1. OPHTALMIC, NASAL & OTIC PREPARATIONS
Ms. RIFFAT YASMIN

2. Contents
Ear Preparations:
Anti infective
Anti inflammatory
Analgesics

3. Learning objectives Discus the Otic preparations
Categories the Otic preparations & their Uses
Determine about Cerumen and its removal methods
Discuss the Ear drops Formulation
Interpret the Solvents used in Otic preparations
Briefly discuss Otitis Externa and its treatment
Enlist the commercially available products

4. OTIC PREPARATIONS Otic preparations are also known as Aural / Ear
Mostly they are used for Local therapeutic effects.
Otic preparations are most commonly available in solutions form, whereas suspensions and ointments have less applications.

5. Uses of Otic Preparations
Ear preparations are usually placed in the ear canal to remove Cerumen ……?
They are also used for the treatment of ear infections, inflammation or pain.
They are categorized as:
Cerumenolytic preparations
Anti-infective preparations
Anti-inflammatory
Analgesic

6. What is Cerumen?

7. Answer.
Cerumen is the combination of the secretions of the Sweat & Sebaceous glands and of the External auditory canal.
If these secretions are not removed 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 impaired hearing.

9. Cerumen-Removing Solutions
Traditional methods: Traditional methods have long been used including: use of light mineral oil, vegetable oils, hydrogen peroxide.
Chemical methods: Different pharmaceutical solutions containing surfactant are used as Cerumenolytic preparations. e.g. Triethanolamine polypeptide oleate condensate.

10. Contd.
Solutions e.g. 10% Sodium bicarbonate, 3% Hydrogen peroxide, 2% Acetic acid, and a combination of 0.5% aluminum acetate and .03% benzethonium chloride, used to remove cerumen.
Debrox: Ear drops containing
Carbamide peroxide

11. Ear Drops Formulation.
Ear drops: Are forms of medicine used to treat or
prevent ear infections, especially infections of the
Outer ear and ear canal
(Otitis externa).
They may be available in
solution or suspension form.

12. 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 emulsifies the cerumen thus facilitate its expulsion.

13. 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 glycol.
Nystatin (a well known antifungal agent) is also formulated to suppress ear fungal infection, in the form of ear drops.

14. Analgesic
When pain is associated with ear infection, certain commercial products are available in combination with anti-infective and analgesics.
Examples : Antipyrine (analgesic); Lidocaine, Benzocaine (local anesthetic).

15. Anti-inflammatory Agents
In order to treat inflammatory condition, Hydrocortisone; Dexamethasone sodium phosphate (Steroids) are used.

16. Contd.
Combination therapy: Sometimes a combination of orally administered anti-infective & topical anti-infective is used for specific time. e.g Fungal infection.
Some preparations are used for their dual use, such as Eye and Ear drops.
Packaging: 5-15mL glass or plastic container with dropper is usually available.

17. 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.

19. Commercial products
Corticosporin otic solution -- contains polymyxin 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 3mg/ml, hydrocortisone 10 mg/ml, neomycin (3.3 mg)
Chloramphenicol otic solution (Chloromycetin, 0.5%, also contains propylene glycol)

20. Contd. Ciprodex ear drops (containing Ciprofloxacin and dexamethasone)
Ciproxin HC ear drops (containing ciprofloxacin and hydrocortisone)
Gentisone HC ear drops (containing Gentamicin and hydrocortisone)

21. THANK YOU

22. Reference:
Ansel’s: Pharmaceutical Dosage Forms & Drug Delivery Systems (8th Ed): by Howard C. Ansel Chapter: 17, pp:
inter science.com