parenterals, injectables, sterile dosage forms, pyrogens, sterilization, sterilization by membrane filtration autoclave, parenteral routes

1. Chapter 14:
STERILE DOSAGE FORMS
Parenterals
Biologicals
Irrigation Fluids
Dialysis Solutions
Pellets or Implants
Ophthalmic Preparations
By:
Asst. Prof. Ma. Lourdes L. Mojares, R. Ph.
CEU School of Pharmacy
Manila

2. INJECTIONS / INJECTABLES
Sterile, pyrogen-free preparations
intended to be administered
parenterally..
PARENTERAL – refers to
injectable routes of administration.
A route of administration OTHER
THAN the oral route.

3. PARENTERALS
CONSIDERATIONS inCOMPOUNDING:
1. Sterile
2. Pyrogen free
3. Isotonic
4. Prepared in environmentally controlled
area
5. Packaged in special hermetic container
6. Use of colorants is strictly prohibited

4. PARENTERALS
STERILE
Absence of microorganisms
PYROGENS / PYROGENES
Fever –producing organic substances
arising from microbial contamination
of a parenteral product.
Usually produces fever-like reactions.

5. PARENTERAL ROUTES
INTRA- Into the joints
ARTICULAR
INTRASYNOVIAL Into the joint fluid area
INTRASPINAL Into the spinal column
INTRATHECAL Into the spinal fluid
INTRA-ARTERIAL Into the arteries
INTRACARDIAC Into the heart
INTRAVENOUS Into the vein
INTRAMUSCULAR Into the muscle

6. PARENTERAL ROUTES
INTRADERMAL Into the skin
INTRACUTANEOUS Into the skin
SUBCUTANOUS Under the skin
HYPODERMIC Under the skin

7. OFFICIAL TYPES OF
INJECTIONS
TYPES EXAMPLE
1. Injection Insulin Injection, USP
2. For injection Cefuroxime for
Injection, USP
3. Injectable emulsion Profopol, USP
4. Injectable suspension Methylprednisolone
Acetate Suspension,
USP
5. For injectable suspension Imipenem and Cilastatin
for Injectable
Suspension, USP

8. SOLVENTS AND VEHICLE
FOR INJECTIONS
AQUEOUS NON-AQUEOUS
 Water for Injection, USP
 Fixed vegetable oils
 Sterile Water for
 corn oil, cottonseed oil,
Injection, USP peanut oil, and sesame
 Bacteriostatic Water for oil
Injection, USP  Glycerin
 Sodium Chloride  Polyethylene glycols
Injection, USP  Propylene glycol
 Bacteriostatic Sodium
 Alcohol
Chloride Injection, USP
 Ringer’s Injection, USP
 Lactated Ringer’s
Injection, USP

9. ADDED SUBSTANCES
 ANTIBACTERIAL PRESERVATIVES
Added to parenteral products in
multiple-dose container / packaging
ONLY (vials).
 BUFFERS
Act as pH stabilizers for pH –sensitive
drugs. Helps resist changes in the pH of
the product.

10. ADDED SUBSTANCES
 SOLUBILIZERS
Aids in increasing solubility of the drug
in the solvent system.
 ANTIOXIDANTS
Protects the drug against degenerative
changes brought about by oxidation.

11. METHODS OF STERILIZATION
1. STEAM STERILIZATION
Employs “steam under pressure” in an
AUTOCLAVE.
Uses 1210C at 15 psi for 20 minutes
setting.
2. DRY HEAT STERILIZATION
Employs “convective heat” in OVENS.
Less effective than steam sterilization.
Uses 1500C to 1700C for hours.

12. AUTOCLAVES CONVECTION OVEN

13. METHODS OF STERILIZATION
3. STERILIZATION BY FILTRATION
Applicable to heat-labile parenterals.
Involves removal of microorganisms by
adsorption on a filter medium or by
sieving mechanism.
Uses a membrane filter or cellulose
ester membrane filter.

14. MEMBRANE FILTER:

15. MEMBRANE FILTRATION SETUP:

16. METHODS OF STERILIZATION
4. GAS STERILIZATION
Applicable to sterile powders and
plastic containers.
The material is autoclaved first, then
the gases are introduced.
Uses the ff. sterilizing gases:
Ethylene oxide
Propylene oxide
Beta-propiolactone

17. GAS STERILIZATION CHAMBERS

18. METHODS OF STERILIZATION
5. STERILIZATION by IONIZING RADIATION
Exposes the material to
RADIATION – EMITTING
ISOTOPES, such as;
gamma rays
cathode rays
beta rays

19. GAS STERILIZATION CHAMBER

20. PACKAGING, LABELING AND
STORAGE OF INJECTIONS
 CONTAINERS
 Must not interact chemically or
physically with the preparation
 Either single- or multiple-dose
containers
 Single-dose package include ampuls,
vials, and prefilled syringes
 Types of glass containers are I, II and
III.

21. LABELING
Product title should be:
 FOR LIQUIDS
 Injection, Injectable Suspension,
and Injectable Emulsion
 FOR SOLIDS
 For Injection
 For Injectable suspension

22. SMALL VOLUME PARENTERALS
 Available in ampules, vials, or pre-filled
syringes / pens.
 Package in single-dose or multiple-dose
containers (2 mL to 30 mL)
Examples:
Heparin Sodium Injection
Insulin Injection
Lidocaine HCl Injection

23. SMALL VOLUME PARENTERALS

24. LARGE VOLUME PARENTERALS
 Administered by intravenous
infusion to replenish body fluids,
electrolytes, or to provide nutrition
 Usually in volumes of 100 mL to 1
Liter
 Employed in maintenance therapy
and replacement therapy
Examples: Ringer’s Inj., Mannitol Inj.,
Sodium Chloride Inj., Dextrose Inj.

25. LAEGE VOLUME PARENTERALS

26. B OGICAL P
IOL RODUCTS
 Sterile
preparations that exert
IMMUNOLOGIC EFFECTS to
develop the immunity from a
disease.
 Normallypackaged as small-
volume parenterals.

27. B OGICAL P
IOL RODUCTS
 Vaccines, Toxoids, Antitoxins, Immune
Serum, Antivenins, Blood derivatives,
Immunologic diagnostic aids.
 Stored in refrigerator (between 2°C and
8°C), or freezer with a temperature of
-15°C.
Examples: MMR Virus vaccine, Poliovirus
vaccine, Tetanus toxoid, Tetanus
antitoxin, Antivenin polyvalent,
Smallpox vaccine, Typhoid vaccine

28. OPHTHALMIC PRODUCTS
1. Solutions
2. Suspension
3. Gels
4. Ointments
5. Drug impregnated inserts
6. Contact lenses
7. Contact lenses care
products

29. Special considerations for
ophthalmic solutions and
suspensions
Sterility
Preservation
Isotonicity
Buffering
Viscosity
Ocular
bioavailability
Packaging