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MANUFACTURING PHARMACY > info > Flashcards

info Flashcards

1
Q

a grp of gas propellants proposed by the Montreal Peotocol as replacement to CFCs

A

hydrofluoroalkanes

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2
Q

the 1st oral cyclosporine ME formulation is

A

Sandimmune Neoral

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3
Q

Devoid of side effects and toxicity in humans

A

GRAS grade

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4
Q

transparent system obtained by the titration of a turbid o/w product w/ hexanol

A

microemulsion

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5
Q

cost effective methods for filling ophthalmic oint since the product can be steriiled-filled

A

Blow Fill Seal Method

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6
Q

designed to minimizethe risk involved in all stages of pharml production that cannot be eliminated through testing the final product

A

cGMP

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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

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8
Q

policy that is followed in releasing finished product and dispensing of raw mat

A

FEFO policy

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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

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10
Q

failure of drug subs to meet spec

A

significant change

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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

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12
Q

it seeks to det the storage condition of a drug product

A

Real time or Long term Stability studies

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13
Q

Zone I

A

temperate zone

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14
Q

Zone II

A

Sub-tropical /mediterranean zone

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15
Q

Zone III

A

Hot dry Zone

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16
Q

Zone IV

A

Hot humid /tropical zone

where phil belongs

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17
Q

Zone IV b

A

Asian testing conditions

HOT /HIGHER HUMIDITY

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18
Q

temp and Rh of Zone IVa

A

30C 65%

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19
Q

temp and Rh of Zone IVb

A

30C 75%

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20
Q

designed to completely exhaust the drug product of all its properties

A

stress test

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21
Q

purposes of stress test

A

identify the pathway of degradation
identify the products of degradation
validation of analytical procedures

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22
Q

det what kind of bottles are to be used

A

stress test

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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)

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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

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25
Q

the stds and guidelines for the container closure systems of pharmls and biologicals are outlined by:

A

ICH

Intl Conference on Harmonization

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26
Q

pharml glass is composed primarily of:

A

Silicon dioxide tetrahedron

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27
Q

glass type I

cheml compo and gen descrp

A

silicon dioxide and boric oxide

highly resistant borosilicate glass

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28
Q

glass type II

cheml compo and gen descrp

A

Sodium oxide, Calcium oxide + SiO2 tx

Treated soda lime glass

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29
Q

glass type III

cheml compo and gen descrp

A

Sodium and calcium oxide

Soda lime glass fro dry products

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30
Q

glass IV NP

cheml compo and gen descrp

A

Sodium and calcium oxide - non parenteral

soda lime glass

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31
Q

it is reqd for storage of dispensed materials, transport of bulk dispensed materials throughout the production area

A

pallets

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32
Q

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

A

dead space

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33
Q

equivalent separation facility, through w/c the staff or articles may leave and enter the ares

A

Anteroom

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34
Q

provides a physical division bet ech end of the area of an anteroom; assists in the operator change of outfit procedures

A

Step-over-bench

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35
Q

uses water miscible liq to inc the solubility of drugd such as ethanol, glycerin, sorbitol and PG

A

co-solvency

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36
Q

inc aq.-solubility of drugs through buffer systems

A

pH control

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37
Q

increasing the drug solubility by adding surfactants and solubilizing agents

A

solubilization

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38
Q

increasing the drug solubility by adding cheml complexing agent to the water insol API, to become water sol

A

complexation

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39
Q

how to correct cap-locking brought abt by sucrose

A

combine sucrose w/ any polyol (glycerin or sorbitol)

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40
Q

doubles the viscosity builder, due to its dextrin content (sweetening agent)

A

liq glucose

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41
Q

plant source of stevia powder; a healthy sugar alt for pt w/ DM

A

Stevia rebaudiana

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42
Q

a sweetening agent that produces a rapid onset of perceived sweetness

A

fructose

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43
Q

w/ bitter after taste

A

saccharin

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44
Q

FILTER MEDIA FOR ORAL LIQ

for syrupy liq

A

nylon

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45
Q

FILTER MEDIA FOR ORAL LIQ

for gelatinous soln

A

Felt cloth

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46
Q

FILTER MEDIA FOR ORAL LIQ

the pharml std in cmpding

A

kraft paper

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47
Q

FILTER MEDIA FOR ORAL LIQ

for microfiltration of sterile solns ONLY

A

CELLULOSE ESTER (membrane) FILTER

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48
Q

test for container closure and caps

A

Stress cracking and corrosion test

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49
Q

test to check the tightness of opening and closing the caps and closures

A

Torque testing

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50
Q

filter aids contribute to:

A

improved clarity and inc the flow rate of liq during filling

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51
Q

dec particle size in susp results to:

A

delayed rate of sedimentation, inc viscosities, uniform abs rate of the drug

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52
Q

techniques to improve drainage of susp

A

addition of protective colloids (silica gel or aluminum hydroxide)
silicone coating of the glass bottles

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53
Q

REDUCTION METHOD FOR SUSP

particles collide w/ each other, causing a fracture. produces 5 microns and below

A

Micronization

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54
Q

micronization uses (equip.)

A

Jet Mill

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55
Q

REDUCTION METHOD FOR SUSP

sprayed by a mist of powder to shrink in size

A

Spray drying

w/ the use of spray dryer

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56
Q

REDUCTION METHOD FOR SUSP

it is equipped w/ a rotor-stator mechanism. produces particles 1 micron and below

A

homogenization

BEST METHOD

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57
Q

homogenization uses

A

homogenizer or colloid mill

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58
Q

type of emulsion for the admin and as a vehicle of fats and oils and fat soluble drugs and vitamins, and unpleasant tasting drugs

A

o/w type

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59
Q

ideal type of emulsion for oral admin and IV inj

A

o/w type

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60
Q

type of emulsion that is used as a vehicle for the dispersion of antigenic materials, vehicle for water-soluble drugs in mineral oil

A

w/o type

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61
Q

ideal type of emulsion for IM inj and topical app

A

w/o type

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62
Q

separation of the internal phase from the external phase of emulsions, wherein the internal phase floats on the surface of the product

A

creaming

lighter density

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63
Q

reverse phenomenon of creaming

A

sedimentation

heavier density

64
Q

irreversible phenomenon due to: absence of protective barrier (interfacial film) along the o/w interface; insuff surface coverage of the emulsifier

A

coalescence

65
Q

reversible phenomena of stable emulsion; the interfacial film is present and there is sufficient surface coverage of the emulsifier

A

flocculation

66
Q

a stable emulsion should not undergo:

A

creaming and sedimentation

67
Q

if sedimentation and creaming occurs, it is due to

A

densities of two phases
droplet sizes
viscosities

68
Q

TYPE OF EMULSIFYING AGENT

fnxn as hydrophillic colloids, w/c incr the viscosity of the aq phase of emulsion

A

natural emulsifier

ex tragacanth, acacia, pectin, alginates

69
Q

TYPE OF EMULSIFYING AGENT

composed of colloidal clays and metallic hydroxides, fnxn as wetting agent to promote flocculation

A

finely divided solids

70
Q

TYPE OF EMULSIFYING AGENT

they are absorbed at oil-water interface as a monomolecular phase

A

synthetic emulsifier

SLS, SPANS, TWEENS, PEG

71
Q

TYPE OF EMULSIFYING AGENT

fnxn as thickener and stabilizer

A

High MW alcohols

ex stearyl and cetyl alc, glyceryl monostearate

72
Q

method of classification of surfactants applicable to NON-IONIC synthetic emulsifier

A

HLB

Hydrophile-Lipophile Balance system

73
Q

to produce an o/w emulsion, choose (what type of emulsifier)

A

more hydrophilic emlsifier w/ a higher HLB no. 8-18

74
Q

to produce an w/o emulsion, choose (what type of emulsifier)

A

more lipophilic emulsifier w/ a lower HLB no. 3-6

75
Q

it is a transparent system obtained by titrating a turbid-oil-in-water (o/w) emulsion w/ a medium-chain alcohol, hexanol

A

microemulsion

76
Q

zwitterionic type of surfactant

A

lecithin

77
Q

this promotes the fmtion of microemulsion, enhance the ability to reduce interfacial tension of the system

A

co-surfactant

78
Q

type of microemulsion w/c almost equal parts of oil and water exist, w/c is typically less than 140 nm

A

water in oil bicontinuous ME

79
Q

oil-in-water emulsion w/ a mean droplet diameter size ranging from 50 to 1000 nm. usually the droplet size is bet 100-500nm

A

nanoemulsion (sub-micron emulsion)

80
Q

nanoemulsion (sub-micron emulsion) is prepared by

A

high shear homogenization

81
Q

it is usually employed in prepn of parenteral nutrition and cosmetic products

A

nanoemulsion (sub-micron emulsion)

82
Q

impalpable powder has an equiv mesh no. of

A

100-200 of std test sieve

83
Q

lipophilic, inh insensible perspiration, act as excellent occlusive dressings, not easily removed by washing w/ water

A

Hydrocarbon bases

ex vaseline, waxes, mineral oil, petroleum jelly, white wax

84
Q

hydrophilic; formed by the addition of substances that possess polar groupings (sulfates, carboxyl, hydroxyl or ether linkages) to a HC Base

A

emulsifiable/absorption bases

85
Q

reffered to as “cream”best for moist skin lesions, due to its absorptive properties, with skin vanishing effect

A

water washable- removable bases

86
Q

also called as Greaseless bases; do not require addition of water in the fmulation

A

water soluble bases

ex PEG

87
Q

vehicle in ophth. oint. suitable for dry eyes since it has emollient property

A

lanolin and lanolin alc

88
Q

bac used in Microbial limit test

A

S. aureus, P. aeruginosa

89
Q

study applicable to semisolid taht contain antifungal, antiviral, corticosteroids, antibiotics, topical for vaginal use

A

Dermatopharmacokinetic studies (DPS)

90
Q

SVP , its fill vol capacity is

A

0.5-30 mL

91
Q

LVPs are packed in

A

PVC (polyvinyl chloride) or polyolefin collapsible bags or glass type 1 vials

92
Q

fill capacity of LVP

A

250 mL, 500 mL, 1000mL

SINGLE DOSE USE

93
Q

the only sterile products that may be filled in excess of 1 L

A

irragation fluid and dialysis soln

94
Q

the API is compressed in a small sterile cylinder w/o any excipients. provides extended release of drug

A

pellets/ implants

95
Q

size of pellets/ implants

A

3.2 mm - 8 mm

96
Q

SOLVENT FOR PARENTERAL FORMULATION

aq. vehicle for the fmaulation of parenteral soln

A

WFI, USP

97
Q

SOLVENT FOR PARENTERAL FORMULATION

fro reconstitution of sterile, parenteral powder

A

SWFI, USP

98
Q

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

A

fixed oils

99
Q

pyrogens are resistant to (what type of sterilization)

A

moist heat/ autoclaving

100
Q

process involves removal of water from the parenteral soln, by sublimation, after it is frozen.

A

Freeze drying/lyophilization

only for heat labile or unstable drug in aq, liq form

101
Q

to control the no. of air-borne MO in the critical areas of production of sterile products

A

installation of UV Lamps

does not kill MO. only CONTROLS

102
Q

provides clean, sterile, draft-free air flow in the production area of sterile products

A

Laminar flow enclosure w/ HEPA filters

103
Q

used to gain access to the critical areas of production of sterile products

A

Air-lock Areas

104
Q

it measures the efficiency of parenteral filling equipment, as well as the efficiency o the person operating the machine

A

Total sterility test

using sterile thioglycollate fluid (FTM) or trypticase soy broth (TSB)

105
Q

filling is done by gravity, a pressure pump filling machine or vacuum filling machine

A

LVP

106
Q

in filling sterile solid, the rate of flow is slow and irregular. this can be remedied by using a filling machine equipped w/ an

A

auger or filling wheel

107
Q

type of sealing wherein applicable only to the std glass ampules (w/ narrow opening) containing liquids

A

Tip Sealing

“BEAD SEAL” -more leakers are produced -faster to do

108
Q

type of sealing wherein applicable only to the funnel-topped glass ampules containing sterile powders

A

pull sealing

more accurate, slower

109
Q

this method kills spores as well as vegetative forms of MO by OXIDATION W/ HEAT.

A

dry heat method

140-260C 45 mins oven

110
Q

this method kills spores and vegetative bacl forms by coagulation of its cell protein

A

moist heat method

121C 2o mins at 15 PSI autoclave

111
Q

ideal for sterilizing rubber stoppers, glasswares, bottles/ampules/vials, uniforms, and cellulose membrane filters

A

moist heat method

112
Q

a mixture of this is limited to sterilization of dry powders and plastic containers

A

gas sterilization

ethylene oxide and beta-propiolactone

113
Q

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

A

test tube inoculation method

“direct transfer method”

114
Q

it is used to induce the fever in rabbits

A

brewer’s yeast

115
Q

this method show physiologic response (to fever) similar to the human body. can detect pyrogens from gram-, gram+ and fungi

A

qualitative fever response in rabbits

116
Q

an in-vitro test for pyrogens based on; gelling, color devt, turbidity or pption or cloudiness

A

LAL method, Limulus amoebocyte lysate

faster method: w/in <hr

117
Q

alternative to LAL method

A

Bacl endotoxin test (BET), monocyte activation test (MAT)

118
Q

horseshoe crab from

A

limulus poliphemus

119
Q

limitation of LAL method

A

detects pyrogen from gram- bac only

120
Q

ampules that have been sealed by this method is subject to leaker’s test

A

fusion

121
Q

a test that a leaker will release air bubbles from the open capillary of the ampule

A

Bubble test

122
Q

a test that a leaker acquires the blue color of the dye in its contents

A

Methylene Blue dye test

123
Q

a special tamperproof feature of coni-snap

A

dual snap ring locking mechanism

124
Q

HGC is also known as

A

dry filled capsules

125
Q

MOP of HGC`

A

centrifugal casting method and pin method

126
Q

SGC is also known as

A

Pearls

127
Q

use to render SGC soft and plastic( elastic)

A

plasticizer such as glycerin and sorbitol

128
Q

MOP of SGC by using set of molds

A

Plate method

ALT: reciprocating die method and rotary die method

129
Q

a heterogenous product derived from the irreversible hydrolytic extraction of treated animal collagen

A

gelatin

130
Q

obtained by partial acid hydrolysis. originates from porcine gelatin (pork skin)

A

type A gelatin

for plasticity, elasticity, clarity

131
Q

obtained by partial alkaline hydrolysis. originates from animal bones (calf)

A

type B gelatin

for rigidity and firmness

132
Q

contain any of the ff. animal gelatin substitute

A

vegetarian capsule

133
Q

a polysacc, water-sol. based cmpd. this animal-subs is impermeable to O2 and gases, therefore it can protect drug sensitive to oxidation

A

pullulan

134
Q

animal gelatin subs in Vegetarian capsules

A

HPMC (hydroxypropylmethyl cellulose)

135
Q

empty HGC contains ___% moisture

A

12-15%

136
Q

empty HGC should be handled in an envt w/in a RH range of

A

30-45%

137
Q

it is mixed w/ water to form an oral susp

A

dispersible tab

138
Q

disintegrates w/in 10-15 sec in the mouth

A

orally disintegrating tablet

139
Q

API is dispersed in a gum base. chewed to release the drug, then removed from the mouth after a period of time

A

chewable gum

140
Q

API is mixed in a gum base of glycerin, gelatin, and water, then molded. permitted to dissolve slowly in the mouth

A

pastilles`

141
Q

API is composed w/ tha hard candy (sugar base) permitted to dissolve slowly in the mouth

A

lozenges

142
Q

serve as a substi for mannitol as a diluent in chewable tablet

A

hydrolyzed starch w/ dextrose (celutab)

143
Q

it is prepared by spheronization (extrusion), 3-step pot method, rotor granulation method

A

implants/pellets

144
Q

the coating soln is composed of acetone, granular sugar and starch; the drug is coated onto small, inert beads w/ the coating soln

A

specialty coated beads or granules

145
Q

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

A

microencapsulation

146
Q

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

A

slowly-eroding matrix

147
Q

the drug is granulated w/ an inert plastic materialo. the granulation is compressed into tab

A

plastic matrix from w/c the drug is leached

148
Q

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

A

chemical complexation

149
Q

a soln of cationic drug is passed through a column exchanger (containing resin), to w/c it complexes by the replacement of H atoms.

A

use of ion-exchange resins

150
Q

TABLET COMPRESSING MACHINE

where the granulation is stored

A

hopper

151
Q

TABLET COMPRESSING MACHINE

distributes the tab granulation into the die cavities

A

feed frame/shoe

152
Q

TABLET COMPRESSING MACHINE

control the size and shapes of compressed tab

A

die cavities

153
Q

TABLET COMPRESSING MACHINE

compacts the tablet material and ejects the compressed tab

A

upper and lower punches

154
Q

TABLET COMPRESSING MACHINE

controls the descent of the upper punches

A

upper adjustment collar

155
Q

TABLET COMPRESSING MACHINE

control the amt of the tab granulation that fills the die cavities

A

weight adjustment collar

156
Q

serve as a binder and diluent; contains 12-15% waterto stabilize hygroscopic drugs and protect from discoloration

A

starch

MANUFACTURING PHARMACY (1 decks)

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