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IP 126 Manufacturing > Solids > Flashcards

Solids Flashcards

(64 cards)

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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
Problems in fluidity
* rat-holing/ piping/ funneling * bridging or arching * flooding
26
storing materials for compressing
Hopper
27
distributing the materials into the die
Feed frame
28
controlling the size | and shape of the tablet
Die
29
guiding the movement of the punches
Cam tracks
30
* for compacting the materials within the die * for shaping the tablet * upper punch and lower punch
Punches
31
force granules into die cavity
Granulation Feeding Device
32
– monitors force at each compression station | – Thomas Tablet Sentinel, Pharmakontroll and Killan control System-MC
Auxiliary Equipment
33
Remove excess powder
Tablet Deduster
34
chills the compression components to allow the compression | of low melting point substance such as waxes
Fette machine
35
due to air-entrapment in the granular material
capping | lamination
36
It is due to rapid expansion of tablets when deep concave punches are used
CRACKING
37
due to very dry granules
CHIPPING
38
due to excess binder in the granules or | wet granules
STICKING PICKING BINDING
39
due to free rotation of the | punches which have some engraving on the punch faces
DOUBLE IMPRESSION
40
due to a colored drug, which has different color than the rest of the granular material
MOTTLING
41
application of material to a moving bed of solids with concurrent use of heated air to facilitate evaporation of solvent
Coating
42
Processes of Applying
1. pan coating 2. dip coating 3. compression coating 4. air suspension coating
43
anhydrous operation wherein the powder or granular coating | material is compressed onto a tablet core of drug with a special tablet press
compression coating
44
* top spray * bottom spray / Wurster * tangential spray
air suspension coating
45
• 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
Sugarcoating
46
provides a moisture barrier and harden the tablet surface
Sealing/Water proofing
47
causes a rapid buildup to round off the tablet edges
Subcoating
48
smoothes out the subcoated surface and increases the tablet size to predetermine dimension
Grossing/Smoothing
49
gives the tablet its color and finished size
Coloring
50
produces the characteristics gloss
Polishing
51
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
Film Coating
52
– 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
Blistering
53
– film becomes chipped and dented, usually at the edges | – Due to a decrease in fluidizing air or speed of rotation of drum
Chipping
54
– 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
Cratering
55
– 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
Picking
56
– 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
Pitting
57
– 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
Blooming
58
– 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
Blushing
59
– 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
Colour variation
60
– 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”
Infilling
61
– film is rough and nonglossy | – Due to nadequate spreading of the coating solution before drying
Orange peel/Roughness
62
– 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
Cracking/Splitting
63
``` Drug is coated onto a particle (made from a mixture of sugar and starch) and then coated with a polymer ```
Sugar seeds / Nonpareils
64
Microscopic droplets that are coated with a very thin membrane
Microcapsules

IP 126 Manufacturing (3 decks)

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