Formulation and Evaluation of Orodispersible Tablet with an ... - IJPI

INTERNATIONAL JOURNAL OF 

RESEARCH ARTICLE 

PHARMACEUTICAL INNOVATIONS ISSN 2249-1031 

Formulation and Evaluation of Orodispersible Tablet with an 

Extended Release Profile 

Chavan Ritesh A.* and Mayee Rahul 

Shri Jagdish Prasad Jhabarmal Tibrewala University, Jhunjhunu, Rajasthan – 333001 

ABSTRACT 

Galantamine is a tertiary alkaloid, selective, competitive and reversible inhibitor of acetyl 

cholinesterase. It is used for symptomatic treatment of mild to moderately severe dementia of 

the Alzheimer type. Current study was focused on formulation development of orodispersible 

tablet of Galantamine which disintegrates extended release pellets. Drug coating of drug was 

done on Celphere CP 203 with the help of Povidone K30 as a binder. Extended release pellets 

were formulated using wurster process. Extended release coating on drug loaded pellets were 

done using eudragit NE 30D as a rate limiting polymer. About 30 % extended release coating 

with eudragit NE 30D showed comparable drug release pattern that of with marketed 

preparation’s pellets of Galantamine ER. Further these pellets were compressed tablets that 

were dispersed within 30 seconds, releasing extended release pellets. These formulations 

showed ideal drug release comparable to precompressed pellets. It showed no rupture of 

extended release pellets that can hamper the drug release pattern. At accelerated stability 

conditions developed formulations were found to be stable for six month. 

Keywords – Galantamine, Extended release orodispersible tablet, extended release pellets, 

Eudragit NE 30D, Antialzhimer drug etc. 

INTRODUCTION 

Orally disintegrating (dissolving) tablets 

(ODTs) are solid dosage forms that are 

placed in the mouth, rapidly 

disintegrate/dissolve when in contact with 

the saliva and then easily swallowed 

without the need for water. The fast 

disintegrating behavior of the ODT in the 

mouth limits the active ingredients that can 

be incorporated to drugs that exhibit good 

taste, stability in gastric conditions and 

have long half-life. 1 Bitter tasting drugs 

can cause discomfort to patients and 

consequently reduce their compliance, 

Volume 3, Issue 3, May − June 2013 

whereas incorporating drugs that suffer 

from instability in gastric fluids reduces 

the efficacy of the dosage form 

(bioavailability). On the other hand, 

delivering active drugs that have short 

half-life in ODTs compromise the 

practicality of the dosage form as more 

frequent administration is required. To 

address these issues, a great deal of interest 

has been directed towards incorporating 

multiparticulate drug delivery system in 

*Corresponding Author 

Chavan Ritesh A 

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ODT formulations. The multiparticulate 

drug delivery system comprises of drug 

particles encapsulated or coated by one or 

more layers of polymers that control the 

release of the drug. The polymer can be 

selected to provide extended, delayed or 

pulsed drug delivery, allowing the rate of 

release of the drug to be tailored as 

required. Moreover, they provide many 

advantages over single-unit dosage forms 

because of their multiplicity and small 

sizes including reduced risk of systemic 

toxicity, enhanced bioavailability, reduced 

risk of local irritation and reduced patient 

to patient variability as a result of their 

more predictable gastric emptying. 

Accordingly, the formulation of 

multiparticulate into ODTs can extend 

their application to more challenging drugs 

(e.g. acid sensitive) by overcoming 

restrictions imposed by the nature of these 

drugs and combine the benefits of ODTs 

and multiparticulate drug delivery system 2, 

3 . The compression of multiparticulate into 

ODT formulations has attracted substantial 

attention in both academia and industry 

and resulted in many scientific 

publications and patent applications. 

However, to produce a tablet with good 

structural integrity, relatively high 

compression pressures are required. These 

high pressures can cause damage to the 

polymer layers of the multiparticulate 

system, and, as a result, compromise their 

release controlling properties. Peroral 

controlled-release multiple unit dosage 

forms (e.g., pellets, granules or sustained 

release pellets, microcapsules, 

microparticles) are becoming more and 

more important on the pharmaceutical 

market, as they provide several advantages 


compared to single-unit dosage forms 

(e.g., tablets or capsules) 4,5 

Galantamine is a tertiary alkaloid, 

selective, competitive and reversible 

inhibitor of acetyl cholinesterase. It is used 

for symptomatic treatment of mild to 

moderately severe dementia of the 

Alzheimer type. Currently available 

formulations for galantamine are in the 

form of pellets, capsules for extended 

release and conventional tablets for 

immediate release 6 . By looking at target 

population for Galantamine, orodispersible 

tablet with extended release profile could 

be favorable option that could administer 

the dosage form easily. The present work 

led to the formulation of orodispersible 

tablets for oral administration. The 

developed formulation which disintegrates 

disperses in oral cavity in less than 30 

seconds without the need of drinking 

water; had pleasant mouth feel and 

improved patient compliance particularly 

for those who have difficulty in 

swallowing 7 . 

MATERIALS AND METHODS 

Materials 

Galantamine Hydrobromide was selected 

as a model drug candidate for the 

formulation trials aqueous dispersion of 

Eudragit NE 30D was used as a rate 

controlling polymer. Talc was used as an 

antitacking agent. Celphere CP 203 pellets 

from Asahi Kasei Excipients were used as 

a core pellets for drug loading. Water and 

Methanol (GR grade) was used as 

solvents. Microcrystalline cellulose of 

various grades viz. Ceolus KG 802 and 

KG 1000 (Blanver) were used as a filler 

which provides good cushioning effect to 

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the pellets. Crosspovidone XL 10 (ISP 

chemicals) was used as a disintegrant. 

Glyceryl Stearate was used a waxy agent 

to promote easy flow of pellets. Flavour 

(firmenich) was used as a flavour. 

Aspartame as a sweetener. Magnesium 

Stearate was used as a lubricant. 

METHODS 

Formulation Development 

Drug loading 

Procedure:- 

Refer the table no. 1 for the formula. 

Galantamine Hydrobromide was dissolved 

in purified water under continuous stirring 

until it gets completely dissolved then 

Povidone K30 was added slowly under 

continuous stirring in vertex. Stirring was 

continued until clear solution obtained. 

Finally above drug loading solution so 

formed was then subjected for drug 

loading over Celphere CP 203 pellets in 

Fluidized Bed Equipment (Pam Glatt) with 

bottom spray attachment of 1.0 mm spray 

gun having fixed column height. After 

drug loading, drug loaded pellets were 

then dried at 50 0 C until LOD achieved 

NMT 1.5 % w/w. and then sifted through 

ASTM mesh # 60. 

Process parameters were set as in table 

no.2. 

Extended Release Coating 

Procedure:- 

Refer the table no. 3 for the formula .Talc 

was dispersed in purified water under 

continuous stirring for 30 min, then 

Eudragit NE 30 D was added under 

continuous stirring and Stirred for another 

30 minutes more. Finally above extended 

release coating solution was then subjected 

for enteric coating over drug loaded pellets 


of Galantamine in Fluidized Bed 

Equipment (Pam Glatt) with bottom spray 

attachment of 1.0 mm spray gun having 

fixed column height. During the process 

samples of extended release coated pellets 

each at 10, 20, 30, 40 and 50 % extended 

release coating, was removed periodically 

and subjected for curing in oven at 50 0 c for 

1 hr. Withdrawn samples were then passed 

through ASTM mesh #30 and 50 and 

retained pellets on ASTM mesh # 50 were 

subjected for dissolution and subsequently 

for further study. Process parameters were 

set as in table no.4. 

From the in vitro drug release patterns and 

curing effects of extended release pellets 

of appropriate coating that matches to in 

vitro drug release profile of marketed 

preparation, were selected for further 

evaluation and subsequently compression 

process. 

Compression of Pellets 

Procedure 

Refer the table no. 5 for the formula 

.Ceolus KG 1000 and 802, Crospovidone 

XL 10, Aspartame and flavor were passed 

through mesh # 30 separately. Magnesium 

Stearate was passed through mesh # 60.All 

ingredients except magnesium Stearate 

was blended with extended release pellets 

were blended in polybag for 5 minutes. 

Magnesium Stearate was then lubricated 

with the above blend for 2 minutes and 

subjected for compression with 13 mm 

biconvex round shaped punch.Compressed 

tablets were evaluated for Appearance and 

dimensions, Thickness, Hardness, 

Friability, Disintegration, in vitro drug 

release and stability studies 8, 9 . 

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Evaluation of Lubricated Blend and 

Pellets 

Angle of repose 

The powder mixture was allowed to pass 

through the funnel fixed to a stand at 

definite height. The angle of repose was 

then calculated by measuring the height 

and radius of the heap of powder formed. 

Then angle of repose had been calculated 

from below formula 

θ = tan -1 (h/r) 

Where: 

θ = Angle of repose 

h = Height of pile in cm 

r = radius in cm. 

Bulk Density 

Accurately weighed quantity of sample, 

and carefully poured into graduated 

cylinder. Then after pouring the powder 

into the graduated cylinder the powder bed 

was made uniform without disturbing. 

Then the volume was measured directly 

from the graduation marks on the cylinder 

as ml. The volume measure was called as 

the bulk volume and the bulk density is 

calculated by following formula: 

Bulk density = Weight of powder /Bulk 

volume 

Tapped Density 

After measuring the bulk volume the same 

measuring cylinder was set into tap density 

apparatus. The tap density apparatus was 

set to 100 taps drop and operated for 50 

taps. Volume was noted as (Va) and again 

tapped for 50 times and volume was noted 

as (Vb). If the difference between Va and 

Vb not greater than 2% then Vb is consider 

as final tapped volume. The tapped density 

is calculated by the following Formula: 

Tapped Density = Va / Vb 

Where 

Va = weight of the powder 

Vb = tapped volume of the packing 

Compressibility index and Hausner 

ratio:- 

Compressibility index and Hausner ratio 

were calculated from bulk and tapped 

density of the sample. These parameters 

show the flow properties of sample. 

Compressibility index = [(D T - D B )/ D T ] x 

100 

Hausner ratio = D T / D B 

D T =Tapped density 

D B = Bulk density 

Friability test 

Roche Friabilator was used to measure the 

friability of the pellets. It was rotated at a 

rate of 25 RPM. 5 g pellets were weighed 

collectively and placed in the chamber of 

the friabilator. After 100 rotations (4 

minutes), the pellets were taken out from 

the friabilator and intact pellets were again 

weighed collectively after removing fines 

using ASTM sieve # 60 sieve. Permitted 

percentage friability limit is 0.8%. The 

percent friability was determined using the 

following formula. 

% friability = [(W 1 – W 2 ) / W 1 ] x 100 

Where 

W 1 = weight of the pellets before test. 

W 2 = weight of the pellets after test. 


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Drug content (Assay calculation) 

This practice was done for the pellets 

obtained after drug coating to check the 

entrapment of the drug in the drug loaded 

pellets. Drug loaded pellets equivalent to 

24 mg of pellets had been dissolved in 

diluents, from this solution 1ml was 

pipette out in to 10ml volumetric flask and 

volume was made up to with methanol 10 . 

In vitro drug release 

In vitro drug release of pellets was carried 

out after functional coating to check drug 

release pattern of the extended release 

pellets prior to the compression and on to 

the compressed tablets. Invitro drug 

release/ dissolution studies were carried 

out using following dissolution conditions. 

Dissolution Conditions:- 

Dissolution Apparatus = USP type 

II (Paddle type). 

Dissolution medium = Phosphate 

buffer pH 6.8 

Temperature = 37 ± 0.5 o C 

Paddle rpm = 100. 

Time Points = 

1,2,3,4,6,8,10,12,14,16,18,20,22,24 

hrs. 

Accurately weighed pellets were placed in 

each flask of dissolution apparatus. The 

apparatus was allowed to run for 24 hours. 

Samples measuring 5 ml were withdrawn. 

Then samples were filtered through 0.45 

Millipore filter and their concentrations 

were determined using High Performance 

Liquid Chromatography System 11 

Curing effect: 

The pellets were cured in a hot air oven for 

24 hours to check the effect of curing on 

drug release; the cured pellets are 

subjected for in vitro release studies 12 . 


EVALUATION OF COMPRESSED 

TABLETS:- 

Appearance and Dimensions:- 

The thickness and diameter of the tablets 

was determined using a Vernier calliper. 

Five tablets from each type of formulation 

were used and average values were 

calculated. It is expressed in mm. 

Weight variation test:- 

Twenty tablets were selected randomly 

from each formulation, weighed 

individually and the average weight and % 

variation of weight was calculated. 

Hardness 

For each formulation, the hardness of 3 

tablets was determined using the Monsanto 

hardness tester. The tablet was held along 

its oblong axis in between the two jaws of 

the tester. Then constant force was applied 

by rotating the knob until the tablet 

fractured. The value at this point was 

noted. 

Friability 

For each formulation, the friability of 20 

tablets was determined using the Roche 

friabilator. A sample of preweighed 20 

tablets was placed in Roche friabilator, 

which was then operated for 25 RPM for 4 

minutes. A loss of less than 1% in weigh in 

generally considered acceptable. Percent 

friability (% F) was calculated as follows, 

% friability = [(W 1 – W 2 ) / W 1 ] x 100 

Whereas W 1 = weight of tablets before 

test. 

W 2 = weight of the tablets after test. 

In vitro disintegration test 

The process of breakdown of a tablet into 

smaller particles is called as disintegration. 

The in-vitro disintegration time of a tablet 

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was determined using disintegration 

apparatus as per USP specifications. 

In vitro drug release 

Same as in vitro drug release testing of 

pellets. 

Stability Studies 

Stability studies were conducted according 

to ICH guidelines by using optimized 

formulation at 40°C/75±5% RH or a 

period of 6 months. The samples were 

withdrawn at 1, 3 and 6 month and 

analyzed for drug content, and dissolution 

study as given in in-vitro release 

dissolution studies by an HPLC method. 

Drug content (Assay calculation) 

Twenty tablets were weighed and 

powdered. The blend equivalent to 24 mg 

of Galantamine was weighed and 

dissolved in sufficient quantity of PH 6.8 

phosphate buffer. The solution was filtered 

through Whatmann filter paper (no.41), 

suitably diluted with pH 6.8 phosphate 

buffer and assayed. 

RESULT AND DISCUSSION 

Drug loading 

Drug solution of Galantamine hydro 

bromide was loaded on Celphere CP 203 

pellets Due to low viscous solution drug 

loading process was done without any 

process issues. Further drug loaded pellets 

were evaluated. 

Moisture Content 

Loss on drying was measured using 

moisture analyzer at 105 0 c and was found 

to be 1.13 %w/w. 

Assay content 

130 mg of drug loaded Pellets equivalent 

to 24 mg of Galantamine was subjected for 

assay determination by HPLC which was 


found to be 98.93 % which shows effective 

drug loading on inert pellets. 

Friability 

Friability of drug loaded pellets was found 

to be 0.361 which showed enough strength 

to withstand any pellets breaking issues 

during pelletisation. 

EXTENDED RELEASE COATING 

Extended release coating was done on drug 

loaded pellets. Due to low glass transition 

temperature of eudragit NE 30D, process 

was done using slow rate of spray rate. 

Also it was found that increasing spray 

rate triggers the sticking of pellets which 

was not ideal condition for rate controlling 

issue. Parameters observed during 

extended release coating were as below. 

Samples were withdrawn at different 

coating levels and then subjected for 

curing at 50 0 c for 1 hr. Cured pellets were 

then passed through ASTM mesh # 30 and 

50. Pellets retained on ASTM mesh #50 

was subjected for dissolution to check 

drug release pattern of the extended release 

pellets and drug release was found to be 

as in table no. 6 and graph no.1. 

It was found that coated 30% extended 

release coated pellets were found to be 

comparable with marketed extended 

release pellets. So these were chosen for 

further studies as below. 

Moisture Content:- 

Loss on drying was measured using 

moisture analyzer at 105 0 c and was found 

to be 0.89 %w/w. 

Friability 

Friability of extended release pellets was 

found to be 0.453 at 300 RPM which 

showed enough strength to withstand any 

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pellets breaking issues during 

compression. 

Effect of Curing on extended release 

pellets. 

The pellets were cured in a hot air oven for 

24 hours at 60 o c to check the effect of 

curing on drug release. Periodically pellets 

were sampled and then subjected for in 

vitro drug release studies and compared 

with previous initial results. It had been 

found that there is no drastic effect on drug 

release after curing for long time. This 

shows the promising stability of extended 

release coating. In vitro drug release was 

found to be as in table no.7 and graph 

no.2. 

Further Extended release pellets were 

evaluated for precompression parameters 

as Angle of Repose, Bulk density, Tapped 

density, Compressibility index, Hausner 

ratio as below which showed good flow 

property as statedin table no.8. 

Further these pellets were subjected for 

blending and lubrication with 

extragranular ingredients 

Compression 

Lubricated blend was then subjected for 

preformulation studies to check flowability 

and compressibility properties as stated in 

table no. 10. Then lubricated blend was 

compressed into tablets by using 13.0 mm 

biconvex round shaped punch. In process 

compression parameters as followed in 

table no. 11. 

Since disintegration was achieved on the 

above parameters hence tablets were 

compressed and subjected for dissolution 

to check that if there was any chance of 

rupturing extended release pellets during 

the compression, as in table no. 12. 


It had been observed that there was no 

impact on dissolution profile of 

compressed tablets and extended release 

pellets, also on this hardness there was no 

rupture of pellets during compression with 

enough tablet friability. 

Stability study 

Stability studies were conducted according 

to ICH guidelines by using optimized 

formulation at 40°C/75±5% RH or a 

period of 6 months. The samples were 

withdrawn at 1,3 and 6 month and 

analyzed for drug content, and dissolution 

study as given in in-vitro release 

dissolution studies by an HPLC method as 

in Table no. 13,14 and graph no. 4. 

REFERENCES 

1. Akbari B.V., Dholakiya R.B., 

Shiyani B.G., Lodhiya D.J. Design, 

development and characterization 

of mouth dissolving tablets of 

cinnarizine using superdisintegrants. 

International journal 

of pharmtech research . Vol.2, 

no.1, pp 97-105 Jan-Mar 2010 

2. Aulton, M.E.,Khan, K.A., The 

strength and compaction of 

millispheres. The design of a 

controlled-release drug delivery 

system for ibuprofen in the form of 

a tablet comprising compacted 

polymer-coated millispheres. Drug 

Dev. Ind. Pharm., 20, 3069-3104, 

1994. 

3. Bechgaard H., Nielsen G.H. 

Controlled-Release Multiple-Units 

and Single-Unit Doses a Literature 

Review. Drug Development and 

Industrial Pharmacy 4, 53 – 67, 

1978. 

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4. Bodmeier, R., Tableting of pellets. 

European Journal of Pharmaceutics 

and Biopharmaceutics . 1997. 

5. Dashevsky, A., Kolter, K., 

Bodmeier, R., Compression of 

pellets coated with various aqueous 

polymer dispersions. Int. J. Pharm. 

279 (1-2), 19-26. 2004. 

6. http://www.drugbank.ca/drugs/DB 

00674 

7. Johansson, B., Nicklasson, F., 

Alderborn, G., Effect of pellet size 

on degree of deformation and 

densification during compression 

and on compactability of 

microcrystalline cellulose pellets. 

Int. J. Pharm., 163, 35-48. 1998. 

8. Johansson, B., Wikberg, M., Ek, 

R., Alderborn, G., Compression 

behaviour and compactability of 

microcrystalline cellulose pellets in 

relationship to their pore structure 

and mechanical properties. Int. J. 

Pharm., 117, 57-73. 1995. 

9. Juslin, M., Turakka, L., 

Puumalainen, P., Controlled 

release tablets. Part 1: The use of 

pellets coated with a retarding 

acrylate plastic in tabletting. 

Pharm. Ind., 42, 829-832, 1980. 

10. Satyakala Ganti. Development of 

HPLC Methods For 

Pharmaceutically Relevant 

Molecules; Method Transfer To 

UPLC. Comparing Methods 

Statistically For Equivalence. 

Temple University Graduate 

Board. January 2011. 

11. T. Jagadeesh, R. Bala Ramesha 

Chary. Development of Oral Multi 

Particulate Drug Delivery System 

of Galantamine Hydrobromide by 

Using Extrusion Spheronization 

technique. International Journal of 

Pharmacy & Technology. IJPT | 

June-2011 | Vol. 3 | Issue No.2 | 

2633-2643 

12. Korber, M., V. Hoffart, et al. 

(2010). "Effect of unconventional 

curing conditions and storage on 

pellets coated with Aquacoat 

ECD." Drug Development and 

Industrial Pharmacy 36(2): 190- 

199. 


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Table No. 1 Formula for drug loading 

Sr. No. Ingredients % w/w 

1 Galantamine Hydrobromide (Eq. to 24 mg of Galantamine) 23.66 

2 Polyvinyl Pyrrolidone (Povidone K30) 2.37 

3 Celphere CP203 73.97 

4 Purified water 107.69 

Table No. 2 Set Parameters of drug loading. 

Parameters 

Set value 

Inlet temperature ( 0 C) 50 

Product temperature ( 0 C) 45 

Exhaust temperature ( 0 C) 45 

Atomisation Air (bar) 0.8-0.9 

Fan speed 20-50 

Peristaltic Pump Speed (RPM) 1-10 

Table No. 3 Formula for extended release coating. 


1 Eudragit NE 30 D * 50.00 

2 Talc 50.00 

3 Purified water q.s. 

*Solid content. 

Table No. 4 Set Parameters of drug loading. 

Parameters 

Set values 

Inlet temperature ( 0 C) 25 

Product temperature ( 0 C) 20-25 

Exhaust temperature ( 0 C) 20-25 

Atomisation Air (bar) 0.9-1.0 

Fan speed 30-75 

Peristaltic Pump Speed (RPM) 1-5 


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Table No. 5 Formula for blending and lubrication of extended release pellets. 


1 Extended Release Pellets 42.25 

2 Ceolus KG 1000* 24.55 

3 Ceolus KG 802 18.45 

4 Glyceryl Stearate 2.50 

5 Crospovidone XL 10 10.00 

6 Orange Flavor 0.50 

7 Aspartame 0.50 

8 Magnesium Stearate 1.25 

Tablet weight 

400.00 mg 

*To be adjusted in accordance with extended release pellets weight 

Table- 6 In vitro drug release profile of extended release pellets at different coating levels. 

Time 

(Hours) 

Marketed 

sample 

Percentage of drug released 

10 % 20 % 30 % 

ERC ERC ERC 

40 % 

ERC 

50 % 

ERC 

0 0 0 0 0 0 0 

1 28 48 38 26 23 14 

2 40 62 51 38 31 20 

3 52 72 60 47 39 31 

4 60 81 69 57 50 38 

6 74 92 83 70 63 52 

8 81 99 89 79 73 68 

10 85 100 95 84 79 75 

12 89 100 96 87 83 79 

14 90 99 99 88 86 84 

16 92 100 100 91 90 88 

18 95 100 99 94 92 89 

20 97 99 100 96 93 92 

22 99 98 100 98 96 93 

24 100 99 99 99 98 95 

F2 Value 35.24 50.52 74.40 50.99 36.71 

ERC= Extended release coating 


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Table-7 In vitro drug release profile of cured extended release pellets at different time 

intervals 


Time 

Cured pellets Cured pellets Cured pellets 

(Hours) 

(Initial) for 12 hrs. for 24 hrs. 

0 0 0 0 

1 26 24 23 

2 38 36 35 

3 47 45 43 

4 57 55 54 

6 70 68 67 

8 79 77 75 

10 84 82 81 

12 87 85 84 

14 88 86 84 

16 91 90 88 

18 94 92 89 

20 96 93 92 

22 98 96 94 

24 99 98 97 

F2 Value 74.40 64.16 59.20 

Table No 8 Precompression parameters of extended release pellets 

Sr. No. Parameters Results Remark 

1 Bulk Density 0.720 g/ml 

2 Tapped Density 0.810 g/ml 

3 Hausners ratio 1.12 Good flow 

4 Compressibility index 10.62 % Good flow 

5 Angle of repose 13.24 o Good flow 


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Table No. 9 Formula for blending and lubrication of extended release pellets 


1 Extended Release Pellets 42.25 

2 Ceolus KG 1000* 24.55 

3 Ceolus KG 802 18.45 

4 Glyceryl Stearate 2.50 

5 Crospovidone XL 10 10.00 

6 Flavor 0.50 

7 Aspartame 0.50 

8 Magnesium Stearate 1.25 

Tablet weight 100.00 

Table No.10 Preformulation parameters of lubricated blend. 


1 Bulk Density 0.660 g/ml 

2 Tapped Density 0.760 g/ml 

3 Hausners ratio 1.15 Good flow 

4 Compressibility index 12.88 % Good flow 

5 Angle of repose 13.24 o Good flow 

Table No. 11 In process compression parameters 


1 Uniformity of weight ( mg) 394-205 

2 Weight variation 2.25 % deviation 

Within Limit 

3 Thickness (mm) 2.50±0.16 mm 

4 Hardness (kP) 2.9-3.5 

5 Friability ( for 100 revolutions) 0.451 Within Limit 

6 In-vitro disintegration time (sec) 18-28 Within Limit 


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Table No. 12 Comparative dissolution profile of Extended release pellets and 

compressed tablets. 

Time (Hours) 


Extended Release Pellets Compressed tablets 

0 0 0 

1 26 24 

2 38 36 

3 47 45 

4 57 55 

6 70 68 

8 79 77 

10 84 82 

12 87 85 

14 88 86 

16 91 90 

18 94 92 

20 96 93 

22 98 97 

24 99 98 

F2 Value 74.40 64.16 

Table No. 13 Drug content according to stability conditions. 

Sr.No. Stability Conditions Drug content 

1 Initial 99.93 % 

2 40 o c/75% RH, 1 month. 99.27 

3 40 o c/75% RH, 2 month. 98.69 

4 40 o c/75% RH, 3 month. 98.21 


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% Drug released 




Table No. 14 In vitro drug release pattern of stabilised formulations. 

Time 

(Hours) 

Initial 


40 o C/75% RH, 

1 month 

40 o C/75% RH 

2 month 

40 o C/75% RH, 

3 month 

0 0 0 0 0 

1 24 23 21 22 

2 36 34 35 33 

3 45 44 42 41 

4 55 56 55 53 

6 68 68 66 65 

8 77 75 73 74 

10 82 82 81 80 

12 85 84 83 82 

14 86 84 83 83 

16 90 88 86 85 

18 92 91 91 89 

20 93 93 94 92 

22 97 97 95 94 

24 98 98 97 98 

F2 values 74.40 61.01 56.46 54.42 

100 

90 

80 

70 

60 

50 

40 

30 

20 

10 

0 

Marketed sample 

10 % Extended release coating 





0 2 4 6 8 10 12 14 16 18 20 22 24 

Time (Hours) 

Graph-1 In vitro drug release profile of extended release pellets at different coating levels 


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100 

90 

80 

70 

60 

50 

40 

30 

20 

10 

0 

0 2 4 6 8 10 12 14 16 18 20 22 24 

Time (Hours) 

Cured pellets (Initial) 

Cured pellets for 12 hrs. 

Cured pellets for 24 hrs. 

Graph -2 In vitro drug release profile of cured extended release pellets at different time intervals 

100 

90 

80 

70 

60 

50 

40 

30 

20 

10 

0 

0 2 4 6 8 10 12 14 16 18 20 22 24 

Time (Hours) 

Extended Release Pellets 

Compressed tablets 

Graph - 3 Comparative dissolution profile of Extended release pellets and compressed tablets. 


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100 

90 

80 

70 

60 

50 

40 

30 

20 

10 

0 

0 2 4 6 8 10 12 14 16 18 20 22 24 

Time (Hours) 

Initial 

40oc/75% RH, 1 month. 

40oc/75% RH, 3month. 

40oc/75% RH, 6 month. 

Graph - 4 In vitro drug release data of stabilised formulation 


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