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IP 126 Manufacturing > Solids > Flashcards

Solids Flashcards

1
Q

Vehicle for automated

material handling system

A

Automatic Guided Vehicle (AGV)

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2
Q

container constructed of
molded plastic, fiberglass, or
plywood with steel reinforcing and is used for storage and
transportation of goods

A

Intermediate Bulk Container (IBC)

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3
Q

batch processing technology

compounding and blending in an enclosed system, dust free and automatically

maintains complete batch integrity, instant product change over, limited need for external dust control, and complete protection against the unwanted migration of materials

A

Parallel Processing

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4
Q 
Method of cleaning the
interior surfaces of
pipes, vessels,
equipment and
associated fittings,
without disassembly
A

Clean in Place (CIP)

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5
Q

Compliance to standards

A

Production Facility

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6
Q

entry from ‘E’ to ‘O’ area is restricted by _____

A

separate gowning procedure

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7
Q

complex multi-stage process

starting materials change their physical characteristics a number of times before the final
dosage form is produced

A

Manufacture of Solid DDS

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8
Q

popular sizes of Hard Shell Capsule

A

0-4

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9
Q

Hard Shell Capsule Parts

A
  1. Tapered rim
  2. Groove
  3. Indentations
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10
Q

Components of a Hard Shell Capsule

A
  1. Active ingredient/s
  2. Bulking Agents
  3. Flow Activators/Antifrictional Agents
  4. Disintegrants
  5. Surfactants
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11
Q

Hard Shell Capsule Stored at _____

A

21-25°C and 35-50% RH

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12
Q

Methods of Filling Hard Shell Capsules

A
  1. Stroking-in or Dribbling-in
  2. Auger or Spindle Dosing
  3. Tamping and Disc Dosing
  4. Tube Dosing, Intermittent Capsule Filling and Closing
  5. Tube Dosing, Continuous Capsule Filling and Closing
  6. Accofil Dosing
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13
Q

Filled with pumpable solutions or suspensions (must not solubilize the shell); also pasty materials and dry powder

A

Soft Shell Capsules (Softgels)

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14
Q

Additional Treatment for Capsules

A
  1. Dusting and Polishing
  2. Banding
  3. Printing
  4. Enteric-coating
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15
Q

Essential Components of a Tablet

A
  • Diluent/ Bulking Agent/ Filler
  • Granulating Agent
  • Flow Activator/Antifrictional Agent
  • Disintegrant
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16
Q

Less Essential Components of a Tablet

A
  • Colorant
  • Flavor and Sweetener
  • Adsorbent
  • Surfactant
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17
Q

Process-related Components of a Tablet

A
  • Diluent/ Bulking Agent/Filler
  • Granulating Agent
  • Flow Activator/Antifrictional Agent
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18
Q

Product-related Components of a Tablet

A
  • Disintegrant
  • Colorant
  • Flavor and Sweetener
  • Adsorbent
  • Surfactant
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19
Q

inert substance added to increase tablet size to a manageable size

A

Diluent

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20
Q

substance that “glue” powders together and cause them to form granules

A

Granulating Agent

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21
Q

an agent that act between surfaces in relative motion to prevent friction and wear

A

lubricant

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22
Q

a material that improves the flow characteristics of granulations by aiding in the flow of materials through smaller apertures in the tablet press

A

glidant

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23
Q

an agent that prevents granulations from sticking to the faces of the punches and die walls

A

anti-adherent

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24
Q

Methods of adding flow activators

A

Spraying; Bolting

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25
Q

Problems in fluidity

A
  • rat-holing/ piping/ funneling
  • bridging or arching
  • flooding
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26
Q

storing materials for compressing

A

Hopper

27
Q

distributing the materials into the die

A

Feed frame

28
Q

controlling the size

and shape of the tablet

A

Die

29
Q

guiding the movement of the punches

A

Cam tracks

30
Q
  • for compacting the materials within the die
  • for shaping the tablet
  • upper punch and lower punch
A

Punches

31
Q

force granules into die cavity

A

Granulation Feeding Device

32
Q

– monitors force at each compression station

– Thomas Tablet Sentinel, Pharmakontroll and Killan control System-MC

A

Auxiliary Equipment

33
Q

Remove excess powder

A

Tablet Deduster

34
Q

chills the compression components to allow the compression

of low melting point substance such as waxes

A

Fette machine

35
Q

due to air-entrapment in the granular material

A

capping

lamination

36
Q

It is due to rapid expansion of tablets when deep concave punches are used

A

CRACKING

37
Q

due to very dry granules

A

CHIPPING

38
Q

due to excess binder in the granules or

wet granules

A

STICKING
PICKING
BINDING

39
Q

due to free rotation of the

punches which have some engraving on the punch faces

A

DOUBLE IMPRESSION

40
Q

due to a colored drug, which has different color than the rest of the granular material

A

MOTTLING

41
Q

application of material to a moving bed of solids with concurrent use of heated air to facilitate evaporation of solvent

A

Coating

42
Q

Processes of Applying

A
  1. pan coating
  2. dip coating
  3. compression coating
  4. air suspension coating
43
Q

anhydrous operation wherein the powder or granular coating

material is compressed onto a tablet core of drug with a special tablet press

A

compression coating

44
Q
  • top spray
  • bottom spray / Wurster
  • tangential spray
A

air suspension coating

45
Q

• coating with colored or uncolored sugar layer
• coating is water soluble and quickly dissolves after swallowing
• protects the enclosed drug from the environment and provides
a barrier to objectionable taste or order
• enhances the appearance of the compressed tablet and permit
imprinting of manufacturing’s information
• provides insulation, taste masking, smoothing the tablet core,
coloring, and modified release

A

Sugarcoating

46
Q

provides a moisture barrier and harden the tablet surface

A

Sealing/Water proofing

47
Q

causes a rapid buildup to round off the tablet edges

A

Subcoating

48
Q

smoothes out the subcoated surface and increases the tablet size to
predetermine dimension

A

Grossing/Smoothing

49
Q

gives the tablet its color and finished size

A

Coloring

50
Q

produces the characteristics gloss

A

Polishing

51
Q

deposition of a thin film of polymer surrounding the
tablet core.

polymer is solubilized into solvent with plasticizers
and pigments tablet core.

Usually spray process is employed

A

Film Coating

52
Q

– detachment of film from the substrate
– Due to entrapment of gases in or underneath the film due to overheating
during spraying or at the end of the coating run

A

Blistering

53
Q

– film becomes chipped and dented, usually at the edges

– Due to a decrease in fluidizing air or speed of rotation of drum

A

Chipping

54
Q

– coating whereby volcanic-like craters appears exposing the surface
– Due to the coating solution penetrates the surface of the tablet, often at
the crown where the surface is more porous, causing localized
disintegration of the core and disruption of the coating

A

Cratering

55
Q

– isolated areas of film are pulled away from the surface when the tablet sticks
together and then part.
– Due to conditions similar to cratering producing an overly wet tablet bed
where adjacent tablets can stick together and then break apart

A

Picking

56
Q

– pits occur in the surface of a tablet core without any visible disruption of the
film coating.
– Due to a temperature of the tablet core greater than the melting point of the
materials used in the tablet formulation

A

Pitting

57
Q

– coating becomes dull immediately or after prolonged storage at high
temperatures.
– due to collection on the surface of low molecular weight ingredients (usually
plasticizers) included in the coating formulation

A

Blooming

58
Q

– whitish specks or haziness in the film.
– due to precipitated polymer exacerbated by the use of high coating
temperature at or above the thermal gelation temperature of the polymers

A

Blushing

59
Q

– uneven color of the film.
– Due to alteration of the frequency and duration of appearance of tablets in
the spray zone or the size/shape of the spray zone

A

Colour variation

60
Q

– Indistinct intagliations
– Due to inability of foam (formed by air spraying of a polymer solution) to
break; foam droplets on the surface breakdown readily due to attrition but the
intagliations form a protected area allowing the foam to accumulate and “set”

A

Infilling

61
Q

– film is rough and nonglossy

– Due to nadequate spreading of the coating solution before drying

A

Orange peel/Roughness

62
Q

– cracks across the crown of the tablet (cracking) or splits around the
edges of the tablet (Splitting)
– Due to internal stress in the film exceeds tensile strength of the film

A

Cracking/Splitting

63
Q 
Drug is coated onto a
particle (made from a
mixture of sugar and
starch) and then coated
with a polymer
A

Sugar seeds / Nonpareils

64
Q

Microscopic droplets
that are coated with a
very thin membrane

A

Microcapsules

IP 126 Manufacturing (3 decks)

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