ENT Preparation, Ear drops, Nasal Drops, Throat Paint. Containing, definitions, formulation aspects, method of preparation, evaluation parameter.

1. Mr. Sumeet M Kharat
M. Pharm, Q.A.
Department of Pharmaceutics
IIP, Sadavali

2. EAR (AURAL/OTIC) PREPARATIONS:
 These solutions occasionally referred as
aural or otic preparations.
 Other otic preparations often include
formulation such as suspensions and
ointments for topical application to the ear.
 The main classes of drugs used for
topical administration to the ear include
analgesic, antibiotics, and anti-
inflammatory agents.

3.  These preparations used to treat infections of
the ear canal.
 Some preparations also contain
corticosteroids for use in the ear to relief the
redness, irritation and discomfort of certain
ear problems.
 Wax softeners are also present in ear
preparations

4. EAR DROPS:
These are the solutions of drops that are instilled into ear
with a dropper. Most of the official ear drops are simple
solutions and are having following applications.
 To treat mild microbial infections. e.g. Chloramphenicol.
Acute infections are treated with systemic antibiotics.
 Softening wax. (e.g. hydrogen peroxide or sodium
bicarbonate ear drops.)
 To remove the excessive cerumen (ear wax)
 Cleansing and drying ear cavity.(e.g. the astringent,
aluminum acetate)

5. FORMULATION ASPECTS OF OTIC
PREPARATIONS:
 The solutions are generally prepared in purified
water, glycerin, propylene glycol, dilute alcohol.
However, vehicle likes glycerin and propylene
glycol is preferred.’
 These are generally used for cleaning the ear,
softening the wax, and for treating the mild
infections.
 To provide sufficient time for aqueous
preparations to act, it is necessary for patient to
remain on their side for a few minutes so the
drops do not run out of the ear.

6. DIRECTION OF ADMINISTRATION:
 Wash your hands.
 Lie down or tilt your head to the side such that
the affected ear is turned upwards.
 Straighten the ear canal by pulling the earlobe
up and back for adults (down and back for
children).
 Instill the prescribed number of drops into the
ear cavity.
 Make sure the dropper does not touch the ear
or any other surface. Keep the ear tilted for a
few minutes to ensure the medication is
absorbed (or a cotton plug may be used to

7. DIRECTION OF ADMINISTRATION:

8. EAR DROP
 Instructions: For Aural Use Only, Not For Injection.
 Storage: Keep the container tightly closed, and store
at room temperature away from direct heat, light and
moisture. Discard 4 weeks after opening.
 Containers: Ear drops are packed in coloured, fluted
glass bottles with a dropper in the cap or plastic
squeeze bottle.
 Marketed Preparations: Ciplox (Cipla), Cioxan
(Alcon), Waxsol Ear Drops (Norgine).

9. PRACTICAL EXPERIMENT:
CHIORAMPHENICOL EAR DROPS BP
Sr NO Ingredient Master formula Use/Category
1 Chloramphenicol BP 5% Antibacterial
antibiotic
2 Propylene Glycol QS 100% Vehicle and softening
agent
Procedure:
1. Weigh required quantity of Chioramphenicol and dissolve it in propylene Glycol
2. Heat to dissolve the drug if necessary.
3 Make up volume with propylene glycol and transfer the solution in a suitable
container.
Storage: It is stored in well closed container with cap and protect it from light.
Precaution: Discard 4 weeks after opening.
Directions: For Aural Use Only, NOT FOR INJECTION.
Dose: Put 2-3 drops in an infected ear.

10. NASAL PREPARATIONS:
 ‘The different Nasal Preparations are Nasal
Drops, Nasal Spray, Nasal Gel.
 Nasal Drops or sprays are aqueous or liquid
paraffin solutions meant for instill into the
nostrils

11. NASAL DROPS
 Nasal drops must be Isotonic, and slightly
buffered. They should not affect mucous
viscosity, normal cilliary movement.
 Nasal drops are used to treat nasal
decongestion, nasal infection and inflammation.
Now a day’s nasal route is used to target drugs
into the brain,
 Vehicle used for formulating nasal drops should
have Optimum pH (= nasal mucosa pH),
Isotonic and Non-Irritating

12.  Nasal solutions prepared so that they are similar In
many respects to nasal Secretions in regards to
toxicity, pH and viscosity.
 The nasal preparations must not interfere with the
cleansing action of the epithelial cilia of nasal
mucosa.
 Nasal drops should he isotonic with 0.9% Sodium
chloride having neutral pH and viscosity similar to
nasal secretions by using 0.5% Methyl cellulose.
 The buffering capacity of nasal mucosa is quite low
and strong alkali solution can cause considerable
damage to cilia. To prevent this, it is advisable to us
buffer of pH 6.5 as a vehicle.
NASAL DROPS

13. DIRECTION OF ADMINISTRATION:

14.  Tilt your head as far back as possible, or lie
down on your back on a flat surface (such as
a bed) and hang your head over the edge.
 Place the correct number of drops into each
nostril without touching the dropper to nostril.
(Do not touch the tip of dropper)Remain in
this position for a few minutes. Clean the
dropper after use.
DIRECTION OF ADMINISTRATION:

15.  Instructions: For Nasal Use Only, Do not touch the tip
of the dropper or squeeze bottle.
 Storage: Keep the container tightly closed, and store
at room temperature away from direct heat, light and
moisture. Discard 4 weeks after opening.
 Containers: nasal drops arc supplied in multi-dose or’
single-dose containers in colored fluted glass bottle
with dropper or in plastic squeeze bottle.
 Marketed Preparations: Otrivin (Novartis), Sinex
(P&G), Nasivion (Merk)
DIRECTION OF ADMINISTRATION:

16. PRACTICAL EXPERIMENT:
EPHEDRINE HYDROCHLORIDE NASAL DROP
Sr No Ingredient Master Formula Use/Category
1 Ephedrin HCL 0.5gm Nasal decongestant
2 Chlorobutanol 0.5gm Preservative
3 Sodium Chloride 0.5gm Isotonicity Agent
4 Water 100ml Vehicle
Procedure:
1. Weight finely powdered Chlorobutanol and dissolve it in half
the quantity of water. Heat if required to dissolve at a
temperature of 60 -70°C.
2. Then add remaining ingredients and make up the volume.
3. Filter the preparation if necessary and transfer it in a suitable
container.
4. Label it properly and submit it.

17.  Storage: Keep away from light.
Store in colour fluted bottle with dropper or in
plastic sequence bottle.
Store in well closed container. For external use
only.
 Precaution: Replace the cap tightly after use
 Dose: Instill 2 to 3 drops in each nostril
repeat 2 to 3 times in a day. .
 Use: Nasal Decongestant
PRACTICAL EXPERIMENT:
EPHEDRINE HYDROCHLORIDE NASAL DROP

18. THROAT PAINTS:
 Throat paints are viscous liquid preparations
used for throat infections.
 These are usually applied to pharynx.
 In such preparations glycerin is used as a
vehicle for prolonged action and adhesion to the
mucous membrane, hence these preparations
comes under the type of preparation called
glycerides.
 These are used as an analgesic in the treatment
of tonsillitis, mouth ulcers etc.
 Glycerin is commonly used as a base in throat
paints because it is viscous; it adheres to
mucous membrane for long period, it has sweet
taste and humectants property

19.  Direction of application: Apply with the help of soft brush
or a cotton swab. Food and Water before and after
application of throat paint, should be avoided for 1 hour
 Labeling instructions: For local application, Store in a cool
place, shake the bottle before Use, not to be swallowed in
large amount
 Examples of Throat Paints:
 Phenol glycerin (diluted with equal volume of glycerin to
reduce its causticity) Produce analgesic effect in tonsillitis
and ulcerative stomatitis.
 Tannic acid Glycerin, has astringent action, relieves from
sore throat

20. COMPOUND IODINE PAINT(MANDL’S PAINT)
Sr No Ingredient Master Formula
1 Potassium Iodide 25gm
2 Iodine 12.5gm
3 Alcohol 90% 40ml
4 Water 25ml
5 Peppermint oil 4ml
6 Glycerol QS 1000ml
Method of preparation:
1. Dissolve potassium iodide in water. Add iodine and stir until it completely
dissolved.
2. Dissolved peppermint oil in alcohol 90% in small container. Transferred it to
iodine solution. Mix well.
3. Add glycerine and mix thoroughly
4. Make up volume with glycerine.
The container must be wide mouthed and is necessary to confirm that the patient
has a throat brush.

21. FORMULATION ASPECTS
Ear Drops
• Excipients
• Method of
preparation
Nasal Drops
• Excipients
• Method of
preparation
Throat Paint
• Excipients
• Method of
preparation

22. METHOD OF PREPARATION :
EAR DROPS, NASAL DROPS AND PAINTS
1. Simple solution
2. Solution by chemical reaction
3. Solution by extraction
4. Solution with heat

23. EALUATUION OF ENT PREPARATIONS
IPQC
• Organoleptic Evaluation
• Specific Gravity
• Density
• pH
• Clarity
• Bulk drug content
• Viscosity
Finished Product
• Organoleptic Evaluation
• Specific Gravity
• Density
• pH
• Clarity
• FP drug content
• Viscosity
• Leak Test

24. Thank
You