international journal of innovative pharmaceutical … (1).pdfdesign and optimization of fast...

RESEARCH ARTICLE Pukale Sachin et.al / IJIPSR / 3 (2), 2015, 46-61

Department of Pharmaceutics ISSN (online) 2347-2154

Available online: www.ijipsr.com February Issue 46

DESIGN AND OPTIMIZATION OF FAST DISSOLVING

TABLETS OF LEVOCETRIZINE HYDROCHLORIDE

1Pukale Sachin*,

2Patil Manojkumar,

3Pirjade-Mujawar Farhat,

4Mali Audumbar,

5Hake Gorakhnath.

Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade, Sangola-413307,

Solapur, Maharashtra, INDIA

Corresponding Author

Pukale Sachin

Department of Pharmaceutics, Sahyadri College of Pharmacy,

Methwade, Sangola-413307, Solapur, Maharashtra, INDIA

Email: [email protected]

Phone: +91 9604757946

International Journal of Innovative

Pharmaceutical Sciences and Research www.ijipsr.com

Abstract The aim of present work is to design and optimization of fast dissolving tablets of Levocetrizine

hydrochloride by direct compression method using different superdisintegrant such as crospovidone (CP)

and sodium starch glycolate (SSG). A 32 factorial design was applied systematically; the amount of

Crosspovidine (X1) and amount of SSG (X2) were selected as independent variables. The percentage

drug release at 3 min Q3, percentage drug release at 9 min Q9 and percentage drug release at 15 min Q15

were selected as dependent variables.The tablets prepared were evaluated for various parameters like

weight variations, hardness, friability, in-vitro dispersion time, drug content, wetting time, in-vitro drug

release, FTIR. The tablets prepared by direct compression method possess a weight variation below

±7.5%, hardness of 4.3 to 4.8 Kg/cm², percentage friability of 0.22 to 0.31, in vitro, Wetting time of 42 to

59 seconds, and in-vitro drug release showed 93.31% to 98.89% within 6 min. The formulation (LFDT9)

contains Crosspovidone and Sodium Starch Glycolate shows better Disintegration time and 98.89% drug

release within 6 min.The study reveals that formulations prepared by direct compression LFDT9 exhibits

highest dissolution using crospovidone at concentration of 6 % & showed faster drug release 98.89 %

over the period of 6 min while comparison to other formulations of Levocetrizine hydrochloride. Hence

batch LFDT9 was optimized.

Keywords: Fast dissolving tablet, Levocetrizine hydrochloride, direct compression, crospovidone,

factorial design.




INTRODUCTION [1,2,3]

Oral routes of drug administration have wide acceptance up to 50-60% of total dosage forms.

Solid dosage forms are popular because of ease of administration, accurate dosage, self

medication, pain avoidance and most importantly the patient compliance. The most popular solid

dosage forms are being tablets and capsules; one important drawback of this dosage forms for

some patients, is the difficulty to swallow. Drinking water plays an important role in the

swallowing of oral dosage forms. Often times people experience inconvenience in swallowing

conventional dosage forms such as tablet when water is not available, in the case of the motion

sickness (kinetosis) and sudden episodes of coughing during the common cold, allergic condition

and bronchitis. For these reason, tablets that can rapidly dissolve or disintegrate in the oral cavity

have attractFast dissolving tablets are also called as mouth-dissolving tablets, melt-in mouth

tablets, orodispersible tablets, rapimelts, porous tablets, quick dissolving etc. Fast dissolving

tablets are those when put on tongue disintegrate instantaneously releasing the drug which

dissolve or disperses in the saliva .

The basic approach in development of fast dissolving tablet is the use of superdisintegrants like

crosspovidone, croscarmellose, sodium starch glycolate (primogel, explotab),

polyvinylpyrollidone (polyplasdone) etc, which provide instantaneous disintegration of tablet

after putting on tongue, their by release the drug in saliva.

Objective:-

1. To develop and optimize fast dissolving tablet of levocetrizine hydrochloride using

different polymer.

2. To develop fast dissolving tablet of levocetrizine hydrochloride to improve bioavailability

and increase drug release with rapid onset of action.

3. To evaluate for the pre-compression characteristics of powder mixture like bulk density,

flow property, angle of repose, compressibility index etc.

4. To evaluate the post-compression characteristics of the tablet like hardness, friability,

disintegration time,wetting time,water absorption ratio.

5. To carry out in vitro dissolution studies of the tablet formulations.




MATERIALS AND METHODS

Materials:-

Levocetrizine hydrochloride was obtained as a gift sample from Gift sample from Emcure, Pune,

Crospovidone,SodiumStarch Glycolate,Mannitol ,Aspartame ,Mg. stearate ,Talc,Microcrystalline

cellulose were purchased from S.D Fine Chemicals, Mumbai.

Methods:-

Preformulation Studies:-

It is extensive information to bring out good quality at high standard at which optimal dosage

desired.Preformulation studies were performed on the drug, which included melting point

determination, solubility and compatibility studies.

Compatibility Studies:- [4,5,6,7]

FTIR Spectroscopy:-

FT-IR spectroscopy was employed to ascertain the compatibility between Levocetrizine

Hydrochloride and selected polymers. The pure drug, drug-polymers combinations and

formulations were subjected to FT-IR studies. Potassium bromide, pure drug and the polymers

were heated to 1050C for one hour to remove the moisture content if present in a hot air oven.

Then in presence of IR lamp, potassium bromide was mixed with drug and or polymer in 9:1

ratio.The spectra were run from 4000 cm-1 to 1000 cm-1 wave number. FT-IR spectrum of

Levocetrizine Hydrochloride was compared with FT-IR spectrum of Levocetrizine Hydrochloride

with polymer.

Analytical Methods:- [8,9,]

Preparation of Phosphate Buffer (PH 6.8):- 50 ml of 0.2 M Potassium Dihydrogen Phosphate

was taken in a 200 ml volumetric flask and to that, 22.4 ml of 0.2 M NaOH was added. Finally

volume was make up to the mark with distilled water.

Preparation Of Stock Solution:- A standard stock solution of Levocetrizine Hydrochloride was

prepared by dissolving accurately weighed 100 mg of Levocetrizine Hydrochloride in phosphate

buffer (pH 6.8) solution in a 100 ml volumetric flask and the volume was made up to 100 ml by

using phosphate buffer (pH 6.8) solution to obtain a primary stock solution of 1000 μg/ml. 1ml of

primary stock solution was further diluted to 100 ml phosphate buffer (pH 6.8) to obtain a

secondary stock solution of 100μg/ml.




Determination Of Analytical Wavelength:- The resulting solution containing 100μg/ml was

scanned between

analytical wavelength.

Calibration Curve Of Levocetrizine Hydrochloride In Phosphate Buffer Ph 6.8 Solution:-

An accurately weighed 100 mg of Levocetrizine Hydrochloride was dissolved in 100 ml of

phosphate buffer (pH 6.8) to get a concentration of 1000 μg/ml. 1ml from above solution was

further diluted to 100 ml phosphate buffer (pH 6.8) to obtain a stock solution of 100μg/ml. From

this stock solution, aliquots with suitable dilutions were made in order to get concentration in

between the Beer’s range of 2-14 μg/ml.The dilutions of 2μg/ml, 4μg/ml, 6μg/ml, 8μg/ml and

10μg/ml were prepared. The absorbance was measured at 231 nm using UV visible

spectrophotometer. The standard curve was obtained by plotting absorbance v/s concentration in

μg /ml.

Formulation Development:- [10,11,12]

Formulation Design study is important for selection of appropriate excipients for preparation

tablets. The three different conc of crospovidone and sodium starch glycolate were used for trial

preparation of tablets. The trial batches of tablets were prepared by direct compression method

using other commonly used excipients.

Preparation Of The Tablet By Direct Compression Method:- Fast dissolving tablets of

Levocetrizine hydrochloride were prepared for F1 to F9 batches by using different concentrations

of superdisintegrants mentioned in table 5.5

Fast dissolving tablets of Levocetrizine hydrochloride were prepared by direct compression

method. The drug and excipients were passed through sieve no (#60) to ensure better mixing.

Superdisintegrants like crospovidone and sodium starch glycolate were used in different

concentration. All the ingredients were mixed in mortar and pestle then magnesium stearate and

talc were added. The formulations were compressed with a tablet compression machine using 8

mm diameter round concave punch. (Karnavati, mini press-I).

Before tablet preparation, the mixture blend subjected for compatibility studies IR and

precompression parameters like angle of repose, bulk density, tapped density, percent

compressibility & hausner’s ratio.




Table No.1 Composition of Levocetrizine Hydrochloride Fast Dissolving Tablet:-

Ingredients(mg.) F1 F2 F3 F4 F5 F6 F7 F8 F9

Levocetrizine Hcl 5 5 5 5 5 5 5 5 5

Crospovidone 4 4 4 6 6 6 8 8 8

Sodium Starch

Glycolate

4 6 8 4 6 8 4 6 8

Mannitol 20 20 20 20 20 20 20 20 20

Aspartame 5 5 5 5 5 5 5 5 5

Mg stearate 1 1 1 1 1 1 1 1 1

Talc 2 2 2 2 2 2 2 2 2

MCC 100 100 100 100 100 100 100 100 100

Total Wt.(mg) 141 143 145 143 145 147 145 147 149

Precompression Evaluation:-[13,14]

Angle Of Repose:- The angle of repose of powder blend was determined by the funnel method.

The accurately weight powder blend were taken in the funnel. The height of the funnel was

adjusted in such a way the tip of the funnel just touched the apex of the powder blend. The

powder blend was allowed to flow through the funnel freely on to the surface. The diameter of the

powder cone was measured and angle of repose was calculated using the following equation.

Tan θ = h/r

Where,

h= height of the powder cone and r = radius of the powder cone

Table No.2:- Standard values of angle of repose.

Angle of Repose ()

(degrees)

Flow

<25 Excellent

25-30 Good

30-40 Passable

>40 Very Poor

Bulk Density: - The accurately weighed amount of sample taken in a 25 ml measuring cylinder

measured volume of packing and tapped 100 times on a plane hard wooden surface and tapped

volume of packing recorded and LBD and TBD calculated by the following formula:




Bulk density [BD] = ( Weight of powder)/( Bulk volume)

Compressibility Index: - The Compressibility Index of the powder blend was determined by

Carr’s compressibility index. It is a simple test to evaluate the LBD and TBD of a powder and the

rate at which it packed down. The formula for Carr’s Index is as below:

Carr’s index = (TBD-LBD)/TBD x100

Hausner’s Ratio (HR):- This was calculated as the ratio of tapped density to bulk density of the

sample

HR = (Tapped Density)/(Bulk Density)

Post-Compression Evaluations [15,16,17,18]

Weight Variation Test:-

Twenty tablets were selected randomly from each batch and weighed individually to check for

weight variation.

Percentage Deviation (PD) =

Where,

W avg = average weight and

W initial =initial weight.

Table No.3 :-Standards for uniformity of weight as per I.P.

Average weight of a tablet Percentage

deviation (%)

130 mg or less

More than 130 mg and less

than 324 mg

324 mg or more

10

7.5

5

Hardness:- Hardness indicates the ability of a tablet to withstand mechanical shocks while

handling. The hardness of the tablets was determined using Monsanto, precisiosn dial type

hardness tester. It is expressed in kg/cm2. Three tablets were randomly picked and hardness of the

tablets was determined.




Thickness:- The thickness of the tablets was determined by using Vernier calipers. Five tablets

were used, and average value was calculated.

Friability Test:-The friability of tablets was determined using Roche Friabilator. It is expressed

in percentage (%). Ten tablets were initially weighed and transferred into Friabilator. The

Friabilator was operated at 25rpm for 4 minutes or run up to 100 revolutions. The tablets were

weighed again. The % friability was then calculated by the following formula.

Percentage Friability =(W-W0)/W x 100

Where,

W0= initially weight

W= weight after friability

Percentages Friability of tablets less than 1% are considered acceptable.

Uniformity Of Drug Content:- Twenty tablets were weighed and powdered in a glass mortar.

Quantity of powder equivalent to 150 mg of Levocetrizine hydrochloride was accurately weighed

and transferred in a 100 ml volumetric flask add final volume in volumetric flask up to 100ml

using 6.8 pH Phosphate buffer. Measure the absorbance of the resulting solution using UV

Visible spectrophotometer at of λmax 231 nm.

Wetting Time:- The method was applied to measure tablet wetting time. A piece of tissue paper

folded twice was placed in a small petri dish (i.d. = 6.5 cm) containing 10 ml of water, a tablet

was placed on the paper, and the time for complete wetting was measured. Three trials for each

batch were performed and standard deviation was also determined. The method was reported by

Yunxia Bi et al.

Invitro Disintegration Time:- The process of breakdown of a tablet into smaller particles is

called as disintegration. The invitro disintegration time of a tablet was determined using

disintegration test apparatus as per I.P. specifications.Place one tablet in each of the 6 tubes of the

basket. Add a disc to each tube and run the apparatus using phosphate buffer (pH 6.8) maintained

disintegration of the tablet with no palpable mass remaining in the apparatus was measured and

recorded.

In Vitro Drug Release Studies Of Levocetrizine Hydrochloride Fast Dissolving Tablets:-

Dissolution rate was studied by using USP type-II apparatus (USP XXIII Dissolution Test

Apparatus at 50 rpm) using 900 ml of buffer pH (6.8) as dissolution medium. Temperature of the




was withdrawn at every 3 min interval, filtered. The absorbance of filtered solution was measured

by UV spectrophotometric method at 231 nm and concentration of the drug was determined from

standard calibration curve.

In Vitro Drug Release Studies Details:-

Apparatus used : USP Type-2 Model), Electrolab.

Dissolution medium : phosphate buffer (pH 6.8)

Dissolution medium volume : 900 ml

Temperature :

Speed of paddle : 50 rpm

Sampling intervals : 3 min

Sample withdraw : 5 ml

Absorbance measured : 231 nm.

RESULTS AND DISCUSSION

Preformulation Studies:-

Determination Of Melting Point:- The melting point of Levocetrizine Hcl was found to be in

the range of 215°C to 2200

Solubility Levocetrizine HCL:-Soluble in acetonitrile,glacial acetic acid, sodium hydroxide &

hydrochloric acid.

Fig. No.1:-Calibration Curve of Levocetrizine Hcl in pH 6.8(phosphate buffer)

(λ max=231 nm)

Compatibility Study FTIR:-IR spectrum indicated that characteristics peaks belonging to

measure functional groups such as principle peaks at wave numbers 1745.58cm-1

.

Levocetrizine Hcl shows characteristic peaks at1745.58cm-1

due to stretching vibration of –

COOH group.The similar peaks were also observed in the spectra of mixture of Levocetrizine




Hcl and polymer no deviation.This indicates that the drug is stable and there is no drug-

disintegrating interaction.

Figure No.2: FTIR of Levocetrizine hydrochloride + Excipients.

Data Obtained For IR Spectra:

Table No.4 : Interpretation of IR Spectra:

Sr No IR spectrum Peaks cm-1

Groups

1 Levocetrizine Hcl 1745.58 COOH

2 Drug + Excipients 1745.58 COOH

Precompression Evaluation Parameters:-

Table No.5: angle of repose, loose bulk density, tapped bulk density, carr’s compressibility

index and hausner’s ratio

Formulation

Code

Angle of

Repose(θ)

Loose Bulk

Density(gm/cm3)

Tapped Bulk

Density(gm/cm3)

Compressibility

Index %

Hausner’s ratio

LFDT1 28.10 0.46 0.55 18.68 1.20

LFDT2 25.32 0.44 0.52 16.36 1.18

LFDT3 23.48 0.41 0.50 15.82 1.16

LFDT4 29.71 0.44 0.54 18.20 1.17

LFDT5 27.39 0.43 0.52 17.47 1.17

LFDT6 24.86 0.41 0.53 20.09 1.27

LFDT7 29.37 0.43 0.53 21.87 1.22

LFDT8 25.12 0.41 0.54 21.63 1.27

LFDT9 23.55 0.40 0.51 24.01 1.31




Post-compression evaluation parameters:

Table No.6: Evaluation of physical parameters:

Table No.7: In-Vitro Drug Release Data batch LFDT1-LFDT

Batch Code Weight Variation Average

Wt in mg ± SD

Hardness

Kg/cm2± SD

Thickness

mm± SD

Friability

%

Drug Content

Uniformity % ± SD

LFDT1 140.35±1.8 4.3±0.20 3.2±0.11 0.25 93.27±1.15

LFDT2 144.50±1.9 4.4±0.20 3.2±0.12 0.27 92.98±1.73

LFDT3 145.80±1.5 4.8±0.10 3.2±0.17 0.23 92.97±1.00

LFDT4 142.20±0.5 4.7±0.15 2.8±0.20 0.30 95.63±2.08

LFDT5 146.75±0.7 4.8±0.11 3.0±0.18 0.22 93.55±1.73

LFDT6 148.80±1.5 4.8±0.05 3.5±0.10 0.34 90.38±2.64

LFDT7 144.05±1.9 4.6±0.17 3.3±0.13 0.25 90.36±1.15

LFDT8 148.90±0.7 4.7±0.20 3.3±0.15 0.28 90.66±2.30

LFDT9 151.20±0.8 4.7±0.17 3.4±0.19 0.31 98.89±1.00

Time(min) LFDT1 LFDT2 LFDT3 LFDT4 LFDT5 LFDT6 LFDT7 LFDT8 LFDT9

0 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

3 89.08 86.19 86.19 64.53 85.61 89.08 85.61 84.75 92.51

6 93.33 95.34 95.05 98.57 95.33 93.33 93.31 95.62 98.89

9 93.27 92.98 92.97 89.44 93.55 90.38 90.36 90.66 95.63

12 90.03 89.44 89.44 96.51 93.49 85.97 85.95 85.96 93.55

15 86.47 87.91 87.91 94.48 88.80 86.15 86.13 84.12 92.91




In-vitro drug release study:

Fig No.3: Comparative in-vitro Release Fig No.4 : Comparative in Vitro Release

Profile for Formulations F1, F2, F3. Profile for Formulations F4, F5, F6

Fig No.5 : Comparative in Vitro Release Fig No.6: Comparative in Vitro Release

Profile for Formulations F7, F8, F9. Profile for Formulations F3, F6, F9.

DISCUSSION:-

Pre-formulation studies:

Standard Calibration Curve:The standard calibration curve of Levocetrizine hydrochloride

was obtained by plotting absorbance vs. concentration.in table 6.1 shows the absorbance values of

Levocetrizine hydrochloride. The standard curve is shown in figure 6.1.The standard calibration

curve shows the correlation coefficient of 0.998. The curve was found to be linear in the

concentration range of 2 to 14 μg/ml (Beer’s range) at 231 nm. The calculations of drug content,

in-vitro drug release and stability studies are based on this calibration curve.

Melting Point:-The melting point of Levocetrizine hydrochloride was determined by capillary

tube method and it was found to be 215-2200C which is same as that of literature value.




Drug-excipients compatibility studies:

FTIR Studies: To study the compatibility of the drug with various polymers, IR spectra of drug

and formulation components were carried out. The IR spectra of drug and all excipients were

shown in figure 6.3 respectively.

Evaluation of tablets:

Angle Of Repose (Θ):

The values were found to be in the range of 23.480 to 29.71

0. All formulations showed the angle

of repose within 300. It indicates that all formulations showed good flow properties.

Bulk Density:The loose bulk density and tapped bulk density for all the formulations varied from

0.40 gm/cm3 to 0.46 gm/cm

3 and 0.51 gm/cm

3 to 0.55 gm/cm

3 respectively. The values obtained

lies within the acceptable range and not large differences found between loose bulk density and

tapped density. This result helps in calculating the % compressibility of the powder.

Percentage Compressibility Index:The percent compressibility of powder mix was determined

by Carr’s compressibility index.The percent compressibility for all the nine formulations lies

within the range of 15.82 to 24.01 %.

Hausner’s Ratio: Hausner’s ratio of the powder was determined from the loose bulk density and

tapped bulk density. Hausner’s ratio of all the formulations lies within the acceptable range. The

Hausner’s ratio of all the formulations is in the range of 1.16 to 1.31.

Post-Compression Evaluation Parameters of Tablet: All the formulations were subjected for

organoleptic, physical and chemical evaluations. Shape, uniformity of thickness, hardness,

friability, weight variation, in-vitro disintegration time, wetting time, water absorption ratio, drug

content, in vitro dissolution studies .

Shape and Color of Tablets: Randomly picked tablets from each formulation batch examined

under lens for shape and in presence of light for color. The tablet shows flat, ovate shape and

white in color.

Thickness: The thickness of the tablets was measured by using Vernier caliper by taking the

tablets randomly. The values are almost uniform in all formulations. Thickness was found in the

range from 2.8±0.20 mm to 3.05±0.10 mm respectively.

Hardness Test: Hardness test was performed by using precision dial type hardness tester.

Hardness was maintained to be within 4.3±0.20 kg/cm2

to 4.8±0.11 kg/cm2, as these tablets are




mouth dissolving.The lower standard deviation values indicated that the hardness of all the

formulations were almost uniform and possess good mechanical strength with sufficient hardness.

Friability: It was found well within the approved range (<1%) in all the formulation. Friability

was in between 0.22% to 0.34%. Results revealed that the tablets possess good mechanical

strength.

Weight Variation Test: All the tablets passed weight variation test as the % variation was within

the pharmacopoeia limit of ±7.5 %. The weight of all the tablets was found to be uniform. This is

due good flow property and compressibility of all the formulations.

Drug Content Uniformity: Three trials from each formulation were analyzed

spectrophotometrically. The mean value and standard deviation of all the formulations were

calculated. The drug content of the tablets was found between 90.36 % to 98.89%.

In-Vitro Disintegration Time: This was determined as per I.P for all the formulations. All the

formulations show disintegration time less than 41 seconds.Disintegration time was observed in

order of Crospovidone < Sodium starch glycolate. Disintegration time of crospovidone has high

water uptake and swelling which leads to faster disintegration time.

In-Vitro Dissolution Studies: All the nine formulations were subjected for the in vitro

dissolution studies using tablet dissolution tester (USP) TDT-08L, Electro Lab.The samples were

withdrawn at different time intervals, filter, diluted and analyzed at 231 nm.The rapid dissolution

was observed in formulations F1, F2, F3 releases 93.33%, 95.34%, 95.05% of drug respectively,

at the end of 6 minutes. formulations F4, F5 and F6 which shows drug release 98.57%, 95.33%,

93.33% respectively at the end of 6 min. Formulations F7, F8, F9 releases 93.31%, 95.62%,

98.89% respectively at the end of 6 minutes.

SUMMARY:

The preformulation studies were carried out during the early stage of this work. It was found that

Levocetrizine hydrochloride is having maximum absorption at 231 nm. The FT-IR spectrum

revealed that polymer and excipients used were compatible with the drug. Fast dissolving tablets

were prepared by direct compression method using various superdisintegrants like crosspovidone,

sodium starch glycolate and tablets were evaluated for pre-compression parameters and post-

compression parameters.




Pre-compression parameters were evaluated for flow properties,such as angle of repose, loose

bulk density, tapped density,Carr’s compressibility index and also Hausner’s ratio was determined

and all the formulations showed good flow property.

Between all the developed formulations, Levocetrizine hydrochloride fast dissolving tablet

formulated by using highest conc of crospovidone and sodium starch glycolate having hardness

(4.70 kg/cm3), friability (0.31%) and drug content (98.89%) and is fulfilling all the parameters. It

has good in-vitro disintegrating time (30 sec).

All the nine formulations of tablets showed in-vitro disintegration time less than one

minute, and wetting time was found less than 60 second. This indicates rapid disintegration time

and water absorption ratio showed good absorptivity in all formulations. Hardness and friability

of all the formulation indicated tablets were mechanically stable and percentage weight variation

and drug content uniformity found within limits. In-vitro release studies revealed that 98.89% of

drug release from crospovidone and sodium starch glycolate for all the formulations was within 6

min.

CONCLUSION:

The preformulation studies of Levocetrizine hydrochloride were performed; the FT-IR

analysis revealed that the superdisintegrants and excipients used were compatible with

Levocetrizine hydrochloride.

Fast dissolving tablets of Levocetrizine hydrochloride can be prepared by direct

compression method using superdisintegrants like crospovidone, sodium starch glycolate.

Amongst all the formulations containing highest concentration of crospovidone and

sodium starch glycolate as superdisintgrants is fulfilling all the parameters satisfactorily. It

has shown excellent in-vitro disintegration and in vitro dissolution.

Apart from all the formulations of F9 formulation showed maximum drug release (98.89

%) at the end of 6 min.

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