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tion and Evaluation of Effervescent Tablets of Paracetamol

Description

Srinath et al

Vol 3(3): 12

May 2011 (76

International Standard Serial Number 0974 – 9446

[Research Article]

Srinath*1,

Pooja Chowdary1,

Palanisamy

Vamsy Krishna

Aparna1,

Syed Shad Ali1,

Rakesh1,

Swetha3 1

Pulla Reddy Institute Of Pharmacy,

Dundigal,

Andha Pradesh,

India Vinayaka Missions College Of PharmacyVinayakamission University,Salem,

TN 3 Cm College Of Pharmacy,

Maisammaguda,

Dulapalli,

Secunderabad,

Andha Pradesh 2

ABSTRACT The oral dosage forms are the most popular way of taking medication despite 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

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,

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 includes an opportunity for formulator to improve taste,

a more gentle action on patient’s stomach and marketing aspects

In present work an attempt has been 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,

compatibility evaluation was performed which implies that drug

bases 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 prepared and evaluated for hardness,

weight variation and solubility

All the formulation shows hardness and weight variation with in limit but the combination of citric acid (12

for the final formulation,(F7) Because these ingredients shows the good effervescent reaction and has no problem in capping and sticking like other formulation

Correspondence to Author

Srinath Pulla Reddy Institute Of Pharmacy,

Dundigal,

Andha Pradesh,

Email [email protected] Key Words Mucoadhesion,

INTRODUCTION

Available online on www

International Journal of Pharmaceutical Research & Development

Effervescent tablet: The oral dosage forms are the most popular way of taking medication despite 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

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

ISSN: 0974 – 9446

opening the container can also result in loss of product quality

The most commonly used effervescent tablet today is aspirin tablet

The aim of this study is to develop and physicochemically evaluate the Effervescent Tablets of Paracetamol

To enhance the onset of action of Paracetamol and increase the solubility of Paracetamol

 To produce faster onset of action  To achieve better patient compliance

 To Avoid the First Pass Effect

► The Effervescent tablets should have satisfactory property

► 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 Due to liberation in CO2 gas,

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 includes an opportunity for formulator to improve taste,

a more gentle action on patient’s stomach and marketing aspects

To manufacture these tablets,

either wet fusion or heat fusion is adopted

The tablets are compressed soft enough to produce an effervescent reaction that is adequately rapid

Water soluble lubricants are used to prevent an insoluble scum formation on water surface

To add sweetness to the formulation,

saccharin is added since sucrose is hygroscopic and add too much of bulk to the tablet

The manufacturing shall be done under controlled climatic condition to avoid effervescent reaction

The packaging is done under 25% RH at 25ºC

Hands of the consumers and atmospheric moisture after Available online on www

► Tablet has a better patient compliance and rapid onset of action

Reason for selection of Effervescent tablets of Paracetamol * Fast onset of action

thus the absorption is faster and more complete than with conventional tablet

faster absorption means faster onset of action

effervescent drug are delivered to the stomach at a pH that is just right for absorption

many medication travel slowly through the gastrointestinal tract or have absorption that is hampered by food or other drug

International Journal of Pharmaceutical Research & Development

compared to tablets or capsule

the number of people who cannot swallow tablet or who dislike swallowing tablet and capsule is growing

with an effervescent dosage form,

one dose can usually delivered in just 3 or 4 ounces of water

Reduced localized contact in the upper gastrointestinal tract leads to less irritation and greater tolerability

buffering also prevent gastric acids from interacting with drug themselves,

which can be a major cause of stomach

taste better than most liquids,

superior taste masking is achived by limiting objectionable characteristics and complementing formulations with flavour and fragrances

the effervescent tablet essentially include flavouring so they they taste much better than a mixture of non effervescent powder in water

which may have better consumption appeal than the traditional dosage form

this is because the carbon dioxide created by the effervescent reaction can enhance active ingredient permeability due to an Available online on www

ISSN: 0974 – 9446

alteration of paracellular pathway

the paracellular pathway is the primary route of absorption of hydrophilic active ingredients in which the solutes diffuse into the intercellular space between epithelial 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 hydrophobic)

the increased absorption of hydrophobic active ingredients could be due to the non polar carbon dioxide gas molecules partition into cell membrane,thus creating an increased hydrophobic environment,which would allow the hydrophobic active ingredients to be absorbed

Effervescent tablet avoid the first pass metabolism and also produce rapid onset of action

Oral liquid also provide rapid onset of action but required carefully handling

slower onset of action and also undergoes first pass metabolism

Effervescent tablet avoid the first pass metabolism and also produce rapid onset of action

Oral liquid also provide rapid onset of action but required carefully handling

METHODS AND MATERIALS: Paracetamol was procured by Shri krishna pharmaceuticals (Mumbai,India),

Citric acid,

Sodium citrate (anhydrus),

Fumaric acid,

Sodium Benzoate was gifted by Thomas baker (Mumbai,

India),

Tartaric acid,

Sodium bicarbonate (anhydrous),

Sodium citrate was gifted by Lar Chemical (Mumbai,

India),

Ascorbic acid,

Mannitol was gifted by Bajaj Health Care

Ltd (Mumbai,

India),

Polyethylene Glycol-6000,

PolyvinylpyrolidoneK-30 was gifted by Nan Hang Industrial Co-Ltd,

Simethicone was gifted by Nouvveaw Exports Pvt

(Mumbai,

India),

Acesulfame Potassium was gifted by Shanghai fortune was Co

PREFORMULATION: Pre-formulation is a branch of pharmaceutical sciences that utilizes biopharmaceutical principles in the determination of physicochemical properties of a drug

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

the goal of pre-formulation studies is to choose the correct form of the substance,

evaluate its physical properties and generate a through understanding of the material’s stability under various conditions,

leading to the optimal drug delivery system

the preformulation study focuses on the physiochemical parameters that could effect the development of efficacious dosage form

these properties may ultimately provide a rationale for formulation design

also it will help in minimizing problems in later stages of drug development,

reducing drug development costs and decreasing product’s time to market

it gives the information needed to define the nature of the drug substance and provide framework for the drug combination with pharmaceutical excipients in the dosage form

Objective: the overall objective of preformulation testing is to generate information useful to the formulation in developing desired,

stable and bioavailable dosage forms

Scope: the use of preformulation parameters maximizes the chances in formulating an acceptable,

efficacious and stable product

preformulation encompasses at least following tests:

solid-state stability excipient compatibility consideration in effervescent tablets formulation: there are several factors,

which influence the release of drug from effervescent tablets

Drug-excipient compatibility study: For drug-excipient compatibility study following excipients were studied which are used in the experiments: S

Excipients

Category

Citric acid

Tartaric acid

Fumaric acid

Ascorbic acid

Sodium bicarbonate

Sodium carbonate

Polyvinylpyrollidone-30

Polyethylene glycol-6000

Mannitol

Sodium citrate

Sodium lauryl sulphate

Sodium benzoate

Acesulfum potassium

Bulk Characterization crystallinity,

polymorphism and hygroscopicity powder properties (flow,

particle characteristics) molecular spectroscopy (ft-ir) ii

Solubility Analysis solubility

ph solubility profile common ion effect thermal effect on solubility solubilization dissolution iii

Stability Analysis stability (heat,

According to the functional category these excipients were mixed in the different ratio

these mixtures were kept at 40oc + 75% RH,

solution stability Available online on www

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

At the interval of 4 weeks,

the sample was withdrawn and was subjected for analysis and related substances

at the interval of 2 weeks and 4 weeks,

the samples were withdrawn and were tested for following parameters: • Moisture content • Assay • Related substances Based on results,

following excipients were finally used to fabricate robust prototype formulation of effervescent tablets of paracetamol

Selected Excipients for Prototype Formulation: TABLE NO-2 S

Excipients 1 Citric acid 2 3 4 5 6 7 8 9 10 11 12 13

Tartaric acid Fumaric acid Ascorbic acid Sodium bicarbonate Sodium carbonate Polyvinylpyrollidone-30 Polyethylene glycol-6000 Mannitol Sodium citrate Sodium lauryl sulphate Sodium benzoate Acesulfum potassium A

Evaluation of Granules of PARACETAMOL

• Angle of repose • Bulk density • Tapped density • Compressibility I) EVALUATION OF GRANULES The ideal characteristics of a tablet that make it a popular and acceptable dosage form are compactness,

chemical stability and efficacy

In general above characteristics of tablet are dictated by the quality of the granulation from which it is made

Many formulation and process variables involved in Available online on www

the granulation step can affect the characteristics of the granulation produced

Therefore various methods to measure certain granulation characteristics have been developed to monitor granulation suitability for tableting

The main characteristics required to be monitored in granulation are flow properties and compressibility

i) Angle of repose: It was measured by fixed funnel method

The fixed funnel method employ a funnel that was secured 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 the conical pile just touches the tip of the funnel

with R being the radius of the base of the conical pile

Tan α = H/R Of Repose

α = Angle

ii) Apparent Bulk Density: (δu) an accurately weighed sample of granulation was carefully added to the measuring cylinder with the aid of funnel

the volume of the packing was determined in an apparatus consisting of a graduated cylinder mounted on a mechanical tapping device

apparent bulk density is determined by the following formula:δU = M VU Where,

M = Mass Of Granulation In Gms

Vu = volume of granulation (initial untapped volume) iii) Packed Bulk Density: (δ δb) The above procedure was followed

The final volume was tapped till no further reduction in volume was noted

packed bulk density is determined by the following formula

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

Vb = volume of granulation (final tapped volume)

in the barrel to indicate the force

The force of fracture was recorded,

and the zero force reading was deducted from it

Ten tablets of each formulation were evaluated

IV) PERCENT COMPRESSIBILITY: (%C)

III) FRIABILITY:

It is an important measure that can be obtained from bulk density measurements

the following formula was used to compute the percent compressibility

Roche friabilator was used to determine friability of the tablets

Twenty preweighed tablets were placed in the friabilator,

which was then operated for 100 revolutions

The tablets were then dedusted and reweighed

The friability was computed by following formula:

m = mass of granulation in gms

δb = packed bulk density

F = 100 (1 –

tablet shape & dimensions hardness thickness friability weight variations disintegration time content uniformity of active ingredients • in-vitro drug release • comparison with marketed conventional tablet I) TABLET DIMENSIONS: Thickness and diameter were measured using a calibrated dial caliper

Ten tablets of each formulation were evaluated

II) HARDNESS: Monsanto hardness tester was used to 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,

The upper plunger was then forced against a spring by turning a threaded bold until the tablet fractures

As the spring compressed,

a pointer rides along a gauge Available online on www

δu = apparent bulk density evaluation of effervescent compressed tablets

f = percentage friability wo = initial weight of 20 tablets w = weight after friability testing IV) WEIGHT VARIATION: Twenty tablets were selected randomly

Tablets were weighed individually and average weight was calculated

Then deviation of each tablet from average weight was calculated and percent deviation was computed

Preformulation study: To ensure the compatibility of drug with excipients the IR spectra for pure drug and prepared granules was obtained and were compared for ensuring no change in the principle peaks

The peaks obtained in prepared granules of formulations were almost identical to those obtained for pure drug reveling that there was no interaction between drug and acids bases and other ingredients

PROTYPE FORMULATIONS BY DIRECT COMPRESSION: FORMULA-1

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

TABLE NOS

INGREDIENTS

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET – 1454

INGREDIENTS

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET

Available online on www

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

FORMULA- 3 TABLE NO-5 S

INGREDIENTS

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET – 1434 MG/TAB FORMULA – 4 TABLE NO-6 S

INGREDIENTS

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET – 4210 MG/TAB FORMULA – 5 Available online on www

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

TABLE NO-7 S

INGREDIENTS

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET

INGREDIENTS

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

INGREDIENTS

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET – 3870 MG/TAB FORMULA

INGREDIENTS

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET

Available online on www

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

INGREDIENTS

All Quantity in mg/tablet COMPRESSION WEIGHT OF TABLET

Wet Granulation:

(i) In base granulation firstly the sodium bicarbonate,

sodium carbonate were blended and passed through sieve no

The Wet granulation process performed into three steps

Dry Mixing & Granulation Lubrication of Granules

(ii) In the second step the binding agent PVP-K-30 was dissolved in organic solvent i

There are two steps in dry mixing & granulation process i

Acid granulation & base granulation

The above organic solvent was mixed with base portions i

sodium bicarbonate & sodium carbonate

The obtained wet mass passed through sieve no

# 20 & kept in tray dried at 600c for 1 hr

(On IR at 1050C for 5 minutes)

Lubrication of acid and base granules:

Compression of Lubricated Granules Dry Mixing & Granulation:

(i) In first step Weight the Citric acid,

Tartaric acid were blended and passed through Sieve No

(ii) In second step simethicone was dissolved in organic solvent i

The above organic solvent was mixed with acid portions i

The obtained wet mass passed through sieve no

# 20 & kept in tray dried at 600c for 1 hr

(On IR at 1050C for 5 minutes)

Available online on www

acid granules and base granules were mixed

After mixing of both granules the Paracetamol,

Acesulphum potassium and lubricating agent sodium benzoate add to the granules and well mixed

Compression of Lubricated Granules:The Lubricated granules were compressed into tablet by using Single rotary tablet

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

Punching machine,

FORMULA-1 TABLE NO-12

PROTYPE FORMULATIONS BY WET GRANULATION: TABLE NO-12 S

INGREDIENTS

All Quantity in mg/tablet COMPRESSION WEIGHT OF TABLET – 1454

INGREDIENTS

Available online on www

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET

INGREDIENTS

All Quantity in mg/tablet COMPRESSION WEIGHT OF TABLET – 1434 MG/TAB FORMULA-4 TABLE NO-15 S

INGREDIENTS

Available online on www

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET – 4225 MG/TAB FORMULA-5

TABLE NO-16

INGREDIENTS

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET

Ingredients

Available online on www

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET

TABLE-18

INGREDIENTS

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET – 3930 MG/TAB FORMULA – 8 TABLE NO-19 S

INGREDIENTS

Available online on www

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET

INGREDIENTS

All Quantity in mg/tablet

COMPRESSION WEIGHT OF TABLET

WET GRANULATION

Capping problem,less effervescence

capping problem,less effervescence

Capping problem,less effervescence

Capping problem,less effervescence

Capping problem,less effervescence

Capping problem,less effervescence

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

Available online on www

International Journal of Pharmaceutical Research & Development

Tablet gives good effervescence but the some particles settle at the bottom of the solution,capping problem also occur

Tablet gives good effervescence,solution become somewhat clear,not so much capping problem

Tablet gives good effervescence but the capping problem also as such

The tablet gives good effervescence,

capping problem but the some particles become settled down,

Tablet gives good effervescence but the capping also as such

The tablet gives good effervescence ,

no capping problem and the solution become found to be clear,hardness of tablet also good compaired to other batches

The tablet gives good effervescence ,

no capping problem and the solution become found to be clear,hardness of tablet not good

Tablet gives slow effervescent

the other properties like hardness,

The tablet found to be good hardness but the capping problem somewhat occur,

solution found to be not clear

Tablet gives slow effervescent

the other properties like hardness,

 In direct compression the simethicone was not used

But in wet granulation method it was used

 From the above study it was concluded that the wet granulation provide good tablet characteristics and was selected as final formulation of Effervescent tablets preparation

RESULTS AND DISCUSSION: Prior to the formulation,

preformulation study was carried out on drug and excipents

formulation part divided into four steps

placebo tablets were made using different acids and bases in different concentrations

the detailed composition is shown in table

the granules were subjected to evaluation such as angle of repose,

the placebo tablets were evaluated for various physical parameters such as thickness,

from these best acid base combination and various other ingredients that are usually water-soluble were selected

Available online on www

ISSN: 0974 – 9446

in second step the tablets were prepared by using selected different acid base concentrations were prepared

the detailed composition is shown in table no

the granules were subjected to evaluation such as angle of repose,

the tablets were evaluated for various physical parameters such as thickness,

weight variation and disintegration

the observations were confirmed to be comparable to those observed in pre-formulation trials

from this study the following proportions of the key excipients were finalized: citric acid 12

the tablets were prepared by different methods,

direct compression and wet granulation

Wet granulation Preparation Of Acid Granule In the preparation of acid granules: the acids were blended with simethecone i

for this simethicone oil dissolved in solvent methylene chloride and then used to coat the sifted blend of the acids

the wet mass the mass was passed through the sieve no

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

Available online on www

10 slope=0

240 r2=0

obtained were dried in a tray drier for about 60 min at 53°c+ 2°c to get lod less than 1

0% on ir

the dried granules were passed through mesh no

Preparation Of Base Granules In the preparation of base granules: the bases i

sodium bicarbonate and sodium carbonate granulated with the pvp-k-30

the pvp-k-30 was dissolved in a solvent methylene chloride to form clear solution

the obtained wet mass was passed through sieve no

0% on ir

the dried granules were passed through mesh no

The Lubrication Of Granules: The lubricants were passed through mesh 40 and were mixed with the blend of sized base granules and sized acid granules

the lubricating agents in the effervescent tablet were water-soluble

from this study it was concluded that the wet granulation process was better than direct compression the granules were subjected to evaluation such as angle of repose,

the tablets were evaluated for various physical parameters such as thickness,

content of active ingredient and in-vitro dissolution study

the promising formulations (formula no

f7) were compared with marketed products for drug content,

carbon dioxide and in-vitro drug release profile

TABLE N-22 STANDARD CALIBRATION CURVE FOR PARACETAMOL(PH-1

0 ml of 0

1 n hcl

the absorbance of all these solutions were measured at 249 nm using u

EVALUATION OF TABLETS: I) TABLET DIMENSIONS: tablet dimension include thickness and diameter of tablet

five tablet of each formulation were evaluated and mean thickness values obtained are shown in table no

die fill was uniform and compression force was consistent

II) FRIABILITY:

International Journal of Pharmaceutical Research & Development

friability values for each formulation are recorded in table no

the values of the preferred formulas are within acceptable limit,

implying good compactness and strength of these formulation

III) AVERAGE WEIGHT AND WEIGHT VARIATION: twenty tablets of each formulation were evaluated

the mean values and weight variation of each formulation are recorded in table no

the values obtained indicate that all the tablets of different formulations meet the ip/ u

the observed narrow range weight variation indicates granule flow ability

desired packing characteristics

ISSN: 0974 – 9446

and uniform dies fill of all the formulations

this is supported by the acceptable flow properties of granules obtained in the pre-formulation

IV) DISINTEGRATION TIME: the disintegration time test was carried out for each for each formulation

the acids and bases are used in 38% and 45% respectively in final formulation

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International Journal of Pharmaceutical Research & Development

ISSN: 0974 – 9446

Available online on www

International Journal of Pharmaceutical Research & Development

ISSN: 0974 – 9446

Available online on www

ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

STABILITY STUDIES: ACCELERATED STABILITY TESTING: since the period of accelerated stability testing can be as long as 3 months for the effervescent tablet

therefore it is essential to devise a method that will help rapid prediction of long-term stability of drug

the accelerated stability testing is defined as the validated method by which the product stability may be predicted by storage of the product under conditions that accelerate the change in defined and predictable manner

the stability studies of formulated tablets were carried out at 40 oc,

rh 75% and at room temperature for one month

the effects of temperature and time on the physical characteristics of the tablet were evaluated for assessing the stability of the prepared formulations

the stability studies were carried out when the room temperature was 20 to 25 oc

the different parameters that were studied are in vitro disintegration time

THE RESULTS WERE SUMMARIZED IN TABLES

TABLE NO:23- STABILITY PARAMETERS OF FORMULATION F7STORED AT ROOM TEMPERATURE INITIAL AFTER 15 DAYS AFTER 30 DAYS PARAMETER Drug Content (%)

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ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

TABLE NO

0 1 2 3 5

INITIAL

AFTER 15 DAYS

AFTER ONE MONTHS

TABLE NO

AFTER ONE INITIAL AFTER 15 DAYS PARAMETER MONTHS Drug content (%) 98% 97

Time 65 70 (sec) 76

TABLE NO

INITIAL

AFTER 15 DAYS

AFTER MONTHS

Drug content (%)

In-vitro disint

Time 65 (sec)

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ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

TABLE NO

THICKNESS (MM)

DISINTEGRATION TIME,

SECONDS % COMPRESSIBILITY

PROPERTY

PROPERTY Bulk Density,

G/CM3 0

Thickness (MM)

tapped density G/CM3 % Compressibility

DIAMETER (MM)

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International Journal of Pharmaceutical Research & Development

TABLE NO

TABLE NO

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ISSN: 0974 – 9446

International Journal of Pharmaceutical Research & Development

TABLE NO

ENO FRUIT SALT,

HISTAC TABLETS FD7

MARKTED EFFERVESCENT SALT

MARKTED EFFERVESCENT TABLET

Bulk density (g/cm3)

Tapped density (g/cm3)

Hardness (kg/cm2)

Thickness (mm)

63g/tab(16

PROPERTY

Disintegration time (sec

SUMMARY AND CONCLUSION: The study was undertaken with an aim to formulate effervescent tablet of analgesic and antipyretic drug (paracetamol)

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literature review showed that paracetamol having simmilar mechanism of action to aspirin because simmilarity in structure

paracetamol act by reducing production of prostaglandin which involved in pain 101

International Journal of Pharmaceutical Research & Development

by inhibiting the cyclo-oxygenase enzyme

In present work an attempt has been 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 1) In the preformulation study,

compatibility evaluation was performed which implies that drug

bases 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

All the formulations were subjected to various evaluation studies

Result of the evaluation of granules and evaluation of tablet dimensions,

In the effervescent tablet the water content can be measured by Karl Fischer titration method

We are also subjected to carbon dioxide content in the effervescent tablets

Uniformity in tablet dimensions implies that die fill was uniform and compression force was constant

Hardness values reveal that tablets are having good mechanical strength and handling characteristics

Friability values dictate good compactness of the formulations

The weight variation of all formulated tablets was satisfactory,

attributed by the acceptable flow properties of granules

Content uniformity of active ingredient of all the formulations are within acceptable limit and ensures dosage uniformity

The promising formulation F7 obtained in evaluation studies

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ISSN: 0974 – 9446

The placebo tablets were prepared by using different acids and bases and its combination in different concentrations

The total nine placebo tablets were prepared and evaluated for hardness,

weight variation and solubility

All the formulation shows hardness and weight variation with in limit but the combination of citric acid (12

and the binding agent PVP-K-30 (2

because these ingredients shows the good effervescent reaction and has no problem in capping and sticking like other formulation

The effervescent tablet can be prepared using different acids such as citric acid,

and ascorbic acid in different concentration

In that also we are used the various lubricants and binding agents

There are 7 formulations that contain the citric acid,

These 7 formulations evaluated for hardness,

All the formulation found effervescent upto 72 sec

But the formula having citric acid(12

so these concentration of acids and bases used for the final formulation

The effervescent tablet were prepared by different preparation method such as Direct compression,

The prepared tablets were evaluated for content uniformity and physical parameters

The direct compression was found there was an capping problem

so the upper surface of tablets not properly set

but with the help of wet granulation technique the powder become free flowing and the compression of the tablets so good as compaired to the direct compression reason behind the choosing the wet granulation because in dry granulation technique the capping and sticking problem occur

International Journal of Pharmaceutical Research & Development

technique the granules become good flowing properties as compaired to direct compression

because wet granulation provides the acids and bases from the environmental moisture

and capping problem was reduced

At the time of manufacturing of effervescent tablet the strictly humidity and temperature should be maintained

of the tablet should be less than 1%

Because if one-water molecules present in the effervescent tablet then the obtained effervescent reaction of the tablet should be very less

The stability study i

accelerated stability study according to I

The stability can also be performed at R

formulation showed no significant variations for the above mentioned parameters and it was stable for the specified time period

From the above summary it was concluded that,

the effervescent tablets of parac etamol can b e formul ated for quick analgesic an d'antipyretic ac tion by effervescence reaction using citric acid (12

gives the better effervescence

the PVP-K-30 used as the binding agent

ACKNOWLEDGEMENT Authors are thankful to Prof

Rama Mohan Gupta,

principal Pulla Reddy Institute of Pharmacy Dundigal,Andhra Pradesh and providing all the facilities for this research Project

REFERENCES 1

Leon Lachman,

Herbert a liberman,

Kanig in “theory and practice of industrial pharmacy” 2nd edition

Available online on www

ISSN: 0974 – 9446 2

mohrle R “Effervescent tablets” in Liberman,

Lachman L

Schwartz

Pharmaceutical dosage form,

“ Tablets” vol-I first Indian reprint (2005) Marcel dekkar inc New york

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Raymond mohrle,

Liberman abd Lachman “Effervescent Tablet” “SPI pharma” Pharmaceutical dosage form Tablets,

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Howard C

Allen Jr,

Nocholas and Popovich in “Effervescent granules”8th edition “pharmaceutical dosage from and drug delievery” international student edition

Patent No-6440926 (Roberto Morelli,

O’ connor,

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Effervescence in chewable base U

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(DE) Solid rapidly disintegrating formulation U

Patent No6245353 (2001) 9

Brentford G

Effervescent formulation of Amoxicillin U

Patent No-6077536 (2000)Beecham Group PLC 10

Losan Pharma Gmph effervescent ibuprofen prepration U

Patent No-6171617 (2001)(Neuenberg

Cima Labs Inc sublingual and buccal effervescent prepration U

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Chiesi Farmaceutici SPA movel method for producing effervescent tablet U

Patent No6284272 (2001) 13

Therapeutic effervescent compisition U

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Saleh in “An approach to the direct compressible effervescent tablets” Lab Pharmacotech,

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International Journal of Pharmaceutical Research & Development

Kalantzi,

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Junginger in “Journal of Pharmaceutical Science” 95,4-14

Wikipedia of paracetamol

Bernard Bannworth,

Fabienne,

Raymond C

Sherskey,sain C

in “Handbook of Pharmaceutical excipients” Ascorbic acid (2000),

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in “Handbook of Pharmaceutical excipients” Fumaric acid (2000),

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in “Handbook of Pharmaceutical excipients” Citric acid (2000),

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in “Handbook of Pharmaceutical excipients” Tartaric acid (2000),

770-771

Raymond C

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in “Handbook of Pharmaceutical excipients” Sodium bicarbonate (2000),

Raymond C

Sherskey,sain C

in “Handbook of Pharmaceutical excipients” Sodium carbonate (2000),

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in “Handbook of Pharmaceutical excipients” Acesulfum potassium (2000),

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in “Handbook of Pharmaceutical excipie