Lab 19: USP 797 Compounding of an Ointment

Lab 19: USP 797 Compounding an Ointment

Learning Objective

18.0 Initiate measurement and calculating techniques as it relates to United States Pharmacopeia (USP) 797 (non-sterile) compounding in

pharmacy practice. -- Students will be able to:

1.0 Identify Common Pharmaceutical Laboratory Equipment

2.0 Define the terminology relating to the non-sterile ointment compounding procedures.

3.0 Demonstrate the technique of preparing an ointment.

4.0 Explain/assist in process of trituration/levigation/spatulation/and geometric dilution.

Terminology

Cream (aka cr.)

Pharmaceutical preparations that combine oil with water, and are usually used topically.

Examples of Cream Base:
Eucerin ; Aquaphor; Dermabase

Terminology

Ointment (oint./ung.)

A highly viscous or semisolid substance used on the skin that may be referred to as an emollient or a salve.

Examples of Ointment Base:

Mineral Oil; Petroleum Jelly; Coal tar

Cream Chemistry

Water-based semisolid.

• Mixed with aqueous liquid (water)

• Skin readily absorbs water through diffusion.

• Quick and short acting way of delivering medication.

Ointment Chemistry

Oil-based semisolid.

• Mixed with non-soluble liquid (oil/fats)

• Creates a hydrophobic barrier on the skin.

• Useful for sustained release of medication or a skin protectant.

Multiple Choice

Cream or Ointment?

Quick delivery of medication.

• Cream

• Ointment

Multiple Choice

Cream or Ointment?

Skin protectant

• Cream

• Ointment

Multiple Choice

Cream or Ointment?

Coal Tar

• Cream

• Ointment

Multiple Choice

Cream or Ointment?

Mineral Oil

• Cream

• Ointment

Multiple Choice

Cream or Ointment?

Aquaphor

• Cream

• Ointment

Terminology

Trituration (n.)

Continuous rubbing or grinding powder utilizing a mortar and pestle.

Purpose: Reduce Particle Size

Mix Powders and Semisolids

Terminology

Spatulation (n.)

Mix powders or semisolids on an ointment pad or slab using a spatula.

Purpose: Reduce Particle Size

Mix Powders and Semisolids

Terminology

Levigation (n.)

Wetting a solid with a small quantity of a non-soluble liquid.

Purpose: Reduce Particle Size

Transform a solid into a
semisolid formulation.

Terminology

Geometric dilution (n.)

Pharmaceutical process that thoroughly mixes the appropriate amount of drug with diluent due to proportion.
Purpose: Combining ingredients into a homogeneous mixture.

Terminology

Comminution (n.)

The process of reducing a material into fragments or particles.

Terminology

Emulsifier (n.)

A substance that stabilizes a mixture of two immiscible substances.

Materials Required for the Lab today...

​​Electronic Balance

Mortar and Pestle

​​Weigh Paper

Compounding Spatula

Ointment Slab / Parchment Paper

Polysorbate 80 (Emulsifier)

Ointment Jar

Ointment Base

White tablets

According to USP 797 regulations...

Non-sterile compounding of any semisolid requires proper handwashing and glove protection​.

PPE WARNING!

Laboratory Procedure (As demonstrated and read aloud...)

What is the purpose of an emulsifier?

What is the difference between communition, trituration, levigation, spatulation, and geometric dilution?

How do I clean up?