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z F1: Pharmaceutics > Exam 1 Lecture > Flashcards

Exam 1 Lecture Flashcards

1
Q

Drug discovery lead identification and target identification

A

Lead Identification: Natural products, synthesis, rational drug design, focus mainly on molecule

Target Identification: genomics proteomics, metabolomics, looks at the target

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2
Q

Bioprospecting

A

Exploitation of biodiversity for the purpose of pharm development

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3
Q

Combinatorial Chemistry

A

large numbers of compounds generated quickly (AxBxC)

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4
Q

What is Pharmacogenomics

A

Study of different genes that determine drug behavior
Genes show small variation in nucleotides (SNPs)
SNPs used to predict drug response in people

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5
Q

Pharmacogenetics clinical use currently

A

Address severe cutaneous adverse reactions
Human Leukocyte Antigen
Cystic Fibrosis

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6
Q

Drug substances are generally administered to the patient as a formulation/ dosage form/ pharm product in combination with one or more __________________

A

non-medicinal agents

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7
Q

Non-medicinal agents may be used for various reasons so the drug is administered how

A

safe, efficacious, and appealing manner

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8
Q

A dosage form is defined as the ________ manifestation that contains the active or inactive ingredients that deliver a ____ of the drug

A

physical, dose

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9
Q

What are some key characteristics of the dosage form

A

state of matter (solid, liquid, gas)
delivery method (injection, transdermal, etc)
release characteristic (SR, CR)
administration site or route (SQ, intraarticular)

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10
Q

What is the need for dosage forms

A

Protect drug substance from degradation from O2/humitity
Protect drug substance from deleterious effects of gastric juices
Conceal offensive taste
Provide liquid preparations of substanced that are insoluable or unstable

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11
Q

What are excipients

A

Non-medicinal agents used in drugs
They should be compatible with drug substances

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12
Q

Requirements for excipients

A

-Must be nontoxic
-Must be commercially available
-Cost must be low
-Can not contraindicated by themselves or because of a component
-Physiologically inert
-Physically and chemically stable
-Free of microbiologic “load”
-No deleterious effect

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13
Q

What are solid dosage forms

A

Oral route of drug
Low error margin
More chemically and physically stable
Longer expiration states

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14
Q

What are some types of solid dosage forms

A

Powders
gelatin capsules
tablets
gummies

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15
Q

What are liquid dosage forms

A

oral use of liquid dosage forms who cant swallow
faster onset action than solid dosage

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16
Q

What are some types of liquid dosage forms

A

solutions
syrups
elixirs
tinctures
suspensions
emulsions

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17
Q

What are semi-solid dosage forms

A

Ointments, pastes, creams, gels
Medicated or non-medicated
Used for topical local effects
Some used for systemic effects (absorbed through skin)

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18
Q

Pharmaceutical inserts

A

-Medicated solid dosage forms for rectum, vagina, urethra
-Melt or soften at body temperature
-Disintegrate in body fluids

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19
Q

Sterile dosage forms

A

-Free of viable microorganisms
-Parenteral, ophthalmic, irrigating preparations are most common
-must be free from microbial contamination and toxic components because they travel throughout the body

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20
Q

Modified-release dosage forms

A

-Delay or extend release of drug
-Enteric coated tablets or capsules that pass through stomach unaltered & release medicine in intestine
-Release in a controlled manner, predetermined tate, duration, location

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21
Q

What are powders

A

-single solid or mixture of solids in a finely divided state
-one or more drugs that can be used or mixed
-external use by dusting onto the skn, bandages, clothing
-internal use applied to mucous membranes, air steams to nose or lungs

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22
Q

Efflorescent powders
Hygroscopic powders
Deliquescent powders

A

Efflorescent powders: drugs containing water that are released when powders are manipulated or stored under low RH
Hygroscopic powders: solid drugs or chemicals that absorb moisture from air
Deliquescent powders: subset of hygroscopic powers

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23
Q

Uses of powders

A

Topical bulk powders (50-150 mcg)
Bulk powder for internal use
Powders and granules for capsules and tablets
Aerosol powders (1-5 mcm)

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24
Q

Physico-chemical properties of powders

A

-Atoms or ions on surface of solid particle exposed to different kinds of forces
-Gives rise to surface free energy which plays a role in interaction between particles

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25
Q

What factors affect the flow properties of powders

A

Powers are hydrogenous entity which include solids, liquids, or gases

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26
Q

Presence or absence of ____________ moisture at the sollid-air interface affects interparticle interactions

A

absorbed

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27
Q

Mechanical Interlocking

A

particles of a certain shape can mechanically interlock and resist flow

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28
Q

How do you measure the flow of powders

A

The angle of repose
-Its the max angle possible between the surface of a pile of powder and horizontal plane

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29
Q

Eutectic Mixtures

A

Mixture of two or more substances that become sticky, pasty, or may liquefy when mixed together at room temp
-Concentration dependent
-Have to be completely miscible

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30
Q

The increase of eutectic mixture dissolution rate is achieved by a combination of what effects

A

Reduction of particle size unachievable with other methods of particle size reduction
Increased wettability
Reduced aggregation and agglomeration

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31
Q

What does d50 sieve opening mean

A

It is the size at which 50% of powder will pass through the sieve

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32
Q

What factors does surface area influence

A

Dissolution rate
Suspendability
Uniform distribution
Penetrability
Level of grittiness

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33
Q

Microscopy

A

Sample sized through the use of calibrated grid background

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34
Q

Sedimentation rate

A

settling velocity of particles measured through a liquid medium using gravity or centrifuge

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35
Q

What are the steps in compounding powders

A

Particle size reduction
Sieving
Mixing
Packaging

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36
Q

What are the particle size reduction techniques used in compounding

A

Trituration (mortar and pestle)
Pulverization by intervention (recrystallization)
Levigation (mortar and pestle with some liquid)

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37
Q

What is geometric dilution and spatulation

A

geometric dilution: blending two or more powder ingredients of in equal quantities until final volume achieved
spatulation: mixing powders on an ointment slab using a spatula

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38
Q

Cambia brand name

A

diclofenac potassium

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39
Q

Psyllium brand name and active ingredient

A

metamucil, psyllium husk

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40
Q

Methylcellulose brand name and active ingredient

A

citrucel, citric acid

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41
Q

Polyethylene Glycol 3350 brand name and active ingredient

A

Miralax, PEG 3350

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42
Q

Nystatin topical powder brand name and active ingredient

A

Nystop, nystatin

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43
Q

Secnidazole brand name and active ingredient

A

solosec, secnidazole antibacterial

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44
Q

Fosfomycin brand name and active ingredient

A

monurol, fosfomycin tromethamine

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45
Q

Nitroglycerin sublingual powder brand name and active ingredient

A

GoNitro, sublingual powder

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46
Q

What are capsules made out of

A

Gelatin, starch, or plant (cellulose)

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47
Q

What are some advantages of capsules

A

-Better bioavailability than tablets
-Ideally suited for clinical trails and used in prelim drug studies

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48
Q

What are hard gelatin capsules made out of

A

cattle bones, cattle hides, pork skin

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49
Q

What are additional additives in hard gelatin capsule shells

A

Dyes
opacifiers
plasticizers
preservatives

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50
Q

How does humidity effect gelatin

A

Moisture gets absorbed and capsules distort/stick together
In dryness capsules become brittle and breal

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51
Q

How is gelatin created

A

By hydrolytic extraction of treated animal collagen
-have a body and cap and interlock

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52
Q

What are important considerations for hard gel capsule manufacturing

A

Viscosity
Mold pin dimensions
Drying time
Moisture content

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53
Q

What are the excipients used in hard gel capsules

A

Diluent/Filler
Disintegrates
Lubricant/Glidant

54
Q

Capsules are filled with powders of various densities therefore need to calibrate with specific powder. What are the calibration steps

A

Only bodies are filled
Pack body
Weight capsules and determine average capacity
use capacity to calculate amount of diluent needed to fill

55
Q

Capsule manufacturing steps

A

Rectification: capsule orientation
Separation of caps from body
Dosing of fill material
Replacement of caps and ejection of filled capsules

56
Q

Capsules quality control test steps

A

Description, identification, strength, impurities
Weight variation test (need 30 units)
Dissolution testing
Content Uniformity Test
Loss on drying
Water determination
Disintegration testing

57
Q

What are the plasticizers used in gelatin

A

Glycerol, sorbitol, water
the amount of plasticizer determine the hardness of the shell

58
Q

What kind of drugs are these
Trimterene
Ramipril
Diltiazem
Disopyramide
Dabigatran

A

Hard gelatin capsules

59
Q

What kind of drugs are these
Aspiring
Doxycycline
Emtricitabine
Typhoid live vaccine
Carbidopa
Methylphenidate

A

Hard gelatin capsules

60
Q

What kind of drugs are these
icosapent ethyl
dronabinol
benzonatate

A

Soft gel

61
Q

What is U.S. pharmacopeia

A

set up standards for medicines, pharm ingredients, and excipients

62
Q

Activities of pharmacopeia include

A

quality standards of article
performance verification tests

63
Q

What is USP 797, USP 797, USP 800

A

USP 797: non-sterile compounding
USP 797: sterile compounding
USP 800: handling hazardous drugs

64
Q

What is simple compounding

A

USP monograph or peer-reviewed journal article
reconstituting or manipulating commercial products

65
Q

What is moderate compounding

A

stability data unavailable
requires speical calculations or procedures

66
Q

What is complex compounding

A

requires special training enviornment, facilities, equipment, and procedures

67
Q

What is the beyond use date for non-preserved aqueous, preserved aqueous, non-aquesous oral liquids, and other non-aqueous forms

A

non-preserved aqueous: 14 days (aw>0.6)
preserved aqueous: 35 days (aw>0.6)
non-aquesous oral liquids: 90 days (aw<0.6)
other non-aqueous forms: 180 days (aw<0.6)

68
Q

What is the difference between master formulation record and compounding record

A

master formulation record: what you should do (reference)
compounding record: what you did (use the reference)

69
Q

What is selection, handling, and storage compounding components

A

selection: use best judgement
handling: use before expiration date
storage: store as directed

70
Q

Immedite release tablets contain what three things

A

wet granulation
double compaction
direct compression

71
Q

What are buccal tablets

A

absorbed directly through oral mucosa

72
Q

What are effervescent tablets

A

produce bubbles when placed in water (mix of acids)

73
Q

What are the two modified-release tablets

A

delayed-release
extended-release

74
Q

Advantages and disadvantages of tablets

A

advantages: lowest cost production, greatest dose precision and least variable, best combine properties
disadvantages: amorphous drugs resist compression and form poor compacts

75
Q

challenges during preparation if tablets

A

need to use more binder and increase compression pressure

76
Q

Difference between lubricants and glidants

A

lubricants: reduces friction
glidants: reduce resistance to flow

77
Q

Direct compression

A

blending the API with excipients
compressing finished tablets

78
Q

Wet granulation

A

moisten powder by adding aqueous or hydro-alcoholic agent, then passed through meshes

79
Q

Fluidized bed granulation

A

powder mix is suspended in air in a fluidized bed granulator

80
Q

Capping and lamination

A

capping: partial or complete separation of the top or bottom crowns of a tablet from main body
lamination: separation of tablet into two or more layers

81
Q

Tablet picking and sticking

A

picking: material from tablet removed by punch
sticking: material removed from adhesion to die wall

82
Q

Mottling

A

unequal distribution of color on a tablet due to dye migration

83
Q

What is this process apart of:
description, identify, assay, impurities, weight variation, loss on drying, water determination, residual solvents, disintegration, tablet friability, breaking force, uniformity test, dissolution test

A

quality control of tablets

84
Q

Importance of tablet coating

A

control release of drug from tablet
protect drug from gastric environment of stomach

85
Q

Film-coated tablets

A

thin layer of polymer
better mechanical strength, good protection
designed to rupture or expose core at desired pH

86
Q

Enteric coated tablets

A

pass unchanged through stomach to intestines
resistance to acid
disintegration in higher pH environment

87
Q

What are warfin, oxycodone hydrochloride, abuse deterrent formulation, doxycycline, isosorbide mononitrate, methylphenidate, OROS, ondansetron ODT

A

Tablet and ODT examples

88
Q

What are ODTs

A

intended to disintegrate rapidly w/in mouth fast

89
Q

Advantages of ODT

A

increase bioavailability
rapid onset aciton

90
Q

What is the difference between excipients used in ODT and tablets

A

ODTs have super disintegrants

91
Q

Melt granulation

A

mix of active agent and water-soluable carrier

92
Q

Effervescent granules

A

contains medicinal agent in a dry mixture usually composed of acid
release CO2

93
Q

Three methods of effervescent granules

A

wet method
hot melt extrusion technique
dry method

94
Q

Solution

A

contains one or more dissolved chemical substances in a suitable solvent or mixture of mutually miscible solvents

95
Q

Spirits and Tinctures

A

Spirits: alcohol vehicles containing volatile substances
Tinctures: alcohol vehicles containing chemical derived from plants and minerals

96
Q

Elixirs
Syrups

A

Elixirs: sweetened hydroalcoholic vehicle containing pharmacological active ingredients
Syrups: sweetened, non alcoholic vehicle containing pharmacological active ingredients

97
Q

Disadvantages of solutions

A

drugs less stable in solution vs solid product
difficult to transport
require proper measurement

98
Q

Ideal solution

A

forces that hold the solute molecules together, solvent molecules together, solvent and solute molecules

99
Q

Non-ideal or real solutions

A

solutions in which the solute-solute, solvent-solvent, solute-solent interactions are not equal

100
Q

The process of dissolution involves

A

-breaking IMF in solute
-separation of molecules of solvent to provide a hole in solvent for the solute molecule
-interaction between solvent and solute molecules or ions

101
Q

Solubility issues with most pharmaceuticals

A

solubility in water depends on presence of polar groups
increase in molecular weight decrease water solubility

102
Q

Factors affecting solubility

A

Particle size
pH
Temperature

103
Q

Sterile water for inhalation

A

same as sterile water for injection
pyrogen free
no parenteral use

104
Q

Sterile water for irrigation

A

same as sterile water for injection
unique packaging requirements

105
Q

Bacteriostatic water for injection

A

made from sterile water for injection
contains one or more antimicrobial agents
pyrogen free
not for neonates

106
Q

Alcohol solvent

A

95% v/v
issue = pharmacological effects

107
Q

Ways to enhance dissolution

A

increase surface area, reduce particle size
add ingredient to vehicle
stir vehicle while adding solute

108
Q

Solubility enhancing technique has to be adopted to improve ____________

A

bioavailability

109
Q

Cosolvents

A

-aux solvent employed to improve solubility of dug substances
-enhance physical and chemical stability of prep
-increase solubility hydrophobic molecules by reducing constant solvent

110
Q

Under no circumstances are ____________ and __________ permitted in any pharmaceutical preparation

A

methyl alcohol and ethylene glycol

111
Q

Surfactants

A

when placed in water it forms micelles
micellar solubilization

112
Q

Complex agents

A

complexation relies on weak forces between drug and complex agent

113
Q

Sprays and liniments

A

sprays: aq or oleaginous solutions in coarse droplets or finely divided solids applied topically to skin or naso tract
liniments: alcoholic or oleaginous solutions or emulsions of medication intended for external use

114
Q

What are disperse systems

A

pharmaceutical preparations comprised of a dispersed phase and dispersion medium

115
Q

What are suspensions

A

a biphasic preparation consisting of solid particles dispersed throughout a liquid phase

116
Q

What is a main reason for preparing suspensions

A

control duration or on set action

117
Q

What is sedimentation

A

smaller particles move slower
density of particles is greater than vehicle

118
Q

What are the two electric properties of suspensions

A

selective adsorption of a particular ion species
ionization due to surface groups

119
Q

Stern layer + diffuse layer =

A

electric layer

119
Q

Effective charge of particle is known as what

A

zeta potential

120
Q

When attractive force exceed repulsion forces and particles come together what do they form

A

floccules

121
Q

How does flocculation affect stability of suspension

A

-enhance stability by decreasing sedimentation rate
-high or low charge leading to irreversible sedimentation of particles (caking)

122
Q

What is rheology

A

study of flow of fluids and deformation of solids

123
Q

Non-newtonian fluids

A

substances that fail to follow newtons equation of flow

124
Q

Plastic fluids

A

does not flow until yield point from stress is reached
ex: flocculated suspensions (more flocculation = higher yield value)

125
Q

Pseudoplastic fluids

A

Linear polymers in solution
viscosity of substance decreases with increasing rate of shear

126
Q

Dilatant fluids

A

certain suspensions with a high percentage of dispersed solids
increase volume when sheared

127
Q

What factors affect rheologic properties and viscosity measurement of disperse systems like suspensions

A

Temperature
Shear rate/Shear stress
Composition and excipients

128
Q

How to prepare a suspension

A

reduce particle size
blend powder
adding wetting agent
add liquid ingredients
transfer suspension into appropriate size conical
use vehicle to rinse material from mortar

129
Q

What are these examples of:
Fluticasone Propionate Inhalation Aerosol
Insulin NPH
Medroxyprogesterone acetate
Amoxicillin/Clavulanate
Cefixinme
Exenatide ER
Aripiprazole ER

A

suspensions

z F1: Pharmaceutics (10 decks)

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