info Flashcards
1
Q
a grp of gas propellants proposed by the Montreal Peotocol as replacement to CFCs
A
hydrofluoroalkanes
2
Q
the 1st oral cyclosporine ME formulation is
A
Sandimmune Neoral
3
Q
Devoid of side effects and toxicity in humans
A
GRAS grade
4
Q
transparent system obtained by the titration of a turbid o/w product w/ hexanol
A
microemulsion
5
Q
cost effective methods for filling ophthalmic oint since the product can be steriiled-filled
A
Blow Fill Seal Method
6
Q
designed to minimizethe risk involved in all stages of pharml production that cannot be eliminated through testing the final product
A
cGMP
7
Q
a quality assurance system for ensuring that the drug products are consistently produced and manufactured acc to quality std
A
AO 43 s 1999
8
Q
policy that is followed in releasing finished product and dispensing of raw mat
A
FEFO policy
9
Q
ability of a particular fmltion and pack to remain w/in its physical, cheml, therapeutic, microbiological, and tox’l specs
A
Drug stability
10
Q
failure of drug subs to meet spec
A
significant change
11
Q
for the purpose of speeding up the degradation of the API of the drug product; TO PREDICT the shelf life and det the exp date of a drug product
A
Accelerated or short term Stability studies
12
Q
it seeks to det the storage condition of a drug product
A
Real time or Long term Stability studies
13
Q
Zone I
A
temperate zone
14
Q
Zone II
A
Sub-tropical /mediterranean zone
15
Q
Zone III
A
Hot dry Zone
16
Q
Zone IV
A
Hot humid /tropical zone
where phil belongs
17
Q
Zone IV b
A
Asian testing conditions
HOT /HIGHER HUMIDITY
18
Q
temp and Rh of Zone IVa
A
30C 65%
19
Q
temp and Rh of Zone IVb
A
30C 75%
20
Q
designed to completely exhaust the drug product of all its properties
A
stress test
21
Q
purposes of stress test
A
identify the pathway of degradation
identify the products of degradation
validation of analytical procedures
22
Q
det what kind of bottles are to be used
A
stress test
23
Q
parameters used in stress test
A
temp of 50,60 onwards in 10 deg increments
> 70% Rh
Light testing
susceptibility to oxidation
susceptibility to hydrolysis (across a wide pH range)
24
Q
process involves in the addition of an excess of an active in an unstable drug prepn , to compensate loss during the manufacture of the prepn
A
Manufacturing overages
25
the stds and guidelines for the container closure systems of pharmls and biologicals are outlined by:
ICH
| Intl Conference on Harmonization
26
pharml glass is composed primarily of:
Silicon dioxide tetrahedron
27
glass type I
| cheml compo and gen descrp
silicon dioxide and boric oxide
highly resistant borosilicate glass
28
glass type II
| cheml compo and gen descrp
Sodium oxide, Calcium oxide + SiO2 tx
Treated soda lime glass
29
glass type III
| cheml compo and gen descrp
Sodium and calcium oxide
Soda lime glass fro dry products
30
glass IV NP
| cheml compo and gen descrp
Sodium and calcium oxide - non parenteral
soda lime glass
31
it is reqd for storage of dispensed materials, transport of bulk dispensed materials throughout the production area
pallets
32
space not effectively flushed w/ clean air, the minimum of obstructions to flow of clean air, such as fittings, ledges, and shelves and no extraneous equipment
dead space
33
equivalent separation facility, through w/c the staff or articles may leave and enter the ares
Anteroom
34
provides a physical division bet ech end of the area of an anteroom; assists in the operator change of outfit procedures
Step-over-bench
35
uses water miscible liq to inc the solubility of drugd such as ethanol, glycerin, sorbitol and PG
co-solvency
36
inc aq.-solubility of drugs through buffer systems
pH control
37
increasing the drug solubility by adding surfactants and solubilizing agents
solubilization
38
increasing the drug solubility by adding cheml complexing agent to the water insol API, to become water sol
complexation
39
how to correct cap-locking brought abt by sucrose
combine sucrose w/ any polyol (glycerin or sorbitol)
40
doubles the viscosity builder, due to its dextrin content (sweetening agent)
liq glucose
41
plant source of stevia powder; a healthy sugar alt for pt w/ DM
Stevia rebaudiana
42
a sweetening agent that produces a rapid onset of perceived sweetness
fructose
43
w/ bitter after taste
saccharin
44
FILTER MEDIA FOR ORAL LIQ
for syrupy liq
nylon
45
FILTER MEDIA FOR ORAL LIQ
for gelatinous soln
Felt cloth
46
FILTER MEDIA FOR ORAL LIQ
the pharml std in cmpding
kraft paper
47
FILTER MEDIA FOR ORAL LIQ
for microfiltration of sterile solns ONLY
CELLULOSE ESTER (membrane) FILTER
48
test for container closure and caps
Stress cracking and corrosion test
49
test to check the tightness of opening and closing the caps and closures
Torque testing
50
filter aids contribute to:
improved clarity and inc the flow rate of liq during filling
51
dec particle size in susp results to:
delayed rate of sedimentation, inc viscosities, uniform abs rate of the drug
52
techniques to improve drainage of susp
addition of protective colloids (silica gel or aluminum hydroxide)
silicone coating of the glass bottles
53
REDUCTION METHOD FOR SUSP
particles collide w/ each other, causing a fracture. produces 5 microns and below
Micronization
54
micronization uses (equip.)
Jet Mill
55
REDUCTION METHOD FOR SUSP
sprayed by a mist of powder to shrink in size
Spray drying
w/ the use of spray dryer
56
REDUCTION METHOD FOR SUSP
it is equipped w/ a rotor-stator mechanism. produces particles 1 micron and below
homogenization
| BEST METHOD
57
homogenization uses
homogenizer or colloid mill
58
type of emulsion for the admin and as a vehicle of fats and oils and fat soluble drugs and vitamins, and unpleasant tasting drugs
o/w type
59
ideal type of emulsion for oral admin and IV inj
o/w type
60
type of emulsion that is used as a vehicle for the dispersion of antigenic materials, vehicle for water-soluble drugs in mineral oil
w/o type
61
ideal type of emulsion for IM inj and topical app
w/o type
62
separation of the internal phase from the external phase of emulsions, wherein the internal phase floats on the surface of the product
creaming
| lighter density
63
reverse phenomenon of creaming
sedimentation
| heavier density
64
irreversible phenomenon due to: absence of protective barrier (interfacial film) along the o/w interface; insuff surface coverage of the emulsifier
coalescence
65
reversible phenomena of stable emulsion; the interfacial film is present and there is sufficient surface coverage of the emulsifier
flocculation
66
a stable emulsion should not undergo:
creaming and sedimentation
67
if sedimentation and creaming occurs, it is due to
densities of two phases
droplet sizes
viscosities
68
TYPE OF EMULSIFYING AGENT
fnxn as hydrophillic colloids, w/c incr the viscosity of the aq phase of emulsion
natural emulsifier
ex tragacanth, acacia, pectin, alginates
69
TYPE OF EMULSIFYING AGENT
composed of colloidal clays and metallic hydroxides, fnxn as wetting agent to promote flocculation
finely divided solids
70
TYPE OF EMULSIFYING AGENT
they are absorbed at oil-water interface as a monomolecular phase
synthetic emulsifier
SLS, SPANS, TWEENS, PEG
71
TYPE OF EMULSIFYING AGENT
fnxn as thickener and stabilizer
High MW alcohols
ex stearyl and cetyl alc, glyceryl monostearate
72
method of classification of surfactants applicable to NON-IONIC synthetic emulsifier
HLB
Hydrophile-Lipophile Balance system
73
to produce an o/w emulsion, choose (what type of emulsifier)
more hydrophilic emlsifier w/ a higher HLB no. 8-18
74
to produce an w/o emulsion, choose (what type of emulsifier)
more lipophilic emulsifier w/ a lower HLB no. 3-6
75
it is a transparent system obtained by titrating a turbid-oil-in-water (o/w) emulsion w/ a medium-chain alcohol, hexanol
microemulsion
76
zwitterionic type of surfactant
lecithin
77
this promotes the fmtion of microemulsion, enhance the ability to reduce interfacial tension of the system
co-surfactant
78
type of microemulsion w/c almost equal parts of oil and water exist, w/c is typically less than 140 nm
water in oil bicontinuous ME
79
oil-in-water emulsion w/ a mean droplet diameter size ranging from 50 to 1000 nm. usually the droplet size is bet 100-500nm
nanoemulsion (sub-micron emulsion)
80
nanoemulsion (sub-micron emulsion) is prepared by
high shear homogenization
81
it is usually employed in prepn of parenteral nutrition and cosmetic products
nanoemulsion (sub-micron emulsion)
82
impalpable powder has an equiv mesh no. of
100-200 of std test sieve
83
lipophilic, inh insensible perspiration, act as excellent occlusive dressings, not easily removed by washing w/ water
Hydrocarbon bases
ex vaseline, waxes, mineral oil, petroleum jelly, white wax
84
hydrophilic; formed by the addition of substances that possess polar groupings (sulfates, carboxyl, hydroxyl or ether linkages) to a HC Base
emulsifiable/absorption bases
85
reffered to as "cream"best for moist skin lesions, due to its absorptive properties, with skin vanishing effect
water washable- removable bases
86
also called as Greaseless bases; do not require addition of water in the fmulation
water soluble bases
ex PEG
87
vehicle in ophth. oint. suitable for dry eyes since it has emollient property
lanolin and lanolin alc
88
bac used in Microbial limit test
S. aureus, P. aeruginosa
89
study applicable to semisolid taht contain antifungal, antiviral, corticosteroids, antibiotics, topical for vaginal use
Dermatopharmacokinetic studies (DPS)
90
SVP , its fill vol capacity is
0.5-30 mL
91
LVPs are packed in
PVC (polyvinyl chloride) or polyolefin collapsible bags or glass type 1 vials
92
fill capacity of LVP
250 mL, 500 mL, 1000mL
SINGLE DOSE USE
93
the only sterile products that may be filled in excess of 1 L
irragation fluid and dialysis soln
94
the API is compressed in a small sterile cylinder w/o any excipients. provides extended release of drug
pellets/ implants
95
size of pellets/ implants
3.2 mm - 8 mm
96
SOLVENT FOR PARENTERAL FORMULATION
aq. vehicle for the fmaulation of parenteral soln
WFI, USP
97
SOLVENT FOR PARENTERAL FORMULATION
fro reconstitution of sterile, parenteral powder
SWFI, USP
98
SOLVENT FOR PARENTERAL FORMULATION
non-aq. vehicle of choice for the formulation of parenteral emulsions. Must be of vegetablle/plant type for faster drug metabolism
fixed oils
99
pyrogens are resistant to (what type of sterilization)
moist heat/ autoclaving
100
process involves removal of water from the parenteral soln, by sublimation, after it is frozen.
Freeze drying/lyophilization
only for heat labile or unstable drug in aq, liq form
101
to control the no. of air-borne MO in the critical areas of production of sterile products
installation of UV Lamps
does not kill MO. only CONTROLS
102
provides clean, sterile, draft-free air flow in the production area of sterile products
Laminar flow enclosure w/ HEPA filters
103
used to gain access to the critical areas of production of sterile products
Air-lock Areas
104
it measures the efficiency of parenteral filling equipment, as well as the efficiency o the person operating the machine
Total sterility test
using sterile thioglycollate fluid (FTM) or trypticase soy broth (TSB)
105
filling is done by gravity, a pressure pump filling machine or vacuum filling machine
LVP
106
in filling sterile solid, the rate of flow is slow and irregular. this can be remedied by using a filling machine equipped w/ an
auger or filling wheel
107
type of sealing wherein applicable only to the std glass ampules (w/ narrow opening) containing liquids
Tip Sealing
"BEAD SEAL" -more leakers are produced -faster to do
108
type of sealing wherein applicable only to the funnel-topped glass ampules containing sterile powders
pull sealing
more accurate, slower
109
this method kills spores as well as vegetative forms of MO by OXIDATION W/ HEAT.
dry heat method
140-260C 45 mins oven
110
this method kills spores and vegetative bacl forms by coagulation of its cell protein
moist heat method
121C 2o mins at 15 PSI autoclave
111
ideal for sterilizing rubber stoppers, glasswares, bottles/ampules/vials, uniforms, and cellulose membrane filters
moist heat method
112
a mixture of this is limited to sterilization of dry powders and plastic containers
gas sterilization
ethylene oxide and beta-propiolactone
113
it is an official method, wherein the turbidity is the measurte of growth of MO. this is applicable for non-filterable viscous parenteral emulsions and susp. as well as topicals
test tube inoculation method
| "direct transfer method"
114
it is used to induce the fever in rabbits
brewer's yeast
115
this method show physiologic response (to fever) similar to the human body. can detect pyrogens from gram-, gram+ and fungi
qualitative fever response in rabbits
116
an in-vitro test for pyrogens based on; gelling, color devt, turbidity or pption or cloudiness
LAL method, Limulus amoebocyte lysate
faster method: w/in
117
alternative to LAL method
Bacl endotoxin test (BET), monocyte activation test (MAT)
118
horseshoe crab from
limulus poliphemus
119
limitation of LAL method
detects pyrogen from gram- bac only
120
ampules that have been sealed by this method is subject to leaker's test
fusion
121
a test that a leaker will release air bubbles from the open capillary of the ampule
Bubble test
122
a test that a leaker acquires the blue color of the dye in its contents
Methylene Blue dye test
123
a special tamperproof feature of coni-snap
dual snap ring locking mechanism
124
HGC is also known as
dry filled capsules
125
MOP of HGC`
centrifugal casting method and pin method
126
SGC is also known as
Pearls
127
use to render SGC soft and plastic( elastic)
plasticizer such as glycerin and sorbitol
128
MOP of SGC by using set of molds
Plate method
ALT: reciprocating die method and rotary die method
129
a heterogenous product derived from the irreversible hydrolytic extraction of treated animal collagen
gelatin
130
obtained by partial acid hydrolysis. originates from porcine gelatin (pork skin)
type A gelatin
for plasticity, elasticity, clarity
131
obtained by partial alkaline hydrolysis. originates from animal bones (calf)
type B gelatin
for rigidity and firmness
132
contain any of the ff. animal gelatin substitute
vegetarian capsule
133
a polysacc, water-sol. based cmpd. this animal-subs is impermeable to O2 and gases, therefore it can protect drug sensitive to oxidation
pullulan
134
animal gelatin subs in Vegetarian capsules
HPMC (hydroxypropylmethyl cellulose)
135
empty HGC contains ___% moisture
12-15%
136
empty HGC should be handled in an envt w/in a RH range of
30-45%
137
it is mixed w/ water to form an oral susp
dispersible tab
138
disintegrates w/in 10-15 sec in the mouth
orally disintegrating tablet
139
API is dispersed in a gum base. chewed to release the drug, then removed from the mouth after a period of time
chewable gum
140
API is mixed in a gum base of glycerin, gelatin, and water, then molded. permitted to dissolve slowly in the mouth
pastilles`
141
API is composed w/ tha hard candy (sugar base) permitted to dissolve slowly in the mouth
lozenges
142
serve as a substi for mannitol as a diluent in chewable tablet
hydrolyzed starch w/ dextrose (celutab)
143
it is prepared by spheronization (extrusion), 3-step pot method, rotor granulation method
implants/pellets
144
the coating soln is composed of acetone, granular sugar and starch; the drug is coated onto small, inert beads w/ the coating soln
specialty coated beads or granules
145
a process by w/c drugs may be encapsulated into microscopic sized, through the formation of thin coating of "wall material" around the subs being encapsulated
microencapsulation
146
portion of the drug intended to provide sustained-release acx is combined w/ a lipid or cellulose material. it is then granulated then placed into capsules or are compressed into tab
slowly-eroding matrix
147
the drug is granulated w/ an inert plastic materialo. the granulation is compressed into tab
plastic matrix from w/c the drug is leached
148
certain drug subs when chemically combined w/ other cheml subs, form cheml complexes that maybe soluble in the body fluids, depending upon the pH of the medium
chemical complexation
149
a soln of cationic drug is passed through a column exchanger (containing resin), to w/c it complexes by the replacement of H atoms.
use of ion-exchange resins
150
TABLET COMPRESSING MACHINE
where the granulation is stored
hopper
151
TABLET COMPRESSING MACHINE
distributes the tab granulation into the die cavities
feed frame/shoe
152
TABLET COMPRESSING MACHINE
control the size and shapes of compressed tab
die cavities
153
TABLET COMPRESSING MACHINE
compacts the tablet material and ejects the compressed tab
upper and lower punches
154
TABLET COMPRESSING MACHINE
controls the descent of the upper punches
upper adjustment collar
155
TABLET COMPRESSING MACHINE
control the amt of the tab granulation that fills the die cavities
weight adjustment collar
156
serve as a binder and diluent; contains 12-15% waterto stabilize hygroscopic drugs and protect from discoloration
starch
