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Pharmaceutics > Capsules > Flashcards

Capsules Flashcards

0
Q

What are shells formed by?

A

Gelatine

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1
Q

What are capsules?

A

Solid dosage forms where the drug substance is enclosed within either a hard or a soft soluble shell

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2
Q

What are the majority of capsules produced today?

A

Hard gelatin capsules

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3
Q

What are antaacids?

A

For neutralisation of excess stomach acid associated indigestion. It also helps to protect the lining of your stomach from acid irritation.

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4
Q

Name a antaacid?

A

Aluminium hydroxide

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5
Q

What capsules are laxatives?

A

Typically soft gelatine capsules

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6
Q

What are loperamide for?

A

Acute diarrhoea

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7
Q

What are ACE inhibitors?

A

ACE inhibitors are medicines that aRe used mainly in the treatment of hypertension and heart failure

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8
Q

Name some ACE inhibitors?

A

Ramipril, Trandolapril

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9
Q

What are Beta-adrenoceptor blockers?

A

Are medicines that are used to treat a number of conditions including angina,high blood pressure,heart failure,heart attack, glaucoma and anxiety

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10
Q

Give examples of beta-adrenocepter blockers?

A

Propranolol, bedranol- modified release capsules or hard gelatin capsules

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11
Q

What are the two stages of hard gelatin capsules?

A

1 stage: shell manufacturing

2 stage: separate filling procedure

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12
Q

What are soft gelatin capsules filled with?

A

Solutions / suspensions of drugs in liquids that will NOT solubilise the shell

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13
Q

What are hard gelatin capsules filled with?

A

Powders, granules, pellets

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14
Q

What shape are hard gelatin capsules?

A

Typically oblong

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15
Q

What shape are soft gelatin capsules?

A

Spherical, oblong, oval , tube, suppository types

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16
Q

What is the size range of soft gelatin capsules?

A

1-480 minims (16.2 minim = 1L)

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17
Q

How many sizes of hard gelatin capsules?

A

8 ranging from volumetric capacity between 0.13-1.37 mL

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18
Q

What is the aim of soft gelatin capsules?

A

To mask the taste of certain unpleasant tasting medication (copaiba balsam)

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19
Q

What percentage of water is used for starch capsules?

A

13-14%

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20
Q

What temperature is used for starch capsules?

A

140-190 oC

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21
Q

What is HPMC?

A

A non gelatin capsule

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22
Q

What five things does the shell of a hard gelatin capsule contain?

A 
Gelatin
Colorants
Opaquing agents
Preservatives
Water
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23
Q

How is gelatin produced?

A

By hydrolysis of collagen taken from animal connective tissue,bone,skin and sinew

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24
Q

What is gelatin?

A

Is a long polypeptide chain which yields 18 amino acids upon hydrolysis with most prevalent: Gly and Ala

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25
Q

What are the two types of gelatin?

A

Type A and B

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26
Q

What is type A gelatin produced by?

A

Acid hydrolysis

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27
Q

What is type B produced by?

A

Alkaline hydrolysis

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28
Q

What is type A mainly manufactured from?

A

Pork skin

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29
Q

What is type B mainly manufactured by?

A

Animal bones

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30
Q

What is the isoelectric point of type A?

A

7.0-9.0

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31
Q

What is the isoelectric point of type B?

A

4.8-5.0

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32
Q

What does type A provide?

A

Plasticity and clarity

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33
Q

What does type B provide?

A

Firmness

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34
Q

What range of weight of capsules is bloom strength suitable for?

A

150g-280g

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35
Q

What is the range of capsules suitable for viscosity?

A

30-60 millipoise

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36
Q

What do colorants do?

A

Easily identify product and improve patient compliance

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37
Q

What are opaquing agents?

A

Substances that protect the drugs from the light or to conceal the contents.

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38
Q

What substances is commonly used for opaquing agent?

A

Titanium dioxide (TiO2)

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39
Q

What is water used for?

A

For the dipping method and to adjust the viscosity

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40
Q

What % of gelatin solution is prepared in large stainless steel tanks?

A

30-40%

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41
Q

Whay is a vacuum applied to the gelatin viscous solution?

A

To remove entrapped air

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42
Q

What is the capsule moisture content?

A

13-16%

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43
Q

What are some problems of capsules relevant to appearance?

A

Small bubbles
Specks in the films
Marks in the cut edge

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44
Q

What is some problems of capsules on usage?

A

Splits
Long bodies
Grease inside

45
Q

What is some problems with capsules from block filling machines?

A

Dented capsules
Imperfect cuts
Capsules with holes

46
Q

How many sizes are capsules manufactured in?

A

8

47
Q

What is the size range for gelatin capsules?

A

000-5

48
Q

What is the largest size acceptable to patients?

A

No. 0 size and 00 having an elongated body

49
Q

What are the sizes used for veterinary used and there respective capacities?

A

Sizes with No. 10,11,12 with capacities of 30,15,7.5g

50
Q

What does a moisture content of <12% mean?

A

Brittle shells/ capsules

51
Q

What does a moisture content of >18% mean?

A

Softened shells/ capsules

52
Q

What relative humidity should be maintained during handling and storing?

A

40-60%

53
Q

What does removal of humidity from the shell result in?

A

Splitting/cracking

54
Q

What does transfer of moisture towards the content result in?

A

Caking of the drug from the powder

55
Q

What would cause failure of the USP standards? And what causes this?

A

Loss of water solubility of the shell due to exposure to high humidity and temperature or traces of reactive aldehydes. Could be due to gelatin-cross linkage

56
Q

What is capsule weight variation depends on?

A

Machine speed, specific volume,flowability, presence of glidant

57
Q

What is capsule weight independent of?

A

Capsule size

58
Q

What does a high CI% mean?

A

Indicates dominant cohesive and frictional interactions between the powder particulates. So it did related to the flowability of the powder used

59
Q

What are lubricant crucial for?

A

To prevent filming in pistons and to reduce friction between the components and the powder and to facilitate the plug ejection

60
Q

What is the Carr Compressibility Index?

A

Is calculated firm the loose and tapped bulk density according the equation

61
Q

What are the powder requirements?

A

Fluidity
Compatibility
Lubricity
Moderate bulk density

62
Q

What are some other materials other than powders?

A

Breads, pellets, microtablets, tablets and pasty and liquid material

63
Q

What does drug release from the shell depend on?

A

Wearability of the powder mass
Rate that dissolution fluid penetrates the powder
Rate of disintegration and de-aggregation of the contents
Nature of the primary drug particles

64
Q

What is the filling blend for hard gelatin capsules?

A 
Active ingredient 
Fillers
Glidant said
Lubricants
Disintegrants
Surfactants
65
Q

What is the dose solubility volume?

A

It’s the volume required to dissolve the dose kg the drug

66
Q

What is the high solubility of the active ingredients?

A

Does soluble in 250ml or less water (volume of gastric fluid)

67
Q

What is low solubility?

A

Dose soluble in more than 250ml of water at 37oC

68
Q

What is the jejunal permeability?

A

2-4x10-4

69
Q

Do class I drugs have high or low solubility?

A

High solubility and permeability

70
Q

What is the advantage of micronisation?

A

Increase the surface area and enhance water solubility

71
Q

What is the limitations of micronisation?

A

High surface/mass ratio which leads to particle aggregation (cohesive interaction) which reduces the surface area for dissolution

72
Q

Why do large particle exhibit poorer flow conspiring to larger particles? And how can this be resolved?

A

Due to cohesive and frictional interactions this can be resolved by granulation

73
Q

What are fillers (diluents)?

A

Increase the bulk of the formulation and can provide cohesion to the powder

74
Q

What are commonly used fillers?

A

Lactose,microcrystalline cellulose and starch. Also inorganic salts

75
Q

What should fillers have?

A

A small particle size

76
Q

What do modified fillers offer?

A

Better compatibility and flowability

77
Q

What do glidants do?

A

They improve the flow properties of the powder mix or granules. They are finely divided dry powders added to formulations in small quantities as they are absorbed into the surfaces of the bulk powder particles

78
Q

What are the mechanisms of glidants?

A

They decrease the roughness by filling surface irregularities
They decrease attractive forces by separating bulk powder particles
They modify electrostatic charges
They act as moisture scavengers
They serve as ball bearing between bulk powder particles

79
Q

Name some commonly used glidants?

A

Colloidal silicas, cornstarch, talc, magnesium stearate

80
Q

What do lubricants do?

A

Ease the ejection of plugs
Reduce filming on pistons and adhesion of powder to metal surfaces
Reduce friction between sliding surface in contact with powder

81
Q

What is the problem with high concentrated hydrophobic lubricants?

A

Causes drug deformities

82
Q

What makes a lubricant effective?

A

Hydrophobic stearates

83
Q

Name some lubricants?

A

Magnesium stearate, calcium stearate, stearic acid

84
Q

Less effective lubricants are less hydrophobic , give some examples?

A

Hydrogenated vegetable oils , PEG, sodium stearate fumarate

85
Q

What do surfactant do?

A

Increase the wetting of the powder made and enhance drug dissolution

86
Q

What can surfactants compensate for?

A

The problem created due to the presence of the lubricant

87
Q

Name some common surfactants

A

Sodium lauryl sulphate, sodium docusate at levels 0.1-0.5%

88
Q

What does hydrophilization and granulation aim to do?

A

Improve sett ability of poorly soluble drugs using hydrophilic polymers

89
Q

What is hydrophilization?

A

Mixing drug with an hydrophilic polymer in a dry state and using a high sheer mixer

90
Q

What could wet granulation using a binder such as PVP do?

A

Improve the solubility of the drug

91
Q

What does granulation do?

A

Reduce the bulk volume, enhances flow properties, reduce agglomeration of fine particles or their adhesion to mental surfaces and improve the content uniformity of low-dose drugs

92
Q

What is the drawback of granulation? So what is used?

A

Sensitive drugs to moisture and temperature. Dry granulation or non-aqueous solvent is used

93
Q

What are some advantages of soft gelatin capsules?

A

High reproducibility , High bioavailability, hermetically sealed due to manufacturing procedure so is suitable for liquids and volatile drugs and drugs vulnerable to atmospheric drugs, wide variety of sizes and shapes

94
Q

What are disadvantages of soft gelatin capsules?

A

Additional quality controls are required, possible interaction between liquid and the soft gelatin shell which could lead to gelatin hydrolysis

95
Q

What are the basic components of a soft gelatin capsule shell?

A 
Gelatin
Plasticizer: gelatin, sorbitol, propylene glycol
Dyes
Opacifiers
Preservatives
Flavors
96
Q

What sit he aim of soft gelatin capsules?

A

To produce the smallest possible capsule consistent with maximum stability, therapeutic effectiveness, manufacture efficiency

97
Q

What can the liquid form be in soft gelatin capsules?

A

Single liquids
Combination of miscible liquids
Solution or suspension of a drug in liquids

98
Q

What does the pH range for a soft gelatin capsule have to be?

A

Liquids pH: 2.5-7.5

99
Q

What happens if Ph is <2.5?

A

Leakage due to gelatin hydrolysis

100
Q

What happens if pH is >7.5?

A

Gelatin solubility reduction due to polymerisation

101
Q

Why can’t aqueous emulsions be filled?

A

Water will be released resulting in leakage

102
Q

Name a hydrophilic liquids used?

A

PEG 400

103
Q

Name a lipophilic liquid?

A

Triglyceride oil

104
Q

What are not allowed for a filling liquid?

A

> 5% water and small alcohols

105
Q

Name a vehicle used for filling liquids

A

PEG 400 a water-miscible non-volatile liquids

106
Q

What temperature requirement must liquids have?

A

Gravity at 35oC or less

107
Q

What must the sealing temperature of gelatin films be?

A

37-40oC

108
Q

What are suspending agents for oily bases?

A 
Beeswax (5%)
Paraffin wax (5%)
Animal stearates (1-6%)
109
Q

What are some suspending agents for non-oily bases?

A

PEG 400, PEG 600 (1-5%)
Solid non-ionics (10%)
Solid glycol esters (10%)

110
Q

What must a container dispensing capsules be?

A

Tight,well-closed and light resistant

111
Q

How do you work out the % of dose in a capsule?

A

Divide the dose in mg by the total weight of the capsule in mg then x 100

Pharmaceutics (6 decks)

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