ointment

Question 1

• Intended for the skin and mucous membrane
• typically simple mixtures of drug substances in an ointment base
• Contains
• Less than 20% water and
• More than 50% hydrocarbons, waxes, or polyphenols as vehicles

Answer 1

OINTMENT

Question 2

Types of Ointments (2)

Answer 2

1. unmedicated ointments
2. medicated ointments

Question 3

_______________

• Used for the physical effects they provide
• Mostly local effects

a. __________
b. __________
c. __________

examples:
- ____________
- ____________
- ____________

Answer 3

1. Unmedicated Ointments

a. Protectants
b. Emollients
c. Lubricants

examples:
- zinc oxide + calamine (calmoseptine)
- aquaphor
- refresh

Question 4

______________

• One or more active medicinal ingredients
• Can either be locally or systemically

examples:
- ___________
- ___________

Answer 4

2. Medicated Ointments

ex:
- betadine
- fusidate sodium

Question 4

ointment bases (4)

Answer 4

1. oleaginous bases (hydrocarbon bases)
2. absorption bases
3. water-removable bases
4. water-soluble bases

Question 4

________________

• Determines the preparation’s properties
• Generally classified by the USP into four groups

1. _____________
2. _____________
3. _____________
4. _____________

Answer 4

• ointment bases

1. Oleaginous bases
2. Absorption bases
3. Water-Removal bases
   4.Water-Soluble bases

Question 4

Use: Emollient effects; effective as occlusive dressings

Properties: Immiscible to water, can be incorporated with water in small amounts

Examples:
· ___________
· ___________
· ___________
* ___________

Answer 4

1. Oleaginous bases (Hydrocarbon bases)

· Petrolatum
· White Petrolatum
· Yellow Ointment
* White Ointment

Question 4

Use: Incorporation of small volume of water in hydrocarbons

Properties: Less occlusive than oleaginous bases but can be used as emollients

Examples:
* ____________
* ____________

Answer 4

2. Absorption bases

Examples:
* Hydrophilic petrolatum
* Lanolin

type A
type B

Question 4

• Permit the incorporation of aqueous solutions
• Formation of water-in-oil (W/O) emulsions

ex.
- ___________
- ___________

Answer 4

a. Type A

• hydrophilic petrolatum
• aquaphor

Question 4

· Is already a w/o emulsion
· Allows incorporation of additional aqueous solution

ex
- ____________

Answer 4

b. Type B

• grades of lanolin

Question 5

Properties:
* Oil-in-water(O/W) emulsions, commonly called _________
* External phase is aqueous
* They are easily washed from skin
* Water-washable bases

Examples:
· ______________

Answer 5

3. Water-Removable bases
- creams

Examples:
· Hydrophilic ointment

Question 5

Properties;
* They are entirely water-washable
* Softens significantly upon addition of water
* Contains high molecular weight PEG
* Contain NO oleaginous components

Examples:
* _______________

Answer 5

4. Water-Soluble bases

Examples:
* Polyethylene Glycol Ointment

Question 6

Selection of Appropriate Base

• The desired rate of drug release from the base
• The desirability of topical or percutaneous drug absorption
• The desirability of occlusion of moisture from the skin

· The stability of the drug in the ointment base

Answer 6

· The effect of the drug on the base’s consistency or features
* The desire for a base that is easily removed by washing with water

• The characteristics of the surface to which it is applied (e.g. ointment is generally applied to dry, scaly skin)

Question 6

preparation of ointment (2)

Answer 6

1. incorporation
   a. levigation
   b. incorporation of liquids
   c. milling
2. fusion

Question 6

• Components are mixed until a uniform preparation is attained
• Often using a mortar and pestle or a spatula on an ointment slab

a. Levigation
b. Incorporation of Liquids
c. Milling

Answer 6

1. Incorporation

a. Levigation
b. Incorporation of Liquids
c. Milling

Question 6

· To reduce the particle size of powdered or crystalline material and prevent grittiness

*The solid material is mixed in an insoluble vehicle (a levigating agent) to create a smooth dispersion

Answer 6

a. legivation

Question 7

• Only very small amounts of aqueous solution can be added to oleaginous ointments
• Hydrophilic bases accept aqueous solutions more readily

Answer 7

b. Incorporation of liquids

Question 7

• can be used to force coarsely formed ointments through rollers to ensure a smooth texture and uniform composition

Answer 7

c. Milling

Question 8

• All or some components are melted together, cooled, and constantly stirred until congealed
• Used for medicated ointments and bases containing components like beeswax, paraffin, stearyl alcohol, and high molecular weight PEGS
• Heat labile and volatile components are added last

Answer 8

2. Fusion

Question 8

• For emulsion bases, melting and emulsification steps are used

1. Heating the water-immiscible and aqueous components SEPARATELY to the SAME temperature (___°C to ___°C)
2. Slowly adding the aqueous solution to the oleaginous mixture with ________ stirring

Answer 8

• 70°C to 75°C
• mechanical

Question 8

Compendial Requirements and Packaging

USP Requirements: (4)

Answer 8

1. Microbial Content
2. Minimum Fill
3. Packaging, Storage, and Labeling
4. Additional Standards

Question 8

______________

• Topical ointments (except __________ preparations) are NOT required to be sterile
• Preparations containing water are more prone to microbial growth
• Dermatologic ointments should specifically be examined for __________ and __________

Answer 8

1. Microbial Content

• ophthalmic
• Pseudomonas aeruginos
• Staphylococcus aureus

Question 8

• Determination of the net weight or volume of the contents

Answer 8

2. Minimum Fill

Question 8

• Packaged in _______, _______, or _______
• For ophthalmic, nasal, vaginal, and rectal → Mostly packaged in ______ or ______
• Well-closed containers
• Cool place

Answer 8

3. Packaging, Storage, and Labeling

• jars, metal, or plastic tubes
• tubes or syringes

Question 9

4. Additional Standards * _______ test * In-vitro drug release profile (________ cell studies) For Ophthalmic Products: o Test for ___________

Answer 9

- Viscosity - Diffusion - metal particles