Unit Ointment
Unit Ointment
Unit Ointment
By
Qusro Bin Hassan
B.Pharm, M.Pharm
Learning outcomes:
Define ointment and classify different types of ointment bases.
Explain different types of ointment bases.
Properties of ointment bases.
Characteristics of ointment bases.
Selection of the appropriate base.
Evaluation of ointments
Requirement for ointments.
Precutaneous Absorption.
Factors influencing absorption through skin.
Describe the different methods of preparation of ointments.
Explain briefly about storage and containers of ointments.
Labeling and advice for ointments during dispensing.
Test requirements for ointments
Official examples of ointments.
Application of ointments.
Definition
An ointment is a viscous, homogeneous, semisolid
preparation intended for externally as well as topically on a
variety of body surfaces. These include the skin and the
mucous membranes of the eye (an eye ointment), vagina, anus,
and nose. An ointment may or may not be medicated, and they
are easily spread.
Ointments intended for application to large open wounds
should be sterile.
They are used as emollients or for the application of active
ingredients to the skin for protective, therapeutic, or
prophylactic purposes.
Types Of Ointments
1. Medicated - those with medicaments for
treatments of cutaneous (skin diseases).
Examples: Sulfur Ointment, Zinc Oxide
Ointment and Compound Resorcinol
Stability
Penetrability
Solvent property
Irritant effects
Ease of application and removal.
Evaluation of ointments
Drug content
Release of medicament from base
Medicament penetration
Consistency of the preparation
Absorption of medicament into blood stream
Irritant effect.
Requirement for ointments
Microbial content: do not need to be sterile, but must
meet the FDA requirement of the test for absence of
bacteria such as S. areus and P. aeruginosa for
dermatological products.
Minimum fill:
Packaging, storage, labeling: (label should include the
type of base used)
Additional standards: viscosity, in vitro release
Percutaneous Absorption
The skin offers greater
resistance to penetration by
drug substance than mucous
membrane because of high
amount of keratin in skin
than mucous membrane.
Drugs may diffuse through
the skin by three different
routes:
Hair follicle region,
Sweat gland,
Stratum corneum.
Factors influencing absorption through skin
2. With cap of the tube off to permit escape of air, the cylinder of
ointment with the paper is inserted into the open bottom of the tube
4. About 1/8 folds are made from the flattened end of the tube and
sealed by pliers or sealing clip on foot operated “crimper” machine.
Note: Ointments made by fusion may be poured directly into the tubes.
Stored at temperatures below 30oC to prevent softening.
labeling
To be applied to the affected parts as directed.
To be rubbed into the shoulder when required.
To be rubbed into the affected area.
To be rubbed gently into the affected area.
To be applied to skin or mucous membrane as
instructed.
TESTS REQUIREMENTS FOR
OINTMENTS
Microbial Content
Meet acceptable standard for microbial
Must contain antimicrobial preservatives
Preservatives: Methylparaben, propyl paraben,
phenols, benzoic acid, sorbic, quaternary
ammonium salts
Example: Betamethasone Valerate Ointment –
must be absence of Staphylococcus aureus and
Pseudomonas aeriginosa
TESTS REQUIREMENTS FOR
OINTMENTS
Minimum Fill Test – net weight and volume
Packaging, Storage, and Labeling – metal, plastic tubes, jar
Well close containers, light sensitive, light resistant
Labeling- type of base used (water soluble or insoluble)
Additional Standards
Examine the viscosity
Vitro drug release to ensure within lot and lot-to-lot
uniformity
Official examples
Salicylic Acid ointment B.P.
Ichthammol ointment B.P.C.
Calamine and Coal Tar ointment B.P.C.
Zinc and Castor Oil ointment B.P.
Methyl Salicylate ointment B.P.C.
Applications
To protect skin or mucous membrane and to
permit rejuvenation of the tissue.
To provide hydration of the skin or an
emollient effect.
To provide a vehicle for applying a medication
either for local or systemic effect e.g. local-
topical antibiotic; systemic-nitroglycerin
ointment for angina.
Sulphur ointment: To treat acne and scabies.
Methyl salicylate ointment: As rubefacient.