Page 1

FORMULATION AND EVELUATION OF FAST DISSOLVING

TABLETS OF ASPIRIN

A project report submitted

In partial fulfillment of the requirement

For the award of the degree of

BACHELOR OF PHARMACY

Rishab Kumar
EnrollmentNo-131594

Under the guidance of

Dr Ritu Gupta

DEPARTMENT OF PHARMACEUTICS
INVERTIS INSTITUTE OF PHARMACY
INVERTIS UNIVERSITY
BAREILLY-LUCKNOW HIGHWAY, NH-24, BAREILLY, U.P
 Page 2

2016---2017

CERTIFICATE

This is to certify that the project report entitled Formulation and Evaluation of
Fast dissolving Tablets of Aspirin is being submitted by Rishab Kumar bearing
a Enrollment no. 131559 in partial fulfillment of the requirement for the award of
the Degree of Bachelor of Pharmacy, for the elective subject Novel Drug
Delivery System at Invertis Institute of Pharmacy, Invertis University, Bareilly.
The Institute wishes him all the success in life
.

Supervisor Head of the department

Dr .Ritu Gupta Mr. Ajit Yadav
Associate professor
 Page 3

ACKNOWLEDGEMENT

It is said that accomplishments must be credited to those who had put up

The foundations of the particular chore. In a work of this magnitude, it was natural to solicit
guidance, help and co-operation from many people and I like to acknowledge all those who
generously provided their time and expertise to maintain the quality of work.

First and foremost I express my profound gratitude and venerable regards to my guide
Dr .Ritu Gupta as a teacher she has always strived to inculcate the scientific attitude in me. I
am thankful to her for his guidance, vital encouragement, incisive criticism and dynamic
assistance. She was always present for me, whenever I needed him and I cherish the amount of
freedom I have enjoyed during this tenure under him.

I would like to express my sincere regards to Mr. Ajit yadav Head of the Department,
who is guardian figure to me. He supported me in my research and instilled confidence to reach
greater heights in my life and Mr. Vipin Agrwal for his help, fruitful knowledge, suggestions
and advice for the work.

This task would have been fruitless without the blessing, support, encouragement and
inspiration o f Mr.Himanshu Joshi and Mr.Shashank Chaturvedi. Here I pay tributes to my
parents for lifting me up in my life. I sincerely thank them for their love, trust, patience &
support without which I would have failed to stand where I am standing today. My deepest sense
of gratitude towards my father, Mr. Sudhir Kumar and my mother Mrs. Chandra Prabha who
has always motivated and contributed towards the pursuance of my studies, without worrying
about all odds. My sincere thanks to my brother Kunal who has always played a role of a wise
advisor and he really deserves heartfelt thanks for her wishes, love and support.

At this moment I really shall not forget my sister Simran who always dreamed of me
reaching to this level. I would really thank all the rest of my family who have directly and
indirectly helped me to achieve my goals.

I am grateful to Dr .Umesh Gautam chancellor of Invertis University for his words of

encouragement and timely support.
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I express my indebtedness to our vice chancellor prof. Jadish Rai for his help and
cooperation throughout my project work.

I express my sincere thanks to Dr. Y.D.S. Arya for his kindness, helpfulness and
motivating thoughts.

I really feel short of words when it comes in expressing my deep sense of gratitude
towards Himanshu Gangwar Devendra, Kunwar Pal Singh, Rajat Gupta , Bharat Singh
,Anurag pdy , Keshav Sharma ,and Riya Mishra for all their cooperation, support and making
me believe that I am capable of doing even better.

Words fail to express my gratitude towards our M.pharm seniors Mr. Ashish Gang war,
Mr. Akhil Chaudhary, and Ms. Sumbul Naaz helped me to achieve my targets.

Date:

Place: Rishab Kumar

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CONTENTS

CHAPTER NO. TITEL NO. PAGE NO.

I NITRODUCTION 6-14

II 15-16
REVIEW OF LITERATURE

III PRE FORMULATION 17-19

IV FORMULATION 20-21

V EVALUATION 22-39

VI RESULT AND 40-42

DISCUSSION
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 Page 7

INTRODUCTION

Drug delivery systems (DDS) are a strategic tool for expanding markets/indications, extending
product life cycles and generating opportunities. DDS make a significant contribution to global
pharmaceutical sales through market segmentation, and are moving rapidly. Fast dissolving drug
delivery (FDDTs,) can be achieved by various conventional methods like direct compression,
wet granulation, molding, spray drying, freeze drying, and sublimation. In order to allow fast
dissolving tablets to dissolve in the mouth, they are made of either very porous and soft- molded
matrices or compressed into tablets with very low compression force, which makes the tablets
friable and/or brittle, which are difficult to handle, often requiring specialized peel-off blister
packaging.

Many pharmaceutical dosages are administered in the form of pills, granules, powders, and
liquids. Generally, a pill design is for swallowing intact or chewing to deliver a precise dosage of
medication to patients. The pills, which include tablets and capsules, are able to retain their
shapes under Moderate pressure. However, some patients, particularly pediatric and geriatric
patients, have difficulty swallowing or chewing solid dosage forms. Many pediatric and geriatric
patients are unwilling to take these solid preparations due to a fear of choking. In order to assist
these patients, several fast-dissolving drug delivery systems have been developed. Fast-
dissolving drug delivery1 In recent years, a variety of improved methods for delivering drugs
have been developed with the aim of improving performance, convenience and compliance

FDDTs disintegrate and/or dissolve rapidly in the saliva without the need for water. Some tablets
are designed to dissolve in saliva remarkably fast, within a few seconds, and are true fast-
dissolving tablets. Others contain agents to enhance the rate of tablet disintegration in the oral
cavity, and are more appropriately termed fast-disintegrating tablets, as they may take up to a
minute to completely disintegrate. When put on tongue, this tablet disintegrates instantaneously,
releasing the drug, which dissolves or disperses in the saliva. Some drugs are absorbed from the
mouth, pharynx and oesophagus as the saliva passes down into the stomach. In such cases,
bioavailability of drug is significantly greater than those observed from conventional tablet
dosage form.
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The advantage of Fast Dissolving Dosage Forms are increasingly being recognized in both
industry and academia

Oral route of administration is the most convenient and preferred route of administration among
the various other delivery system. More than 70% of drugs are available in the market in the
form of oral drug delivery system due to pain avoidance and versatility but a very elderly patient
may not be able to swallow a daily dose of antidepressant. A schizophrenic patient in the
institutional setting can hide a conventional tablet under his or her tongue to avoid their daily
dose of an atypical antipsychotic. A middle aged woman undergoing radiation therapy for breast
cancer may be too nauseous to swallow her H2-blocker.Fast-dissolving/disintegrating tablets
(FDDTs) are a perfect fit for all of these patients.

A fast dissolving drug delivery system, in most cases, is a tablet that dissolves or disintegrates in
the oral cavity without the need of water or chewing these systems were first developed in the
late 1970s for the people who experience difficulties in swallowing traditional oral solid-dosage
forms. The novel technology of oral fast-dispersing dosage forms is known as fast dissolve, rapid
dissolve, rapid melt and quick disintegrating tablets . It improves drug dissolution as well as
onset of clinical effect and the pregastric absorption of drugs, which avoids first pass hepatic
metabolism to reduce the dose than those observed from conventional dosage forms and finally,
increase the bioavailability of drugs. The main proposal of the present review is to study the
practicability of fast dissolving drug delivery and illustrate briefly the ideal properties,
advantages and limitations, conventional and patented technologies, available marketed
formulations in FDTs and evaluation methods. The Centre for Drug Evaluation and Research
(CDER), US FDA defined Oral Disintegrating Tablets (ODT) as A solid dosage form containing
medicinal substances, which disintegrates rapidly, usually within a matter of seconds, when
placed upon the tongue.FDTs disintegrate and/or dissolve instantaneously in the saliva without
the use of water. Some tablets are designed to dissolve in saliva remarkably fast, within a few
seconds, and are true fast-dissolving tablets. Others contain agents to enhance the rate of tablet
disintegration in the oral cavity, and are more appropriately termed fast-disintegrating tablets, as
they may take up to a minute to completely.
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Advantages of Fast Dissolving Drug Delivery System FDDTs,,,,,

Fast dissolving technology offers :

Improved compliance/added convenience

No water needed

No chewing needed

Better taste

Improved stability

Suitable for controlled/sustained release actives

Allows high drug loading.

Ability to provide advantages of liquid medication in the form of solid preparation.

Adaptable and ameanable to existing processing and packaging machinery

Cost- effective.
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Fig.1

LIMITATIONS

The major disadvantages of FDTs are related to the mechanical strength of tablets.

FDT are very porous and soft molded metrics or compressed in a tablet with low compression,
which makes tablet friable and brittle which difficult to handle.

Bad tastes drugs are difficult to formulate as FDT; special precaution should have to be taken
before formulate such kind of drug.

Several FDT are hygroscopic cannot maintain physical integrity under normal condition from
humidity which requires specialized package.

Dryness of the mouth due to decreased saliva production may not be good candidates for these
tablet formulations.

Rate of absorption from the saliva solution and overall bioavailability.

 Page 11

Drug and dosage form stability.

METHODS OF PREPARATION OF FDDDS

Conventional technologies
Various conventional manufacturing techniques for FDDDS
Freeze-drying or lyophilization
It is a pharmaceutical process that allows the drying of heat sensitive drugs and biological under
low temperature by the application of vacuum to remove water by sublimation. Drugs are
dissolved or dispersed in aqueous solution of a carrier, transferred to preformed blister packs and
subjected to nitrogen flush to freeze out, then placed in the refrigerator to complete the process.
Characteristics of lyophilization techniques are, they possess high porosity and specific surface
area, and gets dissolve rapidly in mouth presenting high drug bioavailability. The major
drawback of this system is high cost, time-consuming procedure and fragility, making
conventional packing inappropriate for packing this dosage form and stability issues under stress
condition.
Advantages
The major advantage of using this technique is that the tablets produced by this technology have
very low disintegration time and have great mouth feel due to fast melting effect.
Molding method
Tablets are designed using hydrophilic ingredients, with the aim to get maximum drug
dissolution. Powder mass is wetted with hydro alcoholic solvent and compressed into a dosage
form. The solvent system is then allowed to evaporate. Taste of drug particles is developed by
spray congealing the molten mixture of hydrogenated cottonseed oil, sodium carbonate, lecithin,
polyethene glycol with an active ingredient into lactose based tablet triturate. Characteristics of
molding method are, very porous as solvents are removed by drying leaving porous mass which
promotes rapid dissolution.
Melt granulation
Melt granulation technique is a process by which the pharmaceutical powders are capably
agglomerated by a meltable binder. The benefit of this technique compared to a conventional
 Page 12

granulation is that no water or organic solvents is required. Since there is no drying step, the
process is less time consuming and requires less energy than wet granulation. It is a technique
useful to enhance the dissolution rate of poorly water-soluble drugs, such as griseofulvin.
Mass-extrusion
In this the mixed ingredients are softened by water soluble ingredient i.e. polyethene glycol,
using methanol as solvent, passing through an extruder to form thin cylinders. Which further get
sliced with a heated blade to form small tablets. Characteristics of this method is these products
can be used to mask bitter tasting drugs making small granules thus enhancing oral
bioavailability.
Sublimation
Rapid disintegration and dissolution is acquired by formulating into porous mass by
incorporating inert solid ingredients that volatilize rapidly like urea, camphor ammonium
carbonate, ammonium bicarbonate and hexamethylene-tetramine. They were mixed with other
ingredients and compressed. The volatile material is evolved by reduced pressure and applying
slight temperature leaving the mass in porous form. Characteristics of sublimation method are,
they are porous in nature, solvents like cyclohexane and benzene can be used.

DRUGPROFILE

Description

Aspirin is used to reduce fever and relieve mild to moderate pain from conditions such as
muscle aches, toothaches, common cold, and headaches. It may also be used to reduce pain and
swelling in conditions such as arthritis. Aspirin is known as a salicylate and a nonsteroidal anti-
inflammatory drug (NSAID).

Chemical name: 2acetoxybenzoic acid

Molecular formula: C9H8O4

Molecular weight: 180.159 g/mol

Melting range: 1350C

 Page 13

Volume of distribution: 11.9 L

Structure:

Hafe life: 2hr may increase to 30 hr depending dose

Bioablivility: This metabolism occurs primarily by hepatic conjugation with glycin or

glucuronic acid, each involving different metabolic pathways. The predominant pathway is the
conjugation with glycin, which is saturable. With low doses of aspirin approximately 90% of
salicylate is metabolized through this pathway.

Ultra violet: 243 nm

Dose:

Aspirin comes as a regular tablet, a delayed-release tablet, a chewable tablet, a powder, a gum,
and a rectal suppository.

It's typically taken every four to six hours to treat fever and pain. It's usually taken once a day to
lower the risk of a heart attack or stroke. Typical dosages range from 50 milligrams (mg) to
6,000 mg, daily.
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You should swallow the delayed-release tablets with a full glass of water. These tablets don't
work immediately after they are taken, so you shouldn't use them for quick pain relief.

The chewable tablets can be crushed, chewed, or swallowed whole. You should drink a full glass
of water right after taking this form of the medication.

Overdose

Symptoms of an aspirin overdose include stomach pain, nausea and vomiting, and ringing in the
ears (tinnitus). If you suspect an overdose, contact a poison control center or emergency room
immediately.

Missed Dose

If you miss a dose of aspirin, take it as soon as you remember.

However, if it's almost time for your next dose, skip the missed dose and continue on your
regular dosing schedule. Don't double up on doses to make up for a missed one.

Mechanism of action

Much of this is believed to be due to decreased production of prostaglandins and

TXA2. Aspirin's ability to suppress the production of prostaglandins and thromboxanes is due to
its irreversible inactivation of the cyclooxygenase (COX) enzyme. Cyclooxygenase is required
for prostaglandin and thromboxane synthesis.
 Page 15

Fig 2 mechanism of Aspirin

Uses

Aspirin is used to treat pain, and reduce fever or inflammation. It is sometimes Aspirin should be
used for cardiovascular conditions only under the supervision of a doctor. Used to treat or
prevent heart attacks, strokes, and chest pain (angina).

Side Effects

It should be following side effects associated with drug.

Vomiting

Stomach pain
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 Page 17

LITERATURE REVIEW

1. Chandrika .M.B et al (2016) formulated and evaluated of rapidly disintegrated tablet

ibuprofen tablets by using different super disintegrating agents.

2. Parmar R.B et al (2015) formulated and evaluated of fast dissolving tablet Domperidone.

3. Sharma D.et al (2015) formulated and evaluated of fast disintegrating tablet Salbutamol
sulphate, Cetrizine hydrochloride in combined pharmaceutical doses form: A new era in novel
drug delivery for Pediatrics and Geriatrics.

4. Turnen E. et al (2014) cyclodextrin in fast dissolving drug formulation for intraoral

administration.

5. Mishra .K.S et al (2013) formulated and evaluated rapidly disintegrated tablet Ibuprofen

6. Chowdary K.P.R et al (2013) formulated and evaluated fast dissolving tablet paracetamol
Employing Superdisintegrant

7. Rane DR et al (2012) formulated and evaluated fast dissolving tablet Albandazol

8. Mali P.A et al (2012) formulated and evaluated of fast dissolving tablet of carbamazepine.

9. Parmar D, et al (2012) reported as orally fast dissolving films as dominant dosage form for
quick release.

10. Vaishali .Y. L.et al (2012) formulated and evaluated of fast dissolving film Telmisartan.

11. Basu B.et al (2011) formulated and evaluated of fast dissolving tablet Cinnarizine using
super disintegrant blends and subliming material.

12. Newa M.et al (2008) prepared and evaluated of fast dissolving Ibuprofen- polyethylene
glycol 6000 solid dispersion.
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PREFORMULATION
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UV SPECTROSCOPY:

An U.V spectrophotometric method based on the measurement of absorbance at 253 nm in

phosphate buffer oh pH 5.8 was used for the estimation of paracetamol. The method obeyed
Beers law in the concentration range 0 - 10 g/ml.

Angle of repose:

The 5 g of powder mixture was poured into glass funnel; the lower tip of glass funnel was 5 cm
height from the ground. The height (h) and radius (r) of pile were measured, and then calculated
by equation.

Bulk density

The 20 g of powder mixture was weighted accurately, gently poured into 100 ml glass cylinder
without compacting. The volume of powder mixture was recorded, and then calculated by
equation (2). The study was carried out in triplicate

Tapped density

The 20 g of powder mixture was weighted accurately, poured into 100 ml glass cylinder. It was
tapped using tapped density tester (Erweka D-63150, Germany) for 1,250 strokes. The volume of
tapped powder mixture was recorded, and then calculated by equation (3). The study was carried
out in triplicate

Compressibility index

The volume of powder from bulk density and tapped density testing were used for calculate
compressibility index follow equation

Carrs index or % compressibility index:

It indicates powder flow properties. It is the simple test to evaluate the bulk density and tapped
density of a powder and the rate at which it packed down. The Carrs compressibility index was
calculated by calculating the tapped and bulk density using the 100 ml measuring cylinder
An excess quantity of drug was taken in 10 ml of different solutions in a shaking water bath (100
agitations per minute) for 24 h at room temperature. The solution was then passed through a
Whitman (No. 1) filter and the amount of the drug dissolved was analyzed.

Table1. Precompression parameters of Aspirin fast dissolving tablets,

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S Test F1 F2 F3 F4 F5 F6 F7 F8 F9 F10
No

1 Bulk 0.62 065 0.60 0.62 0.64 0.69 0.61 0.62 0.62 0.60
density
(gm/ml)
2 Tapped 0.87 0.87 0.86 0.80 0.87 0.87 0.89 0.85 0.876 0.85
density 3
(gm/ml)
3 Care 28.73 29.83 28.80 30.25 29.9 30.35 31.23 29.98 28.80 29.80
index 8
4 Angle 25 25 25 24 26 25 26 28 25 25
of .2 . .4 . . .3 .4 .2
.25
repose
(degree) 4 34 5 .45 56 56 0 5 4
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FORMULATION
 Page 22

Materials and Methods

Aspirin CDH New Delhi, Lactose CDH New Delhi, Magnesium sterate CDH New Delhi, Talc
CDH New Delhi,

Table2 Formula

Ingredien F1 F2 F3 F4 F5 F6 F7 F8 F9 F10
t
Aspirin 350 350 350 350 350 350 350 350 350 350
Lactose 70 60 65 70 65 65 70 70 40 70
Starch 40 45 50 30 45 35 40 40 70 60
Meg 20 25 25 25 20 25 20 20 25 10
sterate
Talc 20 20 10 25 20 25 20 20 15 10
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EVALUATION
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1. Weight variation test

The weight variation test for given tablet was successfully done

Formula

% deviation or % weight deviation =

Indivsual weight Avrage weight

100
Avrage weight

Procedure

Taken 20 tablet to perform weight variation test.

Weighed 20 tablet collectively with the aid of electronic balance.
Calculated the average weight of 20 tablets collectively.
Now weighed the individual tablet by using electronic balance.
Calculation of deviation was done by using mentioned formula.

Table 3. Weight variation test for F1

S No Individual weight Average weight % Deviation Inference

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1 338 350 -3.42 Pass

2 347 350 -0.85 Pass
3 335 350 -2.85 Pass
4 355 350 1.42 Pass
5 348 350 -0.57 Pass
6 335 350 -2.85 Pass
7 360 350 2.85 Pass
8 340 350 1.42 Pass
9 355 350 -2.85 Pass
10 340 350 -1.14 Pass
11 346 350 -2 Pass
12 343 350 -4.28 Fail
13 335 350 -1.42 Pass
14 345 350 -2.85 Pass
15 340 350 -1.14 Pass
16 335 350 -1.42 Pass
17 335 350 -1.42 Pass
18 360 350 2.85 Pass

19 350 350 0 Pass

20 340 350 -2.85 Pass

Table 4. Weight variation test for F2

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S No Individual weight Average weight % Deviation Inference

1 360 350 2.85 Pass
2 370 350 5.71 Fail
3 360 350 2.85 Pass
4 330 350 -5.71 Fail
5 325 350 -7.14 Fail
6 370 350 5.71 Fail
7 360 350 2.85 Pass
8 365 350 4.28 Pass
9 360 350 2.85 Pass
10 360 350 2.85 Pass
11 345 350 -1.42 Pass
12 345 350 -1.42 Pass
13 340 350 -2.85 Pass
14 340 350 -2.85 Pass
15 370 350 5.71 Fail
16 370 350 5.71 Fail
17 375 350 7.14 Fail
18 375 350 7.14 Fail
19 330 350 -5.7 Fail
20 360 350 2.85 Fail

Table5. Weight variation test for F3

S No Individual weight Average weight % Deviation Inference

1 360 350 2.85 Pass
2 330 350 -5.71 Fail
3 375 350 7.14 Fail
4 375 350 7.14 Pass
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5 370 350 5.71 Fail

6 370 350 5.71 Fail
7 340 350 -2.42 Pass
8 340 350 -2..42 Pass
9 345 350 -1.42 Pass
10 345 350 -1.42 Pass
11 360 350 2.85 Pass
12 360 350 2.85 Pass
13 365 350 4.28 Pass
14 360 350 2.85 Pass
15 370 350 5.71 Fail
16 325 350 -7.14 Fail
17 330 350 -5.71 Fail
18 360 350 2.85 Pass
19 370 350 5.71 Fail
20 360 350 2.85 Pass

Table 6. Weight variation test for F4

S No Individual weight Average weight % Deviation Inference

1 338 350 -3.42 Pass
2 347 350 -0.85 Pass
3 335 350 -2.85 Pass
4 355 350 1.42 Pass
5 348 350 -0.57 Pass
6 335 350 -2.85 Pass
7 360 350 2.85 Pass
8 340 350 1.42 Pass
9 355 350 -2.85 Pass
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10 340 350 -1.14 Pass

11 346 350 -2 Pass
12 343 350 -4.28 Fail
13 335 350 -1.42 Pass
14 345 350 -2.85 Pass
15 340 350 -1.14 Pass
16 335 350 -1.42 Pass
17 335 350 -1.42 Pass
18 360 350 2.85 Pass
19 350 350 0 Pass
20 340 350 -2.85 Pass

Table 7.Weight variation test for F5

S No Individual weight Average weight % Deviation Inference

1 360 350 2.85 Pass
2 330 350 -5.71 Fail
3 375 350 7.14 Fail
4 375 350 7.14 Pass
5 370 350 5.71 Fail
6 370 350 5.71 Fail
7 340 350 -2.42 Pass
8 340 350 -2..42 Pass
9 345 350 -1.42 Pass
10 345 350 -1.42 Pass
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11 360 350 2.85 Pass

12 360 350 2.85 Pass
13 365 350 4.28 Pass
14 360 350 2.85 Pass
15 370 350 5.71 Fail
16 325 350 -7.14 Fail
17 330 350 -5.71 Fail
18 360 350 2.85 Pass
19 370 350 5.71 Fail
20 360 350 2.85 Pass

Table 8.weight variation test for F6

S No Individual weight Average weight % Deviation Inference

1 338 350 -3.42 Pass
2 347 350 -0.85 Pass
3 335 350 -2.85 Pass
4 355 350 1.42 Pass
5 348 350 -0.57 Pass
6 335 350 -2.85 Pass
7 360 350 2.85 Pass
8 340 350 1.42 Pass
9 355 350 -2.85 Pass
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10 340 350 -1.14 Pass

11 346 350 -2 Pass
12 343 350 -4.28 Fail
13 335 350 -1.42 Pass
14 345 350 -2.85 Pass
15 340 350 -1.14 Pass
16 335 350 -1.42 Pass
17 310 350 -1.42 Pass
18 320 350 2.85 Pass
19 320 350 0 Pass
20 325 350 -2.85 Pass

Table 9. Weight variation test for F7

S No Individual weight Average weight % Deviation Inference

1 360 350 2.85 Pass
2 330 350 -5.71 Fail
3 375 350 7.14 Fail
4 375 350 7.14 Pass
5 370 350 5.71 Fail
6 370 350 5.71 Fail
7 340 350 -2.42 Pass
8 340 350 -2..42 Pass
9 345 350 -1.42 Pass
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10 345 350 -1.42 Pass

11 360 350 2.85 Pass
12 360 350 2.85 Pass
13 365 350 4.28 Pass
14 360 350 2.85 Pass
15 370 350 5.71 Fail
16 325 350 -7.14 Fail
17 330 350 -5.71 Fail
18 360 350 2.85 Pass
19 370 350 5.71 Fail
20 360 350 2.85 Pass

Table 10. Weight variation test for F8

S No Individual weight Average weight % Deviation Inference

1 360 350 2.85 Pass
2 330 350 -5.71 Fail
3 375 350 7.14 Fail
4 375 350 7.14 Pass
5 370 350 5.71 Fail
6 370 350 5.71 Fail
7 340 350 -2.42 Pass
8 340 350 -2..42 Pass
9 345 350 -1.42 Pass
10 345 350 -1.42 Pass
11 360 350 2.85 Pass
12 360 350 2.85 Pass
13 365 350 4.28 Pass
14 360 350 2.85 Pass
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15 370 350 5.71 Fail

16 325 350 -7.14 Fail
17 330 350 -5.71 Fail
18 360 350 2.85 Pass
19 370 350 5.71 Fail
20 360 350 2.85 Pass

Table 11.Weight variation test for F9

S No Individual weight Average weight % Deviation Inference

1 360 350 2.85 Pass
2 370 350 5.71 Fail
3 360 350 2.85 Pass
4 330 350 -5.71 Fail
5 325 350 -7.14 Fail
6 370 350 5.71 Fail
7 360 350 2.85 Pass
8 365 350 4.28 Pass
9 360 350 2.85 Pass
10 360 350 2.85 Pass
11 345 350 -1.42 Pass
12 345 350 -1.42 Pass
13 340 350 -2.85 Pass
14 340 350 -2.85 Pass
15 370 350 5.71 Fail
16 370 350 5.71 Fail
17 375 350 7.14 Fail
18 365 350 4.28 Pass
19 330 350 -5.7 Fail
20 365 350 4.28 Pass
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Table12. Weight variation test for F10

S No Individual weight Average weight % Deviation Inference

1 338 350 -3.42 Pass
2 347 350 -0.85 Pass
3 335 350 -2.85 Pass
4 355 350 1.42 Pass
5 348 350 -0.57 Pass
6 335 350 -2.85 Pass
7 360 350 2.85 Pass
8 340 350 1.42 Pass
9 355 350 -2.85 Pass
10 340 350 -1.14 Pass
11 346 350 -2 Pass
12 343 350 -4.28 Fail
13 335 350 -1.42 Pass
14 345 350 -2.85 Pass
15 340 350 -1.14 Pass
16 335 350 -1.42 Pass
17 335 350 -1.42 Pass
18 360 350 2.85 Pass
19 350 350 0 Pass
20 340 350 -2.85 Pass

2. Friability test
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Procedure

Roche friabilatar A number and deducted tablets (usually 6mg) are placed in tumbling apparatus
made the plastic that revolves at 25 rpm and drops the tablets to distance of 6 niche with each
revaluation normally the tablet are subjected to free for 100 revolution or 10 minutes. The tablets
are then deducted and are weighed the friability is calculated by formula. 25 rpm for 25 min.

Inetial weightFinal weight

Freability= X 100
Initial weight

Table13. Friability

S No Formulation Code Friability %

1 F1 0.8
2 F2 1.0
3 F3 1.2
4 F4 1.0
5 F5 0.8
6 F6 1.1
7 F7 1.2
8 F8 1.3
9 F9 1.0
10 F10 1.1

3. Hardness Test

In hardness test we Monsanto and Pfizer

We put the individual tablet in to the Monsanto and Pfizer,
We repeated the process 6 trims
 Page 35

Apply the force and when the tablet starts braking the records the reading from the points

Table 14. For Hardness

S No Formulation No Hardness kg/cm

1 F1 6
2 F2 7
3 F3 9
4 F4 8
5 F5 5
6 F6 6
7 F7 6
8 F8 8
9 F9 9
10 F10 6

4. Dissolution Test

Procedure

Placed the 900 ml of water which should be free from dissolution air and warm set up to
37 0C
Placed the tablets in the basket and set the apparatus
Start the motor and adjust rotation speed of 50 rpm
Now take the reading after 5 min 10, 15, 30, and 45 minutes by diluting 1 ml of sample
with 10 ml of water.

Table15. Dissolution

S No Time minutes % Amount release Cumulative % Release

1 5 2 2
2 10 4 6
3 30 3 9
4 60 7 16
5 120 12 28
 Page 36

Fig4. Dissolution curve

5. Content Uniformity

In this test, 20 tablets were randomly selected and the percent drug content was determined, the
tablets contained not less than 85% or more than 115% of the labeled drug content can be
considered as the test was passed.

5. Assay

The drug content in each formulation was determined by triturating 20 tablets and powder
equivalent to average weight was added in 100ml of 0.1N Hydrochloric acid, followed by
stirring. The solution was filtered through a 0.45 membrane filter, diluted suitably and the
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absorbance of resultant solution was measured spectrophotometrically at 315nm using 0.1 N

Hydrochloric acids as blank.

6. Disintegration Test:

Disintegration test is widely used in the pharmaceutical industry for

evalution of disintegration capability of formulations (ex: tablets) and quality
control of different dosage forms.

Applications of Disintegration test :

1. Disintegration test is a simple test which helps in the preformulation stage

to the formulator.

2. It helps in the optimization of manufacturing variables, such as

compression force time

3. This test is also a simple in-process control tool to ensure uniformity from
batch to batch and among different tablets.

4. It is also an important test in the quality control of tablets.

Advantages of Disintegration tests:

This test is simple in concept and in practice. It is very useful in

reformulation, optimization and in quality control.

Disadvantages:

Disintegration test cannot be relied upon for the assurance of bioavailability.

The disintegration test for each dosage form is given in the pharmacopoeia. There are some
general tests for typical types of dosage forms. However, the disintegration test prescribed in the
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individual monograph of a product is to be followed. If the monograph does not specify any
specific test, the general test for the specific dosage form may be employed. Some of the types of
dosage forms and their disintegration tests are:

1. Uncoated tablets

Tested using distilled water as medium at 37+/-2 C at 29-32 cycles per minute; test is completed
after 15 minutes. It is acceptable when there is no palpable core at the end of the cycle (for at
least 5 tablets or capsules) and if the mass does not stick to the immersion disc.

2. Coated tablets

The same test procedure is adapted but the time of operation is 30 minutes.

3. Enteric coated/ Gastric resistant tablets

The test is carried out first in distilled water (at room temperature for 5 min.; USP and no
distilled water per BP and IP), then it is tested in 0.1 M HCL(upto 2 hours; BP) or Stimulated
gastric fluid (1 hour; USP) followed by Phosphate buffer, pH 6.8 (1 hour; BP) or Stimulated
intestinal fluid without enzymes (1 hour; USP).

Fig5. Disintegration Apparatus

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Medium: The assembly in suspended in the liquid medium in a suitable

vessel, preferably a 1 litre beaker. The volume of the liquid is such that the
wire mesh at its highest point is at least 25mm below the surface of the
liquid, and at its lower point is at least 25 mm above the bottom of the
beaker. At no time should the top of the basket-rack assembly become
submerged. There is a thermostatic arrangement for heating the liquid and
maintaining the temperature at 37oC 2 degree celsius.
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RESULTS AND DISCUSSION

Paracetamol FDTs were formulated employing four superdisintegrant namely Crospovidone,

Croscarmellose sodium, Primojel and PGS-PEG-Aerosil coprocessed excipient. In each case
three different concentrations of superdisintegrant (2, 4, 5 %) were used. The tablets were
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prepared by wet granulation method as per the formulae and evaluated for various physical
parameters and dissolution rate. The physical parameters of the paracetamol FDTs prepared are
given in Table 2. The hardness of the tablets was in the range 4.5-5.5 kg/cm2. Percent weight
loss in the friability test was less than 0.70 % in all the cases. Drug content of the tablets
prepared was within 1003 % of the labelled claim. All the FDTs prepared disintegrated within 2
min 50 sec. Among the four superdisintegrant tested. Crospovidone and Croscarmellose sodium
gave rapid disintegration of the tablets. FDTs formulated employing 5% Crospovidone (PF3) and
5 % Croscarmellose sodium (PF7) disintegrated within 21 and 28sec and the wetting time of
these tablets were 5 and 8 sec respectively. Water absorption ratio(%) of these tablets was 96.64
% and 74.97 % respectively. The dissolution rate of paracetamol from the FDTs prepared was
studied in phosphate buffer of PH 5.8 as prescribed in IP 2010. All the FDTs prepared gave rapid
dissolution of paracetamol. Paracetamol dissolution from the FDTsprepared followed first order
kinetics with coefficient of determination (R2) values greater than 0.950 in all the cases. The first
order dissolution rate constants (K1) were calculated from the slope of the first order linear plots.

CONCLUSION

Nature and concentration of the superdisintegrant showed influence on the rate of dissolution.
The rate of the drug release was found to be increased by increasing the concentration of the
superdisintegrant and found to be highest for tablets formulated with10 mg of superdisintegrant.
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All the blend exbhited good flow properties and suited for direct compression. The compatibility
studies were conducted by FTIR. The results show the compatible nature between the drugs and
excipients. F6 offered relatively rapid release of Ibuprofen when compared with other
formulations increase in the concentrations of superdisintegrant may lead to increase in the drug
release.

REFERENCES
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1. Int j curr pharm res, vol 9, issue 2, 8-18review article fast dissolving tablets: a review, ashish
masih, amar kumar, shivam singh*, ajay kumar tiwari

School of Pharmaceutical Science, Jaipur National University,

Received: 25 Nov 2016, Revised and Accepted: 23 Jan 2017

2. Prathiva T.K et al (2013) reported as A review of FDDS:A pioneer drug delivery system

3. Deepak Sharma et al (2014) reported as Formulation Development and Evaluation of Fast

Disintegrating Tablets of Salbutamol Sulphate, Cetirizine Hydrochloride in Combined
Pharmaceutical Dosage Form: A New Era in Novel Drug Delivery for Pediatrics and Geriatrics

4. Robertson sally et al (2014) reported as ibuprofen mechanism in news medical life science.

5. Pahwa R., Piplani M., Sharma P. C., Kaushik D., Nanda S. Orally disintegrating tablets
friendly to pediatrics and geriatrics. Archives of Applied Science Research. 2010; 2(2):3548.

6. Divate S., Kavitha K., Sockan G. N. Fast disintegrating tabletsan emerging

trend. International Journal of Pharmaceutical Sciences Review and Research. 2011; 6(2):18
22.

7. Panigrahi R., Behera S. A. Review on fast dissolving tablets. Webmed Central Quality and
Patient. 2010; 1(9):117.

8. Newa Madhuri (2008) prepared and evaluated of fast dissolving Ibuprofen- polyethylene
glycol 6000 solid dispersion.

9. Vaishali .Y. Londhe (2012) formulated and evaluated of fast dissolving film of Telmisartan.
 Page 44

10. Basu Biswajit (2011) formulated and evaluated of fast dissolving tablet of Cinnarizine using
super disintegrant blends and subliming material.

11. Sharma Deepak (2015) formulated and evaluated of fast disintegrating tablet of Salbutamol
sulphate, Cetrizine hydrochloride in combined pharmaceutical doses form: A new era in novel
drug delivery for Pediatrics and Geriatrics.

12. Gupta Sparsh (2015) Novel study in fast dissolving drug delivery system: A review.

13. Turnen Elina (2014) cyclodextrin in fast dissolving drug formulation for intraoral
administration.

14. Parmar Dipika (2012) reported as orally fast dissolving films as dominant dosage form for
quick release.