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PSMA > DISPENSING > Flashcards

DISPENSING Flashcards

(91 cards)

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1
Q

The capability of a particular formulation to remain within its physical, chemical, microbiological, therapeutic and toxicological specifications

A

Drug stability

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2
Q

Usually conducted throughout the clinical trial and during the filing period

A

Pre-market stability

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3
Q

Continuous assurance on the post-approval batches for long-term stability monitoring on the drug product

A

Commercial stability

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4
Q

Manifested by the drug’s molecular structure, chemical change results to different drug molecule, and each active ingredient should retain its chemical integrity and labeled potency within specified limits

A

Chemical stability

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5
Q

Properties of drugs and dosage forms that can be seen or tested by physical means

A

Physical stability

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6
Q

It involves the assessment of flavor, odor, appearance and mouthfeel of a product

A

Organoleptic testing

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7
Q

Sterility or resistance to microbial growth is retained according to the specified requirements

A

Microbiological stability

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8
Q

The therapeutic effect remains unchanged

A

Therapeutic stability

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9
Q

No significant increase in toxicity occurs

A

Toxicological stability

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10
Q

Problem which could occur as a result of interaction between two or more drugs or chemicals

A

Drug instability/Incompatibility

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11
Q

Physical or chemical interaction that leads to visible recognizable change

A

Physical incompatibilities

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12
Q

Remedy for insolubility of components

A

Suspension

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13
Q

Remedy for immiscibility of components

A

Emulsion

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14
Q

Solute which is originally dissolved in the solvent is thrown out of solution

A

Salting out process

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15
Q

The solubility of most drugs __ as the temperature of the solution __

A

Decreases, decreases

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16
Q

Remedy for salting out

A

Use another solvent

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17
Q

Notorious to liquefaction

A

Efflorescent powders

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18
Q

Absorbs moisture but does not dissolve

A

Hygroscopic

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19
Q

Absorbs moisture and dissolves

A

Deliquescence

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20
Q

Liquefaction of solids mixed in dry state

A

Eutexia

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21
Q

Molecules are concentrating at the interface

A

Adsorption

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22
Q

Molecules being absorbed are penetrating into the capillary spaces of the absorbing surface

A

Absorption

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23
Q

Drugs that are __ or __ have greater tendency to sorb to PCV to dissolve in its plasticizer

A

Poor water-soluble, lipophilic

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24
Q

Based on study in animals, drugs that contain surfactants or cosolvents can cause cancer

A

True

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25
Process of liberation of the active ingredients. Other term is volatilization
Vaporization
26
Common in liquid dosage form
Loss of water
27
Visible change in the reaction is not necessarily observed but can be determined by analytical method
Chemical incompatibilities
28
The chemical interactions can be corrected by changing the order of mixing
Tolerated incompatibility
29
Change in the formulation is needed with a compound having equal therapeutic value
Adjusted incompatibilities
30
Tolerated and adjusted incompatibilities
Chemical interactions
31
Immediate and delayed incompatibilities
Nature of chemical interactions
32
Chemical reaction takes place immediately after combining the prescription ingredients
Immediate incompatibilities
33
Chemical reaction proceeds at a very slow rate and no appreciable visible change occurs which may develop on keeping the product for a long time
Delayed incompatibilities
34
Occurs when one drug losses electron to the other; VILEORA
Oxidation
35
Most common type of incompatibility and drug degradation. Triggered by presence of water, acids, bases, and catalyst
Hydrolysis
36
Commonly caused by sodium bicarbonate and carbonate buffers that cause effervescence
Evolution of gas
37
Forming inactive complex
Complexation
38
Action or process of changing from an optically active compound into a racemic compound or an optically inactive mixture
Racemization
39
Formation the pair of diasteriomers that differ only in the configuration about one carbon atom
Epimerization
40
Remedy for epimerization
Suspension of tetracycline
41
Reducing agent + oxidizing agent
Explosive mixtures
42
Two or more molecules combine to form larger molecules that contain repeating structural units
Polymerization
43
Known as photodecomposition; degradation by light; change in color
Photolysis
44
Cake formation
Cementation
45
Gel formation
Gelatinization
46
Emulsifying agent for gel formation
Acacia
47
Undesirable pharmacological interaction between two or more ingredients that leads to potentiation of the therapeutic effects, destruction of the effectiveness and occurrence of a toxic manifestation
Therapeutic incompatibilities
48
Drug, chemical or food causing the intraction
Precipitant drug
49
Drug affected by the interaction
Object drug
50
Supported by well-proven clinical studies
Established
51
Very likely but might not be proven clinically
Probable
52
Might occur and some data might be available
Suspected
53
Could occur and limited data are available
Possible
54
Doubtful; no good evidence of an altered clinical effect is available
Unlikely
55
Injury resulting from medical intervention; preventable; intentional
Adverse drug event
56
Response to a drug that is noxious and unintended, and that occurs at doses normally used in humans; unpreventable; unintentional
Adverse drug reaction
57
Dose dependent, predictable, common, and reproducible
Type A: Augmented
58
Not dose related, unpredictable, rare, unknown mechanism, serious and fatal
Type B: Bizzare
59
Occurs after antigen (pollen) binds IgE found in the surface of mast cell
Type I: Immediate of anaphylactic immune response
60
Initiated by IgG and IgM directed against antigens found on the cell membrane of a given target cell
Type II: Cytotoxic
61
Tissue deposition of antigen-antibody complexes with complement activation and tissue damage
Type III: Immune complex hypersensitivity
62
T-lymphocytes sensitized by antigen release lymphokines after subsequent contact with the same antigen
Type IV: Cell-mediated or delayed type
63
Acute generalized reactions that occur when a previously sensitized person are exposed to a particle antigen
Hypersensitivity reactions
64
Dose related and time dependent
Type C: Continuous
65
Person takes the drug compulsively despite potential harm
Addiction
66
Compulsion to the drug repeatedly and experience unpleasant symptoms
Dependence
67
Reduced effect with repeated used of the drug and need for a higher dose to produce the same effect
Tolerance
68
Time dependent
Type D: Delayed
69
No fetal risk demonstrated in controlled studies
Category A
70
No risks in animal studies but human studies are lacking
Category B
71
Animal studies may or may not have shown risk
Category C
72
There is risk of harm to the human fetus
Category D
73
Contraindicated in pregnancy and must never be used
Category X
74
Associated with thalidomide
Phocomelia
75
Associated with phenytoin
Fetal hydantoin syndrome
76
Uncommon and withdrawal
Type E: End of use
77
Unexpected failure of efficacy, common and dose-related
Type F: Failure of therapy
78
% of Counterfeit drugs
<90%
79
Any ADR produced by the admin of drug or co-exposed of the drug with another substance, which modifies the patient's response to the drug
Drug interaction
80
Occurs when two or more drugs, with or without the same overt effect, are used together to yield a combined effect that has an outcome greater than the sum of the single drugs active components alone
Synergism
81
Describes a particular type of synergistic effect - a drug interaction in which only one of two drugs exerts the action that is made greater by the presence of the second drug
Potentiation
82
Chemical reaction can be reduced by mixing the solution in dilute forms or by changing the order of mixing
Tolerated
83
Potential of effect when 2 drugs with the same active ingredient or with the same action are taken at the same time
Additive
84
Caused by a chemical or physical incompatibility when two or more drug are mixed together
Pharmaceutical interaction
85
Can occur as pharmacokinetic or pharmacodynamic interactions
Drug-herbal interactions
86
The more drugs are used by a patient, the greater potential for a drug interaction
Multiple drug therapy
87
Drugs are used for their primary effect but may also possess secondary effects that may cause the interaction
Multiple pharmacologic effects
88
Patient are be seen by different physicians who may prescribe interacting medications
Multiple prescribers
89
Patients need to follow proper instructions for taking medications
Patient noncompliance
90
Can occur at different rates in different ethnic population and at a lesser extent in different geographical areas
Pharmacogenetic interactions
91

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