Page 4 - FAR 222 Laboratory Manual V2 2019

FAR 222 Dosage Form II Laboratory Manual

2 INTRODUCTION TO STERILE PHARMACEUTICAL

AND MEDICAL PRODUCTS

There are a variety of pharmaceutical and medical products which must be presented for use
in a sterile form:

• injections and intravenous infusions
• eye drops, lotions and ointments
• some topical preparations
• irrigation solutions
• surgical dressings
• sutures
• medical instruments and some other items of medical equipment
• total parenteral nutrition fluids
• some radio pharmaceuticals
• peritoneal dialysis solutions

However, the majority of sterile products encountered in practice will comprise injections and
ophthalmic products. These two types of products are covered in this course.

INJECTIONS

Injections or parenteral products are aqueous or non-aqueous solutions, suspensions or
emulsions. The term parenteral means ‘outside of the intestine’ i.e. bypassing the enteral (oral)
route. It is commonly used to describe administration by injection, infusion or implantation,
through the skin, into body fluids, tissues or organs.

Common dosage forms/types of injection are:

• solutions (aqueous or oily)
• suspensions (aqueous or oily)
• freeze dried solids (for subsequent solution or suspension)
• solids (implants)
• emulsions

Formulation of injections

The basic principle in assessing an injection covered in the lectures of this course are highly
relevant, especially the formulation variables which must be considered when formulating a
parenteral product. Injections are generally simple solutions, suspensions and emulsions. In
formulating such products, the aspects of liquid dosage form preparation covered in FAR 122
Dosage Form I is important. For instance, the control of solubility, inclusion of excipients such

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