Monophasic liquids (for external application)

MONOPHASIC LIQUIDS
(FOR EXTERNAL APPLICATION)
PREPARED BY:
Bhargavi Mistry
[Assistant Professor, School of
Pharmacy Rk University]

LIST OF CONTENTS
prepared by: Bhargavi Mistry 2
Ear drops
Nasal drops
Liniment
Lotion
Gargles
Mouthwash
Throat paint
Enemas
01
02
03
04
05
06
07
08

Ø Gargles are aqueous solutions used for the treatment of throat infections (pharynx
& nasopharynx part).
Ø They are supplied in concentrated forms with directions of dilutions with warm
water before use.
Ø Gargles are used in the posterior region of the mouth cavity by agitating the
solution with expired air. They remained there for a few moments after which they
are thrown out of the mouth.
GARGLES

ADVANTAGES
1) They are used for the treatment of infections of pharynx and nasopharynx.
2) They relieve soreness in mild throat infections and provide deodorant effect.
3) They supplied in concentrate form which reduces the container size.
DISADVANTAGES
1) Germicidal and antibacterial effects are temporary.
2) They are not suitable for patients having some respiratory problems.
3) They might be swallowed.

1) Potassium chlorate and phenol gargles BPC
2) Gargle of phenol BPC
Ø Simple solution method
Vehicle The most suitable vehicle is purified water or with the
combination of alcohol
Flavouring agents Volatile oils or other volatile substances are the most
accepted flavors for the gargles.
Coloring agents Suitable FDA-approved colors can be selected.
Preservatives and
stabilizers
Agents which are suitable for oral liquid preparations can
be selected.
FORMULATION
METHOD
EXAMPLES

1) They are utilized to remove loose food or debris from the mouth.
2) They provide deodorant, local analgesic, or astringent effects.
3) They are able to clean the deposited debris in the teeth cavities.
4) Cleaning of mouth cavity improved if surface active agents are added to
mouthwash.
Ø Mouthwashes are aqueous liquid preparations used for rinsing, deodorant,
refreshing, antiseptic action on the front portion of the mouth cavity
MOUTHWASH
ADVANTAGES

Drug and other excipients like vehicle, flavouring agent, colouring agent.
Simple solutions method
(1) Antibacterial: Phenol, Hydrogen peroxide, Thymol
(2) Astringent: Zinc sulphate, Zinc chloride
(3) Deodorant: Sodium chloride, Sodium bicarbonate
1) Compound sodium chloride mouthwash
2) Zinc sulphate & zinc chloride mouthwash
FORMULATION
METHOD
MEDICAMENT USED
EXAMPLES

1) They are useful for the treatment of Pharyngitis laryngitis, follicular tonsillitis,
and abscesses of the throat
2) They are highly Viscous solutions that retain the drug for an appreciable time on
the applied part.
3) Usually, glycerin is used solvent which Provides viscosity and turns the liquid
sweet.
Ø Throat paints are very viscous liquid preparations used for mouth and throat
infections.
THROAT PAINTS
ADVANTAGES

1) They are applied with the help of a brush or a small cotton piece twisted at one
end of the wooden twig. This sort of the process of application reduces its
usefulness.
2) They initiate salivation hence patient has to spit now and then till salivation
subsides.
Ø Formulation of throat paints requires viscous vehicles; which are able to retain
the drugs at the site for a longer time. E.g. Glycerin, paraffin
Ø Apart from vehicles, other adjuncts like flavoring agents, coloring agents, and
sweetening agents are also employed in the formulation according to their utility.
DISADVANTAGES
FORMULATION

(1) Antiseptics, e.g. Iodine, Crystal violet
(2) Astringents e.g. Tannic acid, Boric acid
(3) Anti-infectives e.g. Phenol, ichthammol
1) Mandle’s paint
METHOD
MEDICAMENT USED
EXAMPLES

Ø Enemas are solutions (monophasic) or suspension (biphasic), intended for
introduction in the rectum or colon to cause evacuation or to bring local or
systemic therapeutic effect.
TYPES EXAMPLES
Cleansing or evacuating Tap water, saline
Carminative enemas Milk & molasses, olive oil
Retention enemas Chloral hydrate, warm oil
Lubricating enemas Vegetable oil, mineral oil
Medicated enemas
Sodium hydrogen phosphate, sodium
phosphate
ENEMAS
TYPES

1) They are suitable for the local effects on rectum.
2) They can be used for those drugs which are not given through oral or parenteral
route e.g. paraldehyde.
3) They can be administered in large volumes, and need to warm up to the body
temperature before administration.
1) A patient feels shy to adopt these dosage forms.
2) They require assistant or nurse for the administration.
3) During administering, liquid pressure should be controlled as high pressure may
result in sever cramping , pain, and rupture of intestinal wall.
ADVANTAGES
DISADVANTAGES

Suitably soluble drugs alone or along with few pharmaceutical aid like stabilizers (if
needed) are sufficient for formulation.
(1) Stimulant laxative e.g. Glycerine, soft soap
(2) Sedatives e.g. Chloral hydrate, Paraldehyde
(3) Anthelmintics e.g. Quassia
(1) Enema of glycerine
(2) Enema of soft soap
FORMULATION
METHOD
MEDICAMENTS USED
EXAMPLE

Ø Eardrops are medicated solutions to be instilled into the ear with the help of a
dropper.
Ø Eardrops are used for cleaning and for treating the infections.
Ø Cleaning of ear is required because ear wax which is a mixture of the secretions of
the sebaceous and ceruminous glands gets accumulated and block the canal.
Ø They are supplied in small volume bottles with either a separate dropper or built
in dropper.
Ø Label on bottle must bear direction like “ FOR EXTERNAL USE ONLY”.
EARDROPS

1) They are used to put in ear canal as drops or the removal of ear wax.
2) They can be used for treatment of ear infection, inflammation and pain.
1) Due to their liquidity, a patient has to tilt his head at 45°angle for about 15 to 30
min.
2) Aqueous solutions are not suitable as they do not get mixed with fatty cerumen.
ADVANTAGES
DISADVANTAGES

1) Vehicle:
Anhydrous glycerin and propylene glycols are selected for the purpose. Their high
viscosity and miscibility with fatty substances make them suitable to remove the
ear wax and retain the drug for a sufficient period of time.
2) Preservatives:
For the purpose of preservation of the preparations (aqueous) from microbial growth,
e.g. Chlorbutanol (0.5%), thimerosal (0.01%), and a combination of parabens are
also employed.
Antioxidant: To prevent the oxidation of the active medicament, e.g. Sodium
bisulfite.
FORMULATION

(1) Anti-infectives e.g. Chloramphenicol
(2) Wax softener e.g. Hydrogen peroxide, Sodium bicarbonate
(3) Antiseptics e.g. Phenol, Boric acid
(4) Astringents e.g. Aluminium acetates.
(5) Anti-inflammatory agents
e.g. Hydrocortisone, Dexamethasone, Sodium phosphate.
(1) Sodium bicarbonate ear drops, BP
(2) Aluminium acetate ear drops, BP
METHOD
MEDICAMENTS USED
EXAMPLE

Ø Nasal drops are aqueous preparations of drugs that are instilled into the nostrils.
Ø The conventional ambered colored glass bottle with a medicinal dropper top should
be used for drop medication.
Ø Label on the container must bear directions like:
“ FOR EXTERNAL USE ONLY”.
“ FOR USE ONLY IN THE NOSE”.
NASAL DROPS

1) They are used to reduce swelling of the nasal mucosa and underlying tissues in
hay fever and catarrh.
Ø DISADVANTAGES:
1) They may induce nasal congestion
2) Oily solutions cause lipoidal pneumonia.
3) Aqueous solutions do not prolong the action.
ADVANTAGES
DISADVANTAGES

1) It should have a pH between 5.5 to 7.5, preferably less than 7.0.
2) It should have mild buffer capacity.
3) It should be isotonic.
4) It does not modify the normal viscosity of mucus.
5) It should be compatible with normal ciliary motion and ionic constituents of nasal
secretions.
6) It should be compatible with active medicament.
7) It may contain preservatives to prevent the growth of microorganisms.
8) It should be sufficiently stable.
9) It should have nearly the same viscosity of nasal mucus.
REQUIREMENTS

Nasal solutions are aqueous in nature. Formulation of such solutions requires the
following adjuncts:
1) Vehicle:
Ø The most suitable vehicle system is purified water.
Ø For oily drops: liquid paraffin used as a vehicle.
2) Preservatives:
Preservatives are necessary to preserve the preparation from the growth of
microorganisms. Eg: Chlorbutanol (0.5%), aromatic alcohols (0.5 — 0.9%)
3) Tonicity adjusting material:
To adjust the tonicity of nasal drops, sodium chloride and/or dextrose are preferred.
4) Buffers: They are required to adjust the pH of nasal drops.
FORMULATION

1) Sympathomimetics, e.g. Ephedrine HC1
2) Anti-inflammatory, e.g. Corticosteroids
3) Adrenergic/decongestant e.g. Oxymetazole HC1, Phenylephrine HCI,
Tetrahydrozoline HCl
1) Ephedrine Hydrochloride Nasal Drops, B.P.C
2) Oxymetazoline Hydrochloride Nasal Drops, U.S.P
METHOD
MEDICAMENTS USED
EXAMPLE

Ø Liniments are alcoholic and oily liquid preparations (monophasic) or Emulsion
(biphasic), intended for external use with friction.
Ø They are applied on the skin with rubbing and should never be applied on the
broken parts of the skin.
Ø The label should contain:
“ KEEP OUT OF THE REACH OF CHILDREN”.
“ APPLY WITH GENTLE RUBBING”.
“ NOT TO BE APPLIED ON BORKEN SKIN”.
LINIMENT

1) Liniments are useful for rubefacient, counter-irritant, and penetration action on the
skin.
2) They may be alcoholic, hydroalcoholic, or oleaginous in nature.
3) Oleaginous liniments are less irritant than alcoholic ones and are prepared when
massage is desired.
ADVANTAGES
DISADVANTAGES
1) Liniments require rubbing hence they are least desirable from the patient’s point
of view.
2) Alcoholic or hydroalcoholic liniments may produce irritation on the skin.
3) They are not suitable to apply on broken or bruised skin.

Monophasic liniments require drug(s) and vehicles.
1) Vehicles:
Ø The vehicle for the monophasic liniments should be selected on the basis of the
type of action desired rubefacient, counterirritant, or just massage and also on the
solubility of the components to be dissolved.
Ø Most commonly used vehicle is alcohol for rubefacient and counterirritant action.
Ø Fixed oils such as almond oil, peanut oil, sesame oil, and cottonseed oil are used
for massage.
2) Perfumes: pleasant-smelling oils like rose oil, jasmine oil, lemon oil, etc..
FORMULATION

1) Counter irritant e.g. Camphor
2) Analgesics e.g. Methyl Salicylate, Aconite
1) Camphor liniment, I.P
2) Aconite liniment
METHOD
MEDICAMENTS USED
EXAMPLE

Ø L o t i o n s a r e a q u e o u s , o i l y, o r a l c o h o l i c l i q u i d p r e p a r a t i o n s
(monophasic) or suspensions and emulsions (biphasic), intended for external
application without friction.
Ø They are usually applied on the affected part with the help of some absorbent
material such as cotton wool or gauze soaked in the lotion.
Ø The purpose of the lotion is to provide cooling, soothing and protective action.
Ø They are supplied in colored fluted bottles in order to distinguish them from
preparation meant for internal use.
Ø The labels must contain:
“ KEEP OUT OF THE REACH OF CHILDREN”.
“ APPLY WITHOUT RUBBING”.
LOTION

1) Lotions are comfortably spread without rubbing.
2) Alcoholic or hydroalcoholic monophasic lotions provide a cooling and soothing
effect after application.
3) Fixed oils can be used as a vehicle that provides the prolonged effect of the drug
due to the high viscosity.
ADVANTAGES
DISADVANTAGES
1) Aqueous, alcoholic, or hydroalcoholic lotions get dried immediately hence not
suitable when prolonged action of the drug is desired.

1) Vehicles:
Ø Usually alcohol and isopropyl alcohol are used.
Ø purified water alone or in combination with alcohol (hydro alcoholic) can be used.
Ø For oil lotions: liquid paraffin (light). Isopropyl myristate is used.
2) Perfumes: Pleasant-smelling oils like rose oil, jasmine oil, lemon oil, etc.
3) Cosolvents: Cosolvents are added for the dual purpose, one for increasing the
solubility of the drug and secondly for providing soothing effect
e.g. glycols-glycerin, propylene glycol
FORMULATION

4) Coloring and Perfuming Agents
5) Preservatives
These are required only when the preparation is absolutely aqueous. Most commonly
used preservatives are parabens. Preservatives are not required if the preparation
contains more than10% alcohol

1) Astringents, e.g. Copper and Zinc shipmates
2) Keratolytic, bacteriostatic and fungicidal agents, e.g. Salicylic Acid, Benzoyl
peroxide
1) Calamine lotion
METHOD
MEDICAMENTS USED
EXAMPLE

1) Dr. A.K. Seth, A textbook of pharmaceutics, 2nd edition 2022, Pee Vee publication,
Page no. 286-300
REFERENCES

THANK YOU

Monophasic liquids (for external application)

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