This ppt covers only the part of Parenterals i.e.,Physiological and Formulation considerations for Parenterals.

1. PARENTERALS
SMALL VOLUME PARENTERALS &
LARGE VOLUME PARENTERALS
 Siddu K M
 M Pharm 1st Year
 Department of Pharmaceutics
 Al-Ameen College of Pharmacy.

2. Definition:
• These are the preparations intended for injection through the
skin or other external boundary tissue, rather than through
the alimentary canal, so that the active substances they
contain are administered using gravity or force directly into a
blood vessel, organ, or tissue.
• The term parenteral is derived from two Greek words.
• Para = Outside
• Enteron = Intestine

3. Different parenteral routes:
1. Intravenous
2. Intramuscular
3. Subcutaneous
4. Intradermal
5. Intra arterial
6. Intra cardiac
7. Intrathecal
8. Intracerebral

4. Advantages:
• Useful for patients who cannot take drugs orally.
• Rapid onset of action
• Useful in emergency situations
• Avoid first pass metabolism
• Can inject drug directly into a tissue(targeted drug delivery)
• Useful for delivering fluids, electrolytes or nutrients.
• Complete bioavailability.

5. Disadvantages:
• Pain on injection
• Difficult to reverse an administered drug effect.
• Sensitivity or allergic reaction at the site of injection.
• Trained person is required.
• More expensive compared to other dosage forms.
• Require specialised equipment, devices and techniques to
prepare and administer the drugs.

6. Classification :
1. Small Volume Parenterals:
An injection that is packed in containers labelled as
containing 100 mL or less
2. Large volume Parenterals
Parenterals that are designed to provide Fluid, calories,
electrolytes or combination of these.
Volume is 100- 1000 mL

7. Physiological considerations:
 pH : the pH of the preparation should be close to the physiological
pH.
All products must be sterile.
All products must be free from pyrogenic contamination.
Products must be isotonic
Injectable solutions must be free from visible particulate matter.

8. Formulation considerations:
 If the route of administration must be intravenous, then only
solutions or micro emulsions can be the dosage form.
 If the route of administration is subcutaneous or
intramuscular, then the likely type of dosage form is a
suspension.
If the drug is insufficiently soluble in water at the required
dosage, then the formulation must contain a co-solvent or a
solute that sufficiently increases and maintains the drug in
solution.

9.  If the drug has significant degradation problems in solution,
then a freeze-dried or other sterile solid dosage form must be
developed.

10. THANK YOU