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Prod331 > Solid Formulation > Flashcards

Solid Formulation Flashcards

1
Q

What are bulk solids?

A

Materials that are handled without a count in large volumes

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2
Q

What are issues with bulk solids?

A

They move awkwardly, they attack their surroundings, they suffer because of their surroundings, they change their pattern of behaves, they change their behaviour with time, they are hypersensitive to small changes

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3
Q

What plays an important role for powders and bulks solids

A

Their characterisation regarding their flow properties

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4
Q

What is the angle of repose of a powdered/granulated material?

A

It is the steepest angle od descent or dip, realative to the horizontal plane, which a material can be piled without slumping

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5
Q

How has the relationship between the angle of repose and flow properties?

A

When the angle of repose is less than 25 degrees, the flow is said to be excellent, on the other hand if the angel of repose is more than 40 degrees, the flow is considered to be poor.

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6
Q

Where do we see angle of repose in nature?

A

Antlions use the angle of repose to trap bugs in their pot, preventing them from escaping

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7
Q

What is granulation?

A

Granulation is a physical process where small particles are combined to form larger particle agglomerates. these agglomerates must be strong enough to withstand sibstantail processing, the original particle identity is retained in the agglomerates

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8
Q

What are the different approches to granulation?

A

Wet granulation/agglomeration and dry granulation

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9
Q

What are the principle mechanics of granulation?

A

Layering, crushing and layering, coalescence, abrasion transfer

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10
Q

What is the mechanism of layering in granulation?

A

Powder mix added forms a surface layer and increase the granule size

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11
Q

What is the mechanism of crushing and layering in granulation?

A

Granules break into fragments that adhere to other granules

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12
Q

What is the mechanism of coalescence in granulation?

A

Two or more granules join to form a larger granule

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13
Q

What is the mechanism of abrasion transfer in granulation?

A

The material abraded to adhere to other granules, increase in size

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14
Q

What are the reasons for granulation in pharmaceutical industry?

A

Improved material flowability, more accurate control of one weights, reducing segregation, improved compressability, increased density for shipping and storage, improved wetting and in vivo dispersion (poorly water soluble materials may be granulated with hydrophilic materials to significantly impove wetting and in-vivo dispersion), improved control of physical properties, reduced dust loss and handling hazards, improved appearance, prevention from caking and lump formation

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15
Q

Describe the basic process of granulation

A

During the granulation process small fine or coarse particles are converted to large agglomerates called granules?

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16
Q

What are the advantages of dry granulations?

A

The active ingredient is temperature and moisture sensitive,

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17
Q

What are the major objective of granulation?

A

To improve flow and compression properties and to prevent segregation of the constituents

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18
Q

What are the tree steps to the agglomeration process?

A

The active ingredients are mixed with excipients, a liquid binder may be added (but any solvents need to be removed later), drying using tray driers or fluidised bed driers

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19
Q

Describe the process of wet granulation

A

Wet granulation, a liquid binder is sprayed, particles are tubing in a drum, fluidised bed, a high shear mixer or similar. Agglomeration results from collision between two or more wet particles forming a moving liquid bridge, if the cohesion strength is greater than the breakup forces the bridge solidifies and agglomerates form

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20
Q

What is important when considering powder behaviour?

A

Particle properties and external variables

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21
Q

What external parameters are important for powder flow?

A

Consolidation, aeration, humidity level, extent of shear/strain, equipment of surface properties

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22
Q

What are some common problems with bulk solids

A

Powders can be intentiall aerated or just pick up air during processing, when flooding/overflowing occurs loss of process control can cause problems. Electrostatic buildup in powders can transform behaviour. Powders that are elcrostatically charges may fly away and stick to nearby surfaces. Particles may undergo attrition if subjected to stress, resulting in a reduction in particle size and change in shape and surface area.

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23
Q

Give examples of granulated products

A

Fertiliser granules, milk powder, cat and dog food, coffee

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24
Q

What is the main binding force in compaction?

A

Van de Waals attraction

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25
Q

Describe van der Waals attraction

A

Two molecules with the same charge, usually repel each other, however, under enough pressure the combine making an agglomerate

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26
Q

Describe rollar compaction

A

In roller compaction ingested material is broken down, sized and lubricated, compression is performed to formulate the tablet as the final dosage form

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27
Q

List the different methods of dry granulation

A

Roller compaction, pneumatic dry granulation

28
Q

List the different methods of wet granulation

A

Fluid bed granulation, high shear granulation, steam granulation, moisture activated granulation, moisture activated dry granulation, thermal adhesion granulation, freeze granulation, melt granulation

29
Q

What are the two types of wet granulation processes?

A

Fluid bed granulators, high shear mixers

30
Q

Describe fluid bed granulation

A

A process by which granule particles are produced in a single piece of equipment by sspraying a binder as solution, suspension or met onto a fluidised powder be, the latter is a bed of wild particles with a stream of air or gas passing upward through the particles at a rate fast enough to set them in motion

31
Q

Describe high shear mixer granulation

A

Dry mixing of the powders until the desired degree of uniformity is achieved. This is obtained by controlling the impeller speed and mixing time. Addition of a liquid binder by either pumping or pouring the liquid through the lid go the mixer, or by spraying it onto the mass through a pneumatic or binary nozzle. Wet mixing following binder addition and this requires additional energy until the desired consistency is obtained. Drying after granulation, the material is dried by the transfer of heat through conduction from the jacket bowl to the product

32
Q

What does the formulation of solid dosage form require?

A

Formulation of the desired structure as well as its controlled breakdown during it s end use by the consumer

33
Q

What are the three main solid dosage forms?

A

Tablets, hard and soft gelatine capsules, sustained release pellets

34
Q

What are the advantages of tablets?

A

Convenient and inexpensive

35
Q

Give examples of suitable excipients of tablets?

A

Spray dried lactose, microcrystalline cellulose, antiadherants, binders, coatings, colours, disintegrants, flavours, glints, lubricants, preservatives, sorbents, sweetness, vehicles

36
Q

What is one of the most important values for characterising tablet production

A

Compression Pressure

37
Q

What are lubricants used for in tablet making?

A

To stop the tablet from sticking to the punch

38
Q

What is friability?

A

The amount of surface area lost from tablet during handling, special machine imitates handling, tablet is weighed before and after and weight is compared

39
Q

What are the different types of tablet?

A

Plain, coated (dissolving), coated (non-dissolving), matrix (non-swelling), matrix (swelling), effervescent

40
Q

Describe plain tablets

A

Consist of active substance + excipients, cheap, paracetamol, vitamin C

41
Q

Describe matrix tablets non swelling

A

Active ingredient is embedded in a poorly soluble matrix which is permeable, the drug is released by leaching

42
Q

Describe matrix non-swelling tablets

A

Polymer matrix, drug immobilised in the dry polymer, water contact makes the polymer swell and the drug is released through pores

43
Q

Describe effervescent tablets

A

Tablets that form gas when in contact with water (pre dissolved, doesn’t take as long to feel the effects as doesn’t need to dissolve in stomach)

44
Q

Why do we coat tablets?

A

To mast the taste/odour, protect the tablet from external environment, enhance ease of swallowing, prevent irritation etc, in digestive track, increase stability, mechanical protection, facilitate handling, increase packing speed, reduce damage during the packaging process, product identification, makes the product more pleasant, branding and labelling, avoid interaction of incompatible material

45
Q

List the different types of coating

A

Sugar coating and film coating

46
Q

Describe the advantages and disadvantages of sugar coating

A

Originally developed for spoonful of sugar concept, advantages, cheap, safe, good complience, can be processed, aesthetically appealing, disadvantages, time consuming, high weight gain, trained personnel, size/weight difference

47
Q

Describe why their is space in the market for film coating

A

Sugar coating is a long process, and is skill bases, it has been replaced by film coating

48
Q

Describe how film coating works

A

Involves spraying a polymer solution, pigment plasticiser as a ting uniform film on the tablet, choice of polymer depends on the sire of release (immediate or modified release)

49
Q

Describe a coating pan for film coating

A

A metal pan mounted at a certain angle, it roates with heated air supply and exhaust duct, coating is applied by spray

50
Q

What is the first important step toward drug dissolution for tablets

A

Breakdown of tablets into granules or primary powder particles, a process known as disintigration

51
Q

What does BP stand for?

A

British Pharmacopeia

52
Q

What is hardness or crushing strength?

A

This measures the degree of force needed to fracture a tablet.

53
Q

What does hardness of a tablet depend on?

A

Granule charectèerisation, type and concentration of lubricant, the space between the upper and lower punch, if these charecteristics are not within the standard they will fail

54
Q

What is a friability test?

A

Measures the resistance of tablets or granules to abrasions or fracture, mimics the kind of force caused by collisions etc during manufacturing and handling, tablet friability testing is recognised all over as a means to determine the resistance of uncoated tablets to the abrasion and shock experienced during the manufacturing process

55
Q

What is the friability method?

A

Accurately weigh the tablet sample and place the tablets in the drum, rotate the drum 100 times, remove the tablets and loose dust, weight them accurately

56
Q

What are capsule?

A

Encapsulate powders, granules, pellets, liquid and semifluids

57
Q

Describe hard shelled capsules

A

They contain dry powdered ingredients or miniature pellets. Made in two halves a small diameter ‘body’ that is filled up then sealed using a larger diameter (cap)

58
Q

Describe soft shell capsules

A

Soft shell capsules are primarily used for oils and for active ingredients that are dissolved or suspended in oil

59
Q

What is collagen?

A

Structural protein in extracellular matrix in connective tissue, most abundant proetein in mammals

60
Q

What is gelatine?

A

Hydrolysed collagen

61
Q

What are the advantages of capsules?

A

Eliminate unpleasant taste and odour as shell is almost tasteless and odourless. Elegant in appearance. Easy to swallow, (suitable shape and slippery when moistened. Consumers prefer due to ease of swallowing, convenience & taste. Easily filled. Formulated to increase bio-availablility of poorly soluble drugs. Differentiation with product, shape colour and size. made from gelatine and so are therapeutically inert. Stability may be improved

62
Q

What are the disadvantages of capsules

A

Unsuitable for small children. Cannot be use with substances that dissolve in or react with gelatine. Become brittle under very dry conditions and may crack during filling. Absorb moisture and will soften under high humidity. Potential stability problems may be associated with capsules containing liquid fills. The manufacture of capsules require specialist manufacture and incur high production cost.

63
Q

List capsule quality controls

A

Permeability and sealing, weight variation test, uniformity of content, disintegration time test, dissolution test

64
Q

Describe permeability and sealing method for capsule quality control

A

Soft gelatine capsules are tested for physical integrity (absence and leakage) by visual inspection. Similarly hard gelatin capsules are tested for any breach of physical integrity (breakage or open cap and body

65
Q

What are sustained release tablets?

A

Tablets that do not disintegrate but ‘peel off’ a layer at a time.

66
Q

What are enteric coated tablets?

A

Tablets the don’t dissolve in the stomach but rather the intestine, they move away from the acidic conditions of the stomach to the more alkaline conditions of the intestines before they dissolve

67
Q

What other types of tablets are there?

A

Chewable, buccal, sublingual, lozenges or triches, layered, vaginal, implantation/implant

Prod331 (6 decks)

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