Emelda, M.Farm.,Apt.

“These are the solution used

for instillation in to ear”
 OTIC PREPARATION
 Otic Preparation are also known as
aural/ear Preparations
 Mostly they are used for local
therapeutic effects
 Otic preparation are most
commonly available in solution
form, whereas suspensions and
ointments have less applications
 Ear preparation are usually placed in the ear canal to
remove cerumen
 They are also used for treatment of ear infections,
inflammation or pain
 They are categorized as :
- Cerumenolytic preparations
- Anti infective preparations
- Anti inflammatory
- Analgesic
What is cerumen
 Cerumen is the combination of the
secretions of the Sweat & Sebaceus glands
and of The External auditory canal
 I f t hese secret ions are n o t re m o v e d
periodically they get dry and compact,
sticky mass that holds dead epithelial cells,
fallen hairs, dust, and other contaminants
 Excessive accumulation of cerumen may
cause itching, pain, inflammation and
impared hearing
Cerumen-removing solutions
 Traditional Methods
Traditional methods have long been used
including : use of light mineral oil,
vegetable oils, hydrogen peroxide
 Chemical methods
D i ff e r e n t p h a r m a c e u t i c a l s o l u t i o n s
containing surfactant are used as
cerumenolytic preparations :
Tr ie t h a n o la m in e p o lyp e p t id e o le a t e
condensate
 Solution ex 10% sodium bicarbonate,
3% Hydrogen peroxide, 2% Acetic Acid
and a combination of 0,5% aluminium
acetate and 0,03% benzethonium
chloride, used to remove cerumen
 Debro : Ear drop containing Carbamide
peroxide
Ear Drop Formulation
 Ear Drop
Ear drop Are form of medicine used to
treat of prevent ear infections, especially
infections of the outer ear and ear canal
(Otitis externa)
 They may be available in solution or
suspension form
Solvent of Otic Preparations
 Anhydrous Glycerin, Propylene glycol
are used as main solvent
 Being anhydrous/hygroscopic in nature
they absorb the moisture from the
inflamed area thus relieve the
inflammation
 Propylene glycol emulsifiers the
cerumen thus facilitate its expulsion
Anti Infective Agents
 Topical use of certain anti infective
agents such as Chloramphenicol,
colistin sulfate, Neomycin, Polymyxin B
sulfate in ear preparations.
 These agents are formulated as Ear
Drops in anhydrous glycerin, propylene
gycol
 Nystatin (a well known antifungal agent)
is also formulated to suppress ear
fungal infection, in the form of ear drops
Analgesic
 When pain is associated with ear
infection, certain commercial products
are available in combination with anti-
infective and analgesic
 Example : Antipyrin (Analgesic);
lidocaine, Benzocaine (Local anasthetic)
Anti-Inflammatory Agents
 In order to treat inflammatory condition
Hydrocortisone; dexamethasone sodium
phospate (steroids) are used
 Combination Therapy : Sometimes a
combination of orally administered anti-
infective & topical anti infective used for
specific time Ex: fungal infection
 Some preparations are used for their
dual use, such as Eye and Ear drops
 Packaging : 5-15 ml glass or plastic
container with dropper is usually
available
Otitis Externa
 Otitis externa (also known as “External
otitis” and “Swimmer’s ear”) is an
inflammation of the outer ear/ear canal
associated with pain
 Inflammation may be due to
bacterial/fungal infection and sometimes
inflammation is not associated with
infection but with eczema
 A Combination of antibiotic-steroid is
best for the treatment of otitis externa
Commercial Products
 Corticosporin otic Solution – contain
polymixin B (10.000 U), neomycin (3,5 mg),
Hydrocortisone (10 mg/ml)
 Gentamycin 0,3% -- contains gentamycin 3
mg/ml
 Coly-Mycin Otic Solution – Colistin Sulfate
3 mg/ml, hydrocortisone 10 mg/ml,
neomycin (3,3 mg)
 Chloramphenicol otic Solution
(Chloromycetin 0,5%, also contains
propylene glycol)
 Ciprode ear drops (Containing
Ciprofloacin and dexamethasone)
 Ciproxin HC ear drops (Containing
Ciprofloacin and Hydrocortisone)
 Gentisone HC ear drops (Containing
Gentamicin and Hydrocortisone)
 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
Use of Ear Drop
 Antibacterial
 Softening the wax
 Mild Infections
Example
Sodium bicarbonate ear drop
R/
Sodium bicarbonate 5g
Glycerin 30 ml
Purified Water up to 100 ml
Prepare ear drop, Send 30 ml
Direction :
Place 2-3 drop in each ear as directed
Storage & Labelling
Container :
§ Ear drop should be packed in colored,
fluted glass bottle and supplied with
dropper
Labelling :
§ For External use Only
§ Not For Injection
§ Doscontinue the use of irritation Persist
Storage :
§ Throat paints are supplied in well closed
glass container in cool place
Composition of ear drops
 Active ingredients
 Vehicle
 Anti microbial preservatives
 Adjuvant
 Suitable container for administration
Ear drops should posses
following properties
 Foreign Particles
 Sterility
 pH
 Tonicity
 Viscosity
 Surface Activity
Foreign particles
All products should be clear and free
from :
- Foreign Particles, Fibers and Filaments
- These solutions should be clarified very
carefully by passing through bacteria
proof filters such as membrane filters,
sintered glass filter
Sterility
Tonicity
Surface Activity