Topic 1: Sterile Dosage Forms Flashcards
are pharmaceutical dosage forms that are injected through one or more layers of skin
parenteral preparations
provide the most rapid onset of action of any parenteral route
intravenous
pass out of vessel into the tissue, blood, lymph
extravasation
Clotting within a blood vessel
thrombosis
into a substance or a cell
infiltration
inflammation of the vein
phlebitis
air is introduced into the vein
air emboli
A complication wherein a circulating clot carried by the blood stream lodges into a blood vessel
embolism
Drugs intended for prolonged or delayed absorption
intramuscular
needles used for intramuscular injections
2 inch to 3 inches long
20 to 22 gauge in size.
vol of admin for intramuscular
NMT 5 ml - gluteal region
NMT 2 ml - deltoid arm
Women tend to have more fat in this region than men, so the possibility of an ___ is significant.
intralipomatous injection
complications of intramuscular
Abscesses
Cysts
Embolism
Hematoma
Skin sloughing
Scar formation
The usual site for intradermal injections
anterior surface of the forearm
needles for intradermal injections
3/8 inches long
23 to 26 gauge
Drugs that are injected for diagnostic determinations, desensitization, or immunization.
intradermal
vol of admin for intradermal injections
0.1 mL
it can be used for both short term and very long term therapies
subcutaneous
vol of admin for subcutaneous injections
2 mL
needles for subcutaneous injections
3/8 to 1 inch
24 to 26 gauge
drugs that are intradermally injected are agents for
diagnostic determinations, desensitization, or immunization
syringe used for intradermal injection
tuberculin syringe
administration is injection of a drug directly into the heart.
intracardiac
refers to injection of large volumes of a solution into subcutaneous tissue to provide a continuous, abundant drug supply. This route occasionally is used for antibiotic administration in children
hypodermoclysis
administration refers to injection into the spinal column
intraspinal
administration means injection into a joint space
intra-articular
administration refers to injection into the joint fluid
intrasynovial
administration is injection into the spinal fluid; it sometimes is used for antibiotics
intrathecal
Liquid preparation that are drug substances or solutions thereof
injection
Dry solids added with suitable vehicles
for injection
Liquid preparation dissolved or dispersed in an emulsion medium
injectable emulsion
Liquid preparation of solid suspended in a suitable liquid medium
injectable suspension
Dry solids added with vehicles to make them injectable suspension
for injectable suspension
is the vehicle of the greatest importance for sterile products and especially, for parenterals since it is the vehicle for all natural fluids
water
It must meet the requirements for water for injection, USP
water
Meets requirements for Purified Water USP plus the USP “Pyrogen Test”
water for injection
It must not contain more than 1mg/100mL of total solids
water for injection
Meets requirements for Water for Injection USP plus passes the USP “Sterility Test”
Sterile Water for Injection
Packaged in single dose containers not larger than 1 L
sterile water for injection
Sterile water with antimicrobial agents
Bacteriostatic Water for Injection
Packaged in container not more 30 mL
Bacteriostatic Water for Injection
Bacteriostatic Sodium chloride
benzyl alcohol poisoning
gasping syndrome
sterile, isotonic
Sodium chloride for Injection
NaCl for injection vol
154 mEq of Na and Cl per L solution
Contains 1 or more antimicrobials
Bacteriostatic Sodium chloride
“NOT FOR USE IN NEONATES”
Bacteriostatic Water for Injection
Bacteriostatic Sodium chloride
Ringer’s injection contains
NaCl, KCl, CaCl2
Electrolyte replenisher and plasma volume expander
ringer’s injection
Fluid and electrolyte replenisher and systemic alkalizer.
Lactated Ringer’s
vehicle component for single dose
sterile water for injection
vehicle components for multiple doses
bacteriostatic for injection, bacteriostatic sodium chloride
must not be toxic, irritating or sensitizing and must not exert any adverse effect on the ingredients of the formulation
non-aqueous vehicle
most frequently used non-aqueous solvents
polyethylene glycol
propylene glycol
alcohol
glycerin
fixed oils
used as solvent for IM injection
Corn oil
cottonseed oil
peanut oil
sesame oil
The most commonly used agents include the two mercurials
phenylmercuric nitrate
thimerosal
the four homologous esters of
p-hydroxybenzoic acid
phenol
benzyl alcohol
chlorobutanol
is one of the pathways of degradation of which can be accelerated during thermal sterilization.
oxidation
Antioxidants used in sterile products are classified into
Reducing agents
Blocking agents
Synergist
Chelating agents
Inert gases
antioxidants which function by being preferentially oxidized;
Reducing agents
antioxidants which block an oxidative chain reaction in which they are not usually consumed;
Blocking agents
ompounds increase the effectiveness of antioxidants, particularly those blocking oxidative reactions
Synergist
Reducing agents examples
ascorbic acid, sodium bisulfite, and metabisulfite, sodium formaldehyde sulfoxylate, thiourea.
Blocking agents examples
ascorbic acid esters, butyl hydroxytoluene(BHT) and tocopherols.
Synergist examples
ascorbic acid, citric acid, citraconic acid, phosphoric acid and tartaric acid.
those that complex with catalysts which otherwise would accelerate the oxidative reactions;
chelating agents
chelating agent example
ethylenediaminetetraacetic acid salts
like nitrogen and carbon dioxide have been used to displace oxygen from solution and reduced the possibility of the oxidative changes in the formulation
inert gases
added to maintain the required pH for many products
buffers
The principal buffer systems used to stabilize pH are the
acetates, citrates and phosphates
Compounds contributing to the isotonicity of a product
tonicity contributors
Reduced the pain of injection in the areas with nerve endings
tonicity contributors
LEORA
Loss of Electron Oxidation Reducing Agents
GEROA
Gain of Electron Reduction Oxidizing Agents