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Medicines design II - solid dosage forms > L10 Tablets > Flashcards

L10 Tablets Flashcards

0
Q

Define tablet

A

Compressed powder of drug and inert excipients

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1
Q

Define medicine

A

A drug suitable for administration to the public

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2
Q

Define capsule

A

Drug and excipient contained in a gelatin shell

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3
Q

Caplet define

A

Compressed powder in the shape of a capsule

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4
Q

When did first tableting machine appear

A

1843 - to form potassium carbonate compacts

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5
Q

Wellcome first used the word tablet in 1878. Now the most popular dosage form …. %

A

70% with over 500 pharmacopeia entries

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6
Q

Eight types of tablet

Which ones much had soluble excipients?

A 
Un coated
Sugar/film coated
Controlled release
4 Effervescent
Soluble
Chewable
Sublingual
8 Lozenges
4-8 must be soluble as pt don't like grittiness
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7
Q

Advantages of tablets

A
  • Convenience light,portable, compact)
  • accurate dosage / min variability
  • greater physiochemical stability than liquid preps
  • rate of release can be tailored
  • mass production
  • simple and cost effective
  • patient acceptability
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8
Q

Disadvantages of tablets

A

Swallowing
Difficulty to prepare certain formulations (eg. Sub 50microg)
Poor wetting and low solubility drugs
Bitter taste/bad odour
Oxygen/moisture sensitivity requires coating of some tablets p

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9
Q

Essential tab properties

A
  • accurate/uniform dose
  • uniform weight/appearance/diameter
  • recognisable/patentable shape (difficult to make Viagra diamond -less counterfeits)
  • must withstand stress of processing and a handellnig
  • capable of breaking down in the stomach
  • suitable dissolution rate
  • moisture and temperature stability
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10
Q

For particulate systems to be made into tablets 3 requirements

A
  1. Particles sufficiently free flowing
  2. When cub jet to force the particles compact and adhere with adequate strength
  3. Adhesion by the tablet must be avoided
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11
Q

Outline of tablet manufacturing process

A

Mixing - for consistency and flow characteristics
Tableting - fill, compaction, ejection
Coating - protective/palatable coaching

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12
Q

Purpose of granulation

A

Ensure drug is in every part if powder and thorough mixing

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13
Q

Tablet punches and dies are changed every…. To ensure….

A

Five days to ensure quality control, unique identifier

Security and accountability

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14
Q

Output of tableting machines

A

3000 to one million per hour

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15
Q

Principle of how tableting machine works

A

Die is filled to certain depth with powder
Compressed between two punches
Compression force ended by removal of upper punch
Lower punch moves upward to eject tablet

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16
Q

Two types of tablet press

A

Single (eccentric punch press)

Rotary presses

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17
Q

Single punch ores movement is controlled by

A

Eccentric cam

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18
Q

what is the niche for signs punch machines?

A

Developing formulations in early batches for manufacturing due to limited availability of drug substance. In research and development labs.

Slow production rates 85/mi

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19
Q

Feed of a single punch machine is called

A

Shoe - fills up die and later pushes formed tablet away

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20
Q

Commercial manufacture machines are usually

A

Rotary tablet machines. Up to 79 station each producing 105

/min

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21
Q

How do we ensure a tablet is the exact weight

A

Use the volume of the die, fill in with powder.

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22
Q

Plastic deformation

A

Not reversible once stress is removed.
There is a yield point. Until then Young’s modulus applies.
Once energy cannot be held anymore it is released as heat and plastic deformation occurs

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23
Q

Plastic deformation is desirable/undesirable

A

Desirable. No bonds formed by tablet stays this shape

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24
Three stages of powder compression
Densification - rearrangement of powders to minimize free space, dependent on force, size, friction Deformation - particles have no more room, plastic, eleaxtic, fragmentation may occur (lactose) Bonds form- particles very close together so gecko forces kick in, van der waals, electrostatic, solid bridges by dissolution and recrystallisation
25
Why do we use metal for dies etc?
deformation produces a lot of heat, conduct the heat away
26
Four types of tablets by production method
Moulded Compressed Sintered Effervescent
27
Moulded tablets formed by
Moulding a soft mass with suitable solvent - advantage is quick disintergreation in water
28
Prep process of moulded tablets
``` Drug + diluent Moisten with alcohol Mix into wet mass Fill holes in top portion of mould Press top portion of mould into lower and press to place tablets in top of pegs Dry, remove and package. ```
29
Compressed tablets can be divided into two methods
1. Wet granulation 2. Dry methods: - dry granulation (slugging or roller compaction) - direct compression
30
Why is dry granulation more popular than direct compression
Ensures consistency and distribution of drug in tablet
31
Why do we make particles smaller for direct compression?
Gravity with segregate particles bit size if they are too large. Smaller size makes them stick to eachother more so less segregation
32
Direct compression in three steps
Size reduction Mix active, filler, disintergrant, glident, diluent, lubricant Compression
33
Direct compression - Dry mixing function
Ensure uniformity throughout blend
34
Steps that should be taken to reduce agglomerate and lumps in direct compression
Size reduction and sieving
35
Four blender available for direct compression
Ribbon Double cone V Bin
36
Compression vehicles for direct compression
``` Anhydrous lactose Dicalcium phosphate Granulated mannitol MCC starch Compressible sugar ```
37
Granulation define
Process in which primary powder particles adhere to form large multi particulate entities called granuales
38
Granules are formed by... 2
Direct compression or by binding agent
39
Powdered or granulated material is easier to compress into a tablet
Granulated
40
What process of granulation is most common
70% of companies us wet granulation
41
Three examples of wet granulation
Wet massing Spray granulation High sheer granulation
42
Advantage of high sheer granulation ?
You can use acoustic Shane to know when it's done
43
When is wet gran especially hard?
Low solubility
44
Why granulate?
To produce uniform, normalised particles with: Good flow properties Increased compressibility Agglomeration and segregation resistance Reduction in dusting (easier to handle, doesn't go up in a cloud)
45
How large are granules?
200-400microm
46
what else is added to the granules
Plasticisers and binders | For compressibility and to resist segregation
47
Polymeric binding distribution in dry granules
Polymer adheres to granule surface
48
Polymer distribution for wet granules
Rather than a dot of polymer it's a line
49
Polymer distribution in spray granules
Polymer covering surface
50
High sheer granulation is similar to wet but...
We spray
51
Advantages of dry granulation over wet
``` econmical Less equipment and space Eliminate addition of moisture and heat Can cope with wide range of materials Process is easily scaled up Mechanical strength of the product is uniform ```
52
Slugging is a method of wet or dry granulation?
dry
53
Slugging
``` Ingredients mixed and precompressed on a table press than operates at significantly higher pressure than normal table press. Formed slug (1inch) is subsequNtly ground to uniform size. ```
54
why is slugging used
For powder that cannot be directly compressed because of poor flow or compression properties. Maybe for heat or moisture sensitive materials such as aspirin or vitamins
55
Communition is
Particle size reduction (from slug).
56
Slugging, what is out into the slug?
Drug Filler Lubricant
57
Steps of slugging
``` Blending Precompression Communition Sizing Blending (glident,lubricant,disintergrant) ```
58
Dry granulation can be achieved by slugging or
dry roller compaction
59
Dry roller compaction is
Granulation achieved by passing powder between two rollers that compacts material to much higher pressure than tablet compress
60
What sort of materials is dry roller compaction used for
Low density - to achieve sufficient bulk to allow tablet compression
61
Dry roller compaction achieves ribbons which are
25mm wide and 10-15mm thick | These are milled to produce granules
62
What is used to break up the products if dry roller compaction
Hammer mill
63
Why is 20%going into the lung not 100%?
Reproducibility not efficiency is key. | A drop in 20% wouldn't be as significant as a drop in 100%
64
compaction force is controlled by
Hydraulic pressure in roller Rotational speed of roller Rotational speed of feed screws
65
Two mills for granulation?
Oscillating type granulator | Hammer mill
66
Wet granulation process is commonly
Grinding down of drug +binder+/- intra granular excipients
67
Wet gran steps
``` Put in mixer/granulator Put through screen (wet) Dry in fluidised bed dryer Blend with extra granular excipients Compation ```
68
Disadvantages of wet gran
Laborious, Expensive Drug particles experience extensive processing
69
Particle bonding in wet granulation is driven by...
Surface tensional forces and adhesion and cohesion forces between molecules. Adhered particles form a nucleus. Liquid bridges subsequently develop, evaporation leads to solid bridging and therefore increase in tensile strength. Eg
70
Granulating liquid is ideally
A mild solvent of excipient powder to increase solid bridging
71
Why are very few wet granulation solvents available
We cannot eliminate all the solvent upon drying
72
Three wet granulation solvents
Water Isopropanol Ethanol
73
What is genreally used as a bider in wet granulation
Polymer solutions | Gelatin, starch, Synthetic polymers such as PVP
74
Why is water not and ideal solvent in when granulation
Requires a lot of heat to evaporate it
75
Steps of high sheer granulation
``` Mixing Agglomeration Drying Milling Mixing Tableting ```
76
Wet granulation intra granual excipients
Active (possibly percolated) Filler Binder (usually aqueous polymeric solution) Disintergrant (1)
77
Wet granulation extra granular excipients
Lubricant Glident Disintergrant (2)
78
Wet granulation steps
``` Size reduction Dry mixing Wet massing Size enlargement Drying Size fractionation Dry mixing Compression ```
79
What are high shear mixers
Very effecient Ideal for wet granulation Amount and additional rte of binder solution must be strictly controlled Granulation end points can be measured in processsvit

Medicines design II - solid dosage forms (11 decks)

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