Wetting time
A piece of tissue paper folded twice containing amaranth powder on the upper surface
was placed in a small Petri dish (ID =6.5 cm) containing 6 ml of distilled water, a tablet
was put on the paper and the time required for formation of pink color was measured as
wetting time. Three trials for each batch were performed and standard deviation was also
determined. [8, 16]
Disintegration time
Initially, the disintegration time for fast dissolving tablets was measured using the
conventional test for tablets as described in the Pharmacopoeia. Tablets were placed in
the disintegration tubes and time required for complete disintegration, that is without
leaving any residues on the screen was recorded as disintegration time. [7, 16] A modified
method was also used to check the disintegration time. In about 3 tablets were tested from
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each formulation. In disintegration time study tablet was put into the 100 ml distilled
water contained in beaker at the 37±2°C. Time required for complete dispersion of tablet
was measured as the disintegration time. [9, 16]
In-vitro dissolution studies
Following parameters were used for the dissolution study[16]:
1. Apparatus : IP dissolution apparatus (Type I)
2. Speed of the paddle : 50 rpm
3. Stirrer : Paddle type
4. Temperature : 37 °C + 0.5 °C
5. Dissolution medium : distilled water
6. Volume of medium : 900 ml
7. Sample withdraw at each time intervals : 1 ml
Sample volume of 1 ml was withdrawn at regular time intervals from a zone midway
between the surface of dissolution medium and the top of rotating paddle not less than 1
cm apart from the vessel wall. The volume withdrawn was replaced by fresh volume of
dissolution medium to maintain constant volume of medium. The filtered samples and
take second dilution from filter media withdraw make up volume up to 25 ml. and that
second dilution were analyzed spectrophotometrically at 263 nm using distilled water as a
blank. Drug content in dissolution sample was determined by calibration curve. [16]
HPLC METHOD FOR Cefadroxil
Prepare the following solutions freshly.
Test solution. Weigh and powder 20 tablets. Weigh accurately a quantity of the powder
containing about 0.2 g of cefadroxil, dissolve in phosphate buffer pH 5.0 by shaking for
30 minutes and dilute to 200.0 ml the same solvent. Filter the solution.
Reference solution. A 0.1 per cent w/v solution of cefadroxil RS in phosphate buffer pH
5.0.
Chromatographic system
a stainless steel column 25 cm x 4 mm, packed withoctadecylsilyl silica gel (3 to 10
μm),
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mobile phase: a mixture of 96 volumes of phosphatebuffer pH 5.0 and 4 volumes of
acetonitrile,
flow rate. 1.5 ml per minute,
spectrophotometer set at 230 nm,
a 20 μl loop injector.
Inject the reference solution. The test is not valid unless the relative standard deviation
for replicate injections is not more than 2.0 per cent.Inject alternately the test solution and
the reference solution. [16]
Stability studies
Stability testing can be as long as two years process, it is time consuming and expensive.
Therefore it is essential to devise a method that will help rapid prediction of long-term
stability of dosage form. The accelerated stability testing is defined as the validated
method by which the product stability may be predicted by storage of the product under
conditions that accelerate the change in defined and predictable manner [3, 14].
Stability studies of the formulated tablets were carried out at 40 ± 1°c and 75 % relative
humidity in stability chamber for one month. Tablets were withdrawn at 7th,14th, 21th and
28th days intervals and evaluated for hardness, drug content, wetting time, in-vitro
disintegration time and in-vitro dissolution studies[1,16]. (ICH-Guidelines)
Preformulation study-
Melting point-
Active pharmaceutical ingredient calculate melting point by filling capillaryand check
there result should be accepted.[6,10]
Meltinng point- 198-199 (uncorrect)
Physical appearance- off white colour
Odour-odourless
Compatibility study
FT-IR study-
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Figure 1:cefadroxil drug
Table 7: Cefadroxil IR Interpritaton
Spectra functional Group 805.31 phenyl ring substitution band 817.85 phenyl ring substitution band
1258.59 C-O group stretching
1337.66 C-N amine group bending
1600.01 N-H amine group stretching 1608.69 C=C bond in aromatic ring 1738.89-1608.69
Finger print region gives phenyl ring substitution overtone
1754.08 C=O Carboxylic group
3018.7 N-H primary amine group bending
3031.23 aromatic ring substitution
Figure 2: cross carmellose
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Table 8: Cross carmellose IR interpritation
Spectra functional Group
579.87 C-Br stretching
587.95 C-H alkyne bending
740.88 C-H phenyl ring substitution bending
953.83 C-H out of plane
1143.83 C-H stretching
1457.27 C-H deff. Alkyne Bending
1590.36 NH2 amine
2390.36 -NH- stretching
2356.06 -NH2- stretching
2963.13 C-H alkane Stretching
3025.45 C-H aromatic ring stretching
3178.79 N-H secondary amine Stretching
3367.22 O-H stretching alcohol
Figure 3: cefadroxil with crosscarmellose
Table 9: Cefadroxil With crosscarmellose IR interpretation
Spectra functional Group 579.87 C-Br stretching 587.95 C-H alkyne bending 740.88 C-H phenyl ring substitution bending 805.31 phenyl ring substitution band 817.85 phenyl ring substitution band 953.83 C-H out of plane 1143.83 C-H stretching 1258.59 C-O group stretching 1337.66 C-N amine group bending 1457.27 C-C stretching
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1590.36 C-H deff. Alkyne Bending 1600.01 N-H amine group stretching 1608.69 C=C bond in aromatic ring
1738.89-1608.69 Finger print region gives phenyl ring substitution overtone
1754.08 C=O Carboxylic group 2356.06 NH2 amine 2963.13 C-H alkane Reaching 3018.7 N-H primary amine group bending 3031.23 aromatic ring substitution 3178.79 N-H secondary amine Stretching 3367.22 O-H stretching alcohol
Figure 4 : Aloe vera Powder
Table 10: Aloe vera Powder IR interpretation
Spectra functional Group
1067.64 C-O stretching gives alcohol,ether,carboxylic group
1150.58 C-N stretching
1218.09 C-O stretching gives carboxylic group
1303.92 NO2 stretching
3256.91 C-H alkyne stretching
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Figure 5: Cefadroxil with alovera
Table 11: Cefadroxil with alovera IR interpretation
Spectra functional Group 805.31 phenyl ring substitution band 817.85 phenyl ring substitution band 1067.64 C-O stretching gives alcohol,ether,carboxylicgroup 1150.58 C-N stretching 1218.09 C-O stretching gives carboxylic group 1258.59 C-O group stretching 1303.92 NO2 stretching 1337.66 C-N amine group bending 1600.01 N-H amine group stretching 1608.69 C=C bond in aromatic ring 1738.89-1608.69 Finger print region gives phenyl ring substitution overtone 1754.08 C=O Carboxylic group 3018.7 N-H primary amine group bending 3031.23 aromatic ring substitution 3256.91 C-H alkyne stretching
Figure 6: Sago Starch
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Table 12: Sago Starch IR interpretation
Spectra functional Group
832.71 C-H bending phenyl ring substitution
996.27 C-H alkene Bending
1075.35 C-N stretching Amine
1337.98 C-N Amines
1634.13 NO2 stretchingasymmetric
1662.09 O-H stretching alcohol, phenol
2885.6 C=O stretchingcarboxylic group
3250-3550 stretching Phenol
Figure 7: cefadroxil with sago starch
Table 13: cefadroxil with sago starch IR interpretation
Spectra functional Group
805.31 phenyl ring substitution band
817.85 phenyl ring substitution band
832.71 C-H bending phenyl ring substitution
996.27 C-H alkene Bending
1075.35 C-N stretching Amine
1258.59 C-O group stretching
1337.66 C-N amine group bending
1337.98 C-N Amines
1600.01 N-H amine group stretching
1608.69 C=C bond in aromatic ring 1738.89-1608.69
Finger print region gives phenyl ring substitution overtone
1754.08 C=O Carboxylic group
2885.6 C=O stretchingcarboxylic group
3018.7 N-H primary amine group bending
3031.23 aromatic ring substitution
3250-3550 stretching Phenol
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IR graph-from above IR spectrum shows that above polymer shows no inter action with
active drug. Cefadroxil was subjected to Drug- Excipient compatibility studies with
various excipients like croscarmellose sodium, aloe vera powder, sago starch, all tablet
excipient. The mixture has shown no colour change. Hence no interaction between drug
and excipient. [16]
Report
When FTIR spectrum of Cefadroxil (pureDrug), excipients and optimized
formulation of Cefadroxil tablets (F2) were compared, there were no major changes in the
position spectrum. It indicates the absence of physical and chemical interaction among
active component Cefadroxil and excipients. So, the orodispersible tablet of Cefadroxil
has no interaction with added excipients. [8, 16]
Calibration curve –
Table 14: Calibration curve
Figure 8: Calibration curve
Concentration Absorbance 00 0
10 0.287 20 0.571 30 0.847 40 1.095 50 1.365
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Table 15: Calibration curve result
Parameter Result Calibration curve Cefadroxil 1mole/cm 263nm Eqn calibration curve Y=MX+C Regration eqn Y=0.027X Slope 0.027 Intercept 0.0
FORMULATION Evaluation-
Table 16: Evaluation of Blend
Formulation Code
Angle of repose (θ)
Bulk Density
(gm/cm3)
Tapped Density
(gm/cm3)
Carr’s Index (%)
Hausner’s ratio
H1 28.94±0.93 1.21±0.09 1.39±0.10 13.15±1.00 1.15±0.01
H2 26.70±0.87 1.29±0.04 1.50±0.06 13.78±1.22 1.16±0.02
H3 29.03±0.33 1.30±0.05 1.49±0.07 12.75±1.18 1.15±0.02
H4 29.53±1.33 1.19±0.06 1.38±0.06 13.99±0.63 1.16±0.01
H5 28.28±0.88 1.37±0.06 1.57±0.07 12.76±0.82 1.15±0.01
H6 27.03±0.38 1.25±0.09 1.45±0.10 13.99±0.31 1.16±0.00
The prepared blend were evaluated for the blend property like angle of repose, bulk
density, tapped density, Carr’s index, Hausner’s ratio. Results obtained are shown in
above table 16
The below results predict that, angle of repose less than 30° gives the excellent flow
property to the powder blend. Carr’s index is in the range of 10-20% which is considered
as excellent compression property. Hausner’s ratio value is also lower. Similarly, the bulk
density and tapped values was found to be near to one. Hence, have good flow property.
All these results indicated that, the powder blends possess satisfactory flow and
compressibility properties. [8,16]
Preparation of tablets
Fast dispersible tablets containing 250 mg of Cefadroxil were prepared by direct
Compression method and the various formulae used in the study are shown in Table. All
the ingredients without magnesium stearate and aerosil were mixed uniformly followed
by addition of magnesium stearate and Aerosil. The prepared powder blend was
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evaluated for various parameters like bulk density, tapped density, angle of repose,
compressibility index and Hausner ratio. After evaluation of powder blend the tablets
were compressed with a sixteen‐station rotary punch‐tableting machine (clit single rotary
compression machine.) using 9 mm oval shape punches set. [16]
In-Vitro Evaluation Of Tablet
Tablet 17: Evaluation of tablet
Parameter F1 F2 F3 F4 F5 F6
Thickness 4.12±0.01 4.12±0.00 4.13±0.01 4.12±0.02 4.10±0.02 4.22±0.16
Weight variation passes passes passes Passes passes Passes
Friability 0.54±0.00 0.50±0.07 0.67±0.14 0.54±0.00 0.58±0.08 0.63±0.08
Hardness(kg\cm2) 5±0.0 5±0.6 6±1.2 7±0.6 6±1.2 5±0.6
Disintegration time(sec.)
30.67±0.5 17.67±2.52 31.00±2.65 25.33±8.08 24.00±2.00 23.67±4.5
Dispersion time(sec.)
47.00±6.2 28.00±8.00 47.33±7.02 42.33±7.23 39.67±3.06 46.00±2.0
% drug release 101.48 103.9 102.22 103.33 103.07 103.33
% Assay 100.68 96.30 96.81 101.59 101.57 97.51
From the above formulation prepared six batches are prepared which shows respective
thickness was found to be 4.10-4.22 ranges, friability was ranges to be 0.5.-0.7,hardness
was found to be 5-7 kg/cm2,disintegration time was found to be 15-40 sec.,dispersion
time was 25-50 sec.,% drug release found to be 100-104%,%assay was found to be 95-
102% from the above result we can select F2 formulation as optimize batch so good
result than other formulation.[13]
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Table 18: Cumulative Percentage of Drug Release
Cumulative percentage drug release
Time F1 F2 F3 F4 F5 F6
2 87.04±0.37 88.02±0.77 86.79±0.56 87.78±0.37 87.04±0.9 87.28±0.21
4 88.02±0.77 90.74±1.34 87.65±0.77 88.77±0.56 88.52±1.43 88.52±0.00
6 87.65±0.57 93.46±4.13 88.27±0.56 90.25±0.56 89.88±0.21 90.37±0.00
8 89.01±0.57 95.93±5.53 89.01±0.5 91.36±0.42 91.60±0.42 93.09±0.43
10 90.12±0.57 97.28±4.97 90.86±1.82 93.95±1.71 93.33±0 94.44±0.64
12 91.48±1.34 98.40±4.06 93.09±3.74 96.05±2.1 94.81±1.74 96.30±0.64
14 91.60±2.14 100.12±2.63 93.83±4.76 97.78±3.20 97.53±1.49 98.27±1.71
16 92.59±1.96 101.85±1.92 94.69±5.57 99.01±2.87 98.89±0.61 100.25±2.14
18 93.58±1.86 102.96±0.00 95.93±5.14 101.11±1.3 100.37±0.6 101.23±1.7
20 95.43±2.2 103.52±0.7 96.79±4.4 101.60±1.8 100.62±0.9 101.60±1.0
22 97.04±1.9 103.89±0.2 98.02±3.6 101.73±1.9 101.11±1.6 101.98±1.5
24 98.15±2.2 103.89±0.2 99.26±2.6 101.73±1.9 101.48±2.3 101.98±1.5
26 99.01±2.2 99.38±2.5 101.48±2.31 101.98±1.5
28 99.01±2.26 101.48±2.31
30 99.01±2.26
Figure 9:Percentage of drug release
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Percentage Assay by HPLC method
As Per IP prepare solution of phosphate buffer 5,and prepare a Reference solution as well
as test solution and calculate area peak by the HPLC software brown, Japan. For that first
take 3 reference solution peak ,calculate their average and used for al bathes. HPLC peak
area as well as graph shown below from that we can calculate percentage assay[12]
Figure 10: HPLC For Standard 1
Figure 11: HPLC For Standard 2
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Figure 12 :HPLC For Standard 3
Reference solution area peak
Average area was found to be 7914591.444
Figure 13: HPLC For F1 batch
% Assay =100.68
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Figure 14:HPLC for F2 Batch
% Assay = 96.30
Figure 15:HPLC For F3 Batch
%Assay = 96.81
Figure 16:HPLC For F4 Batch
% Assay =101.59
Figure 17: HPLC For F5 Batch
% Assay = 101.57
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Figure 18: HPLC For F6 Batch
% Assay = 97.51
Stability study-
This result was noted after 45 days of formulation and shows good result of formulation.
Table 19: Stability study
Parameter F1 F2 F3 F4 F5 F6 Thickness 4.13±0.01 4.11±0.00 4.12±0.01 4.12±0.02 4.10±0.02 4.14±0.16
Weight variation passes passes passes Passes passes Passes
Friability 0.4±0.00 0.5±0.07 0.76±0.14 0.5±0.00 0.7±0.08 0.5±0.08
Hardness(kg\cm2) 5±0.0 5±0.6 6±1.2 7±0.6 5±1.2 5±0.6
Disintegration time(sec.)
29.58±0.5 19.67±2.52 36.00±2.65 40.33±8.08 27.00±2.00 26.67±4.5
Dispersion time(sec.)
51.00±6.2 28.09±8.00 54.33±7.02 52.03±7.23 36.67±3.06 46.00±2.0
% drug release 99.48 101.04 96.22 98.24 97.07 98.96
CONCLUSION
The present work led to the development of dispersible tablets for oral administration
comparing a therapeutically effective amount of cefadroxil by direct compression method
using various super disintegrating agents that disperse in oral cavity up to 20 seconds
with or without the drinking water, had a pleasant mouth feel and this and improved
patient compliance, particularly for those who have difficulty in swallowing (such as
pediatric and geriatric patient). Formulation F2 containing crosscarmellose (12%) with
appropriate amount of other excipients was considered to be the optimized formulation
with desired drug release (104.07%) within 20 minutes. Dispersible tablet shows all
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parameter like hardness,friability,disintegration time, dispersion time,thickness as5,
0.50sec., 17.67, 28.00, 4.12respectively.
The stability study was done for 3 months all parameters such as hardness, weight
variation, thickness, friability, disintegration time, and in-vitro dissolution studied at the
end of every month, the results shows that no significant changes in that parameters.
ACKNOWLEDGEMENT
The authors acknowledge the P.S.G.V.P. Mandala’s College of Pharmacy, Shahabadfor
support to carry out the research work and Adora Pharma manufacturer,
Aurangabadproviding facilities to carry out the research work andprovide theall research
project help.
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For Correspondence: Bhupendra R. Tiwari Email: bhupendratiwari30@gmail.com
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