(Finals) DDS_2 Lec Flashcards
1
Q
products that are administered to the body by injection
A
Parenterals
2
Q
True or false:
Because this route of administration bypasses the normal body defense mechanisms, it is essential these products are prepared with a higher degree of care and skills than utilized in preparing conventional oral or topical products
A
True
3
Q
A finished Parenteral product must be:
A
- Sterile
- Non-pyrogenic
- Free from extraneous insoluble materials
4
Q
What should be added to parenteral products to make it isotonic with the blood?
A
Excipients
This helps in adjusting the pH, increase solubility, prevent deterioration of API, provide adequate antimicrobial properties.
5
Q
Containers for parenteral preparations are made as far as possible from materials that are:
A
Sufficiently transparent
6
Q
Containers for parenteral preparations are made as far as possible from materials that are sufficiently transparent to permit the visual inspection of the contents, except for
A
Implants, and in other justified and authorized cases
7
Q
Sterile, pyrogen-free preparations which may be sterile solutions, emulsions or suspension, intended to be administered parenterally
A
Injections
8
Q
How are injections prepared?
A
dissolving, emulsifying or suspending the active substance(s) and any added excipients in water, in a suitable non-aqueous liquid, that may be non-sterile where justified, or in a mixture of these vehicles
9
Q
The word ________ denotes routes of administration other than the oral route
A
Parenteral
10
Q
No antimicrobial preservative is added when:
A
- The volume to be injected in a single dose exceeds 15 mL, unless otherwise justified,
- The preparation is intended for administration by routes where, for medical reasons, an antimicrobial preservative is not acceptable
11
Q
An antimicrobial preservative is not acceptable in:
A
Intracisternally, Epidurally, Intrathecally, or by any route giving access to the Cerebrospinal fluid, or intra- or retro-ocularly
Such preparations are presented in single-dose containers.
12
Q
Sterile, aqueous solutions or emulsions with water as the continuous phase
A
Infusions
13
Q
Principally intended for administration in large volume
A
Infusions
14
Q
True or False:
Infusions do not contain any added antimicrobial preservative
A
True
15
Q
Sterile gels with a viscosity suitable to guarantee a modified release of the active substance(s) at the site of injection
A
Gels for Injections
16
Q
Sterile, solid preparations of a size and shape, suitable for parenteral implantation and release of the active substance(s) over an extended period of time
A
Implants
17
Q
Flexible pharmaceutical preparations of varying sizes, containing one or more active substances
A
Transdermal Patches
18
Q
Intended to be applied to the unbroken skin in order to deliver the active substance(s) to the systemic circulation after passing through the skin barrier
A
Transdermal Patches
19
Q
Transdermal patches are intended to be applied to the:
A
Unbroken Skin
20
Q
Supports a preparation which contains the Active Substance:
A
Outer Covering
(Transdermal Patches)
21
Q
The transdermal patches are covered on the site of
the release surface of the preparation by a:
A
Protective Layer
22
Q
Determines the diffusion pattern of the active substance to the skin
A
Matrix
23
Q
Assure the adhesion of the preparation to the skin
A
Pressure-sensitive adhesives
24
Q
Injections performed into a vein
A
Intravenous (IV)
25
Injections performed into a muscle
Intramuscular (IM)
26
Injections performed into a skin
Intradermal (ID), or Intracutaneous
27
Injections performed under the skin
Subcutaneous (SC, sub-Q, SQM or SubQ)
28
Drugs injected into an organ:
Thru the smooth, white tissue that covers the ends of bones where they come together to form joints
Intra-articular
29
Drugs injected into an organ:
Joint fluid area
Intrasynovial
30
Drugs injected into an organ:
Spinal column
intraspinal
31
Drugs injected into an organ:
space under the arachnoid membrane of the brain or spinal cord
Intrathecal
usually in spinal anesthesia or in chemotherapy or pain management applications
32
Drugs injected into an organ:
into an artery
Intra-arterial
33
Drugs injected into an organ:
Into the heart
Intracardial
34
Space inside the bony spinal canal but outside the membrane called the dura mater
Epidural space
35
Drugs injected into an organ:
Gives anesthesia from the waist down
Intraepidural
36
Drugs injected into an organ:
puncture of the cistern cerebellomedullaris thru the posterior atlanto-occipital membrane to obtain cerebrospinal fluid
Intracisternal
37
Drugs injected into an organ:
Injection thru pleura due to accumulation of fluid within the visceral and parietal layers of the pleura when there is an imbalance between formation and absorption
Intrapleural
38
Injections onto the skin
Epicutaneous
39
Injections onto the bone marrow
Intraosseous infusion
40
Injections into the urinary bladder
Intravesical infusion
41
Injections through the eye
Intravitreal
42
Injection into the base of the penis
Intracavernous injection
43
Injection in the vagina
Intravaginal administration
44
Injection: Extra-amniotic administration, between the endometrium and fetal membranes
Intrauterine
45
Injection into the cerebrum (direct injection into the brain)
Intracerebral
46
Into the cerebral ventricles (administration into the ventricular system of the brain)
Intracerebroventricular
47
Last line of opioid treatment for terminal cancer patients with intractable cancer pain
Intracerebroventricular
48
Administration that provides rapid action compared to other routes of administration
Intravenous Route
49
True or False:
An intravenous drug that has been administered can be retrieved
False
If an adverse drug reaction happens, it cannot be easily removed from circulation
50
Best peripheral veins for IV therapy:
Basilic vein
Cephalic vein
51
True or False:
The antecubital vein is preferred for IV therapy
False, because its is a point of great flexion with a high risk of extravasation (leakage of fluid)
52
Main hazard of IV infusion
Thrombus formation
53
Induced by catheter or needle touching the wall of the vein
Thrombus formation
54
Route of administration that is less rapid, but generally of greater duration than that obtained from intravenous administration
Intramuscular Route
55
Injections performed deep into the skeletal muscles
IM injections
56
True or False:
The point of injection of IM should be as far as possible from major veins and blood vessels
True
57
The most frequent used site for IM injection in adults
Upper outer quadrant of the gluteus maximus
58
The most frequent used site for IM injection in infants
Deltoid muscles of the upper arm or the midlateral muscles of the thigh
59
Maximum volume of medication that conveniently administered by the IM Route is generally?
5ml in the gluteal region
2ml in the deltoid of the arm
60
Injection of a liquid into the dermis, just below the epidermis
Intradermal Route
61
True or False:
When correctly administering Intradermal route, the tip of the needle is still visible through the skin
True
62
Example of Intradermal route give 1:
Mantoux Test for TB
63
Injection of a liquid into the fatty layer of tissue just below the dermis of the skin but above the muscle layer
Subcutaneous Route
(s.q., SQ, subQ, s.c., S.C., or subcu.)
64
Slower absorption of the drug because only few blood vessels in this layer as compared to intramuscular injection
Subcutaneous Route
(s.q., SQ, subQ, s.c., S.C., or subcu.)
65
Where painkilling drugs are passed into the small of the back via a fine tube
Epidural Route
66
Called a regional anesthetic
Epidural Route
67
Components of Parenteral routes include:
1. Vehicles
2. Closures
3. Solvents
4. Containers
68
Most frequiently employed solvent on a large scale:
Water for Injection, USP
69
Often used as isotonic vehicle.
Aqueous vehicle
70
Primarily used to effect solubility of certain drugs and to reduce hydrolysis
Water-Miscible vehicle
71
The fixed oils are the most important
Non-Aqueous vehicle
72
Examples of Aqueous vehicle:
1. Sodium Chloride Injection
2, Ringer's Injection
3. Lactated Ringer's Injection
73
Examples of Water-Miscible Vehicle:
1. Ethyl alcohol
2. Polyethylene glycol
3. Propylene glycol
74
Examples of Non-aqueous vehicle:
1. Corn oil
2. Cottonseed oil
3. Peanut oil
75
Prepared in multiple dose containers and are required to prevent microorganism growth
Anti-microbial agents
76
Examples of limited concentration of Anti-microbial agents are as follows:
a. phenylmercuric nitrate and thomersol 0.01 %
b. benzethonium chloride and benzalkonium chloride 0.01%
c. Phenor or cresol 0.5%
d. Chlorobutanol 0.5%
77
They are added to maintain the pH and are used to stabilize a preparation against the chemical degradation that can occur if there is a marked change in pH
Buffers
78
Buffers commonly used are:
a. Citrate and acetate buffer
b. Sodium benzoate and benzoic acid
c. Sodium tartrate and tartaric acid
d. Phosphate buffer
79
sodium bisulfate, 0.1% is most commonly used
Antioxidants
80
Added to reduce pain of injection
Tonicity Agents
81
Tonicity agents examples:
a. Sodium chloride
b. Potassium chloride
c. Dextrose
d. Mannitol
e. Sorbitol
82
Surfactants. Examples are:
a. Polyoxyethylenesorbitanmooleate
b. Sorbitanmonooleate
83
Chelating agents example
Ethylenediaminetetraacetic acid
84
Products of the growth of microorganisms
Pyrogens
85
Unwanted contaminants which cause febrile reaction in human beings
Pyrogens
86
Some new plastic materials used are:
a. PET – polyethylene terephthalate
b. APET – amorphous PET
c. PETG – PET glycol
87
Movement of components of a container into the contents
Leaching
88
Description of Type 1 Glass
Highly resistant Borosilicate
89
Description of Type 2 Glass
Treated Soda Lime glass
90
Description of Type 3 Glass
Soda Lime glass
91
Description of Type NP Glass
General purpose Soda Lime
92
sealed by Tip Sealing or Bead Sealing and Pull Sealing
Single Dose containers
93
Single dose containers are commonly called as what?
Ampoules
94
The USP limits the size of multiple containers to what volume?
30mL
95
The USP limits the size of single dose containers to what volume?
1000mL
96
Protects the contents from extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage and distribution
Well-closed container
97
Classification of container:
Protects the contents from contamination by extraneous liquids, solids, or vapors
from loss of articles, and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage and distribution and is capable of tight reclosure.
Tight container
98
Classification of container:
Impervious / resistant to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution. Those sterile are generally used to hold preparations intended for injection or parenteral administration.
Hermetic container
99
Classification of container:
Quantity of drug contained is intended as a single dose and when opened cannot be resealed with assurance that sterility has been maintained
Single-dose container
100
Classification of container:
These are hermetically sealed containers that permit withdrawal of successive portions of the contents without changing the strength or endangering the quality or purity of the remaining portion
Multiple-dose container
101
Classification of container:
defined as significantly difficult for children under 5 years of age to open or to obtain a harmful amount of its contents within a reasonable tim
Child-resistant container
102
This forms part of the container.
Closures
103
Pharmaceutical rubbers:
Butyl Rubbers
Natural Rubbers
Neoprene Rubbers
Polyisoprene rubbers
Silicone rubbers
104
Complete destruction of all living organisms and their spores or their complete removal from the preparation.
Sterilization
105
Five General Methods Used in sterilization
1. Steam sterilization
2. Dry-heat sterilization
3. Sterilization by filtration
4. Gas sterilization
5. Sterilization by ionizing radiation
106
Done by detecting the presence of viable forms of bacteria, fungi and yeast in parenteral products
Sterility test
106
The test for sterility may be carried out either by:
✔ Membrane filtration method
✔ Direct inoculation of culture media method
107
This is done to check the presence or absence of pyrogens in all aqueous parenterals
Pyrogen test
108
The test involves the measurement of rise in body temperature of rabbits following intravenous injection of a sterile solution of a parenteral preparation being examined
Pyrogen test
109
the amount just sufficient to cause positive USP pyrogen test response
Minimum pyrogenic dose (MPD)
110
Performed to ensure that the parenterals are free from visible foreign particles
Clarity test
111
This test is performed only for ampoules which have been sealed by fusion to ensure that there should not be any leakage in them
Leaker test
112
Incompletely sealed ampoule is termed a
Leaker
113
Leaker test is done by immersing the ampules in a dye solution, what dye solution is used?
1% Methylene Blue
in a 25inch or 64cm vacuum for a minimum of 15 minutes
114
Defective ampoules will contain what?
Blue solution
115
LAL is an aqueous extract of blood cells (amoebocytes) from the horseshoe crab what?
Limulus polyphemus
115
Test used to determine if a bacterial cell produces an endotoxin.
Limulus Amebocyte Lysate Test (LAL)
116
This is performed according to method given in the monograph of the parenteral preparation in the pharmacopoeia
Assay
117
Done to check the quantity of medicament present in the parenteral preparation
Assay
118
The most used of the small volume injections
Insulin preparations
118
The active principle of the pancreas
Insulin
119
Volumes of Large Volume Parenterals (usually)
250mL or more
120
True or False:
Large Volume Parenterals may not contain bacteriostatic agents.
True
not necessarily need ng bacteriostatic agents
121
Complete the temperature:
Cold - _____ degrees C
Cool - _____ degrees C
Room temp - _____ degrees C
Warm - _____ degrees C
Excessive Heat - _____ degrees C
Cold = not exceeding 8
Cool = 8-15
Room temp = 20-25, may allow 15-30
Warm = 30 - 40
Excessive Heat = 40 above
122
Daily water requirement?
25-40mL/kg of body weight
123
patients that require parenteral fluids are given? to reduce the caloric deficit that usually occurs in patients undergoing maintenance or replacement therapy
5% Dextrose
for Caloric requirement
123
Particularly important for normal cardiac and smooth muscle function
Potassium
for Electrolyte requirement
124
The infusion of large amounts of basic nutrients sufficient to achieve active tissue synthesis and growth
Parenteral Hyperalimentation
125
Such pharmaceutical products as vaccines, toxins, toxoids, antitoxins, immune serums, blood derivatives, certain diagnostic aids, and others
Biologics
126
Biologics are stored at what temp
At a refrigerator between 2 - 8 deg C, avoid Freezing
127
Sterile, small usually cylindrical-shaped solid objects about 3.2 mm in diameter and 8 mm in length
Pellets or implants
128
True or False:
Solutions for irrigation of body tissues and for dialysis are not injected into the vein
True
but are employed outside the circulatory system
129
Removes toxic substances normally excreted by the kidney
Peritoneal dialysis solutions
