FINAL 03 - Parenterals Flashcards
Refers to various small volume and large volume injectable preparations and irrigation fluids
Sterile dosage forms
An essential requirement since infection easily arises
Sterility
Sterile, pyrogen-free preparations intended to be administered parenterally
Injections
Fever producing organic substances arising from microbial contamination
Pyrogens
Refers to the injectable routes of administration
Parenteral
Greek word which means outside
Para
Greek word which means intestine
Enteron
In __________, intravenous injection of drugs were first used in the experiments of Sir Christopher Wren
1656
An architect of St. Paul’s cathedral and amateur physiologist
Sir Christopher Wren
In __________, intravenous medication was first given to humans by Johann Daniel Major of Kiel
1662
In 1662, intravenous medication was first given to humans by __________
Johann Daniel Major of Kiel
Blood clot within the blood vessel or heart
Thrombus
Clot that circulates and carried by the blood the blood stream
Embolus
Obstruction of the blood vessel that results in a block or occlusion
Embolism
Flow rates for intravenous fluids range from __________ to __________ mL/hour
42-150 mL/hour
Automated intravenous delivery system for intermittent self-administration of analgesic
Patient controlled analgesia (PCA)
Oleaginous suspension can only be administered through the __________ route
Intramuscular
Volume of medication administered in the gluteal region
5 mL
Volume of medication administered in the deltoid of the arm
2 mL
Technique that is useful for intramuscular injections of medication that strain upper tissue by sealing the medications in the lower muscle
Z-track technique
Route for injection of small amounts of medication; usual route for insulin injection
Subcutaneous route
Syringes to be used for subcutaneous route are up to 3 mL capacities and has __________ to __________ gauge needles
24-26 gauge
The more vascular layer of the skin just beneath the epidermis
Corium
Site of injection for intradermal route
Anterior forearm
Liquid preparations that are drug substances or solutions (Types of injections)
Injection
Dry solids that upon addition of suitable vehicles yield solutions confirming in all respects to the requirements for injections (Types of injections)
For injection
Liquid preparation of drug substance dissolved or dispersed in a suitable emulsion medium (Types of injections)
Injectable emulsion
Liquid preparation of solid suspended in a suitable liquid medium (Types of injections)
Injectable suspension
Dry solid that upon addition of suitable vehicle yields preparation conforming in all respects to the requirements for injectable suspensions (Types of injections)
For injectable suspension
Most frequently used solvent in the large scale manufacturing of injections (Examples of solvents and vehicles for injection)
Water for injection, USP
Not more than 1mg/100mL water for injection (Examples of solvents and vehicles for injection)
Purified water, USP
Used as solvent or diluent for already sterilized and packaged injectable medication (Examples of solvents and vehicles for injection)
Sterile water for injection, USP
Sterile water for injection containing one or more suitable antimicrobial agents/bacteriostatic agents (Examples of solvents and vehicles for injection)
Bacteriostatic water for injection, USP
This statement was the result of problems encountered with neonates and toxicity of the bacteriostat, benzyl alcohol
Not for use in neonates
Benzyl alcohol poisoning is recognized as __________
Gasping syndrome
Sterile solution of NaCl in water for injection (Examples of solvents and vehicles for injection)
Sodium chloride injection, USP
Sterile isotonic solution of NaCl in water for injection (Examples of solvents and vehicles for injection)
Bacteriostatic sodium chloride injection
Sterile solutions of NaCl, KCl, and CaCl2 in water for injection (Examples of solvents and vehicles for injection)
Ringer’s injection, USP
Contains NaCl, KCl, CaCl2, and Na lactate (Examples of solvents and vehicles for injection)
Lactated ringer’s injection
Purified by distillation or osmosis and rendered sterile with no antimicrobial agents except when used in humidifiers or other similar devices (Examples of solvents and vehicles for injection)
Sterile water for inhalation, USP
Sterilized and suitably packaged with no antimicrobial agent or other added substance
Sterile water for irrigation, USP
Vehicles that are used when physical or chemical factors limit the use of a wholly aqueous vehicle
Nonaqueous vehicles
Means destruction of all living organisms and their spores or their complete removal from the preparation
Sterilization
Type of sterilization conducted in an autoclave and employs steam under pressure (Methods of sterilization)
Steam sterilization
115.5°C or 240°F for 30 minutes (Examples of steam pressure)
10 lb steam pressure
121.5°C or 250°F for 20 minutes (Examples of steam pressure)
15 lb steam pressure
126.5°C or 260°F for 15 minutes (Examples of steam pressure)
20 lb steam pressure
Type of sterilization carried out in ovens, heated gas, or electricity and are generally thermostatically controlled (Methods of sterilization)
Dry heat sterilization
Type of sterilization that depends on the physical removal of microorganism by adsorption on the filter medium or by sieving mechanism (Methods of sterilization)
Sterilization by filtration
Commercially available filter which is a thin plastic membrane of cellulosic esters with millions of pores per square inch
Millipore filter
Pore sizes of millipore filter
14-0.025um
Type of sterilization that requires specialized equipment resembling an autoclave and many combination steam autoclaves and ethylene oxide sterilizers (Methods of sterilization)
Gas sterilization
Sterilization with ethylene oxide gas requires __________ to ___________ hours of exposure
4-16 hours
Is through to sterilize by interfering with the metabolism of bacterial cell
Ethylene oxide
Type of sterilization which is sterilization by gamma rays and by cathode rays, but application of such techniques is limited (Methods of sterilization)
Sterilization by ionization radiation
Ophthalmic and injectable preparations are sterilized by __________ and __________ (AB)
Autoclaving, Bacterial filtration
Best value to validate sterility for steam sterilization
Biological indicator
Steam sterilization (Biological indicator)
Bacillus stearothermophilus
Dry heat sterilization (Biological indicator)
Bacillus subtilis
Ethylene oxide sterilization (Biological indicator)
Bacillus stearothermophilus
Ionizing radiation sterilization (3 Biological indicators) (BP, BS, BS)
Bacillus pumilus, Bacillus subtilis, Bacillus stearothermophilus
Formula of F value to express thermal death
Fo = D121 (Log A – Log B)
Time required to kill a particular organism under specified conditions
Thermal death time
2 oxidizing agents used in removing pyrogens (PB)
Potassium permanganate, Barium hydroxide
Test for pyrogens that use healthy mature rabbits each weight NLT 1.5 kg which have not lost body mass when kept on a constant diet for NLT 1 week (Pyrogen tests)
Rabbit test
Test for pyrogens which uses an extract from the blood cells of horse shoe crabs (Limulus polyphemus) (Pyrogen tests)
Bacterial endotoxin test, USP
Test used for detecting the presence of bacterial endotoxins (Pyrogen tests)
Limulus amebocyte lysate (LAL) test
Hermetic container for parenteral administration as a single dose
Single-dose container
Hermetic container that permits withdrawal of successive portions of the contents
Multiple-dose container
This preparation’s expiration date is set after 24 months after filling
Insulin preparations
The goal of __________ is to achieve tight blood glucose control by mimicking insulin secretion by the normal pancreas
Insulin therapy
2 components of normal insulin secretion (BB)
Basal insulin, Bolus insulin
Are intermediate acting or long-acting insulins that mimic basal secretions of insulin (Components of normal insulin secretion)
Basal insulins
Are rapid-acting or short-acting insulins that mimic the extra insulin the pancreas secrete (Components of normal insulin secretion)
Bolus insulin
Sterile aqueous solution of insulin that is administered intravenously (Types of insulin)
Insulin injection
2 problems encountered due to insulin injection (LL)
Lipohypertrophy, Lipodystrophy
Build-up of fibrous tissue
Lipohypertrophy
Insulin produced by using a special non-disease forming laboratory of E. coli strain and recombitant DNA technology (Types of insulin)
Human insulin
Solution that consists of zinc insulin lispro crystals dissolved in a clear aqueous liquid (Types of insulin)
Lispro insulin solution
Recombitant ultra-short acting insulin using Saccharomyces cerevisiae (baker’s yeast) as the production organism (Types of insulin)
Insulin aspart
Suspension which is an NPH (Neutral Protamine Hagedorn) insulin; protamine is added (Types of insulin)
Isophane insulin suspension
A manufactured premixed insulin lispro and Neutral Protamine Lispro (NPL) in fixed ratio (Types of insulin)
Humalog mix
A suspension that is a smaller amorphous form that has the most prompt hypoglycemic action and contains zinc chloride (Types of insulin)
Insulin zinc suspension
Long-acting basal insulin preparation intended for once daily subcutaneous administration for type I diabetes (Types of insulin)
Insulin glargine
Sterile suspension of zinc insulin crystals in an aqueous solution medium buffered with sodium acetate (Types of insulin)
Extended insulin zinc suspension
Pumps given for patients that needs to achieve and maintain blood glucose to nearly normal levels on a constant basis (Types of insulin)
Insulin infusion pumps
2 other injectable products (PI)
Pallets/Implants, Irrigation and dialysis solution
Set of 6 flexible closed capsules of dimethylsiloxane-methyl vinyl siloxane copolymer; an excellent contraceptive (Examples of pallets/implants)
Levonorgestrel implants
A Goserelin acetate implant that is a treatment for prostatic cancer (Examples of pallets/implants)
Zoladex implant
Gel that assist in reproduction (Examples of pallets/implants)
Crisone gel
A treatment for dry eyes (Examples of pallets/implants)
Lacrisert
Solution that does not enter into the circulatory system; packaged as LVP
Irrigation and dialysis solution
Solution intended as bathe or wash for wounds, surgical incisions or body tissues
Irrigation solutions
Solutions that are separations of substances from one another in solution by taking advantage of their differing diffusibility through membranes
Dialysis solutions
Joints (Route of administration)
Intraarticular
Joint fluid area (Route of administration)
Intrasynovial
Spinal column (Route of administration)
Intraspinal
Spinal fluid (Route of administration)
Intrathecal
Arteries (Route of administration)
Intraarterial
Heart (Route of administration)
Intracardiac
Vein (Route of administration)
Intravenous
Muscle (Route of administration)
Intramuscular
Skin (2 routes of administration)
Intradermal, Intracutanous
Under the skin (2 routes of administration) (SH)
Subcutaneous, Hypodermic