DISPERSIBLE TABLETSSUBLINGUAL TABLETS

CHEWABLE TABLETS

INTRODUCTION TO SPECALISED INTRODUCTION TO SPECALISED TABLETTABLET

Most tablets are intended to be swallowed, Most tablets are intended to be swallowed, the active ingredient being absorbed from the active ingredient being absorbed from the gastro interstitial tract.the gastro interstitial tract.

There are some types of tablets, which are There are some types of tablets, which are intended for administration by other route intended for administration by other route are called specialized tablet.are called specialized tablet.

The adsorption of this tablets is through The adsorption of this tablets is through mucosal lining of the mouth , either mucosal lining of the mouth , either sublingually ( i.e. .from area beneath the sublingually ( i.e. .from area beneath the tongue) , from area between the cheek tongue) , from area between the cheek and gumand gum

INTRODUCTION TO INTRODUCTION TO DISPERSIBLETABLETSDISPERSIBLETABLETS

This tablets are added to water to make a solution This tablets are added to water to make a solution containing a fixed concentration of active containing a fixed concentration of active ingredient.ingredient.

Most commonly used for preparation of antacid Most commonly used for preparation of antacid solution.solution.

Because of toxic nature made in different shapes Because of toxic nature made in different shapes like diamond, triangle.like diamond, triangle.

They are marketed with word poison.They are marketed with word poison. Packed in bottle of distinctive shape with rough Packed in bottle of distinctive shape with rough

edges.edges. Difficulty of using this tablet is some components Difficulty of using this tablet is some components

used are highly toxic , hazardous, lethal if used are highly toxic , hazardous, lethal if swallowed orally.swallowed orally.

EXAMPLE OF DISPERSIBLE TABETEXAMPLE OF DISPERSIBLE TABET

IngredientsIngredientsQuantity Quantity RoleRole

of ingredientof ingredient

Amoxicillin Amoxicillin trihydratetrihydrate

250 mg250 mg AntibioticAntibiotic

Dicalcium phosphateDicalcium phosphate 250mg250mg DiluentDiluent

Sodium starch glycol Sodium starch glycol ateate

2.5%w\w2.5%w\w Super disintegrating agntSuper disintegrating agnt

Pvpk – 30Pvpk – 30 5%w\w5%w\w Disintegrant,binder & Disintegrant,binder & adhesiveadhesive

Magnesium stearateMagnesium stearate 0.5%w\w0.5%w\w LubricantLubricant

TalcTalc 1%w\w1%w\w Pharmaceutical Pharmaceutical aid ,lubricantaid ,lubricant

SOLPRIN DISPERSIBLE TABLET

AMOXICILIN DISPERSIBLE TABLET

INTRODUCTION TO CHEWABLE INTRODUCTION TO CHEWABLE TABLETTABLET

Chewable tablets are pleasant tasting tablets Chewable tablets are pleasant tasting tablets formulated to disintegrate in mouth smoothly formulated to disintegrate in mouth smoothly with chewing.with chewing.

This tablet have better bioavaibility .This tablet have better bioavaibility . Advantages of this tablets are , Advantages of this tablets are , 1) the dose of antacid is to large, so that 1) the dose of antacid is to large, so that

antacid tablet is large to swallow.antacid tablet is large to swallow. 2) Activity of antacid is related to it’s partial 2) Activity of antacid is related to it’s partial

size, if tablet chewed prior to swallowing better size, if tablet chewed prior to swallowing better bioavability is produced.bioavability is produced.

Disadvantage is that bad taste drug present in Disadvantage is that bad taste drug present in large concentration with significant obstacles.large concentration with significant obstacles.

EXAMPLE OF CHEWABLE TABLETEXAMPLE OF CHEWABLE TABLET

PEDIATRIC COUGH AND COLD CHEWABLE TABLET

DERAMAX CHEWABLE TABLET

IngredientIngredient Quantity Quantity per tabletper tablet

Role of Role of ingredientsingredients

Chlorpheniramine Chlorpheniramine maleatemaleate

1 mg1 mg AntihistaminicAntihistaminic

Pseudophedrine Hcl Pseudophedrine Hcl 15 mg15 mg DecongestantDecongestant

DextromethorphanDextromethorphan 5 mg5 mg Cough Cough suppressantssuppressants

INRODUCTION TO SUBLINGUAL INRODUCTION TO SUBLINGUAL TABLETTABLET

Sublingual tablets are small, flat and are intended Sublingual tablets are small, flat and are intended to be placed in beneath the tounge.to be placed in beneath the tounge.

Drug administered by this route produce systemic Drug administered by this route produce systemic drug effect.drug effect.

Rapid onset of action.Rapid onset of action.Advantages:Advantages: First pass : Liver is bypassed thus no loss of drug.First pass : Liver is bypassed thus no loss of drug. Rapid absorptionRapid absorption Drug stability : PH in mouth is neutral thus drug Drug stability : PH in mouth is neutral thus drug

may be more stable.may be more stable.Disadvantages:Disadvantages: Holding of dose in mouth is inconvenient.Holding of dose in mouth is inconvenient. Small dose only easily accomplished.Small dose only easily accomplished.

A) INTRODUCTION TO MOLDED A) INTRODUCTION TO MOLDED SUBLINGUAL TABLETSUBLINGUAL TABLET

This tablets are introduced by Fuller in 1878.This tablets are introduced by Fuller in 1878. This tablets are placed beneath the This tablets are placed beneath the

toungeand held there until absorption is toungeand held there until absorption is completed.completed.

Molded tablets are referred as tablet triturate.Molded tablets are referred as tablet triturate. Molded tablets are design to dissolve in small Molded tablets are design to dissolve in small

amount of water to make aqueous solution amount of water to make aqueous solution which can be administered may parentally are which can be administered may parentally are known as hypodermic tablets. known as hypodermic tablets.

This tablets are introduced because of there This tablets are introduced because of there rapid disintegration rate.rapid disintegration rate.

EXAMPLE OF MOLDED SUBLINGUAL EXAMPLE OF MOLDED SUBLINGUAL TABLETTABLET

CODEINE PHOSPHATE TABLETS (30 mg)

IngredientsIngredients Quantity perQuantity pertablettablet

Codeine phosphate powderCodeine phosphate powderLactose (bolted)Lactose (bolted)Sucrose (powder)Sucrose (powder)Alcohol-Water (60:40)Alcohol-Water (60:40)

30.0 mg30.0 mg17.5 mg17.5 mg1.5 mg1.5 mg

q.sq.s

B)B) INTRODUCTION TO COMPRESSED INTRODUCTION TO COMPRESSED SUBLINGUAL TABLETSUBLINGUAL TABLET

Compressed sublingual tablets are prepared to Compressed sublingual tablets are prepared to dissolve rapidally in saliva and available for dissolve rapidally in saliva and available for absorption.absorption.

Erytrityl tetra nitrate , is so bromide dinitrate iso Erytrityl tetra nitrate , is so bromide dinitrate iso roterenol hydrochloride are marketed as compressed roterenol hydrochloride are marketed as compressed sublingual tablets.sublingual tablets.

This tablets have less weight variation and better This tablets have less weight variation and better content uniformity.content uniformity.

The requirement for uniformity of dosage unit is The requirement for uniformity of dosage unit is meet if each of 10 tablets listed lies in range of 85 to meet if each of 10 tablets listed lies in range of 85 to 115 %.115 %.

This tablets are harder and less fragile thus avoiding This tablets are harder and less fragile thus avoiding weight and potency loss that occur by the erosions of weight and potency loss that occur by the erosions of molded target edges.molded target edges.

EXAMPLE OF COMPRESSED EXAMPLE OF COMPRESSED SUBLINGUAL TABLETSUBLINGUAL TABLET

Sr. NoSr. No IngredientsIngredients Quantity Given Quantity Given

11 NitroglycerinNitroglycerin 3mg3mg

22 MannitolMannitol 2mg2mg

33 Microcrystalline celluloseMicrocrystalline cellulose 100mg100mg

44 LactoseLactose 495mg495mg

55 Sodium saccharineSodium saccharine0.01%0.01%

66 Rose oilRose oil 0.01%0.01%

77 Amaranth solutionAmaranth solution0.01%0.01%

RAW MATERIALS USED FOR RAW MATERIALS USED FOR MANUFACTURING OF TABLETMANUFACTURING OF TABLET

DiluentsDiluents Binder and adhesiveBinder and adhesive Disintegrating agentsDisintegrating agents LubricantsLubricants Granulating agentsGranulating agents AntiadherantsAntiadherants Colors ,flavor and sweetening agent Colors ,flavor and sweetening agent Important raw material for dispersible tablet:Important raw material for dispersible tablet: superdisintegrantsuperdisintegrant

RAW MATERIALS USED (CONT)RAW MATERIALS USED (CONT)

Important raw materials used for chewable Important raw materials used for chewable tablets are:tablets are:

Flavoring agentsFlavoring agents Coloring agentsColoring agents FD & C colorsFD & C colors D & C colorsD & C colors External D & C colorsExternal D & C colors Dyes Dyes Excipients : Mannitol, Sorbitol, Xylitol, Excipients : Mannitol, Sorbitol, Xylitol,

Aspartame, Cyclamate, and Saccharin.Aspartame, Cyclamate, and Saccharin.

METHOD OF MANUFACTURINGMETHOD OF MANUFACTURING

METHOD OF GRANULATION:METHOD OF GRANULATION:

1) Dry granulation1) Dry granulation

Direct compressionDirect compression Compression granulationCompression granulation

2) WET GRANULATION :2) WET GRANULATION :

SINGLE PUNCH TABLET MACHINESINGLE PUNCH TABLET MACHINE

Cycle of the machine.Cycle of the machine. Upper punch rises to allow hopper Upper punch rises to allow hopper

shoe to move over die.shoe to move over die. Lower punch drops and granule Lower punch drops and granule

feed from shoe.feed from shoe. The shoe moves aside and upper The shoe moves aside and upper

punch drops and compress punch drops and compress granule .granule .

The upper punch rises upward The upper punch rises upward and the lower punch rise upto and the lower punch rise upto surface to eject the tablet.surface to eject the tablet.

The hopper shoe again move The hopper shoe again move forward over the die and pushes forward over the die and pushes the compressed tablet.the compressed tablet.

The lower punch is dropped. The lower punch is dropped.

METHOD OF MANUFACTURING OF MOLDED METHOD OF MANUFACTURING OF MOLDED SUBLINGUAL TABLETSUBLINGUAL TABLET

HAND MOLDING.HAND MOLDING.

MACHINE MOLDING.MACHINE MOLDING.

HAND MOLDING OF TABLETHAND MOLDING OF TABLET Powder mixture is blended.Powder mixture is blended. Mold plate is placed on Mold plate is placed on

tileand mass is forced into tileand mass is forced into tablet mold with pressure tablet mold with pressure this is done with spatula.this is done with spatula.

To remove tablet mold plate To remove tablet mold plate placed on top of plate which placed on top of plate which has projecting pegs that has projecting pegs that coinside with holes.coinside with holes.

By pressing mold platedown By pressing mold platedown tablet are forced out of the tablet are forced out of the dies on the top of pegs.dies on the top of pegs.

There are two longer guide There are two longer guide pins which coinside with pins which coinside with holes in mold plate, so that holes in mold plate, so that no damage to tablet.no damage to tablet.

The tablets are removed and The tablets are removed and allow to dry in oven. allow to dry in oven.

MACHINE MOLDING OF TABLETMACHINE MOLDING OF TABLET

• The damped mass is placed in The damped mass is placed in hopper (A).hopper (A).

• Mass is allowed to drop into Mass is allowed to drop into circular section of rotating circular circular section of rotating circular feed plate(B).feed plate(B).

• Feed plate is placed above mold (C)Feed plate is placed above mold (C)• Mold plate contain 4 sets of diesMold plate contain 4 sets of dies• The mass in feed plate moves over The mass in feed plate moves over

1 set of dies in which foot of 1 set of dies in which foot of packing spinner (D) forces the packing spinner (D) forces the tablet mass.tablet mass.

• Mold plate moves to 2Mold plate moves to 2ndnd position, & position, & surface of tablet is smoothed by surface of tablet is smoothed by foot of smoothing spineer (E).foot of smoothing spineer (E).

• Excess powder is removed by rack Excess powder is removed by rack off (F)off (F)

• Tablets are ejected on conveyer Tablets are ejected on conveyer belt (G) by the ejection punches belt (G) by the ejection punches (H).(H).

• Tablets are dry at room temp. Tablets are dry at room temp.

EVALUATION OF TABLETSEVALUATION OF TABLETS

QUALITY EVALUATION OF TABLETQUALITY EVALUATION OF TABLET::1)1) In process quality control:In process quality control:2)2) Terminal quality control test:Terminal quality control test:a)a) General appearanceGeneral appearanceb)b) Weight variationWeight variation3) Hardness 3) Hardness 4)4) Friability Friability 5)5) Uniformity of weightUniformity of weight6)6) Unoformity of content Unoformity of content

EVALUATION OF TABLETS EVALUATION OF TABLETS (cont)(cont)

7)Disintegration 7)Disintegration

8) Dissolution8) Dissolution

9)Stability testing.9)Stability testing.

MANUFACTURINF DEFECTS MANUFACTURINF DEFECTS FOUND IN TABLETFOUND IN TABLET

1)1) CappingCapping

2)2) Picking and StickingPicking and Sticking

3)3) MottlingMottling

4)4) Weight variationWeight variation

MANUFACTURINF DEFECTS MANUFACTURINF DEFECTS FOUND IN TABLET (cont)FOUND IN TABLET (cont)

5) Hardness variation5) Hardness variation

6)Double impression6)Double impression

7)Poor flow7)Poor flow

OTHER MAHINES USED FOR OTHER MAHINES USED FOR TABLETTINGTABLETTING

REFERENCESREFERENCES Herbert A. Liebermann , Leon lachman , Pharmaceutical Herbert A. Liebermann , Leon lachman , Pharmaceutical

dosage form tablet volume 1, 2nd edition page no. 367 dosage form tablet volume 1, 2nd edition page no. 367 Herbert A. Liebermann , Leon lachman , Pharmaceutical Herbert A. Liebermann , Leon lachman , Pharmaceutical

dosage, form tablet volume 1 , 2nd edition , page dosage, form tablet volume 1 , 2nd edition , page no . 329no . 329

. Herbert A. Liebermann , Leon lachman , Pharmaceutical . Herbert A. Liebermann , Leon lachman , Pharmaceutical dosage , form tablet volume 1, page no . 367,390dosage , form tablet volume 1, page no . 367,390 Herbert A. Liebermann , Leon lachman , Pharmaceutical Herbert A. Liebermann , Leon lachman , Pharmaceutical

dosage dosage form,tablet volume 1 , page no . 354,335-339form,tablet volume 1 , page no . 354,335-339 R.M.Mehta , pharmaceutics , volume 1 , 3rd edition by vallabh R.M.Mehta , pharmaceutics , volume 1 , 3rd edition by vallabh

prakashion , page no. 238prakashion , page no. 238 D.P.S. Kohli and D.H.Shah , drug formulation manual , 3rd D.P.S. Kohli and D.H.Shah , drug formulation manual , 3rd

edition by eastern publishers , page no.13, 24edition by eastern publishers , page no.13, 24 Leon lachman , Joseph .l. kanig, theory & practice of industrial Leon lachman , Joseph .l. kanig, theory & practice of industrial

pharmacy, 3rd edition by Varghese publishing , page no. 293pharmacy, 3rd edition by Varghese publishing , page no. 293 Encyclopedia volume 2Encyclopedia volume 2 Web links :Web links : www.\ http. Wikipedia . com.www.\ http. Wikipedia . com. http\ images . comhttp\ images . com