Monophasic liquid dosage form ppt

MONOPHASIC LIQUID DOSAGE
FORM
Dr MEENA KHARWADE
Assistant professor,
AIKTC , New Panvel,
Navi Mumbai, Maharashtra

INTRODUCTION
• A solution is a liquid-preparation that contains
one or more soluble chemical substances
dissolved in a specified solvent.
• One phase system

Gargles
- They are aqueous solutions used in the prevention or
treatment of throat infections.
- Usually they are prepared in a concentrated solution with
directions for the patient to dilute with warm water before
use.
- They brought in intimate contact with mucous membrane of
throat and allowed to remain in contact with it for few
seconds before thrown out of the mouth
- Container-clear, glass bottles with plastic screw cap. Colored
bottles are required to be used if protection is required.
- Labelling- ‘for external use only” and proper dilution
instruction should be written on label
- Method of preparations- They are usually prepared by
dissolving all ingredients in solvents and then make up the
volume as required.

Advantages and Disadvantages
Advantages-
1. Easy to use for the treatment of infection of pharynx
just by gargling the solution using air from the lungs
2. Relieve Soreness In Mild Throat Infection
3. Supplied in conc. For so reduce container size
4. Suitable for variety of drugs like antibiotic, antiseptic
etc
Disadvantages
1. Temporary effect of drugs
2. Not suitable for patients having respiratory problems
3. They might be swallowed

Formulation component of gargles
additives ingredients use
cosolvent glycerine, propylene glycol etc used to enhance solubility
of drug
vehicle Water, sometimes alcohol To dissolve the excipients
Colouring agent Amaranth, tartrazine solution or any
FDA approved colour etc
Attractiveness
Flavouring agent cardamom oils, cinnamon oils,
menthols
To enhance acceptability
preservatives Phenol,Chorocresol,Benzoic acid and
its salts
To inhibit the growth of
microorganism.
Medicament 1. phenol,thymol
2. -potassium chlorate
3. volatile oil
4. potassium permangnate
1. Anti-infective-
2. Astringent
3. Antiseptic and
deodorants-
4. Bactericidal-
antioxidant Ascorbic acid,Sodium bisulfite,Sodium
metabisulfite, thiourea
to prevent oxidative
degradation of drugs

Mouthwashes
• These are non-sterile aqueous solution with
pleasant taste and odour used for oral hygiene
(clean and deodorize buccal cavity) and to treat
infections of the mouth.
• Container-white flutted bottles
• Labelling-proper directions for mouthwash
dilution must be mentioned
• “for external use only”provided in pH RANGE OF
5 TO 9.5
• “Not to be swallowed in large amount”

Advantages and disadvantages
• Advantages-
1. Utilized to remove Loosen debris and food
from the mouth
2. Provide deodorant, refreshning, local
analgesics or astringent effects
3. Sometimes used to treat the mouth infection
by using antibacterial agent.
Disadvantage- If pH not monitored properly
then may damage mouth tissues.

Classifications of mouthwashes
• Mouthwashes (mouthrinses) are generally classified as –
1. cosmetic or
2. therapeutic or
3. Combination of the two.
• 1.Cosmetic rinses are commercial products that remove
oral debris before or after brushing, temporary suppress
bad breath, diminish bacteria in the mouth and refresh the
mouth with a pleasant taste.
• 2.Therapeutic rinses ALONG WITH benefits of their
cosmetic counterparts, they also contain an added active
ingredient, (for example fluoride or chlorhexidine), that
help protect against some oral diseases.

cosolvent glycerine, propylene glycol etc used to enhance solubility
of drug
vehicle Water, sometimes alcohol To dissolve the excipients
Colouring agent Amaranth, tartrazine solution or any
FDA approved colour etc
Attractiveness
Flavouring agent spearmint, peppermint, eucalyptus and
menthol
They get rid of the
unpleasant smell and taste
of the other raw materials
and give a cold, refreshing
taste.
preservatives Phenol,Chorocresol,Benzoic acid and
its salts like sodium benzoate
microorganism.
Medicament 1. phenol,thymol
2. zinc sulphate, zinc chloride
3. volatile oil
4. potassium permangnate
1. Anti-infective-
2. Astringent
3. Antiseptic and
deodorants-
4. Bactericidal-

Deoderant sodium chloride and sodium
bicarbonate as a hypertonic solution
To deodourize the mouth cavity
Sweetening
agent
sodium saccharin, sorbitol, glycerol,
Xylitol
improve the taste
alcohol The amount of alcohol is usually
ranging from 18 - 26 % .
preservative and a semi-active
ingredient.
Abrasives- e.g.calcium carbonate, calcium
phosphate, aluminium hydroxide,
sodium bocarbonate
Abrasives are the substances that
are used for abrading, grinding or
polishing. They remove substances
adhering to the surface of the teeth
without scratching it and bring out
their natural luster
Anti-halistosis
agents
zinc ion the anaerobic,Gram-negative
bacteria use sulphurcontaining
amino acids as substrates in their
production of volatile sulphur-
containing compounds (VSC) which
gives unpleasant smell in mouth .
This agent stops this

Method of preparation-
• Solution method where most of the
ingredients are dissolved in solvent or co-
solvent mixture to form clear solution

THROAT PAINT
• Viscous liquid preparation Used for mouth and throat infection
• Paints can be applied onto skin and mucous membranes. But all
paints cannot be used for application onto mucous membrane
• Container-airtight, coloured fluted bottle
• LABELING-’for external use only”, it should also contain auxillary
label like: Throat paints usually contain volatile oils as flavouring
agents. Therfore to prevent their volatalisation at higher
temperature,
• NOT TO BE SWALLOWED IN LARGE QUANTITIES KEEP THE
CONTAINER TIGHTLY CLOSED.
• Storage-dispensed in air tight container and stored in cool place
• Direction: Throat paints should contain the direction to the patients
as, Apply with camel brush, as directed.

Advantages-
1. Used for treatment of throat infection and mouth
infection
2. Highly viscous solution so retain to the applied place
for longer period of time
3. Glycerine used as a solvent which provides viscosity
and turns liquid sweet.
Disadvantages-
1. Applied with the help of brush or small cotton piece
2. They initiate salivation, hence patient has to spit

Formulations-
1. SOLVENT- Viscous solvent must be used so as to retain the
formulation at the site of action for longer time e.g. glycerin, liquid
paraffine
2. Medicament-
Antiseptic-e.g Iodine, crystal violet
Astringent-tannic acid, boric acid
Anti-infective-phenol, thymol
3.Flavoring agent-They get rid of the unpleasant smell and taste of the
other raw materials and give a cold, refreshing taste. E.g.water-
insoluble essential oils, such as spearmint, peppermint, eucalyptus
and menthol are often used as flavouring agent dissolved with the
help of cosolvents
4.. Colouring agent- an attractive appearance e.g. FD&C Colours
5. Sweetening agent- improve the taste e.g. sodium saccharin,
sorbitol, glycerol, Xylitol
6. Preservatives- prevent the growth of micro-organisms in
mouthwashes. E.g. sodium benzoate, methyl paraben and ethyl
paraben

Method of preparation
• Simple solution method with the aid of heat

Syrup
- It is a concentrated aqueous solution of a sugar, usually
sucrose with or without medicinal and flavoring agent.
- Flavored syrups are a convenient form of masking
disagreeable tastes.
- Advantages-
1. Act as, antioxidant by retarding the oxidation, as
sugar is hydrolyzed in to laevulose and dextrose.
2. Act as preservative by retarding the growth of
bacteria, fungi and mould because of high osmotic
pressure.
3. Good patient compliance especially pediatric patients
as syrups are sweet in test.
4. Pleasant means of administrating liquid dosage form
of a disagreeable taste
5. Much like by children and adults
6. Suitable for water soluble drugs.

Disadvantages of syrup
1. Not suitable for diabetic patients
2. Children may mistakenly taken extra dose as
pleasant taste
3. Concentration if not appropriate result in
microbial growth
4. If kept in cold place , sucrose crystallizes and
is warm place occur fermentation.

Types of syrup
• 1. simple syrup- when water is used alone for the
preparation of sucrose solution.
E.g. simple syrup IP. Consist of 66.7 % w/w of
sucrose in water
• 2. medicated syrups-when syrup contains
medicinal substances used for therapeutic purpose
E.g. codeine phosphate syrup,ferrous sulphate syrup
• 3.Flavoured syrups-when syrup contains aromatic
or flavouring agents
E.g. orange syrup,lemon syrup

Formulation component of syrup
Main ingredients Sucrose or other sugar
substituent
Sweetener, preservative
vehicle Water, glycerin As a solvent for dissolving
ingredients
Chemical stabilizers Glycerin, sorbital, propylene
glycol
To prevent crystallization of
sucrose
Colouring agent Amaranth, tartrazine
solution etc
Attractiveness
Flavouring agent Raspberry juice, lemon
juice, vanilla flavour etc
preservatives Benzoic acid, sodium
benzoate, methyl paraben
microorganism
medicament Lincomycin
Analgesic
antiemetic
Antibiotic
Meperidine Hydrochloride
Chhlorpromazine HCL

Method of preparations
• Three methods-
1. Solution with the aid of heat-sugar is added to
purified water and heat is applied until solution
forms. Then solution allowed to cool and volume is
adjusted.
2. Solution with agitation-sugar and ingredients are
dissolved in purified water by placing in container and
allowed to agitate the mixture for long time till whole
of the sugar dissolves and then make up the volume
3. Percolation method-sucrose is percolated with
purified water as solvent by slowly passing the solvent
through column of crystallization of sucrose to
dissolve it. The percolate is collected. This process is
repeated until the whole sugars dissolves.

• DISPENSING-in well dried, well stoppered
bottles, narrow mouthed, amber coloured
bottles with plastic screw cap
• Storage-store in cool place
• Label-store in fairly cool temperature, not
exceeding 25 ◦C in dark place.

Defination:
• Elixirs as clear, sweetened hydroalcohol liquids
intended for oral use containing flavoring
substances or active medicinal agents.
Their primary solvents are alcohol and water, with
glycerin, sorbitol and syrup sometimes as an
additional solvent and/or sweetening agents.
Alcohol concentration 4-40%

Advantages of presence of alcohol
1. Enhances the solubility of insoluble drugs in
water
2. If more than 20 % alcohol present, no
requirement of preservative as alcohol acts
as a preservative

Types of elixir
• 1. non-medicated elixir- do not contain
medicament, but contain flavoured substances
to make it acceptable
• 2. medicated elixir-when elixir contains
medicinal substances used for therapeutic
purpose like antibiotic, antihistaminics,
antitussive etc
E.g. piperazine citrate elixir, paracetamol elixir

Formulation component of elixir
vehicle Water, glycerin, alcohol As a solvent for dissolving ingredients
Colouring agent Amaranth, tartrazine solution etc Attractiveness
Flavouring agent Raspberry juice, lemon juice,
vanilla flavour, orange oil, tincture
of lemon etc
To enhance acceptability of the product
preservatives Benzoic acid, sodium benzoate,
methyl paraben, chloroform spirit,
methyl ester of p- hydroxy
benzoic acid.
To inhibit the growth of microorganism
medicament Antibiotic, antihistaminics,
sedative
Therapeutic purpose
Sweetening agent Sucrose, saccharine, syrups,
glycerine
To enhance the taste
stabilizer EDTA, Citric acid To stabilize the product byminimize the darkening
that occurs on storage. Disodium edetate should
be used to sequester heavy metals that catalyse
decomposition of the antibiotics.

Method of preparation:
• Dissolve the water-soluble ingredients in part of the water,
add and dissolve the sucrose in it.
• Dissolve the other ingredients in the alcohol.(Concentration of
alcohol should be 5- 40% to make clear solution)
• The aqueous solution is then added to the alcoholic solution
with constant stirring and make up the volume with the
solvent or vehicle specified in the formulation. Elixirs should be
brilliantly clear and therefore strained or Filtered, if necessary
• A high alcoholic content is maintained during preparation by
adding aqueous phase to the alcoholic solution.

Storage
It should be dispensed in narrow mouthed, screw capped, colorless
plain bottle.
In cool place , to prevent volatilization of alcohol at high
temperature
Advantages over syrups
less sweet than syrups
• Elixirs are more fluid than syrups.
• It often is desirable, it is more effective in masking such tastes.
• More stable than syrups
• Elixirs are more readily prepared and manufactured than syrups.
• An Elixir may contain both water and alcohol soluble ingredients.

Disadvantage of elixirs
• Alcohol is not good for children.
• Because they contain volatile materials, it must
be stored in a watertight screw-top jar and away
from sources of ignition.
Label-
All necessary requirements of liquid dosage form
meant for internal use. Amount of alcohol content
must be mentioned

Eardrops
Solutions of drugs intended to be instilled into
the ear with a dropper.
• Container- coloured , fluted glass bottle with
dropper in the cap
• Labelling- ‘FOR EXTERNAL USE ONLY’
• Storage-’store in cool place’

Advantages-
1. Use for the removal of ear wax
2. Used in treatment of ear infection, inflammation
and pain
Disadvantages-
1. Due to liquid nature, patient has to tilt the head
at 45◦C For about 10-15 minutes
2. Aqueous solutions are not suitable as they
donot get mixed with fatty serum

FORMULATIONS
• 1. Solvent-Unhydrous Glycerine and propylene glycol used mainly for
two purpose-
A. To soften the ear wax As they are miscible with fatty ear wax and make
maximum contact between medication and ear tissue.
B. Hygroscopicity of vehicle draw moisture from tissue thus reduce
inflammation and prevent growth of microorganism
2.Preservative- to prevent growth of microorganism
e.g. chlorbutanol (0.5%), thiomersal (0.01%)
3.Antioxident- to prevent oxidation of active medicament
e.g. sodium biosulphate
4. medicament-
Antiinfective- chloramphenicol
Wax softner-hydrogen peroxide,sodium bicarbonate
Antiseptic-phenol, boric acid
Astringent-aluminium acetate
Anti-inflammatory agent-hydrocartisone,dexamethasone

METHOD OF PREPARATION
• SIMPLE SOLUTION METHOD

Nasal drops
• Aqueous solution that are instilled into the
nose with dropper
• Container- coloured fluted bottles fitted with
dropper or in suitable plastic container
• Labelling- ‘FOR EXTERNAL USE ONLY’
• Storage- stored in cool place

• Advantages-
1. Used to reduce swelling of the nasal mucosa
2. Used to reduce nasal congestion
Disadvantages-
1. They may induce nasal congestion if not used
as per direction given
2. Aqueous solution donot prolong the action

Requirement for nasal vehicle
1. pH Must be between 5.5 to 7.5.
2. Have mild buffer capacity
3. Compatible with nasal tissue
4. Compatible with other active ingredients
5. Must contain preservatives
6. Stable
7. Have a proper viscosity

Formulation ingredients
• 1. Vehicle- water and preparation must be isotonic
• 2. preservatives- prevent growth of microorganism in
product
• E.g. chlorbutanol(0.5%), BKC (0.01-0.05%)
• 3.Tonicity adjusting material- to adjust tonicity of nasal
drops
• E.g. sodium chloride, dextrose
• 4. Buffer- to adjust the pH of product
• E.g. phosphate buffer pH 6.5
• 5. Medicament-
• Ephedrine hydrochloride, corticosteroid etc

Method of preparations
• Simple solution method if required heating
can be done

Enemas
• Enemas are aqueous or oily solutions or suspensions or
o/w type emulsions,which are intended to introduce
into rectum for cleansing,therapeutic or diagnostic
purposes.
• They are also used to cause evacuation and for local or
systemic or therapeutic action of the medicaments
• DISPENSING Enemas are dispensed in coloured,fluted
glass bottle along with rectal nozzle.
• Now-a-days enemas are supplied in single use,squeeze
plastic bottles or disposable polyethylene or polyvinyl
chloride bags sealed with rectal nozzle,which should be
lubricated before administration

• DIRECTION: Warm up to the body temperature(37 o C),before
use(only for large volume enemas) and administer as directed .
• STORAGE: Enemas should be stored in a cool and dark place .
• LABEL : Label should bear all necessary requirements of liquid
dosage forms,except dose.
• Auxillary label-FOR RECTAL USE ONLY.
• LUBRICATE THE NOZZLE BEFORE USE.
• WARM TO THE BODY TEMPERATURE BEFORE USE.-(ONLY FOR
LARGE VOLUME ENEMAS)
• STORE IN A COOL AND DARK PLACE.
• USE WITH IN TWO DAYS AFTER ISSUE OR DISCARD THE REMAINING
PORTION AFTER TWO DAYS OF ISSUING.
• KEEP AWAY FROM THE REACH OF CHI LDREN.

ADVANTAGES AND DISADVANTAGES
• Advantages-
1. Suitable for local and systemic effect also
2. The drugs which are not given by oral or
parenteral routes preferred by this route
3. Administered in large volume
4. Used for study of lower GIT, if contain x ray
contrast medium
Disadvantages-
1. Patient uncomfortable
2. Require assistant or nurse for administration

Types of enema
• There are three types of enemas-
• 1)Cleansing enemas
• 2)Therapeutic enemas
• 3)Diagnostic enemas
• 1.Cleansing enemas These are also called Evacuating
enemas . They are used to evacuate faeces in constipation
and before any surgery of the gut.
• Volume of enema is depending upon the age and condition
of the patient.
• The large volume enemas should be warmed to body
temperature(37 o C),before administration to prevent cold
shock. (warm water stimulate intestinal mucosa and cold
water produce cramping

Type of enema
• 2.Therapeutic enemas These are Medicated enemas .These
are used to produce medicated effects in the bowel or in
lower part of the colon in children and comatose patients.
• This action may be obtained by its local action(as in the
case of piles, ulcerative colitis and inflammatory bowel
disease) or systemic(therapeutic) action
• They contain therapeutic agents like, Sedatives :Chloral
hydrate,Paraldehyde Anthelmintics :Quassia(for thread
warms) Anti-inflammatory agents :Corticosteroids(for
ulcerative colitis) Nutrients :Vitamins,Minerals
• 3.Diagnostic enemas They contain radio opaque
substances,which are used for X-ray examination of lower
bowel or colon part. Eg: Barium sulphate suspension

Formulations of enema
• 1. medicament-
• Laxative-e.g. glycerine, soft soap
• Sedative-e.g. chloral hydrate
• Anthalmentics-e.g. quasia
Drug must be soluble in suitable solvents
Method of preparations-simple solution
method

Liniments
• Alcoholic or oily clear solutions intended for
applications to the skin with friction or
massage and should not be applied to broken
skin.
• They are rubbed onto the affected area;
because of this, they were once called
embrocation.
• They are applied with friction and rubbing of
the skin, the oil or soap base providing for
ease of application and massage.

General uses of Liniments
Antipruritic - usedto relieve itching
Astringents - causesbiological tissueto contract
Emollients - products that soften skin or treat dry skin
Analgesics-reduce pain
Rubefacient-Substance thatcausesredness (Rubar)
Counterirritant- an agent applied locally to produce
superficial inflammation with the object of reducing
inflammation in deeperadjacent structures.

• Advantages-
1. Used as rubefacient, counter-irritant and
penetrating action in skin
Disadvantages-
1. Liniments required rubbing so patient may be
uncomfortable
2. Alcoholic or hydroalcoholic solutions may
produce irritation to skin

Formulation component of liniment
vehicle Alcohol, oils like peanut oil,
sesame oil, cotton seed oil
etc
Solvent select based on action whether
massage or deep penetration into skin
needed
Flavouring
agent
Rose oil, jasmine oil, lemon
oil etc
To enhance acceptability of the product by
pleasant smelling
medicaments Counter irritant-camphor
Analgesics- methyl salicylate
Therapeutic purpose

How Liniments are prepared
The vehicle should be selected for the type of action
desired (rubefacient, counterirritant, massage)and also
on the solubility of the desired components in the
varioussolvents
Prepared in the samemanner assolutions

Alcoholicliniments
1. used generally for their
rubefacient,
counterirritant mildly
astringent, and
penetrating effects
2. penetrate theskin more
readily than do those
with an oilbase.
3. Alcohol used as solvent
4. E.g. soap liniment
1. Milder in their action but
is more useful when
massage isrequired
2. less irritating to the
skin, depending on their
ingredients
3. may function solely as
protectivecoatings.
4. Oil used as solvent
5. E.g. camphor liniment
There are two ty pesof L in iments
ALCOHOLIC LINIMENTS OLEAGINOUS LINIMENTS

Liniments:
Liniments should NOT be applied to skin that is
bruised/Broken becauseexcessiveirritation might occur.
This application should be marked for “external use
only”
Dermatologist prescribe products of this type but only
those containing the rubefacients are advertised
extensively and usedby consumersfor treating minor
muscular aches andpains.

• Dispensing-amber coloured container, narrow
mouthed bottle, tightly closed with coloured
plastic screw cap
• Label-
1. for external use only
2. Not to be applied on broken skin
3. Shake well before use
Storage-Store in cool and dark place, away from
the flame

Lotions
• Clear solutions aqueous or oily, suspensions
or emulsions intended for applications to skin
without friction.

• Advantages-
1. They are soothing and applied gently by dapping
2. Comfortably spread without rubbing
3. Alcoholic lotions provide cooling effect on
applications
• Disadvantages-
1. Alcoholic or hydroalcoholic lotions gets dried
easily, hence not suitable for prolonged action

Formulation component of llotions
vehicle Alcohol, isopropyl alcohol,
water, liquid paraffine
isopropyl myristate etc
For making the content soluble
Cosolvent Glycols, glycerine, propylene
glycol, PEG 400, 600
FOR INCREASING THE SOLUBILITY OF
DRUGS IN SOLVENTS
Flavouring
agent and
colouring agent
Colours for FD&C
Cherry, raspberry, apple, rose
medicamnets Astringent-copper, zinc
shipmates
Keratolytics, fungicidal,
bacteriostatics
Therapeutic purpose
Preservatives Chlorbutanol
Benzyl alcohol
B-phenylethyl alcohol etc
In order to prevent microbial growth

Methods of preparations
• Simple solution method

• Dispensing-coloured flutted bottles
• Labelling
1. For external use only
2. Sake well before use
• Storage-well closed , air tight container cool
place

Monophasic liquid dosage form ppt

Monophasic liquid dosage form ppt

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Monophasic liquid dosage form ppt