otic preprations

1. OTIC
PREPRATIONS

2. >Introduction
>Otic Soutions
>Otic Suspension
>Otic Drops
>Anti-infective, anti-inflammation and analgesic ear
preprations
>Preservatives
>Packaging
>Uses
CONTENTS

3. INTRODUCTION

4. • The waxy material of the ear is called
cerumen, or commonly known as ear wax
• Cerumen is formed from the combination
of the oily secretions from the exocrine
glands with fatty fluid from the apocrine
glands in the external auditory canal.
Ear Wax

5. • Otic prepartions sometimes referred to as
ear or aural preparations
• Solutions are most frequently used in the
ear, with suspensions and ointments also
finding some applications.
• Ear preparations are usually placed in the
ear canal by drops in small amount for
removal of excessive cerumen or for
treatment of ear infection, inflammations or
pain.
Otic Preparations

6. • Excessive accumulation of cerumen in the
ear may cause itching, pain, and impaired
hearing.
• Through the years, light mineral oil,
vegetable oils, hydrogen peroxide have
been used to soften the impacted cerumen
for its removal.
• Recently, solutions of synthetic surfactants
have been developed for their ability to
remove earwax.
Cerumen Removing Preparation

7. • Anhydrous Glycerin, Propylene glycol
are used as main solvents.
• Being anhydrous/ hygroscopic in nature
they absorb the moisture from the
inflamed area thus relieve the
inflammations.
• Propylene glycol emulsifies the cerumen
thus facilitate its explusion.
Solvents

8. Cerumen removal usually involves placing
the otic solutions in the ear canal with the
patient’s head tilled at a 45° angle, inserting
a cotton plug to retain the medication in the
ear for 15 to 30 minutues, followed for
gentle fushing of the ear canal with
lukewarm water using a soft rubber ear
cyringe.
Cerumen removing method

9. • Propane glycol is used to emulsify the
cerumen to facilitate its removal.
• Carbamide peroxide in glycerin or
propylene glycol release oxygen on contact
with cerumen which disrupts the integrity
of impacted wax allowing its easy removal.
Examples of Otic Solutions

10. OTIC SUSPENSIONS

11. Subtle difference in the formulation of otic
suspension may be bothersome to the patient.
This is so especially as it relates to difference in
inactive or inert ingredients that are considered
equivalent on the basis of active ingredients and
strength. E.g Several suspension and
combinations of polymyxin B sulfate, neomycin
sulfate, and hydrocortisone have been shown to
be more acidic at Ph 3.0 to 3.5 than the standard
product, Cortisporin TC otic, whose Ph 4.8 TO 5.1
Otic suspensions

12. Consequently there is a risk that when drops
are legally substituted, a burning and
stinging sensation can occur when the drops
are introduced into the ear of young
children, especially those with
tympanostomies. It has been demonstrated
that with time, the pH of these formulations,
including Cortisporin, becomes more acidic,
possibly pH 3.0 canal on later use.

13. PedOtic suspension
• Manufacturer ; Glaxo wellcome
• Active ingredient; Polymyxin B sulfate, neomycin
sulfate, hydrocortisone
• Vehicle; Mineral oil, propylene glycol, water for
injection
• Use; Superficial bacterial infection
Example

14. OTIC DROPS

15. Some eardrops by virtue of their low pH may
cause stinging upon administration. Parents
and children should be
forewarned,especially if a child has
tympanostomy tubes in the ear. The patient
should also understand how long to use the
product. For antibiotic eardrops it is not
necessary to finish the entire bottle, because
therapy could last 20 to 30 days, depending
upon the dosage regimen.
Otic Drops

16. • Patient should be instructed to continue
using the drops for 3 days after symptoms
disappear. Product for otitis externa may take
up to 7 to 10 days to demonstrate efficay.
• If a child prone to develope ear infection as a
result of swimming and showering, it might
be advisible to recommend the parents to
consult a physician for prophylactic
medication to use during swimming and
consider using ear plugs that fit snugly in the
ear when swimming or shovering.

17. Debrox drops
• Active ingredients; Carbamide peroxide
• Vehicle; Anhydrous glycerin
• Use; Earwax removal
Example

18. ANTI-INFECTIVE, ANTI-
INFLAMATION AND ANALGESIC
EAR PREPRATIONS

19. Anti infective preparation
Topical use of anti infective agents such as
Chloramphenicol, Colistin sulfate, neomycin,
polymyxin B sulfate in ear preparation.
These agents are formulated as ear drops in
anhydrous glycerin, propylene glycol.
Nystatin [ awell known antifungal agent] is
also formulated to suppress ear fungal
infection, in the form of ear drops.
Anti infective, anti inflammation,
and analgesic Ear Preparations

20. Analgesic preparation
When pain is associated with ear infection,
certain commerical products are available in
combination with anti infective and
analgesics.
Examples ; Antipyine (analgesic),
Lidocaine, Benzocaine (local anesthetic)

21. Anti inflammatory preparation
Liquid ear preparation of anti inflammatory
agents hydrocortisone and dexamethasone
sodium phosphate are prescribed for their
effects against the swelling and inflammation
that frequently accompany allergic and
irritative manifestations of the ear.

22. Extemporaneous preparation
Pharmacist may also be called on
extempraneous preparation of a solution of
acetic acid 2% to 2.5% in rubbing alcohol
(70% isopropyl alcohol or ethanol ),
propylene glycol, or anhydrous glycerin. The
source of acetic acid can be glacial acetic
acid, USP, or Acetic acid NF, Boric acid 2%
to 5% dissolvedin either ethanol or
propylene glycol has also recommanded.

23. Some otic preparations require
preservatives. The commonly used
preservatives;
Chlorobutanol (0.5%)
Thimerosal (0.01%)
And various combinations of parabeans.
Preservatives

24. Otic preparations are mostly packed in
small glass or plastic containers with
dropper.
Packaging

25. • Ear preparation are usually placed in the
ear canal to remove Cerumen.
• They are also used for the treatment of ear
infection, inflammation or pain.
• They are categorized as;
– Cerumenolytic preparations
– Anti infective preparations
– Anti inflammatory
– Analgesic
Uses