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FORMULATION AND EVALUATION OF EFFERVESCENT TABLETS OF

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 Srinath et al., IJPRD, 2011; Vol 3(3): 12; May 2011 (76 - 104) International Standard Serial Number 0974 – 9446

[Research Article]
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FORMULATION AND EVALUATION OF EFFERVESCENT TABLETS OF PARACETAMOL

K.R.Srinath*1, C. Pooja Chowdary1,

Palanisamy.P2, Vamsy Krishna.A2,
S. Aparna1, Syed Shad Ali1, P. Rakesh1, K.Swetha3
1
Pulla Reddy Institute Of Pharmacy, Dundigal, Medak, Andha Pradesh, India
2
Vinayaka Missions College Of PharmacyVinayakamission University,Salem, TN
3
Cm College Of Pharmacy, Maisammaguda, Dulapalli, Secunderabad, Andha Pradesh

ABSTRACT

The oral dosage forms are the most popular way of taking medication despite Correspondence to Author
having some disadvantages like slow absorption and thus onset of action is
prolong. This can be overcome by administrating the drug in liquid from but,
many APIs have limited level of stability in liquid form. So, Effervescent Tablets
acts as an alternative dosage form. The tablet is added into a glass of water just
before administration and the drug solution or dispersion is to be drunk
immediately. The tablet is quickly broken apart by internal liberation of CO2 in
water due to interaction between tartaric acid and citric acid with alkali metal
carbonates or bicarbonates in presence of water. Due to liberation in CO2 gas, Mr. K.R.Srinath
the dissolution of API in water as well as taste masking effect is enhanced. The
advantages of effervescent tablets compared with other oral dosage forms Pulla Reddy Institute Of
includes an opportunity for formulator to improve taste, a more gentle action on Pharmacy, Dundigal, Medak,
patient’s stomach and marketing aspects. In present work an attempt has been Andha Pradesh, India
made to formulate an effervescent tablet containing immediate release of
paracetamol using various acids and bases. In present work we are used
different acids and bases in different concentration. In the preformulation study, Email
compatibility evaluation was performed which implies that drug; acids, bases [email protected]
and other excipient are compatible with each other. The formulation of tablets
was done by using wet granulation as well as dry granulation in that technique
wet granulation which was found acceptable.The total nine placebo tablets were Key Words
prepared and evaluated for hardness, disintegration time, weight variation and Mucoadhesion, bioadhesion,
solubility. All the formulation shows hardness and weight variation with in limit oral mucosa, mucin.
but the combination of citric acid (12.56%), tartaric acid (25.17%), sodium
bicarbonate (38.20%), sodium carbonate (6.41%) ,binding agent PVP-K-30
(2.94%) and sodium benzoate (0.52%). for the final formulation,(F7) Because
these ingredients shows the good effervescent reaction and has no problem in
capping and sticking like other formulation
INTRODUCTION

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International Journal of Pharmaceutical Research & Development ISSN: 0974 – 9446

Effervescent tablet: opening the container can also result in loss of product
quality. The most commonly used effervescent tablet
The oral dosage forms are the most popular way of today is aspirin tablet.
taking medication despite having some The aim of this study is to develop and physico-
disadvantages like slow absorption and thus onset of chemically evaluate the Effervescent Tablets of
action is prolong. This can be overcome by Paracetamol. To enhance the onset of action of
administrating the drug in liquid from but, many APIs Paracetamol and increase the solubility of Paracetamol.
have limited level of stability in liquid form. So,
effervescent tablets acts as an alternative dosage
To produce faster onset of action
form. The tablet is added into a glass of water just
To achieve better patient compliance.
before administration and the drug solution or
To Avoid the First Pass Effect.
dispersion is to be drunk immediately. The tablet is
quickly broken apart by internal liberation of CO2 in ► The Effervescent tablets should have satisfactory
water due to interaction between tartaric acid and property.
citric acid with alkali metal carbonates or
bicarbonates in presence of water. ► Tablet having the greater bioavailability than other
dosage form.

► The stability of Effervescent tablets can be increased.

► The effervescent tablets require strictly humid

control area. The Effervescent
tablets can be made in a normal area where the
humidity and temperature Condition not
maintained.
Effervescent Tablets ► Tablet has a better patient compliance and rapid
onset of action.
Due to liberation in CO2 gas, the dissolution of API in
water as well as taste masking effect is enhanced. Reason for selection of Effervescent tablets of
The advantages of effervescent tablets compared Paracetamol
with other oral dosage forms includes an opportunity
for formulator to improve taste, a more gentle action * Fast onset of action. - Effervescent tablet have major
on patient’s stomach and marketing aspects. To advantage that the drug product is already in solution
manufacture these tablets, either wet fusion or heat at the time it is consumed.thus the absorption is faster
fusion is adopted. The tablets are compressed soft and more complete than with conventional tablet.faster
enough to produce an effervescent reaction that is absorption means faster onset of action.effervescent
adequately rapid. Water soluble lubricants are used drug are delivered to the stomach at a pH that is just
to prevent an insoluble scum formation on water right for absorption.many medication travel slowly
surface. To add sweetness to the formulation, through the gastrointestinal tract or have absorption
saccharin is added since sucrose is hygroscopic and that is hampered by food or other drug.
add too much of bulk to the tablet. The
manufacturing shall be done under controlled
climatic condition to avoid effervescent reaction. The * No need to swallow tablet - effervescent medications
packaging is done under 25% RH at 25ºC. Hands of are administered in liquid form so they easy to take as
the consumers and atmospheric moisture after

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International Journal of Pharmaceutical Research & Development ISSN: 0974 – 9446

compared to tablets or capsule.the number of people alteration of paracellular pathway.the paracellular

who cannot swallow tablet or who dislike swallowing pathway is the primary route of absorption of
tablet and capsule is growing.with an effervescent hydrophilic active ingredients in which the solutes
dosage form, one dose can usually delivered in just 3 diffuse into the intercellular space between epithelial
or 4 ounces of water. cells.it is postulated that the carbon dioxide widens the
intercellular space between cell which leads to greater
absorption of active ingredients(both hydrophilic and
* Good stomach and intestinal tolerance - hydrophobic).the increased absorption of hydrophobic
effervescent tablet dissolve fully in a buffered active ingredients could be due to the non polar carbon
solution. Reduced localized contact in the upper dioxide gas molecules partition into cell membrane,thus
gastrointestinal tract leads to less irritation and creating an increased hydrophobic environment,which
greater tolerability.buffering also prevent gastric acids would allow the hydrophobic active ingredients to be
from interacting with drug themselves, which can be a absorbed.
major cause of stomach.
* Conventional tablets are often assosiate with slower
onset of action and also undergoes first pass
* More portability - effervescent tablet is more easily metabolism. Effervescent tablet avoid the first pass
transported than liquid medication because no water metabolism and also produce rapid onset of action. Oral
is added until it is ready to use. liquid also provide rapid onset of action but required
carefully handling.slower onset of action and also
undergoes first pass metabolism. Effervescent tablet
* Improved palatability - drugs delivered with avoid the first pass metabolism and also produce rapid
effervescent base, taste better than most liquids, onset of action. Oral liquid also provide rapid onset of
mixture and suspensions.superior taste masking is action but required carefully handling.
achived by limiting objectionable characteristics and
complementing formulations with flavour and
fragrances.the effervescent tablet essentially include METHODS AND MATERIALS:
flavouring so they they taste much better than a
mixture of non effervescent powder in Paracetamol was procured by Shri krishna
water.morever, they produce fizzy tablets, which may pharmaceuticals (Mumbai,India), Citric acid, Sodium
have better consumption appeal than the traditional citrate (anhydrus), Fumaric acid, Sodium Benzoate was
dosage form. gifted by Thomas baker (Mumbai, India), Tartaric acid,
Sodium bicarbonate (anhydrous), Sodium citrate was
gifted by Lar Chemical (Mumbai, India), Ascorbic acid,
* More consistent response - drugs delivered with Mannitol was gifted by Bajaj Health Care. Ltd (Mumbai,
effervescent technology have predictable and India), Polyethylene Glycol-6000, Polyvinylpyrolidone-
reproducible pharmacokinetics profile that are much K-30 was gifted by Nan Hang Industrial Co-Ltd,
more consistent than the tablets or capsule. Simethicone was gifted by Nouvveaw Exports Pvt.Ltd,
(Mumbai, India), Acesulfame Potassium was gifted by
Shanghai fortune was Co.Ltd. China.
* Accurate dosing - researchers have been shown that
effervescent tablets enhance the absorption of PREFORMULATION:
number of active ingredients compaired to Pre-formulation is a branch of pharmaceutical
conventional formulations.this is because the carbon sciences that utilizes biopharmaceutical principles in the
dioxide created by the effervescent reaction can determination of physicochemical properties of a drug
enhance active ingredient permeability due to an

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International Journal of Pharmaceutical Research & Development ISSN: 0974 – 9446

substance. the goal of pre-formulation studies is to solid-state stability

choose the correct form of the substance, evaluate its excipient compatibility
physical properties and generate a through
understanding of the material’s stability under various consideration in effervescent tablets formulation:
conditions, leading to the optimal drug delivery there are several factors, which influence the release of
system. the preformulation study focuses on the drug from effervescent tablets.
physiochemical parameters that could effect the  particle size
development of efficacious dosage form. these
 dose
properties may ultimately provide a rationale for
 solubility
formulation design. also it will help in minimizing
problems in later stages of drug development, Drug-excipient compatibility study:
reducing drug development costs and decreasing
For drug-excipient compatibility study following
product’s time to market. it gives the information
excipients were studied which are used in the
needed to define the nature of the drug substance experiments:
and provide framework for the drug combination with
S.NO.
pharmaceutical excipients in the dosage form. Excipients Category
Objective:
1.
the overall objective of preformulation testing is Citric acid acidifying agent
to generate information useful to the formulation in 2.
developing desired, stable and bioavailable dosage Tartaric acid acidifying agent
3.
forms. Fumaric acid acidulant
Scope: 4.
the use of preformulation parameters maximizes Ascorbic acid antioxidant
the chances in formulating an acceptable, safe, 5.
Sodium bicarbonate alkalizing agent
efficacious and stable product. 6.
preformulation encompasses at least following tests: - Sodium carbonate alkalizing agent
7.
i. Bulk Characterization Polyvinylpyrollidone-30 binding agent.
8.
crystallinity, polymorphism and hygroscopicity Polyethylene glycol-6000 binding agent
powder properties (flow, compaction, density, 9.
particle size, surface area etc.) Mannitol binding agent
10
microscopy (morphology, particle characteristics) Sodium citrate buffering agent
molecular spectroscopy (ft-ir) 11
ii. Solubility Analysis Sodium lauryl sulphate lubricant
solubility. 12
Sodium benzoate lubricant
ph solubility profile 13
common ion effect Acesulfum potassium sweetener.
thermal effect on solubility
solubilization
dissolution
According to the functional category these
iii. Stability Analysis excipients were mixed in the different ratio. these
stability (heat, light, acid, base, oxidizer) mixtures were kept at 40oc + 75% RH, and 45oc
solution stability

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International Journal of Pharmaceutical Research & Development ISSN: 0974 – 9446

At the interval of 4 weeks, the sample was the granulation step can affect the characteristics of the
withdrawn and was subjected for analysis and related granulation produced. Therefore various methods to
substances. at the interval of 2 weeks and 4 weeks, measure certain granulation characteristics have been
the samples were withdrawn and were tested for developed to monitor granulation suitability for
following parameters: tableting. The main characteristics required to be
• Moisture content monitored in granulation are flow properties and
• Assay compressibility.
• Related substances i) Angle of repose:
Based on results, following excipients were finally It was measured by fixed funnel method. The
used to fabricate robust prototype formulation of fixed funnel method employ a funnel that was secured
effervescent tablets of paracetamol with its tip at a given height H, above graph paper that
was placed on a flat horizontal surface. Granules were
carefully poured through the funnel until the apex of
Selected Excipients for Prototype Formulation:
the conical pile just touches the tip of the funnel. Thus,
TABLE NO-2 with R being the radius of the base of the conical pile.
S.NO. Excipients
1 Tan α = H/R Where, α = Angle
Citric acid Of Repose
2 Tartaric acid
3 Fumaric acid ii) Apparent Bulk Density: (δu)
4 Ascorbic acid an accurately weighed sample of granulation
5 Sodium bicarbonate was carefully added to the measuring cylinder with the
6 Sodium carbonate aid of funnel. then the volume was noted. the volume
7 Polyvinylpyrollidone-30 of the packing was determined in an apparatus
8 Polyethylene glycol-6000 consisting of a graduated cylinder mounted on a
9 Mannitol mechanical tapping device. apparent bulk density is
10 Sodium citrate determined by the following formula:-
11 Sodium lauryl sulphate
12 Sodium benzoate δU = M
13 Acesulfum potassium VU
A. Evaluation of Granules of PARACETAMOL Where, M = Mass Of Granulation In Gms
• Angle of repose
Vu = volume of granulation (initial
• Bulk density
untapped volume)
• Tapped density
• Compressibility δb)
iii) Packed Bulk Density: (δ
I) EVALUATION OF GRANULES The above procedure was followed. The final
The ideal characteristics of a tablet that make volume was tapped till no further reduction in volume
it a popular and acceptable dosage form are was noted.
compactness, physical stability, rapid production
capability, chemical stability and efficacy. In general packed bulk density is determined by the
above characteristics of tablet are dictated by the following formula.
quality of the granulation from which it is made.
b = m/vb
Many formulation and process variables involved in

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International Journal of Pharmaceutical Research & Development ISSN: 0974 – 9446

where, m = mass of granulation in gms in the barrel to indicate the force. The force of fracture
was recorded, and the zero force reading was deducted
Vb = volume of granulation (final from it. Ten tablets of each formulation were
tapped volume) evaluated.
IV) PERCENT COMPRESSIBILITY: (%C) III) FRIABILITY:
Roche friabilator
It is an important measure that can be was used to determine friability of the tablets. Twenty
obtained from bulk density measurements. the preweighed tablets were placed in the friabilator, which
following formula was used to compute the percent was then operated for 100 revolutions. The tablets
compressibility. were then dedusted and reweighed. The friability was
computed by following formula:
c = δb - δu x 100
δb F = 100 (1 –
Wo
)
where, δb = packed bulk density
w
δu = apparent bulk density
where, f = percentage friability
evaluation of effervescent compressed tablets wo = initial weight of 20 tablets

w = weight after friability testing

• tablet shape & dimensions
• hardness IV) WEIGHT VARIATION:
• thickness
Twenty tablets were selected randomly. Tablets
• friability
were weighed individually and average weight was
• weight variations calculated. Then deviation of each tablet from average
• disintegration time weight was calculated and percent deviation was
• content uniformity of active computed.
ingredients
• in-vitro drug release Preformulation study:
• comparison with marketed To ensure the compatibility of drug with
conventional tablet excipients the IR spectra for pure drug and prepared
I) TABLET DIMENSIONS: granules was obtained and were compared for ensuring
Thickness and diameter were measured using no change in the principle peaks - non interference and
a calibrated dial caliper. Ten tablets of each possible degradation.
formulation were evaluated.
The peaks obtained in prepared granules of
II) HARDNESS: formulations were almost identical to those obtained
for pure drug reveling that there was no interaction
Monsanto hardness tester was used to between drug and acids bases and other ingredients.
evaluate hardness of tablet. The tester consists of a
barrel containing a compressible spring held between
two plungers. The lower plunger was placed in
contact with the tablet, and a zero reading was taken.
PROTYPE FORMULATIONS BY DIRECT COMPRESSION: -
The upper plunger was then forced against a spring by
turning a threaded bold until the tablet fractures. As FORMULA-1
the spring compressed, a pointer rides along a gauge

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International Journal of Pharmaceutical Research & Development ISSN: 0974 – 9446

TABLE NO-

S.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 34.37

2 citric acid (anhydrus) 231.63 15.92

3 ascorbic acid 200 13.75

4 sodium bicarbonate 277.86 19.10

5 sodium citrate 200 13.75

6 peg-6000 30 2.06

7 polyvinylpyrolidone-k-30 15 1.031

All Quantity in mg/tablet. COMPRESSION WEIGHT OF TABLET – 1454.5 MG/TAB

FORMULA- 2
TABLE NO-4

S.NO. INGREDIENTS QTY.(MG) % W/W

1
paracetamol 500 35.51
2 citric acid (anhydrus) 104.5 7.421
3 tartaric acid 201 14.27
4 sodium bicarbonate 352.5 25.03
5 polyvinylpyrolidone-k-30 18 1.27
6 sodium lauryl sulphate 18 1.27
7 aerosil 06 0.426
8 mannitol 208 1.477
All Quantity in mg/tablet. COMPRESSION WEIGHT OF TABLET - 1408 MG/TAB

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International Journal of Pharmaceutical Research & Development ISSN: 0974 – 9446

FORMULA- 3
TABLE NO-5
S.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 34.86

2 citric acid(anhydrus) 104.5 7.28

3 tartaric acid 201 14.01

4 sodium bicarbonate 352.5 24.58

5 sodium carbonate 18 12.55

6 sodium citrate 20 1.394

7 mannitol 208 14.50

8 polyvinylpyrolidone-k-30 20 1.394

9 acesulphum potassium 10 0.697

All Quantity in mg/tablet. COMPRESSION WEIGHT OF TABLET – 1434 MG/TAB
FORMULA – 4
TABLE NO-6
S.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 11.83

2 citric acid (anhydrus) 520 12.30

3 tartaric acid 1045 24.73

4 sodium bicarbonate 1574 37.25

5 sodium carbonate 265 6.272

6 sodium benzoate 18 0.42

7 mannitol 208 4.92

8 polyvinylpyrolidone-k-30 60 1.42

9 acesulphum potassium 20 0.47

All Quantity in mg/tablet. COMPRESSION WEIGHT OF TABLET – 4210 MG/TAB
FORMULA – 5

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TABLE NO-7
S.NO. INGREDIENTS QTY.(MG) % W/W
1 paracetamol 500 12.48
2 citric acid (anhydrus) 485 12.11

3 tartaric acid 982 24.52

4 sodium bicarbonate 1483 37.03

5 sodium carbonate 250 6.24

6 sodium benzoate 10 0.24

7 mannitol 220 5.49

8 polyethylene glycol- 6000 40 0.99

9 acesulphum potassium 20 0.48

All Quantity in mg/tablet. COMPRESSION WEIGHT OF TABLET - 3989 MG/TAB
FORMULA- 6
TABLE NO-8
SR.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 12.5

2 citric acid (anhydrus) 485 12.12

3 tartaric acid 982 24.55

4 sodium bicarbonate 1483 37.07

5 sodium carbonate 250 6.25

6 sodium benzoate 15 0.37

7 mannitol 225 5.62

8 polyvinyl pyrolidone-k-30 60 1.5

All Quantity in mg/tablet. COMPRESSION WEIGHT OF TABLET - 4000 MG/TAB

FORMULA-7
TABLE NO-9

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International Journal of Pharmaceutical Research & Development ISSN: 0974 – 9446

S.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 12.72

2 citric acid (anhydrus) 490 12.46

3 tartaric acid 982 24.98

4 sodium bicarbonate 1483 37.73

5 sodium carbonate 250 6.36

6 sodium benzoate 20 0.50

7 polyvinylpyrolidone-k-30 115 2.92

8 acesulphum potassium 30 0.76

All Quantity in mg/tablet.

COMPRESSION WEIGHT OF TABLET – 3870 MG/TAB

FORMULA - 8 TABLE
NO-10
S.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 13.36

2 citric acid (anhydrus) 480 12.83

3 tartaric acid 970 25.93

4 sodium bicarbonate 1400 37.44

5 sodium carbonate 240 6.41

6 sodium benzoate 25 0.66

7 polyvinylpyrolidone-k-30 80 2.31

8 acesulphum potassium 20 0.53

All Quantity in mg/tablet.
COMPRESSION WEIGHT OF TABLET - 3715 MG/TAB
FORMULA-9
TABLE NO-11

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International Journal of Pharmaceutical Research & Development ISSN: 0974 – 9446

S.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 13.53

2 citric acid (anhydrus) 480 12.99

3 tartaric acid 960 25.98

4 sodium bicarbonate 1350 36.53

5 sodium carbonate 210 5.68

6 sodium benzoate 30 0.81

7 polyvinylpyrolidone-k-30 100 2.70

8 acesulphum potassium 15 0.40

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET -3695 MG/TAB 2) Base granulation

Wet Granulation: - (i) In base granulation firstly the sodium bicarbonate,
sodium carbonate were blended and passed through
The Wet granulation process performed into three
steps. sieve no.# 40.
(ii) In the second step the binding agent PVP-K-30 was
Dry Mixing & Granulation
dissolved in organic solvent i.e. methylene chloride.
Lubrication of Granules
The above organic solvent was mixed
Compression of Lubricated Granules with base portions i.e. sodium bicarbonate & sodium
Dry Mixing & Granulation: - carbonate. The obtained wet mass passed through sieve
no.# 20 & kept in tray dried at 600c for 1 hr.until the
There are two steps in dry mixing & granulation L.O.D.was observed about below 1%. (On IR at 1050C for
process i.e. Acid granulation & base granulation. 5 minutes).
1) Acid granulation Lubrication of acid and base granules: -
(i) In first step Weight the Citric acid, Tartaric acid
were blended and passed through Sieve No.# 40. after drying at R.T.of both granules i.e. acid granules
and base granules were mixed. After mixing of both
(ii) In second step simethicone was dissolved in
granules the Paracetamol, Acesulphum potassium and
organic solvent i.e.methylene chloride.
lubricating agent sodium benzoate add to the granules
The above organic solvent was mixed with and well mixed.
acid portions i.e. citric acid & tartaric acid. The
Compression of Lubricated Granules:-
obtained wet mass passed through sieve no.# 20 &
kept in tray dried at 600c for 1 hr.until the L.O.D.was The Lubricated granules were
observed about below 1%. (On IR at 1050C for 5 compressed into tablet by using Single rotary tablet
minutes).

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Punching machine, 12 stations, with 24.8mm punch FORMULA-1

sets. TABLE NO-12
PROTYPE FORMULATIONS BY WET GRANULATION: -
TABLE NO-12

S.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 34.37

2 citric acid (anhydrus) 231.63 15.92

3 ascorbic acid 200 13.75

4 sodium bicarbonate 277.86 19.10

5 sodium citrate 200 13.75

6 peg-6000 30 2.06

7 polyvinylpyrolidone-k-30 15 1.031

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET – 1454.5 MG/TAB

FORMULA-2
TABLE NO-13
S.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 35.51

2 citric acid (anhydrus) 104.5 7.421

3 tartaric acid 201 14.27

4 sodium bicarbonate 352.5 25.03

5 polyvinylpyrolidone-k-30 18 1.27

6 sodium lauryl sulphate 18 1.27

7 aerosil 06 0.426

8 mannitol 208 1.477

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All Quantity in mg/tablet. COMPRESSION WEIGHT OF TABLET - 1408 MG/TAB

FORMULA-3
TABLE NO-14
S.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 34.86

2 citric acid (anhydrus) 104.5 7.28

3 tartaric acid 201 14.01

4 sodium bicarbonate 352.5 24.58

5 sodium carbonate 18 12.55

6 sodium citrate 20 1.394

7 mannitol 208 14.50

8 polyvinylpyrolidone-k-30 20 1.394

9 acesulphum potassium 10 0.697

All Quantity in mg/tablet
COMPRESSION WEIGHT OF TABLET – 1434 MG/TAB

FORMULA-4
TABLE NO-15
S.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 11.83

2 citric acid (anhydrus) 520 12.30

3 tartaric acid 1045 24.73

4 sodium bicarbonate 1574 37.25

5 sodium carbonate 265 6.272

6 sodium benzoate 18 0.42

7 mannitol 208 4.92

8 polyvinylpyrolidone-k-30 60 1.42

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International Journal of Pharmaceutical Research & Development ISSN: 0974 – 9446

9 simethicone 15 0.35

10 acesulphum potassium 20 0.47

All Quantity in mg/tablet. COMPRESSION WEIGHT OF TABLET – 4225 MG/TAB
FORMULA-5 TABLE NO-16

S.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 12.48

2 citric acid (anhydrus) 485 12.11

3 tartaric acid 982 24.52

4 sodium bicarbonate 1483 37.03

5 sodium carbonate 250 6.24

6 sodium benzoate 10 0.24

7 mannitol 220 5.49

8 simethicone 15 0.37

9 polyethylene glycol- 6000 40 0.99

10 acesulphum potassium 20 0.48

All Quantity in mg/tablet. COMPRESSION WEIGHT OF TABLET - 4004 MG/TAB
FORMULA- 6
TABLE NO-17

s.no. Ingredients QTY.(MG) % W/W

1 paracetamol 500 12.5

2 citric acid (anhydrus) 485 12.12

3 tartaric acid 982 24.55

4 sodium bicarbonate 1483 37.07

5 sodium carbonate 250 6.25

6 sodium benzoate 15 0.37

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International Journal of Pharmaceutical Research & Development ISSN: 0974 – 9446

7 mannitol 225 5.62

8 polyvinylpyrolidone-k-30 60 1.5
All Quantity in mg/tablet. COMPRESSION WEIGHT OF TABLET - 4000 MG/TAB
FORMULA-7 TABLE-18

S.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 12.72

2 citric acid (anhydrus) 490 12.46

3 tartaric acid 982 24.98

4 sodium bicarbonate 1483 37.73

5 sodium carbonate 250 6.36

6 sodium benzoate 20 0.50

7 polyvinylpyrolidone-k-30 115 2.92

8 simethicone 60 1.52

9 acesulphum potassium 30 0.76

All Quantity in mg/tablet. COMPRESSION WEIGHT OF TABLET – 3930 MG/TAB
FORMULA – 8
TABLE NO-19

S.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 13.36

2 citric acid (anhydrus) 480 12.83

3 tartaric acid 970 25.93

4 sodium bicarbonate 1400 37.44

5 sodium carbonate 240 6.41

6 sodium benzoate 25 0.66

7 polyvinylpyrolidone-k-30 80 2.31

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8 simethicone 25 0.66

9 acesulphum potassium 20 0.53

All Quantity in mg/tablet. COMPRESSION WEIGHT OF TABLET - 3740 MG/TAB
FORMULA - 9
TABLE NO-20

S.NO. INGREDIENTS QTY.(MG) % W/W

1 paracetamol 500 13.53

2 citric acid (anhydrus) 480 12.99

3 tartaric acid 960 25.98

4 sodium bicarbonate 1350 36.53

5 sodium carbonate 210 5.68

6 sodium benzoate 30 0.81

7 polyvinylpyrolidone-k-30 100 2.70

8 simethicone 50 1.35

9 acesulphum potassium 15 0.40

All Quantity in mg/tablet. COMPRESSION WEIGHT OF TABLET -3695 MG/TAB

TABLE NO – 21
FORMUL OBSERVATION
A
DIRECT COMPRESSION WET GRANULATION

F1 Capping problem,less effervescence capping problem,less effervescence

F2 Capping problem,less effervescence Capping problem,less effervescence

F3 Capping problem,less effervescence Capping problem,less effervescence

F4 Tablets having very quick Tablets having very quick

effervescence but the tablet surface effervescence,the tablet surface
found rough. become smooth compaired to direct
compression.

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F5 Tablet gives good effervescence but Tablet gives good

the some particles settle at the bottom effervescence,solution become
of the solution,capping problem also somewhat clear,not so much capping
occur. problem.

F6 Tablet gives good effervescence but Tablet gives good effervescence but
the capping problem also as such. the capping also as such.
F7 The tablet gives good effervescence, The tablet gives good effervescence ,
capping problem but the some no capping problem and the solution
particles become settled down, the become found to be clear,hardness of
hardness also not good. tablet also good compaired to other
batches.
F8 The tablet found to be good hardness The tablet gives good effervescence ,
but the capping problem somewhat no capping problem and the solution
occur, solution found to be not clear. become found to be clear,hardness of
tablet not good.
F9 Tablet gives slow effervescent.the Tablet gives slow effervescent.the
other properties like hardness, other properties like hardness,
appearance are not so good. appearance are satisfactory.

In direct compression the simethicone was not in second step the tablets were prepared by
used. But in wet granulation method it was using selected different acid base concentrations were
used. prepared. the detailed composition is shown in table
no. the granules were subjected to evaluation such as

From the above study it was concluded that angle of repose, bulk density, tapped density. the
the wet granulation provide good tablet tablets were evaluated for various physical parameters
characteristics and was selected as final such as thickness, hardness, friability, weight variation
formulation of Effervescent tablets and disintegration. the observations were confirmed to
preparation. be comparable to those observed in pre-formulation
trials. from this study the following proportions of the
RESULTS AND DISCUSSION: key excipients were finalized:
Prior to the formulation, preformulation study citric acid 12.5%, tartaric acid 25.17%, sodium
was carried out on drug and excipents. in the present bicarbonate 38.02%, and sodium carbonate 6.41%.
work, formulation part divided into four steps. in first in third step, the tablets were prepared by
step, placebo tablets were made using different acids different methods, viz. direct compression and wet
and bases in different concentrations. the detailed granulation.
composition is shown in table. the granules were Wet granulation
subjected to evaluation such as angle of repose, bulk Preparation Of Acid Granule
density, tapped density. the placebo tablets were In the preparation of acid granules: the acids
evaluated for various physical parameters such as were blended with simethecone i.e. citric acid and
thickness, hardness, friability, weight variation, tartaric acid. for this simethicone oil dissolved in solvent
disintegration, and solubility. from these best acid methylene chloride and then used to coat the sifted
base combination and various other ingredients that blend of the acids. the wet mass the mass was passed
are usually water-soluble were selected. through the sieve no.20 # and the wet granules so

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obtained were dried in a tray drier for about 60 min at

concentration absorbance
53°c+ 2°c to get lod less than 1.0% on ir. the dried
mcg/ml
granules were passed through mesh no. 16 prior to
lubrication. 1 0.022
Preparation Of Base Granules
2 0.044
In the preparation of base granules: the bases
i.e. sodium bicarbonate and sodium carbonate 3 0.064
granulated with the pvp-k-30. the pvp-k-30 was 4 0.087
dissolved in a solvent methylene chloride to form
clear solution. the obtained wet mass was passed 5 0.115
through sieve no.20 # and was dried at 53°c+ 2°c for 6 0.135
about 1 hour to get lod less than 1.0% on ir. the dried
granules were passed through mesh no. 16 prior to 7 0.157
lubrication. 8 0.180
The Lubrication Of Granules:
The lubricants 9 0.206
were passed through mesh 40 and were mixed with 10 0.240
the blend of sized base granules and sized acid slope=0.0229 r2=0.996
granules. the lubricating agents in the effervescent
tablet were water-soluble. Fig.No.1-Standard Curve Of Paracetamol
from this study it was concluded that the wet
Standard curve of Paracetamol
granulation process was better than direct
compression 0.3 y = 0.0229x
the granules were subjected to evaluation R2 = 0.9968
0.25
such as angle of repose, bulk density, tapped density.
the tablets were evaluated for various physical 0.2
A b s o rb a n c e

parameters such as thickness, hardness, friability, 0.15

weight variation, disintegration, content of active 0.1

ingredient and in-vitro dissolution study. the
0.05
promising formulations (formula no. f7) were
compared with marketed products for drug content, 0
0 2 4 6 8 10 12
disintegration, carbon dioxide and in-vitro drug
concentration(mcg/ml)
release profile.
TABLE N-22 STANDARD CALIBRATION CURVE FOR
PARACETAMOL(PH-1.2) EVALUATION OF TABLETS:
accurately weighed 100 mg of paracetamol was I) TABLET DIMENSIONS:
dissolved in 100.0 ml of 0.1n hcl. 10.0 ml of this stock tablet dimension include thickness and diameter
solution was further diluted to 100.0 ml with 0.1n of tablet. five tablet of each formulation were evaluated
hcl.from this dilution 10.0 ml was further diluted upto and mean thickness values obtained are shown in table
100.0 ml with 0.1 n hcl.the aliquots of 1.0 ml., 2.0 ml, no.-.
3.0 ml, 4.0 ml, 5.0 ml, 6.0 ml, 7.0 ml, 8.0 ml, 9.0 ml the value indicates that, die fill was uniform and
and 10 ml were pipetted out and were made upto 10 compression force was consistent.
ml volume with 0.1 n hcl individually. the absorbance II) FRIABILITY:
of all these solutions were measured at 249 nm using
u.v.spectrometer.

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friability values for each formulation are and uniform dies fill of all the formulations. this is
recorded in table no.-. the values of the preferred supported by the acceptable flow properties of granules
formulas are within acceptable limit, implying good obtained in the pre-formulation.
compactness and strength of these formulation. IV) DISINTEGRATION TIME:
III) AVERAGE WEIGHT AND WEIGHT VARIATION:
the disintegration time test was carried out for each for
twenty tablets of each formulation were evaluated. each formulation. table no.- shows the results of the
the mean values and weight variation of each disintegration time of each formulation .the acids and
formulation are recorded in table no. the values bases are used in 38% and 45% respectively in final
obtained indicate that all the tablets of different formulation.
formulations meet the ip/ u.s.p. requirements.
the observed narrow range weight variation indicates
granule flow ability; desired packing characteristics

FIG.NO.2- IDENTIFICATION OF PARACETAMOL BY H.P.L.C.

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FIG.NO.3-IMPURITY PROFILE OF PARACETAMOL

FIG.NO.4- IR CURVE OF API (PARACETAMOL)

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FIG.NO.5- IR CURVE OF API (PARACETAMOL) + CITRIC ACID + TARTARIC ACID

FIG.NO.7- IR CURVE OF API (PARACETAMOL) + SODIUM BICARBONATE + SODIUM CARBONATE

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the stability studies of formulated tablets were

STABILITY STUDIES: carried out at 40 oc, rh 75% and at room temperature
ACCELERATED STABILITY TESTING: for one month. the effects of temperature and time on
since the period of accelerated stability testing the physical characteristics of the tablet were evaluated
can be as long as 3 months for the effervescent tablet. for assessing the stability of the prepared
therefore it is essential to devise a method that will formulations.the stability studies were carried out when
help rapid prediction of long-term stability of drug. the room temperature was 20 to 25 oc. the different
the accelerated stability testing is defined as parameters that were studied are in vitro disintegration
the validated method by which the product stability time.
may be predicted by storage of the product under THE RESULTS WERE SUMMARIZED IN TABLES
conditions that accelerate the change in defined and
predictable manner.

TABLE NO:23- STABILITY PARAMETERS OF FORMULATION F7STORED AT ROOM TEMPERATURE

INITIAL AFTER 15 DAYS AFTER 30 DAYS
PARAMETER

Drug Content (%) 98% 97.7% 96%

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TABLE NO.24.- STABILITY STUDY OF IN-VITRO DISSOLUTION FOR FORMULATION F7 AT R.T.

% DRUG RELEASE
TIME (MIN)
INITIAL AFTER 15 DAYS AFTER ONE MONTHS

0 0 0 0

1 100.15 100.1
104.5

2 102.45 99.91 99.29

3 95.76 95.84
99.24
5 94.22 94.53
99.15

TABLE NO.25- STABILITY PARAMETERS OF FORMULATION F7 STORED AT TEMPERATURE 40OC AND RH 75%.
AFTER ONE
PARAMETER INITIAL AFTER 15 DAYS
MONTHS
Drug content (%) 98% 97.7% 96%
In-vitro disint. Time
65 70
(sec) 76

TABLE NO.26- STABILITY STUDY OF IN-VITRO DISSOLUTION FOR FORMULATION F7 STORED AT TEMPERATURE 40OC
AND RH 75%
AFTER ONE
PARAMETER INITIAL AFTER 15 DAYS
MONTHS

Drug content (%) 104.5% 97% 98%

In-vitro disint. Time

65 70
(sec) 76

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TABLE NO.27- PROPERTIES OF THE PREPARED FORMULATIONS

PROPERTY FD1 FD2 FD3 FD4 FD5 FD6 FD7 FD8 FD9

THICKNESS (MM) 5.60 5.39 5.49 5.95 5.90 5.85 5.85 5.88 5.83

DISINTEGRATION
TIME, SECONDS 90 100 65 69 75 70 62 66 72
% COMPRESSIBILITY
14.96 31.57 26.76 18.30 20.48 27.67 12.50 13.13 13.13

TABLE NO.28: EFFECT OF ACIDS AND BASES ON EFFERVESCENT TIME OF TABLETS

FD1 FD2 FD3 FD4 FD5 FD6 FD7 FD8 FD9
PROPERTY

Bulk Density,
G/CM3
0.50 0.52 0.52 0.58 0.66 0.66 0.625 0.58 0.58
tapped density
G/CM3
0.588 0.76 0.71 0.71 0.83 0.90 0.7142 0.66 0.66
%
Compressibility 14.96 31.57 26.76 18.30 20.48 27.67 12.50 13.13 13.13

Thickness (MM) 5.60 5.39 5.49 5.95 5.90 5.85 5.85 5.88 5.83

disintegration 90 100 65 55 59 70 62 66 72
TIME (SEC.)

water content 1.8 1.8 1.8 1.6 3.4 1.4 1.0 1.2 1.4
( l.o.d.) %

DIAMETER (MM) 24.8 24.8 24.8 24.8 24.8 24.8 24.8 24.8 24.8

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TABLE NO.29- COMPOSITION OF EFFERVESCENT TABLETS OF PARACETAMOL (WET GRANULATION)

Ingredients F1 F2 F3 F4 F5 F6 F7 F8 F9

paracetamol 500 500 500 500 500 500 500 500 500

citric acid (anhydrus) 231.63 104.5 525 520 485 485 490 480 480

tartaric acid - 201 1045 1045 982 982 982 970 960

ascorbic acid - - - - - - - - -

fumaric acid 191.96 - - - - - - - -

sodium bicarbonate 277.86 352.5 1577 1574 1483 1483 1483 1400 1350

sodium carbonate - - 265 265 250 250 250 240 210

sodium citrate 200 - 20 - - - - - -

sodium benzoate - - - 18 10 15 20 25 30

mannitol 208 208 208 220 225 - - -

peg-6000 30 20 - - 40 - - - -

pvp-k-30 15 18 20 60 60 115 80 100

simethicone - - - 15 15 60 25 50

acesulphum potassium - - 10 20 20 30 20 15

TABLE NO.30- COMPOSITION OF EFFERVESCENT TABLETS OF PARACETAMOL (DIRECT COMPRESSION)

Ingredients F1 F2 F3 F4 F5 F6 F7 F8 F9

paracetamol 500 500 500 500 500 500 500 500 500

citric acid (anhydrous) 231.63 104.5 525 520 485 485 490 480 480

tartaric acid - 201 1045 1045 982 982 982 970 960

ascorbic acid - - - - - - - - -

fumaric acid 191.96 - - - - - - - -

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International Journal of Pharmaceutical Research & Development ISSN: 0974 – 9446

sodium bicarbonate 277.86 352.5 1577 1574 1483 1483 1483 1400 1350

sodium carbonate - - 265 265 250 250 250 240 210

sodium citrate 200 - 20 - - - - - -

sodium benzoate - - - 18 10 15 20 25 30

mannitol 208 208 208 220 225 - - -

peg-6000 30 20 - - 40 - - - -

pvp-k-30 15 18 20 60 60 115 80 100

acesulphum potassium - - 10 20 20 30 20 15

TABLE NO.31-COMPARISON OF F7 FORMULATION WITH LEADING MARKETED SAMPLES I.E.ENO FRUIT SALT, HISTAC
TABLETS

FD7 MARKTED EFFERVESCENT SALT MARKTED EFFERVESCENT TABLET

PROPERTY

Bulk density (g/cm3) 0.625 0.7142 0.5882

Tapped density (g/cm3) 0.7142 0.7692 0.666

% Compressibility 12.50 7.15 11.62

Hardness (kg/cm2) 3.9 _ 4.7

Thickness (mm) 5.85 _ 5.62

Disintegration
time (sec.) 62 30 55
Water content 1.0 0.7 0.8
(l.o.d.) %
Diameter (mm) 24.8 _ 24.8

Co2 content 0.63g/tab(16.34%) 19% 16.23%

SUMMARY AND CONCLUSION: literature review showed that paracetamol having

The study was undertaken with an aim simmilar mechanism of action to aspirin because
to formulate effervescent tablet of analgesic simmilarity in structure.paracetamol act by reducing
and antipyretic drug (paracetamol). The production of prostaglandin which involved in pain

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International Journal of Pharmaceutical Research & Development ISSN: 0974 – 9446

and fever process, by inhibiting the cyclo-oxygenase The placebo tablets were prepared by
enzyme. using different acids and bases and its
In present work an attempt has been combination in different concentrations. The total
made to formulate an effervescent tablet nine placebo tablets were prepared and evaluated
containing immediate release of paracetamol using for hardness, disintegration time, weight
various acids and bases. In present work we are variation and solubility. All the formulation
used different acids and bases in different shows hardness and weight variation with in limit
concentration but the combination of citric acid (12.56 %),
1) In the preformulation study, tartaric acid (25.17%), sodium
compatibility evaluation was performed bicarbonate(38.20%),sodium carbonate (6.41%)
which implies that drug; acids, bases and for the final formulation, and the binding agent
other excipient are compatible with each PVP-K-30 (2.94%) and sodium benzoate
other. (0.52%).because these ingredients shows the
2) The formulation of tablets was done good effervescent reaction and has no problem in
by using wet granulation as well as dry capping and sticking like other formulation.
granulation.in that technique wet
granulation which was found acceptable. The effervescent tablet can be prepared
using different acids such as citric acid, tartaric
acid, fumaric acid, and ascorbic acid in different
All the formulations were subjected to concentration. In that also we are used the various
various evaluation studies. Result of the lubricants and binding agents. There are 7
evaluation of granules and evaluation of tablet formulations that contain the citric acid, tartaric
dimensions, hardness, friability, weight variations. acid, sodium bicarbonate, and sodium carbonate.
These 7 formulations evaluated for hardness,
friability, and weight variation, effervescent
• In the effervescent tablet the water content can
time etc.all the formulation. All the formulation
be measured by Karl Fischer titration method. We
found effervescent upto 72 sec. But the formula
are also subjected to carbon dioxide content in
having citric acid(12.56%),tartaric acid
the effervescent tablets.
(25.17%),sodium bicarbonate(38.20%)and sodium
• Uniformity in tablet dimensions implies that die
carbonate(2.94%).so these concentration of
fill was uniform and compression force was
acids and bases used for the final formulation.
constant.
The effervescent tablet were prepared by
• Hardness values reveal that tablets are having good
different preparation method such as Direct
mechanical strength and handling characteristics.
compression, wet granulation. The prepared
• Friability values dictate good compactness of the tablets were evaluated for content uniformity and
formulations. physical parameters. The direct compression was
• The weight variation of all formulated tablets found there was an capping problem. so the upper
was satisfactory, attributed by the surface of tablets not properly set. but with the help of
acceptable flow properties of granules. wet granulation technique the powder become free
• Content uniformity of active ingredient of flowing and the compression of the tablets so good
all the formulations are within acceptable as compaired to the direct compression reason
limit and ensures dosage uniformity. behind the choosing the wet granulation because
• The promising formulation F7 obtained in in dry granulation technique the capping and
evaluation studies. sticking problem occur.but by wet granulation

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International Journal of Pharmaceutical Research & Development ISSN: 0974 – 9446

technique the granules become good flowing 2. mohrle R “Effervescent tablets” in Liberman,
properties as Lachman L. Schwartz. Pharmaceutical dosage
form, “ Tablets” vol-I first Indian reprint (2005)
compaired to direct compression. because Marcel dekkar inc New york -285-292.
wet granulation provides the acids and bases 3. Raymond mohrle, Liberman abd Lachman
from the environmental moisture. and capping “Effervescent Tablet” “SPI pharma”
problem was reduced. At the time of Pharmaceutical dosage form Tablets, Vol-I
manufacturing of effervescent tablet the 4. Howard C.Ansel, Lloyd, Allen Jr, Nocholas and
strictly humidity and temperature should be Popovich in “Effervescent granules”8th edition
maintained. the L.O.D.of the tablet should be “pharmaceutical dosage from and drug
less than 1%. Because if one-water molecules delievery” international student edition.-200
present in the effervescent tablet then the 172-178.
obtained effervescent reaction of the tablet 5. U.S. Patent No-6440926 (Roberto Morelli,
should be very less. sylvestre cabceil)
The stability study i.e. accelerated stability 6. O’ connor, R.E.ipple E.G. Schwartz, “Powder as
study according to I.C.H.guidelines can be dosage form” Remingtion 19th edition 1611-
performed i.e 400 C ,75% RH. The stability can 1614
also be performed at R.T, 45°C, cold temperature 7. Brentford G.B. Effervescence in chewable base
i.e. 2-5°C. formulation showed no significant U.S. Patent No-5962022 (1999) Smithkline
variations for the above mentioned parameters Beecham
and it was stable for the specified time period. 8. Astra Medica A.G.(DE) Solid rapidly
From the above summary it was disintegrating formulation U.S. Patent No-
concluded that, the effervescent tablets of 6245353 (2001)
parac etamol can b e formul ated for quick 9. Brentford G.B. Effervescent formulation of
analgesic an d antipyretic ac tion by Amoxicillin U.S. Patent No-6077536 (2000)-
effervescence reaction using citric acid Beecham Group PLC
(12.56%), tartaric acid (25.17%), sodium 10. Losan Pharma Gmph effervescent ibuprofen
bicarbonate (38.20%) and sodium carbonate prepration U.S. Patent No-6171617 (2001)-
(2.94%).gives the better effervescence. the PVP-K-30 (Neuenberg. DE)
used as the binding agent. sodium benzoate (0.5%) as 11. Cima Labs Inc sublingual and buccal effervescent
lubricating agent. prepration U.S. Patent No-6200604 (2001)
(Minneapolis, MN)
ACKNOWLEDGEMENT 12. Chiesi Farmaceutici SPA movel method for
producing effervescent tablet U.S. Patent No-
Authors are thankful to Prof.(Dr.) V.Rama 6284272 (2001)
Mohan Gupta, principal Pulla Reddy Institute of 13. Therapeutic effervescent compisition U.S.
Pharmacy Dundigal,Andhra Pradesh and providing all Patent No-4687662
the facilities for this research Project. 14. S.I.Saleh in “An approach to the direct
compressible effervescent tablets” Lab
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*****

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