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MONOPHASIC LIQUID
DOSAGE FORM
POONAM SABLE
Contents
• Introduction
• Classification of Monophasic liquid
• Formulation Consideration
• Manufacturing Consideration
• Recent advance in monophasic liquid
• Recent approach in monophasic
liquid formulation
• Conclusion
• Recommendation
Introduction
• Monophasic dosage form refers to liquid preparation
containing two or more components in one phase
system, it is represent by true solution.
• A true solution is a clear homogenous mixture that is
prepared by dissolving solute in a suitable solvent.
• The component of the solution which is present in a
large quantity is known as “SOLVENT” where as the
component present in small quantity is termed as
“SOLUTE”.
LIQUIDMEANT FOR INTERNAL
ADMINISTRAION
Liquid meant for internal administration
includes following categories of preparation :
1.MIXTURES
2.SYRUPS
3. ELIXIRS
4. LINCTUSES
mixtures
A mixture is a liquid preparation
meant for oral administration in which
medicament or medicaments are
dissolved , suspended or dispersed in
a suitable vehicle.
DEFINITION:
mixtures
Generally several doses are
dispensed in a bottle.
 In case a bottle contain one
dose, it is called draught.
 Mixtures are prescribed for
acute conditions such as
cough,indigestion,constipation,
diarrhea etc.
 It should be extemporaneously
prepared and supplied in small
doses.
classification of mixtures
1 . Simple mixture containing
soluble substances
2 . Mixture containing diffusible
solids
3 . Mixture containing in diffusible
solids
4 . Mixture containing Precipitate
forming liquids
5 . Mixture containing Slightly
soluble liquid
classification of mixtures
1.SIMPLE MIXTURE containing soluble substances
 It contains only soluble ingredients.
 It is represented by true solution
 It is a clear homogenous mixture.
E.g.: Carminative mixture,
Expectorant mixture etc.
1 . S I M PL E MIXTURE containing soluble substances
Method of dispensing:
1. Dissolve Solid in 3/4th Vehicle.
2. Examine the solution by holding against
light .
3. Filter if any foreign particles find.
4. Add other ingredients
5. Add more vehicle to produce final volume
6. Fill in bottle and label.
7. Cork it and Clean bottle.
8. Attach label wrap bottle and dispense
1 . S I MP LE MIXTURE containing soluble substances
Rx
Potassium Bromide - 4.0 g
Tincture of nux vomica – 4.0 ml
Chloroform Water - add up to 90 ml
 Direction: One tablespoonful to be taken three times
after meals
 Method of dispensing:
1.Dissolvepotassiumbromidein3/4th ofchloroformwater.
2.Filterthesolutiontoremoveforeignparticles.
3.Addtincturenuxvomica.
4.Incorporatemoreofchloroformwatertomakerequiredvolume.
5.Transferthemixturetoabottle,corklabelanddispense.
2 . MIXTURE containing diffusible solid
• Diffusible solids are insoluble in water.
• Uniformly dispersed in the vehicle on
shaking.
• No need of suspending agent.
• Example:
 Bismuth carbonate.
 Bismuth sub nitrate.
 Magnesium carbonate.
 Magnesium oxide
 Quinine sulphate
 Light kaolin
2 . MIXTURE containing diffusible solid
METHOD OF DISPENSING
1. Powderdruginmortaraddsolubledrugandmix.
2. Measure 3/4th of vehicle. Make smooth cream by
portionofvehicle.
3.Transfer content from mortar into a measuring
apparatus.
4.Addanyliquidingredient.
5.Addmorevehicletoproducefinalvolume.
6.Fillinbottleandlabel.Corkit.
7. Attach label “ Shake well before use” wrap bottle
anddispense.
2 . MIXTURE containing diffusible solid
Drug+ soluble material + Vehicle a part from 3/4th
Smooth cream
Add remaining vehicle from 3/4th
Add any liquid ingredient
Make up the volume with remaining vehicle.
Transfer the mixture to the bottle and add
secondary label.
Add to measure
2 . MIXTURE containing diffusible solid
EXAMPLE
Rx
Magnesium sulphate 15.0 g
Magnesium carbonate 2.0 g
Peppermint water 90.0 ml
Prepare a mixture.
Direction:
One teaspoonful to be taken two hours
before breakfast.
Method of Dispensing:
Diffusible mixture
2 . MIXTURE containing diffusible solid
EXAMPLE
Rx
Magnesium sulphate 15.0 g
Magnesium carbonate 2.0 g
Peppermint water 90.0 ml
Prepare a mixture.
Direction:
One teaspoonful to be taken two hours
before breakfast.
Method of Dispensing:
Diffusible mixture
3 . MIXTURE containing in diffusible solid
EXAMPLE
 Indiffusiblesolidsareinsolubleinvehicle.
 Not evenly distribute throughout the vehicle
on shaking or not distribute in vehicle for
sufficientlylongtime.
 Ex. Acetyl salicylic acid, Quinine salicylate,
calomel, Phenacetin, chalk powder.
Suspendingofdrugisrequired.
 So suspending agents are added in
formulation.
3 . MIXTURE containing indiffusible solid
SELECTION OF SUSPENDING AGENT
Compound Tragacanth Powder:
It content 20% acacia, 15% tragacanth, 20%
starch and rest sucrose.
In the proportion of 2g/100 ml of the mixture.
It is used when the vehicle is other than water
or chloroform
Tragacanth mucilage:
In the proportion of 1/4th of the volume of the
mixture. It is used when the vehicle is water or
chloroform water.
3 . MIXTURE containing indiffusible solid
SELECTION OF SUSPENDING AGENT
Compound Tragacanth Powder:
It content 20% acacia, 15% tragacanth, 20%
starch and rest sucrose.
In the proportion of 2g/100 ml of the mixture.
It is used when the vehicle is other than water
or chloroform
Tragacanth mucilage:
In the proportion of 1/4th of the volume of the
mixture. It is used when the vehicle is water or
chloroform water.
3 . MIXTURE containing indiffusible solid
METHOD OF DISPENSING
Solid’s + Tragacanth powder (2%)
Triturate the powder with a portion from ¾ of vehicle
Smooth cream is formed
Add remaining portion of vehicle from 3/4th
Examination
Add other liquid ingredient + soluble ingredients
Make up the volume with remaining vehicle
3 . MIXTURE containing in diffusible solid
METHOD OF DISPENSING CONT....
Solid’s +Tragacanth Mucilage(1/4th)
Triturate
Smooth cream is formed
Add 1/2 of the vehicle.
Examination
Add other liquid ingredient + soluble ingredients
Make up the volume with remaining vehicle
3 . MIXTURE containing in diffusible solid
EXAMPLE
Rx
Ppt chalk powder -----------30 grain.
Catechu tincture ------------ 20 minim.
Cinnamon water ------------ 1 fl.oz.
 Direction: Secundis hora sumenda
 Method of Preparation:
Method of dispensing using tragacanth powder
3 . MIXTURE containing in diffusible solid
EXAMPLE
Rx
Acetyl salicylic acid-----------1 gram
oxyphenbutazone ------------ 0.25g
Simple syrup------------ 15 ml.
Water -------------------add up to 90 ml
 Direction: two tablespoonful to be taken
3times a day.
 Method of Preparation:
Method of dispensing using mucilage of
tragacanth
4 . MIXTURE containing in diffusible solid
EXAMPLE
Rx
Acetyl salicylic acid-----------1 gram
oxyphenbutazone ------------ 0.25g
Simple syrup------------ 15 ml.
Water -------------------add up to 90 ml
 Direction: two tablespoonful to be taken
3times a day.
 Method of Preparation:
Method of dispensing using mucilage of
tragacanth
4 . MIXTURE containing in diffusible solid
EXAMPLE
Rx
Acetyl salicylic acid-----------1 gram
oxyphenbutazone ------------ 0.25g
Simple syrup------------ 15 ml.
Water -------------------add up to 90 ml
 Direction: two tablespoonful to be taken
3times a day.
 Method of Preparation:
Method of dispensing using mucilage of
tragacanth
DIFFERENCE
Diffusible mixture
1.These mixture containing
medicament which is mixed upon
taking the powder drug is evenly
diffuse throughout uniformly.
2.In formulation suspending agent is not
required.
3. Substances not float on surface
of vehicle.
4. E.g. bismuth carbonate, bismuth
sub nitrate.
In diffusible
mixture
1.These mixture are contain
substances which not gets mix
uniformly on mechanical
shaking or stirring.
2. In formulation suspending
agent is required.
3. Substances float on surface
of vehicle.
4. E.g. acetyl salicylic acid,
calomel.
4. Mixture containing precipitate forming liquids
Certain liquid preparations contain resinous
matter.
when mixed with water, the resin is
precipitated - which may adhere to sides of
bottle or - form a clotted precipitate.
This will not re-diffuse upon shaking.
To prevent this, suspending agent is used.
Ex. resin extract, tinctures etc.
4. Mixture containing precipitate forming liquids
Certain liquid preparations contain resinous
matter.
when mixed with water, the resin is
precipitated - which may adhere to sides of
bottle or - form a clotted precipitate.
This will not re-diffuse upon shaking.
To prevent this, suspending agent is used.
Ex. resin extract, tinctures etc.
4. Mixture containing precipitate forming liquids
METHOD OF DISPENSING CONT....
Solid’s +Tragacanth Mucilage(1/4th)
Smooth cream is formed
Add precipitate forming liquid in the center of cream
Examination
Add precipitate forming liquid in the center of cream
Add other liquid ingredient + soluble ingredients
Make up the volume with remaining vehicle
4. Mixture containing precipitate forming liquids
METHOD OF DISPENSING CONT....
Solid’s + Precipitate forming liquid + Tragacanth
Mucilage(1/4th)
Smooth cream is formed
Add 1/2 of the vehicle.
Examination
Triturate
Add other liquid ingredient + soluble ingredients
Make up the volume with remaining vehicle
4. Mixture containing precipitate forming liquids
Example
Rx
Potassium iodide 2.0ml
Tincture lobelia ether 4.0 ml
Tincture stramonium 16.0 ml
Chloroform water add up to 90.0 ml
 DIRECTION: One dessertspoonful to be taken four
times a day.
 METHOD OF DISPENSING:
Using Precipitate forming mixture method
5. MIXTURE CONTAINING SLIGHTLY
SOLUBLE LIQUID
The insoluble portion of slightly soluble liquids is not
readilydiffusible.
So a suspending agent such as tragacanth powder or
tragacanth mucilage are needed to dispense such
mixtures.
Ex.Paraldehydeliquid
5. MIXTURE CONTAINING SLIGHTLY
SOLUBLE LIQUID
Example
Rx
Paraldehyde ---------4.0 ml
Syrup--------------------- 8.0 ml
Liquid extract of glycyrrhiza--- 2.0 ml
Water add upto ------30.0 ml
 Direction: Take as directed
5. MIXTURE CONTAINING SLIGHTLY
SOLUBLE LIQUID
METHOD OF DISPENSING
Paraldehyde + tragacanth mucilage in bottle
Shake vigorously
Dissolve syrup and liquid extract of glycyrrhiza in
water.
Bottle Content
Shake vigorously
Make up the volume by adding water
5. MIXTURE CONTAINING SLIGHTLY
SOLUBLE LIQUID
METHOD OF DISPENSING
Paraldehyde + tragacanth mucilage in bottle
Shake vigorously
Dissolve syrup and liquid extract of glycyrrhiza in
water.
Bottle Content
Shake vigorously
Make up the volume by adding water
FORMULATION
1. Drug
2. Vehicles
3. Adjuncts
a.Chemical Stabilizers
b. Preservatives
c. Coloring Agents
d. Flavoring Agents
FORMULATION
• Drug: Antibiotics , antipyretics, analgesic, etc
• Vehicles: following vehicles are used.
 Water: purified water
 Aromatic water: Multiple use, e.g. chloroform water,
Cinnamon water, etc.
 Medicated vehicle: Infusions, ex. Senega infusion as
expectorant.
• Adjuncts: Adjuncts are generally used to improve the
Safety, efficacy and palatability.
 Chemical Stabilizers: e.g. Antioxidant: Ascorbic acid
(0.1%), Sodium metabisulphite (0.1%) etc.
 Preservatives: Chloroform (o.25%), Benzoic acid (0.1%)
Methyl paraben, propyl paraben, etc.
FORMULATION
• Coloring Agents:
E.g. Coal tar dyes.
• Flavoring Agents:
The following flavouring agents are commonly used in
mixtures.
 Aromatic water
 Syrup and Glycerol.
 Spirit lemon to cover the taste of alkaline
citrates.
 Orange syrup and compound orange spirit.
STORAGE OF MIXTURES
 Mixtures are dispensed in plain glass
bottles with uniform internal diameter.
 The mixture should be dispensed and
supplied to the patient for not more than 3
days to prevent deterioration.
 The bottle should be fitted with a suitable
cork which ensures its easy removal and to
prevent spilling of Mixture.
SYRUPS
 is sweet, viscous,
 concentrated or nearly saturated
 aqueous solution of sucrose containing
66.7%w/w of sugar”
“ Syrup is sweet, viscous, concentrated or
nearly saturated aqueous solution of
sucrose containing 66.7%w/w of sugar”
SYRUPS
 Flavored syrups:
Flavored syrups contain flavoring agents.
Orange syrup BPC, lemon syrup BPC etc.
 Medicated syrups:
It contain medicaments dissolve in it.
 Artificial syrups:
• Used for diabetic patients,
• Artificial syrups are prepared from polyols such as sorbitol,
glycerine, propylene glycol or cellulose polymers such as
methyl cellulose, hydroxy methyl cellulose and artificial
sweetener such as sodium saccharine, sodium cyclamate.
• Artificial sweeteners are 500 times sweeter than sucrose and
they are non-caloric and they do not elevate the blood
glucose level.
SYRUPS
Advantages of syrups:
 Act as, antioxidant by retarding the oxidation,
as sugar is hydrolyzed in to levolose and
dextrose.
 Act as preservative by retarding the growth of
bacteria, fungi and mould, as osmotic
pressure is 16 times greater than the isotonic
solution.
 Good patient compliance especially pediatric
patients as syrups are sweet in test.
SYRUPS
Disadvantages:
Fluctuation in storage temperature may cause
crystallization of sucrose from saturated syrups.
SYRUPS
Method of Preparation
1. Simple solution method
2. By process of extraction
3.Syrup made by chemical interaction
SYRUPS
1.Simple solution method
Ex.1.. Prepare and dispense 100 ml of simple
syrup.
Rx
Sucrose 66.7 g
Purified water 100 g
MOP:
1.Add sucrose to purified water
2. and heat it to Dissolve sucrose
3.Cool add more purified water
SYRUPS
1.Simple solution method
Ex.2.. Prepare and dispense 100 ml of ginger
syrup IP.
Rx
strong ginger tincture 50ml
syrup, sufficient to produce 1000 ml
MOP:
The syrup is prepared by mixing strong
ginger tincture in small quantity at a
time with syrup.
SYRUPS
2.By Process Of Extraction
Ex. Prepare and dispense 100 ml of
tolu syrup IP
Rx
Tolu balsam ------12.5 g
Sucrose ------------660 g
Purified water ----1000 g
MOP:
1. Add boiling purified water to the tolu balsam
contained in tared vessel
2. Cover vessel lightly & boil gently for half an hour
3. Cool,filter add sucrose
4. Heat on water bath to dissolve sucrose.and finally
add purified water to make up the volume.
SYRUPS
3.Syrups made by chemical
interaction
SYRUPS
3.Syrups made by chemical
interaction
SYRUPS
3.Syrups made by chemical
interaction
SYRUPS
Formulation of syrups
1. VEHICLES
2. ADJUNCTS
• Chemical stabilizers
• Colouring agents
• Flavouring agents
• preservatives
SYRUPS
Formulation of syrups
1. VEHICLES:
• syrups are prepared by
using purified water.
• potable water should not be
used.
• because it contains both
volatile and non volatile
impurities.
SYRUPS
Formulation of syrups
2. ADJUNCTS
a. CHEMICAL STABILIZERS:
• Glycerine, sorbitol and
propylene glycol is added in
small quantity to the syrup to
prevent the crystallisation of
sucrose.
• Certain surfactants like
tweens can be combined with
syrup to dissolve certain
ingredients to the syrup to
make a clear syrup.
SYRUPS
Formulation of syrups
2. ADJUNCTS
b.COLOURING AGENTS:
Many syrups are attractively
coloured with coal tar dyes
such as amaranth,
compound tartrazine,and
green s and tartrazine.
SYRUPS
Formulation of syrups
2. ADJUNCTS
C.FLAVOURING AGENTS:
i) Tinctures: tincture lemon and
tincture ginger
ii) Fruit juices: raspberry juice,
wildcherry
iii) Essence: vanilla and orange
SYRUPS
Formulation of syrups
2. ADJUNCTS
d. Preservatives:
• The syrups containing 66.7% w/w of
sucrose have high osmotic pressure
which prevents growth of bacteria ,fungi
and moulds.
• So no preservative is needed.
• Generally benzoic acid sodium benzoate
and parabens are used for preservation.
• Use of sterilized container and closures
is also effective way of preserving
syrups
Storage of syrups
• The syrup should b stored in
well dried completely filled and
well stopper bottle in cool dark
place.
• The syrup should be stored at a
temperature not exceeding
25degree Celsius
• The glass bottle fitted with white
polypropylene moulded or black
thermosetting plastic screw
closures are commonly used for
the storage of bottles.the
bottles may be colourless or
ambered coloured.
ELIXIRS
Definition:
clear,
sweetened and
flavored
hydro alcoholic liquid preparation
intended for oral use.
ELIXIRS
Definition:
“Elixirs are clear, sweetened and
flavored hydro alcoholic liquid
preparation intended for oral
use.”
•The main ingredients of elixirs are ethyl
alcohol
•(5-40%), water, glycerin or propylene
glycol,
•flavoring agents, coloring agents and
some
•suitable preservative.
ELIXIRS
Types of Elixirs
1. Flavored Elixirs
2. Medicated Elixirs
Flavored Elixir:
Non-medicated and are used as flavoring
agent or vehicle.
Eg. Syrups containing lemon juice, orange
juice, raspberry juice.
Medicated Elixir:
Elixir contain potent medicament.
Ex. antibiotic, antihistaminic or sedative
etc.
ELIXIRS
Example
Rx
Piperazine citrate 180 g
Chloroform spirit 5 ml
Glycerin 100 ml
Orange oil 0.25 ml
Syrup 500 ml
Purified water q.s. upto 1000 ml
Make an elixir, Send: 30 ml
Label:
One teaspoonful to be given at night.
ELIXIRS
Formulation of Elixirs
1. Vehicles:
Water, Alcohol, syrup, glycerin, sorbitol
and propylene glycol
1. Adjuncts:
Used to improve Safety, efficacy and
palatability.
Chemical Stabilizer:
Citric acid and disodium edtate in
Neomycin Elixir.
Preservative:
20% alochol, syrup and methyl paraben
and propyl paraben
Colouring Agent:
Coal tar dyes.
Flavouring agent:
black current syrup, raspberry syrup,
lemon syrup and orange syrup
etc.
ELIXIRS
Storage of Elixir:
The Elixirs are stored in a well-closed
air tight glass container having screw cap
at cool place protected from light.
LINCTUSES
Definition:
• viscous,
• Monophasic liquid preparation
• containing a high concentration
of syrup
• intended to sipped and
• swallowed slowly
• for treatment of cough.
LINCTUSES
Definition:
“Linctuses are viscous,
monophasic liquid preparation
containing a high concentration of
syrup intended to sipped and
swallowed slowly for treatment of
cough.”
LINCTUSES
Use:
1. Demulcent.
2. Sedative.
3. Expectorant action.
LINCTUSES
Example
Rx
Codeine phosphate 3.0 g
Lemon syrup 200 ml
Benzoic acid 20 ml
Chloroform spirit 20 ml
Compound tartrazine
solution 10 ml
Syrup q. s to 1000 ml
Prepare linctus, send 30 ml
Direction:
Sip and swallow slowly (without aid of
water)
LINCTUSES
Formulation
1. Vehicles
2. Adjuncts
Used to improve Safety, efficacy and
palatability.
1. Chemical Stabilizer
2. Preservative
3. Coloring Agent
4. Flavoring agent
LINCTUSES
Formulation
1. Vehicles:
Syrup, (Tolu syrup), glycerin, sorbitol.
1. Adjuncts:
Used to improve Safety, efficacy and
palatability.
1. Chemical Stabilizer:
Mostly stable because of syrup.
2. Preservative:
High concentration of syrup acting as
preservative.
Tolu syrup has antibacterial action due to
benzoic acid and
cinnamic acid present in it.
Benzoic acid in codeine phosphate
linctuses.
3. Coloring Agent:
Coal tar dyes.
4. Flavoring agent:
black current syrup, lemon syrup, and
benzaldehyde etc.
LINCTUSES
STORAGE:
Linctuses are supplied in well closed air
tight container having screw cap stored in a
cool place, protected From light.
Market available Syrup/Elixir/Linctus
Liquids meant for external administration
Liquids used in the mouth
• Gargles :Aqueous solutions containing antiseptics or antibiotics used to
treat throat infections. Available in concentrated form with direction for
dilution with warm water before use. eg: Povidone Iodine gargle.
• Mouthwash: Aqueous solution with a pleasant taste and odor used to
clean and deodorize the buccal cavity. Have antiseptic and astringent
activity.eg: Antiseptics-phenol derivatives.
• Throat paints : Viscous liquid preparation used for mouth and throat
infections. Eg: Phenol glycerine, Compound Iodine.
Liquids meant for external administration
Liquids used in the mouth
• GARGLES : “Gargles are concentrated, clear solution used in
theposteriorregionof mouthtopreventthethroatinfection.”
Liquids meant for external administration
Liquids used in the mouth
• GARGLES :
D e f i n i t i o n :
concentrated, clear solution used in the posterior region of mouth to
preventthethroatinfection.
Use:
1. Antiseptic/antibacterial.
2. Astringent.
3. Relieve soreness in mild throat infection.
Liquids meant for external administration
Liquids used in the mouth
 Gargles are supplied inconcentrated form.
 These are used after diluting with warm
water
 They are brought in intimate contact with the
mucous membrane of thethroat.
 Allowed to remain in contact with it for few
second, before they thrown out ofthe mouth.
Gargles have medicateduse.
Liquids meant for external administration
EXAMPLE:
Potassium chlorate & Phenol Gargle B.P.C.
Rx
Potassium chlorate 30 g
Patent Blue V 0.009 g
liquefied phenol 15 ml
Water up to 1000 ml
Prepare mouthwash, send 30ml
Direction: Dilute with warm water before use
Liquids meant for external administration
Container:White fluted glass bottle with plastic
screw cap.
Coloured bottle used for preparation whichneed
protection.
Labelling:
1. “For external useonly”
2. “Diluted with warm water beforeuse”
3. “Not to be swallowed in largeamount”
Storage:
Gargle are supplied in well closed air tight glass
container having plastic screw cap.
Liquids meant for external administration
Liquids used in the mouth
Mouthwash:
“Mouthwashes are concentrated, clear aqueous solution with a pleasant
tasteintendedtocleananddeodorizethemouthorbuccalcavity.”
Liquids meant for external administration
Liquids used in the mouth
Mouthwash: Definition:
concentrated,
•clear aqueous solution with a pleasant
taste
•intended to be used to clean and
•deodorize the mouth or buccal cavity.
Liquids meant for external administration
Use of Mouthwash
1. Antiseptic/antibacterial.
2. Astringent.
3. Cooling, refreshing action.
Liquids meant for external administration
Mouthwash contain antibacterial agents, alcohol, glycerin,
sweetening agent, flavouring agent and colouring agents.
They are also used in oral mucous disease to treat mouth
infections and to maintain oral hygiene.
Mouthwashes are used after diluting with warm water.
Mouthwash have cosmetic value more.
Liquids meant for external administration
Example:
Compound sodium chloride mouthwash B.P.C.
Rx
Sodium chloride 15gm
Sodium bicarbonate 10 gm
Peppermint Water up to 1000 ml
Prepare mouthwash, send 50 ml
Method:
Dissolve the weighed quantity of sodium chloride and sodium bicarbonate in 3/4th
of the peppermint water. add more of peppermint water to produce the required
volume. Transfer to a bottle, label and dispense.
Direction:
Dilute with 20 times its volume with warm water before use
Liquids meant for external administration
Storage condition and labeling
Container:
White fluted plastic bottle with screwcap.
Labeling:
1. “For external use only”
2. “Diluted with warm water before use”
3. “Not to be swallowed in large amount”
Storage:
Mouthwashes are supplied in well closed air tight
plastic
container having screw cap.
THROAT PAINTS
Throat paints are viscous liquid preparations used for mouth and
throat infections. Glycerin is commonly used as a base because
being viscous, it adheres to mucous membrane for a long period.
it also provides a sweet taste to the preparation.
The commonly used throat paints are boroglycerin,tannic acid
glycerin, compound iodine paint( Mandl’s paint)
CONTAINERS:
Throat paints should be dispensed in airtight ,colored fluted bottle
in order to distinguish them from preparations meant for internal
use.
Glass stoppers are used in such bottles.
THROAT PAINTS
THROAT PAINTS
LABELLING:
The container should be labeled ‘FOE EXTERNAL USE ONLY”.
STORAGE:
Throat paints should be stored in airtight containers and in cool
place.
THROAT PAINTS
EXAMPLE:
Prepare and dispense 50 ml of iodine paint compound.
(MANDL’S PAINT ) B.P.C.
Potassium iodide 25 gm
Iodine 12.5gm
Alcohol 40.0ml
Water 25ml
Peppermint oil 4ml
Glycerin to produce 1000ml
THROAT PAINTS
(i) Potassium iodide is dissolved in water.
(ii) Iodine is added in the concentrated potassium iodide
solutions to form KI3 (or higher iodides).
(iii) Peppermint oil is dissolved in alcohol 90%v/v and
the alcoholic solution is added to the iodine solution.
(iv) Volume is made up with glycerin
Market available Gargle,Mouthwash
and Throatpaints
Liquids meant for external administration
Liquids instill into body cavity
• Ear drops
• Nasal drops
• Douches
• Nasal sprays.
Liquids meant for external administration
Liquids instill into body cavity
• Ear drops
Liquids meant for external administration
Liquids instill into body cavity
• Ear drops
 solution
 used for instillation
 in to ear
Liquids meant for external administration
Liquids instill into body cavity
• Ear drops
“These are the solution used for instillation in to ear.”
• The solution are prepared in water, glycerin, propylene
glycol or alcohol.
• ▫ Vehicle like glycerin and propylene glycol are
preferred as they increase contact time and soften the
wax.
• Uses of Ear Drop
1. Antibacterial.
2. Softening the wax.
3. Mild infections
• Example:
Sodium bicarbonate ear drop
Rx
Sodium bicarbonate 5gm
Glycerin 30ml
Purified Water up to 100 ml
Prepare ear drop, send 30 ml
• Direction:
Place 2-3 drop in each ear as directed.
• Ear Drop
Container:
▫ Ear drop should be packed in colored, fluted glass
bottle and supplied with dropper.
Labelling:
1. “For external use only”
2. 2.“Not for injection”
3. “Discontinue the use if irritation persist”
Storage:
▫ These are supplied in well closed glass container
in cool place.
• Nasal Drop
• Nasal Drop
DEFINITION:
•aqueous solution
•used for instillation in to nostril.
“ These are the aqueous solution used for instillation in
to nostril.”
• Nasal Drop
The oily vehicles are not used because they inhibit the
movement of cilia and produce lipoid pneumonia.
These are isotonic with blood plasma. Phosphate
buffer of pH 6.5 is used as vehicle
Use of Nasal drop
1.Antibacterial.
2.Nasal decongestion
• Nasal Drop
Example
Ephedrine Nasal Drop B.P.C.
Rx
Ephedrine 0.5gm
Chlorobutal 0.5gm
Sodium Chloride 0.5gm
Water upto 1000ml
Prepare nasal drop, send 30 ml
Direction:
Place 2-3 drop in each nostril as directed
• Nasal Drop
Storage and labeling
Container:
 Nasal drop should be packed in colored, fluted glass bottle
and supplied with dropper.
Labeling:
1. “For external use only”
Storage:
 Nasal drop are supplied in well closedglass container
in cool place.
• Nasal Drop
Storage and labeling
Container:
 Nasal drop should be packed in colored, fluted glass bottle
and supplied with dropper.
Labeling:
1. “For external use only”
Storage:
 Nasal drop are supplied in well closedglass container
in cool place.
DOUCHES
DOUCHES
DOUCHES
NASAL SPRAY
Market available Eye drop, Nasaldrop &
douches
Liquids to be applied to the skin
LINIMENTS:
•Liquids or semisolid preparations
•Meant for application to the skin
•Usually applied to the skin with friction
and rubbing of the skin.
Liquids to be applied to the skin
LINIMENTS:
•The liniments may be alcoholic roily solutions or emulsions.
•In alcoholic liniments, alcohol helps in the penetration of medicament into the skin
and also increases its counter irritant and rubefacient action.
•In oily liniments, rachis oil is commonly used which spreads more easily on the skin.
•Soap is also included as one of the ingredient in some of the liniments which helps
in easy application of liniment on the skin.
LINIMENTS
Generally liniments contain medicaments possessing:
analgesic
Rubefacient
soothing
counter irritant and stimulating properties.
Containers:
It should be dispensed in coloured fluted bottles in order to
distinguish from preparations meant for internal use.
LINIMENTS
LABELLING:
The label must state ;
•“FOR EXTERNAL USE ONLY”
•“SHAKE THE BOTTLE WELL BEFORE USE
•THE LABEL SHOULD CARRY THE WARNING “NOT TO BE APPLIED
TO OPEN WOUND OR BROKEN SKIN”
STORAGE:
It should be stored in tightly closed airtight container
in cool place.
LINIMENTS
Example: Prepare and dispense 100 ml of turpentine liniment I.P.
TURPENTINE LINIMENT I.P.
Soft soap 90gm
Camphor 50gm
Turpentine oil 650ml
Purified water 1000ml
METHOD:
•Mix the soft soap with small quantity of purified water .
•Prepare the solution of camphor in turpentine oil, till a thick creamy
emulsion is formed.
•Add sufficient purified water to produce the required volume. Mix it
thoroughly
•Transfer the preparation to a bottle, label and dispense.
LOTIONS
Lotions are liquid preparations meant for external application
without friction.
•They are applied direct to the skin with the help of some absorbent
material such as cotton, wool or gauze soaked in it.
•Lotions may be used for local actions as;
•Cooling,
•soothing or protective purposes.
•They are generally applied for antiseptic action,e.g., calamine
lotion.
•Alcohol is sometimes included in aqueous lotions for its cooling
and soothing effect. E.g., salicylic acid lotion.
LOTIONS
Containers:
Lotions should be dispensed in coloured fluted bottles in order to
distinguish them from preparations meant for internal use.
Labelling:
the containers should be labelled “FOR EXTERNAL USE ONLY”
Sometimes on long standing lotions have a tendency to separate
out,therefore the container should be labelled, “SHAKE WELL
BEFORE USE”.
STORAGE:
lotions should be stored in a well filled,well closed in an air tight
container in a cool place.
LOTIONS
EXAMPLE: Prepare and dispense 100ml of calamine lotion I.P.
CALAMINE LOTION I.P.
Calamine 150gm
Zinc oxide 50gm
Bentonite 30gm
Sodium citrate 5gm
Liquified phenol 5ml
Glycerin 50ml
Rose water 1000ml
METHOD:
• Dissolve sodium citrate in water.
•Triturate the calamine, zinc oxide and bentonite with the
solution of sodium citrate.
•Add liquefied phenol. add the glycerin.
•Add purified rose water in sufficient quantity to produce the
required volume.transfer the lotion to a bottle,cork,label and
dispense.
Market available Liniment & Lotion
QUESTIONS
 LOTIONS
1. They are used for topical effect such as
local cooling, soothing protective
&emollient effect.
2. Applied without friction
3. Vehicle is mostly aqueous Lotions
4. can be applied on broken skin.
5. Applied with cotton gauze
6. Alcohol is added for cooling action
7.These are liquid preparation
8. Sulphur lotion.
 LINIMENTS
1. They are used for counter
irritant,rubefacient,soothing or
stimulating purpose.
2. Applied with friction
3. Vehicle is mostly oily or alcoholic
4.These are used for application to the
unbroken skin
5. Applied directly
6. alcohol is added to improve
penetration power
7. These are semi-liquid preparations
8. Turpentine liniment
QUESTIONS
MOUTHWASH:
1. Mouth washes are aqueous solutions
with pleasant taste and smell for
refreshing effect.
2. Used to cleanse & deodorize buccal
cavity
3. These are used for rinsing mouth
cavity
4. More used for cosmetic Purpose
5. It contains antibacterial agent, Coloring &
flavoring agent.
6. Example : compound sodium
chloride mouth wash.
GARGLES:
1. Gargles are aqueous solutions to
prevent & treat throat infections.
2.Used to relieve soreness in mild
throat infections.
3. These are gargled to bring into
intimate contact with mucous
membrane of throat
4. used for medicated purpose
5. It contains antibacterial agent -
Phenol, thymol and Astringent-
Potassium chlorate.
6. Example: phenol gargle,potassium
chlorate gargle
QUESTIONS
Give reason: Why oily vehicle is not used in the preparation of nasal
drops.
Because oily drop inhibits the movement of cilia in the nasal mucosa and if
used for longer periods, may reach to lung and cause lipoid pneumonia.
Advantages of syrups
It retards oxidation as it is partly hydrolysed into reducing sugars such as
levulose
and dextrose.
It prevents decomposition of many vegetables substances .
They are palatable.
Glycerine is used as vehicle in throat paint.
Glycerine is viscous in nature and adheres to the throat
Increases contact time and prolong the action
It is also act as soothing agent
QUESTIONS
Why gargles are submitted in concentrated form?
Gargles are submitted in concentrated form because,
The quantity of solution require for doing one time gargle is around 20 ml.
Therefore if it is dispensed in dilute form it requires the large quantity
which is practically impossible to dispense.
Therefore they are dispensed in concentrated form.
Give the reasons, “glycerine is choice of vehicle for throat paints.”
Glycerine is used as vehicle in throat paint because-
Glycerine is viscous in nature and adheres to the throat
Increases contact time and prolong the action
It is also act as soothing agent
 Elixir
1. Elixirs are clear, sweetened and
flavoured hydro alcoholic liquid
preparation intended for oral use.
2. Uses: Can be used as Antibiotic
Antihistaminic Sedative purpose
3. More viscous than elixir and less
viscous than linctus .
 4. Ex Tolu syrup, ginger syrup
ect
 Syrup
1. Syrup is sweet, viscous,
concentrated or nearly
saturated aqueous solution
of sucrose containing
66.7% w/w of sugar
2. UCan be simple syrup use
for sweetening and
flavouring purpose and
medicated syrup for
therapeutic purpose
3. less viscous than syrup
4. Ex chloral hydrate elixir ect
QUESTIONS
Mixture:
A mixture is a liquid preparation meant for oral administration in
which medicament or medicaments are dissolved, suspended or
dispersed in a suitable vehicle.
Draught:
These are the liquid preparation to swallow once whole
QUESTIONS
Define:
(i)Throat paints
Throat paints are viscous liquid preparations for application of mucous
membrane of buccal cavity using brush
(ii)Douches
Douches are medicated soln. for rinsing body cavity mostly for bladder, vagina,
rectum, nasal cavity.
Why simple syrup I.P. is considered as self preservative?
Simple syrup I.P. contains 66.7%w/v sucrose which having high osmotic
pressure
which prevent the growth of bacteria, fungi and moulds which are the chief
causes of
decomposition in solution of vegetable matter.
Monophasic liquid dosage form

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Monophasic liquid dosage form

  • 2. Contents • Introduction • Classification of Monophasic liquid • Formulation Consideration • Manufacturing Consideration • Recent advance in monophasic liquid • Recent approach in monophasic liquid formulation • Conclusion • Recommendation
  • 3. Introduction • Monophasic dosage form refers to liquid preparation containing two or more components in one phase system, it is represent by true solution. • A true solution is a clear homogenous mixture that is prepared by dissolving solute in a suitable solvent. • The component of the solution which is present in a large quantity is known as “SOLVENT” where as the component present in small quantity is termed as “SOLUTE”.
  • 4. LIQUIDMEANT FOR INTERNAL ADMINISTRAION Liquid meant for internal administration includes following categories of preparation : 1.MIXTURES 2.SYRUPS 3. ELIXIRS 4. LINCTUSES
  • 5. mixtures A mixture is a liquid preparation meant for oral administration in which medicament or medicaments are dissolved , suspended or dispersed in a suitable vehicle. DEFINITION:
  • 6. mixtures Generally several doses are dispensed in a bottle.  In case a bottle contain one dose, it is called draught.  Mixtures are prescribed for acute conditions such as cough,indigestion,constipation, diarrhea etc.  It should be extemporaneously prepared and supplied in small doses.
  • 7. classification of mixtures 1 . Simple mixture containing soluble substances 2 . Mixture containing diffusible solids 3 . Mixture containing in diffusible solids 4 . Mixture containing Precipitate forming liquids 5 . Mixture containing Slightly soluble liquid
  • 8. classification of mixtures 1.SIMPLE MIXTURE containing soluble substances  It contains only soluble ingredients.  It is represented by true solution  It is a clear homogenous mixture. E.g.: Carminative mixture, Expectorant mixture etc.
  • 9. 1 . S I M PL E MIXTURE containing soluble substances Method of dispensing: 1. Dissolve Solid in 3/4th Vehicle. 2. Examine the solution by holding against light . 3. Filter if any foreign particles find. 4. Add other ingredients 5. Add more vehicle to produce final volume 6. Fill in bottle and label. 7. Cork it and Clean bottle. 8. Attach label wrap bottle and dispense
  • 10. 1 . S I MP LE MIXTURE containing soluble substances Rx Potassium Bromide - 4.0 g Tincture of nux vomica – 4.0 ml Chloroform Water - add up to 90 ml  Direction: One tablespoonful to be taken three times after meals  Method of dispensing: 1.Dissolvepotassiumbromidein3/4th ofchloroformwater. 2.Filterthesolutiontoremoveforeignparticles. 3.Addtincturenuxvomica. 4.Incorporatemoreofchloroformwatertomakerequiredvolume. 5.Transferthemixturetoabottle,corklabelanddispense.
  • 11. 2 . MIXTURE containing diffusible solid • Diffusible solids are insoluble in water. • Uniformly dispersed in the vehicle on shaking. • No need of suspending agent. • Example:  Bismuth carbonate.  Bismuth sub nitrate.  Magnesium carbonate.  Magnesium oxide  Quinine sulphate  Light kaolin
  • 12. 2 . MIXTURE containing diffusible solid METHOD OF DISPENSING 1. Powderdruginmortaraddsolubledrugandmix. 2. Measure 3/4th of vehicle. Make smooth cream by portionofvehicle. 3.Transfer content from mortar into a measuring apparatus. 4.Addanyliquidingredient. 5.Addmorevehicletoproducefinalvolume. 6.Fillinbottleandlabel.Corkit. 7. Attach label “ Shake well before use” wrap bottle anddispense.
  • 13. 2 . MIXTURE containing diffusible solid Drug+ soluble material + Vehicle a part from 3/4th Smooth cream Add remaining vehicle from 3/4th Add any liquid ingredient Make up the volume with remaining vehicle. Transfer the mixture to the bottle and add secondary label. Add to measure
  • 14. 2 . MIXTURE containing diffusible solid EXAMPLE Rx Magnesium sulphate 15.0 g Magnesium carbonate 2.0 g Peppermint water 90.0 ml Prepare a mixture. Direction: One teaspoonful to be taken two hours before breakfast. Method of Dispensing: Diffusible mixture
  • 15. 2 . MIXTURE containing diffusible solid EXAMPLE Rx Magnesium sulphate 15.0 g Magnesium carbonate 2.0 g Peppermint water 90.0 ml Prepare a mixture. Direction: One teaspoonful to be taken two hours before breakfast. Method of Dispensing: Diffusible mixture
  • 16. 3 . MIXTURE containing in diffusible solid EXAMPLE  Indiffusiblesolidsareinsolubleinvehicle.  Not evenly distribute throughout the vehicle on shaking or not distribute in vehicle for sufficientlylongtime.  Ex. Acetyl salicylic acid, Quinine salicylate, calomel, Phenacetin, chalk powder. Suspendingofdrugisrequired.  So suspending agents are added in formulation.
  • 17. 3 . MIXTURE containing indiffusible solid SELECTION OF SUSPENDING AGENT Compound Tragacanth Powder: It content 20% acacia, 15% tragacanth, 20% starch and rest sucrose. In the proportion of 2g/100 ml of the mixture. It is used when the vehicle is other than water or chloroform Tragacanth mucilage: In the proportion of 1/4th of the volume of the mixture. It is used when the vehicle is water or chloroform water.
  • 18. 3 . MIXTURE containing indiffusible solid SELECTION OF SUSPENDING AGENT Compound Tragacanth Powder: It content 20% acacia, 15% tragacanth, 20% starch and rest sucrose. In the proportion of 2g/100 ml of the mixture. It is used when the vehicle is other than water or chloroform Tragacanth mucilage: In the proportion of 1/4th of the volume of the mixture. It is used when the vehicle is water or chloroform water.
  • 19. 3 . MIXTURE containing indiffusible solid METHOD OF DISPENSING Solid’s + Tragacanth powder (2%) Triturate the powder with a portion from ¾ of vehicle Smooth cream is formed Add remaining portion of vehicle from 3/4th Examination Add other liquid ingredient + soluble ingredients Make up the volume with remaining vehicle
  • 20. 3 . MIXTURE containing in diffusible solid METHOD OF DISPENSING CONT.... Solid’s +Tragacanth Mucilage(1/4th) Triturate Smooth cream is formed Add 1/2 of the vehicle. Examination Add other liquid ingredient + soluble ingredients Make up the volume with remaining vehicle
  • 21. 3 . MIXTURE containing in diffusible solid EXAMPLE Rx Ppt chalk powder -----------30 grain. Catechu tincture ------------ 20 minim. Cinnamon water ------------ 1 fl.oz.  Direction: Secundis hora sumenda  Method of Preparation: Method of dispensing using tragacanth powder
  • 22. 3 . MIXTURE containing in diffusible solid EXAMPLE Rx Acetyl salicylic acid-----------1 gram oxyphenbutazone ------------ 0.25g Simple syrup------------ 15 ml. Water -------------------add up to 90 ml  Direction: two tablespoonful to be taken 3times a day.  Method of Preparation: Method of dispensing using mucilage of tragacanth
  • 23. 4 . MIXTURE containing in diffusible solid EXAMPLE Rx Acetyl salicylic acid-----------1 gram oxyphenbutazone ------------ 0.25g Simple syrup------------ 15 ml. Water -------------------add up to 90 ml  Direction: two tablespoonful to be taken 3times a day.  Method of Preparation: Method of dispensing using mucilage of tragacanth
  • 24. 4 . MIXTURE containing in diffusible solid EXAMPLE Rx Acetyl salicylic acid-----------1 gram oxyphenbutazone ------------ 0.25g Simple syrup------------ 15 ml. Water -------------------add up to 90 ml  Direction: two tablespoonful to be taken 3times a day.  Method of Preparation: Method of dispensing using mucilage of tragacanth
  • 25. DIFFERENCE Diffusible mixture 1.These mixture containing medicament which is mixed upon taking the powder drug is evenly diffuse throughout uniformly. 2.In formulation suspending agent is not required. 3. Substances not float on surface of vehicle. 4. E.g. bismuth carbonate, bismuth sub nitrate. In diffusible mixture 1.These mixture are contain substances which not gets mix uniformly on mechanical shaking or stirring. 2. In formulation suspending agent is required. 3. Substances float on surface of vehicle. 4. E.g. acetyl salicylic acid, calomel.
  • 26. 4. Mixture containing precipitate forming liquids Certain liquid preparations contain resinous matter. when mixed with water, the resin is precipitated - which may adhere to sides of bottle or - form a clotted precipitate. This will not re-diffuse upon shaking. To prevent this, suspending agent is used. Ex. resin extract, tinctures etc.
  • 27. 4. Mixture containing precipitate forming liquids Certain liquid preparations contain resinous matter. when mixed with water, the resin is precipitated - which may adhere to sides of bottle or - form a clotted precipitate. This will not re-diffuse upon shaking. To prevent this, suspending agent is used. Ex. resin extract, tinctures etc.
  • 28. 4. Mixture containing precipitate forming liquids METHOD OF DISPENSING CONT.... Solid’s +Tragacanth Mucilage(1/4th) Smooth cream is formed Add precipitate forming liquid in the center of cream Examination Add precipitate forming liquid in the center of cream Add other liquid ingredient + soluble ingredients Make up the volume with remaining vehicle
  • 29. 4. Mixture containing precipitate forming liquids METHOD OF DISPENSING CONT.... Solid’s + Precipitate forming liquid + Tragacanth Mucilage(1/4th) Smooth cream is formed Add 1/2 of the vehicle. Examination Triturate Add other liquid ingredient + soluble ingredients Make up the volume with remaining vehicle
  • 30. 4. Mixture containing precipitate forming liquids Example Rx Potassium iodide 2.0ml Tincture lobelia ether 4.0 ml Tincture stramonium 16.0 ml Chloroform water add up to 90.0 ml  DIRECTION: One dessertspoonful to be taken four times a day.  METHOD OF DISPENSING: Using Precipitate forming mixture method
  • 31. 5. MIXTURE CONTAINING SLIGHTLY SOLUBLE LIQUID The insoluble portion of slightly soluble liquids is not readilydiffusible. So a suspending agent such as tragacanth powder or tragacanth mucilage are needed to dispense such mixtures. Ex.Paraldehydeliquid
  • 32. 5. MIXTURE CONTAINING SLIGHTLY SOLUBLE LIQUID Example Rx Paraldehyde ---------4.0 ml Syrup--------------------- 8.0 ml Liquid extract of glycyrrhiza--- 2.0 ml Water add upto ------30.0 ml  Direction: Take as directed
  • 33. 5. MIXTURE CONTAINING SLIGHTLY SOLUBLE LIQUID METHOD OF DISPENSING Paraldehyde + tragacanth mucilage in bottle Shake vigorously Dissolve syrup and liquid extract of glycyrrhiza in water. Bottle Content Shake vigorously Make up the volume by adding water
  • 34. 5. MIXTURE CONTAINING SLIGHTLY SOLUBLE LIQUID METHOD OF DISPENSING Paraldehyde + tragacanth mucilage in bottle Shake vigorously Dissolve syrup and liquid extract of glycyrrhiza in water. Bottle Content Shake vigorously Make up the volume by adding water
  • 35. FORMULATION 1. Drug 2. Vehicles 3. Adjuncts a.Chemical Stabilizers b. Preservatives c. Coloring Agents d. Flavoring Agents
  • 36. FORMULATION • Drug: Antibiotics , antipyretics, analgesic, etc • Vehicles: following vehicles are used.  Water: purified water  Aromatic water: Multiple use, e.g. chloroform water, Cinnamon water, etc.  Medicated vehicle: Infusions, ex. Senega infusion as expectorant. • Adjuncts: Adjuncts are generally used to improve the Safety, efficacy and palatability.  Chemical Stabilizers: e.g. Antioxidant: Ascorbic acid (0.1%), Sodium metabisulphite (0.1%) etc.  Preservatives: Chloroform (o.25%), Benzoic acid (0.1%) Methyl paraben, propyl paraben, etc.
  • 37. FORMULATION • Coloring Agents: E.g. Coal tar dyes. • Flavoring Agents: The following flavouring agents are commonly used in mixtures.  Aromatic water  Syrup and Glycerol.  Spirit lemon to cover the taste of alkaline citrates.  Orange syrup and compound orange spirit.
  • 38. STORAGE OF MIXTURES  Mixtures are dispensed in plain glass bottles with uniform internal diameter.  The mixture should be dispensed and supplied to the patient for not more than 3 days to prevent deterioration.  The bottle should be fitted with a suitable cork which ensures its easy removal and to prevent spilling of Mixture.
  • 39. SYRUPS  is sweet, viscous,  concentrated or nearly saturated  aqueous solution of sucrose containing 66.7%w/w of sugar” “ Syrup is sweet, viscous, concentrated or nearly saturated aqueous solution of sucrose containing 66.7%w/w of sugar”
  • 40. SYRUPS  Flavored syrups: Flavored syrups contain flavoring agents. Orange syrup BPC, lemon syrup BPC etc.  Medicated syrups: It contain medicaments dissolve in it.  Artificial syrups: • Used for diabetic patients, • Artificial syrups are prepared from polyols such as sorbitol, glycerine, propylene glycol or cellulose polymers such as methyl cellulose, hydroxy methyl cellulose and artificial sweetener such as sodium saccharine, sodium cyclamate. • Artificial sweeteners are 500 times sweeter than sucrose and they are non-caloric and they do not elevate the blood glucose level.
  • 41. SYRUPS Advantages of syrups:  Act as, antioxidant by retarding the oxidation, as sugar is hydrolyzed in to levolose and dextrose.  Act as preservative by retarding the growth of bacteria, fungi and mould, as osmotic pressure is 16 times greater than the isotonic solution.  Good patient compliance especially pediatric patients as syrups are sweet in test.
  • 42. SYRUPS Disadvantages: Fluctuation in storage temperature may cause crystallization of sucrose from saturated syrups.
  • 43. SYRUPS Method of Preparation 1. Simple solution method 2. By process of extraction 3.Syrup made by chemical interaction
  • 44. SYRUPS 1.Simple solution method Ex.1.. Prepare and dispense 100 ml of simple syrup. Rx Sucrose 66.7 g Purified water 100 g MOP: 1.Add sucrose to purified water 2. and heat it to Dissolve sucrose 3.Cool add more purified water
  • 45. SYRUPS 1.Simple solution method Ex.2.. Prepare and dispense 100 ml of ginger syrup IP. Rx strong ginger tincture 50ml syrup, sufficient to produce 1000 ml MOP: The syrup is prepared by mixing strong ginger tincture in small quantity at a time with syrup.
  • 46. SYRUPS 2.By Process Of Extraction Ex. Prepare and dispense 100 ml of tolu syrup IP Rx Tolu balsam ------12.5 g Sucrose ------------660 g Purified water ----1000 g MOP: 1. Add boiling purified water to the tolu balsam contained in tared vessel 2. Cover vessel lightly & boil gently for half an hour 3. Cool,filter add sucrose 4. Heat on water bath to dissolve sucrose.and finally add purified water to make up the volume.
  • 47. SYRUPS 3.Syrups made by chemical interaction
  • 48. SYRUPS 3.Syrups made by chemical interaction
  • 49. SYRUPS 3.Syrups made by chemical interaction
  • 50. SYRUPS Formulation of syrups 1. VEHICLES 2. ADJUNCTS • Chemical stabilizers • Colouring agents • Flavouring agents • preservatives
  • 51. SYRUPS Formulation of syrups 1. VEHICLES: • syrups are prepared by using purified water. • potable water should not be used. • because it contains both volatile and non volatile impurities.
  • 52. SYRUPS Formulation of syrups 2. ADJUNCTS a. CHEMICAL STABILIZERS: • Glycerine, sorbitol and propylene glycol is added in small quantity to the syrup to prevent the crystallisation of sucrose. • Certain surfactants like tweens can be combined with syrup to dissolve certain ingredients to the syrup to make a clear syrup.
  • 53. SYRUPS Formulation of syrups 2. ADJUNCTS b.COLOURING AGENTS: Many syrups are attractively coloured with coal tar dyes such as amaranth, compound tartrazine,and green s and tartrazine.
  • 54. SYRUPS Formulation of syrups 2. ADJUNCTS C.FLAVOURING AGENTS: i) Tinctures: tincture lemon and tincture ginger ii) Fruit juices: raspberry juice, wildcherry iii) Essence: vanilla and orange
  • 55. SYRUPS Formulation of syrups 2. ADJUNCTS d. Preservatives: • The syrups containing 66.7% w/w of sucrose have high osmotic pressure which prevents growth of bacteria ,fungi and moulds. • So no preservative is needed. • Generally benzoic acid sodium benzoate and parabens are used for preservation. • Use of sterilized container and closures is also effective way of preserving syrups
  • 56. Storage of syrups • The syrup should b stored in well dried completely filled and well stopper bottle in cool dark place. • The syrup should be stored at a temperature not exceeding 25degree Celsius • The glass bottle fitted with white polypropylene moulded or black thermosetting plastic screw closures are commonly used for the storage of bottles.the bottles may be colourless or ambered coloured.
  • 57. ELIXIRS Definition: clear, sweetened and flavored hydro alcoholic liquid preparation intended for oral use.
  • 58. ELIXIRS Definition: “Elixirs are clear, sweetened and flavored hydro alcoholic liquid preparation intended for oral use.” •The main ingredients of elixirs are ethyl alcohol •(5-40%), water, glycerin or propylene glycol, •flavoring agents, coloring agents and some •suitable preservative.
  • 59. ELIXIRS Types of Elixirs 1. Flavored Elixirs 2. Medicated Elixirs Flavored Elixir: Non-medicated and are used as flavoring agent or vehicle. Eg. Syrups containing lemon juice, orange juice, raspberry juice. Medicated Elixir: Elixir contain potent medicament. Ex. antibiotic, antihistaminic or sedative etc.
  • 60. ELIXIRS Example Rx Piperazine citrate 180 g Chloroform spirit 5 ml Glycerin 100 ml Orange oil 0.25 ml Syrup 500 ml Purified water q.s. upto 1000 ml Make an elixir, Send: 30 ml Label: One teaspoonful to be given at night.
  • 61. ELIXIRS Formulation of Elixirs 1. Vehicles: Water, Alcohol, syrup, glycerin, sorbitol and propylene glycol 1. Adjuncts: Used to improve Safety, efficacy and palatability. Chemical Stabilizer: Citric acid and disodium edtate in Neomycin Elixir. Preservative: 20% alochol, syrup and methyl paraben and propyl paraben Colouring Agent: Coal tar dyes. Flavouring agent: black current syrup, raspberry syrup, lemon syrup and orange syrup etc.
  • 62. ELIXIRS Storage of Elixir: The Elixirs are stored in a well-closed air tight glass container having screw cap at cool place protected from light.
  • 63. LINCTUSES Definition: • viscous, • Monophasic liquid preparation • containing a high concentration of syrup • intended to sipped and • swallowed slowly • for treatment of cough.
  • 64. LINCTUSES Definition: “Linctuses are viscous, monophasic liquid preparation containing a high concentration of syrup intended to sipped and swallowed slowly for treatment of cough.”
  • 66. LINCTUSES Example Rx Codeine phosphate 3.0 g Lemon syrup 200 ml Benzoic acid 20 ml Chloroform spirit 20 ml Compound tartrazine solution 10 ml Syrup q. s to 1000 ml Prepare linctus, send 30 ml Direction: Sip and swallow slowly (without aid of water)
  • 67. LINCTUSES Formulation 1. Vehicles 2. Adjuncts Used to improve Safety, efficacy and palatability. 1. Chemical Stabilizer 2. Preservative 3. Coloring Agent 4. Flavoring agent
  • 68. LINCTUSES Formulation 1. Vehicles: Syrup, (Tolu syrup), glycerin, sorbitol. 1. Adjuncts: Used to improve Safety, efficacy and palatability. 1. Chemical Stabilizer: Mostly stable because of syrup. 2. Preservative: High concentration of syrup acting as preservative. Tolu syrup has antibacterial action due to benzoic acid and cinnamic acid present in it. Benzoic acid in codeine phosphate linctuses. 3. Coloring Agent: Coal tar dyes. 4. Flavoring agent: black current syrup, lemon syrup, and benzaldehyde etc.
  • 69. LINCTUSES STORAGE: Linctuses are supplied in well closed air tight container having screw cap stored in a cool place, protected From light.
  • 71. Liquids meant for external administration Liquids used in the mouth • Gargles :Aqueous solutions containing antiseptics or antibiotics used to treat throat infections. Available in concentrated form with direction for dilution with warm water before use. eg: Povidone Iodine gargle. • Mouthwash: Aqueous solution with a pleasant taste and odor used to clean and deodorize the buccal cavity. Have antiseptic and astringent activity.eg: Antiseptics-phenol derivatives. • Throat paints : Viscous liquid preparation used for mouth and throat infections. Eg: Phenol glycerine, Compound Iodine.
  • 72. Liquids meant for external administration Liquids used in the mouth • GARGLES : “Gargles are concentrated, clear solution used in theposteriorregionof mouthtopreventthethroatinfection.”
  • 73. Liquids meant for external administration Liquids used in the mouth • GARGLES : D e f i n i t i o n : concentrated, clear solution used in the posterior region of mouth to preventthethroatinfection. Use: 1. Antiseptic/antibacterial. 2. Astringent. 3. Relieve soreness in mild throat infection.
  • 74. Liquids meant for external administration Liquids used in the mouth  Gargles are supplied inconcentrated form.  These are used after diluting with warm water  They are brought in intimate contact with the mucous membrane of thethroat.  Allowed to remain in contact with it for few second, before they thrown out ofthe mouth. Gargles have medicateduse.
  • 75. Liquids meant for external administration EXAMPLE: Potassium chlorate & Phenol Gargle B.P.C. Rx Potassium chlorate 30 g Patent Blue V 0.009 g liquefied phenol 15 ml Water up to 1000 ml Prepare mouthwash, send 30ml Direction: Dilute with warm water before use
  • 76. Liquids meant for external administration Container:White fluted glass bottle with plastic screw cap. Coloured bottle used for preparation whichneed protection. Labelling: 1. “For external useonly” 2. “Diluted with warm water beforeuse” 3. “Not to be swallowed in largeamount” Storage: Gargle are supplied in well closed air tight glass container having plastic screw cap.
  • 77. Liquids meant for external administration Liquids used in the mouth Mouthwash: “Mouthwashes are concentrated, clear aqueous solution with a pleasant tasteintendedtocleananddeodorizethemouthorbuccalcavity.”
  • 78. Liquids meant for external administration Liquids used in the mouth Mouthwash: Definition: concentrated, •clear aqueous solution with a pleasant taste •intended to be used to clean and •deodorize the mouth or buccal cavity.
  • 79. Liquids meant for external administration Use of Mouthwash 1. Antiseptic/antibacterial. 2. Astringent. 3. Cooling, refreshing action.
  • 80. Liquids meant for external administration Mouthwash contain antibacterial agents, alcohol, glycerin, sweetening agent, flavouring agent and colouring agents. They are also used in oral mucous disease to treat mouth infections and to maintain oral hygiene. Mouthwashes are used after diluting with warm water. Mouthwash have cosmetic value more.
  • 81. Liquids meant for external administration Example: Compound sodium chloride mouthwash B.P.C. Rx Sodium chloride 15gm Sodium bicarbonate 10 gm Peppermint Water up to 1000 ml Prepare mouthwash, send 50 ml Method: Dissolve the weighed quantity of sodium chloride and sodium bicarbonate in 3/4th of the peppermint water. add more of peppermint water to produce the required volume. Transfer to a bottle, label and dispense. Direction: Dilute with 20 times its volume with warm water before use
  • 82. Liquids meant for external administration Storage condition and labeling Container: White fluted plastic bottle with screwcap. Labeling: 1. “For external use only” 2. “Diluted with warm water before use” 3. “Not to be swallowed in large amount” Storage: Mouthwashes are supplied in well closed air tight plastic container having screw cap.
  • 83. THROAT PAINTS Throat paints are viscous liquid preparations used for mouth and throat infections. Glycerin is commonly used as a base because being viscous, it adheres to mucous membrane for a long period. it also provides a sweet taste to the preparation. The commonly used throat paints are boroglycerin,tannic acid glycerin, compound iodine paint( Mandl’s paint) CONTAINERS: Throat paints should be dispensed in airtight ,colored fluted bottle in order to distinguish them from preparations meant for internal use. Glass stoppers are used in such bottles.
  • 85. THROAT PAINTS LABELLING: The container should be labeled ‘FOE EXTERNAL USE ONLY”. STORAGE: Throat paints should be stored in airtight containers and in cool place.
  • 86. THROAT PAINTS EXAMPLE: Prepare and dispense 50 ml of iodine paint compound. (MANDL’S PAINT ) B.P.C. Potassium iodide 25 gm Iodine 12.5gm Alcohol 40.0ml Water 25ml Peppermint oil 4ml Glycerin to produce 1000ml
  • 87. THROAT PAINTS (i) Potassium iodide is dissolved in water. (ii) Iodine is added in the concentrated potassium iodide solutions to form KI3 (or higher iodides). (iii) Peppermint oil is dissolved in alcohol 90%v/v and the alcoholic solution is added to the iodine solution. (iv) Volume is made up with glycerin
  • 89. Liquids meant for external administration Liquids instill into body cavity • Ear drops • Nasal drops • Douches • Nasal sprays.
  • 90. Liquids meant for external administration Liquids instill into body cavity • Ear drops
  • 91. Liquids meant for external administration Liquids instill into body cavity • Ear drops  solution  used for instillation  in to ear
  • 92. Liquids meant for external administration Liquids instill into body cavity • Ear drops “These are the solution used for instillation in to ear.” • The solution are prepared in water, glycerin, propylene glycol or alcohol. • ▫ Vehicle like glycerin and propylene glycol are preferred as they increase contact time and soften the wax.
  • 93. • Uses of Ear Drop 1. Antibacterial. 2. Softening the wax. 3. Mild infections
  • 94. • Example: Sodium bicarbonate ear drop Rx Sodium bicarbonate 5gm Glycerin 30ml Purified Water up to 100 ml Prepare ear drop, send 30 ml • Direction: Place 2-3 drop in each ear as directed.
  • 95. • Ear Drop Container: ▫ Ear drop should be packed in colored, fluted glass bottle and supplied with dropper. Labelling: 1. “For external use only” 2. 2.“Not for injection” 3. “Discontinue the use if irritation persist” Storage: ▫ These are supplied in well closed glass container in cool place.
  • 97. • Nasal Drop DEFINITION: •aqueous solution •used for instillation in to nostril. “ These are the aqueous solution used for instillation in to nostril.”
  • 98. • Nasal Drop The oily vehicles are not used because they inhibit the movement of cilia and produce lipoid pneumonia. These are isotonic with blood plasma. Phosphate buffer of pH 6.5 is used as vehicle Use of Nasal drop 1.Antibacterial. 2.Nasal decongestion
  • 99. • Nasal Drop Example Ephedrine Nasal Drop B.P.C. Rx Ephedrine 0.5gm Chlorobutal 0.5gm Sodium Chloride 0.5gm Water upto 1000ml Prepare nasal drop, send 30 ml Direction: Place 2-3 drop in each nostril as directed
  • 100. • Nasal Drop Storage and labeling Container:  Nasal drop should be packed in colored, fluted glass bottle and supplied with dropper. Labeling: 1. “For external use only” Storage:  Nasal drop are supplied in well closedglass container in cool place.
  • 101. • Nasal Drop Storage and labeling Container:  Nasal drop should be packed in colored, fluted glass bottle and supplied with dropper. Labeling: 1. “For external use only” Storage:  Nasal drop are supplied in well closedglass container in cool place.
  • 106. Market available Eye drop, Nasaldrop & douches
  • 107. Liquids to be applied to the skin LINIMENTS: •Liquids or semisolid preparations •Meant for application to the skin •Usually applied to the skin with friction and rubbing of the skin.
  • 108. Liquids to be applied to the skin LINIMENTS: •The liniments may be alcoholic roily solutions or emulsions. •In alcoholic liniments, alcohol helps in the penetration of medicament into the skin and also increases its counter irritant and rubefacient action. •In oily liniments, rachis oil is commonly used which spreads more easily on the skin. •Soap is also included as one of the ingredient in some of the liniments which helps in easy application of liniment on the skin.
  • 109. LINIMENTS Generally liniments contain medicaments possessing: analgesic Rubefacient soothing counter irritant and stimulating properties. Containers: It should be dispensed in coloured fluted bottles in order to distinguish from preparations meant for internal use.
  • 110. LINIMENTS LABELLING: The label must state ; •“FOR EXTERNAL USE ONLY” •“SHAKE THE BOTTLE WELL BEFORE USE •THE LABEL SHOULD CARRY THE WARNING “NOT TO BE APPLIED TO OPEN WOUND OR BROKEN SKIN” STORAGE: It should be stored in tightly closed airtight container in cool place.
  • 111. LINIMENTS Example: Prepare and dispense 100 ml of turpentine liniment I.P. TURPENTINE LINIMENT I.P. Soft soap 90gm Camphor 50gm Turpentine oil 650ml Purified water 1000ml METHOD: •Mix the soft soap with small quantity of purified water . •Prepare the solution of camphor in turpentine oil, till a thick creamy emulsion is formed. •Add sufficient purified water to produce the required volume. Mix it thoroughly •Transfer the preparation to a bottle, label and dispense.
  • 112. LOTIONS Lotions are liquid preparations meant for external application without friction. •They are applied direct to the skin with the help of some absorbent material such as cotton, wool or gauze soaked in it. •Lotions may be used for local actions as; •Cooling, •soothing or protective purposes. •They are generally applied for antiseptic action,e.g., calamine lotion. •Alcohol is sometimes included in aqueous lotions for its cooling and soothing effect. E.g., salicylic acid lotion.
  • 113. LOTIONS Containers: Lotions should be dispensed in coloured fluted bottles in order to distinguish them from preparations meant for internal use. Labelling: the containers should be labelled “FOR EXTERNAL USE ONLY” Sometimes on long standing lotions have a tendency to separate out,therefore the container should be labelled, “SHAKE WELL BEFORE USE”. STORAGE: lotions should be stored in a well filled,well closed in an air tight container in a cool place.
  • 114. LOTIONS EXAMPLE: Prepare and dispense 100ml of calamine lotion I.P. CALAMINE LOTION I.P. Calamine 150gm Zinc oxide 50gm Bentonite 30gm Sodium citrate 5gm Liquified phenol 5ml Glycerin 50ml Rose water 1000ml METHOD: • Dissolve sodium citrate in water. •Triturate the calamine, zinc oxide and bentonite with the solution of sodium citrate. •Add liquefied phenol. add the glycerin. •Add purified rose water in sufficient quantity to produce the required volume.transfer the lotion to a bottle,cork,label and dispense.
  • 116. QUESTIONS  LOTIONS 1. They are used for topical effect such as local cooling, soothing protective &emollient effect. 2. Applied without friction 3. Vehicle is mostly aqueous Lotions 4. can be applied on broken skin. 5. Applied with cotton gauze 6. Alcohol is added for cooling action 7.These are liquid preparation 8. Sulphur lotion.  LINIMENTS 1. They are used for counter irritant,rubefacient,soothing or stimulating purpose. 2. Applied with friction 3. Vehicle is mostly oily or alcoholic 4.These are used for application to the unbroken skin 5. Applied directly 6. alcohol is added to improve penetration power 7. These are semi-liquid preparations 8. Turpentine liniment
  • 117. QUESTIONS MOUTHWASH: 1. Mouth washes are aqueous solutions with pleasant taste and smell for refreshing effect. 2. Used to cleanse & deodorize buccal cavity 3. These are used for rinsing mouth cavity 4. More used for cosmetic Purpose 5. It contains antibacterial agent, Coloring & flavoring agent. 6. Example : compound sodium chloride mouth wash. GARGLES: 1. Gargles are aqueous solutions to prevent & treat throat infections. 2.Used to relieve soreness in mild throat infections. 3. These are gargled to bring into intimate contact with mucous membrane of throat 4. used for medicated purpose 5. It contains antibacterial agent - Phenol, thymol and Astringent- Potassium chlorate. 6. Example: phenol gargle,potassium chlorate gargle
  • 118. QUESTIONS Give reason: Why oily vehicle is not used in the preparation of nasal drops. Because oily drop inhibits the movement of cilia in the nasal mucosa and if used for longer periods, may reach to lung and cause lipoid pneumonia. Advantages of syrups It retards oxidation as it is partly hydrolysed into reducing sugars such as levulose and dextrose. It prevents decomposition of many vegetables substances . They are palatable. Glycerine is used as vehicle in throat paint. Glycerine is viscous in nature and adheres to the throat Increases contact time and prolong the action It is also act as soothing agent
  • 119. QUESTIONS Why gargles are submitted in concentrated form? Gargles are submitted in concentrated form because, The quantity of solution require for doing one time gargle is around 20 ml. Therefore if it is dispensed in dilute form it requires the large quantity which is practically impossible to dispense. Therefore they are dispensed in concentrated form. Give the reasons, “glycerine is choice of vehicle for throat paints.” Glycerine is used as vehicle in throat paint because- Glycerine is viscous in nature and adheres to the throat Increases contact time and prolong the action It is also act as soothing agent
  • 120.  Elixir 1. Elixirs are clear, sweetened and flavoured hydro alcoholic liquid preparation intended for oral use. 2. Uses: Can be used as Antibiotic Antihistaminic Sedative purpose 3. More viscous than elixir and less viscous than linctus .  4. Ex Tolu syrup, ginger syrup ect  Syrup 1. Syrup is sweet, viscous, concentrated or nearly saturated aqueous solution of sucrose containing 66.7% w/w of sugar 2. UCan be simple syrup use for sweetening and flavouring purpose and medicated syrup for therapeutic purpose 3. less viscous than syrup 4. Ex chloral hydrate elixir ect
  • 121. QUESTIONS Mixture: A mixture is a liquid preparation meant for oral administration in which medicament or medicaments are dissolved, suspended or dispersed in a suitable vehicle. Draught: These are the liquid preparation to swallow once whole
  • 122. QUESTIONS Define: (i)Throat paints Throat paints are viscous liquid preparations for application of mucous membrane of buccal cavity using brush (ii)Douches Douches are medicated soln. for rinsing body cavity mostly for bladder, vagina, rectum, nasal cavity. Why simple syrup I.P. is considered as self preservative? Simple syrup I.P. contains 66.7%w/v sucrose which having high osmotic pressure which prevent the growth of bacteria, fungi and moulds which are the chief causes of decomposition in solution of vegetable matter.