[TERM2:L5]: Parenterals Flashcards
- are free from any microorganisms, dust, fibres, and foreign particles, and should be isotonic
- Sterility in these preparations is essential because they are placed in direct contact with the internal body fluids or tissues, where infection can easily arise.
Sterile dosage forms
Organic metabolic products shed from gram negative bacteria, which can cause fever and hypotension in patients when they are in excessive amounts in intravenous (IV) injections.
Pyrogens
(bacterial endotoxin)
Other name for Pyrogens
bacterial endotoxin
Sterile, pyrogen-free preparations intended to be administered parenterally
Injection
Official Types of Injection
- Injection
Liquid preparations that are drug substances or solutions thereof
EXAMPLE: Insulin Injection, USP - For Injection
Dry solids that, upon addition of suitable vehicles, yield solutions conforming in all respects to the requirements for injections
EXAMPLE: Cefuroxime for Injection, USP - Injection emulsion
Liquid preparation of drug substance dissolved or dispersed in a suitable emulsion medium
EXAMPLE: Propofol, USP - Injectable suspension
Liquid preparation of solid suspended in a suitable liquid medium
EXAMPLE: Methylprednisolone Acetate Suspension, USP - For injectable suspension
Dry solid that, upon addition of suitable vehicle, yields preparation conforming in all respects o the requirements for injectable suspensions
EXAMPLE: Imipenem and Cilastatin for Injectable Suspension, USP
Liquid preparations that are drug substances or solutions thereof
Injection
Example of Injection
Insulin Injection, USP
Dry solids that, upon addition of suitable vehicles, yield solutions conforming in all respects to the requirements for injections
For Injection
Example of For Injection
Cefuroxime for Injection, USP
Liquid preparation of drug substance dissolved or dispersed in a suitable emulsion medium
Injection emulsion
Example of Injection emulsion
Propofol, USP
Liquid preparation of solid suspended in a suitable liquid medium
Injectable suspension
Example of Injectable suspension
Methylprednisolone Acetate Suspension, USP
Dry solid that, upon addition of suitable vehicle, yields preparation conforming in all respects o the requirements for injectable suspensions
For injectable suspension
Example of For injectable suspension
Imipenem and Cilastatin for Injectable Suspension, USP
Solvents and Vehicles for Injections (AQUEOUS SOLVENTS)
WPSB-SB-RL
- Water for Injection, USP
- Purified Water, USP
- Sterile Water for Injection, USP
- Bacteriostatic Water for Injection, USP
- Sodium chloride Injection, USP
- Bacteriostatic sodium chloride Injection, USP
- Ringer’s Solution, USP
- Lactated Ringer’s Injection, USP
- Most frequently used solvent in the large-scale manufacturer of injections
- Purified water free of pyrogens
- Obtained by distillation or reverse osmosis
- For parenterals that are to be sterilized after preparation
Water for Injection, USP
- Obtained by distillation, ion-exchange, reverse osmosis, etc.
- Preparation of aqueous dosage forms but not for parenterals
- Has pH of about 5-7
Purified Water, USP
- Water for injection rendered sterilize and packaged into single-dose containers < 1 Liter
- Used for already sterilized and packaged medication
- Must be pyrogen free and do not contain any microbial agent or any added substances
Sterile Water for Injection, USP
- Sterile water for injection containing one or more suitable antimicrobial agents
- May be packaged in single or multi-dose containers < 30 mL
- USP labeling requirements demand that the label state not for use in neonates because it contains benzyl alcohol which causes benzyl alcohol toxicity presenting as gasping syndrome
Bacteriostatic Water for Injection, USP
- Sterile isotonic solution of sodium chloride (0.9%) in water for injection
- Used as a sterile vehicle in solutions or suspensions of drugs for parenteral administration
Sodium chloride Injection, USP
- Sterile isotonic solution of sodium chloride in water for injection and contains one or more suitable antimicrobial agents, which must be specified on the labelling
- Used to flush a catheter or IV line to maintain its patency in adults but not for neonates
Bacteriostatic sodium chloride Injection, USP
- Sterile solution of sodium chloride, potassium chloride, and calcium chloride in water for injection.
- Ringer’s is employed as a vehicle for other drugs or alone as an electrolyte replenisher and plasma volume expander
Ringer’s Solution, USP
- Has different quantities of the three salts in Ringer injection, and it contains sodium lactate
- This injection is a fluid and electrolyte replenisher and a systemic alkalizer.
Lactated Ringer’s Injection, USP
Solvents and Vehicles for Injections (NONAQUEOUS SOLVENTS)
FG-PPEID
- Fixed vegetable oils
- Glycerin
- Polyethylene glycols
- Propylene glycol, alcohol
- Ethyl oleate
- Isopropyl myristate
- Dimethylacetamide
Fixed vegetable oils USP restrictions
-Remain clear when cooled 10°C (50°F)
-Must not contain mineral oil or paraffin
-Must meet officially stated requirements of iodine number and saponification number
-Vegetable oil used must be indicated in the labeling for patients may be allergic to some
Commonly used oils as nonaqueous solvents
Corn oil
Cottonseed oil
Peanut oil
Sesame oil
Parenteral Routes of Administration
Intravenous - into the vein
Subcutaneous - under the skin
Intradermal - into the skin
Intramuscular - into the muscles
Intra-articular - in the joint space
Intrasynovial - in the joint fluid area
Intrathecal - spinal column
Intra-arterial - arteries
Intracardiac - heart
process of giving medication directly into a patient’s vein/ fastest way to deliver medications and fluid replacement throughout the body, because they are introduced directly into th
Intravenous (IV) injection
provide rapid action compared with other routes of administration, gives 100% bioavailability.
IV drugs
first used IV route using bladder and quill to inject substances into the veins of dogs
Sir Christopher Wren (1656)
IV medication was first given to humans but was abandoned due to thrombosis and embolism in patients.
Johann Daniel Major of Kiel (1662
clot formed within the blood vessels, causes thrombosis
Thrombus
clot that circulates and carried in the bloodstream, causes embolism
Embolus
technique used to deliver a medication deep into the skeletal muscles.
Intramuscular injection
Site of administration of Intramuscular Route
Adults: upper outer quadrant of gluteus maximus I
Infants: deltoid muscles of upper arm or midlateral muscles of thigh
less rapid but generally longer lasting than those obtained from IV administration.
IM injections
- used for injection of small amounts of medication.
- usually made in the loose interstitial tissue of the outer upper arm, the anterior thigh, or the lower abdomen.
Subcutaneous Route
Patients taking insulin daily should rotate their injection sites to prevent _____________ which may prevent the drug from being absorbed properly.
lipodystrophy
Should not be prepared for SC injection
Irritating drugs and thick suspensions
shallow or superficial injection of a substance into the dermis; which is located between the epidermis and the hypodermis.
Intradermal injection (ID)
Commonly used for injecting agents for diagnostic determination, desensitization or immunization
Intradermal Route
Site of Intradermal Route of administration
anterior forearm
how much should be administered in intradermal route
Usually, only about 0.1 mL may be administered in this manner.
destruction of all living organisms and their spores or their complete removal from the preparation
Sterilization
Methods of Sterilization
- Steam Sterilization (moist heat sterilization)
- Dry Heat Sterilization
- Sterilization by Filtration
- Gas Sterilization
- Sterilization by Ionizing Radiation
- Conducted in an Autoclave/employs Steam under pressure
- Happens at 121°C & 15 psi for 15-20 minutes
- Common method of Choice
- MOA: Protein coagulation
Steam Sterilization (moist heat sterilization)
- Carried out in ovens designed for this purpose
- Less effective in killing microorganisms than in moist heat
- Happens at 150-170°C for not less than 2 hours
- MOA: Oxidation
Dry Heat Sterilization
- Physical removal of microorganism by adsorption on the filter medium or by a sieving mechanism
- For heat-sensitive solutions
Sterilization by Filtration
- For heat-labile enzyme preparation
- MOA: Alkylation
- Uses: Ethylene Oxide
Gas Sterilization
Done using gamma rays and cathode rays
Sterilization by Ionizing Radiation
characterized preparation of specific microorganisms resistant to a particular sterilization process. They are used to monitor a sterilization cycle and/or periodically to revalidate the process.
Biologic indicator
commonly employed because of their resistance to these modes of sterilization.
Bacillus stearothermophilus
dry heat sterilization
Bacillus subtilis
ionizing radiation
B. pumilus, B. stearothermophilus, and B. subtilis
Contains not more than 0.5 USP EU/mL for injections containing less than 5% dextrose and not more than 10.0 USP EU/mL for injections containing between 5% and 70% dextrose
Dextrose Injection
Contains not more than 200.0 USP EU/mg of digoxin.
Digoxin Injection
Contains not more than 0.71 USP EU/mg of gentamicin
Gentamicin Injection
Pyrogens and Pyrogen Testing: Official Tests
Pyrogen Test
Bacterial Endotoxin Test
- Done in rabbits
- Nmt 10ml/kg within a period of 10 minutes
- Pass if: no rabbit shows individual rise in temp 0.6°C or above, sum does not exceed 1.4°C
Pyrogen Test
- Uses Limulus Amebocyte Lysate (LAL) from the horseshoe crab, Limulus polyphemus
- Quantities defined in Endotoxin Units (EU)
Bacterial Endotoxin Test
- A hermetic container holding a quantity of sterile drug intended for parenteral administration as a single dose; when opened, it cannot be resealed with assurance that sterility has been maintained
Single-dose container
- A hermetic container that permits withdrawal of successive portions of the contents without changing the strength, quality, or purity of the remaining portion
Multiple-dose container
