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Med Design 2 > Price > Flashcards

Price Flashcards

1
Q

What does product development involve

A

Converting candidate drugs into dosage forms for registration and sale

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2
Q

Define generic drug

A

A drug which is bio equivalent to a leading brand they must be identical in dose, route, safety and efficacy as the innovator brand

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3
Q

Preformulation and bio pharmaceutical studies will highlight what

A

The most relevant physicochemical and biopharmaceutical properties of potential candidate drugs to aid candidate drug selection

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4
Q

What is preformulation

A

The physicochemical characterisation of the properties of the compounds

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5
Q

What does preformulation provide

A

Critical information for formulation development and scale up

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6
Q

For dosage form there must be a clear understanding of what

A

Stability and solubility of the active pharmaceutical ingredient (API)
An awareness of means of inhibiting decomposition increasing the shelf life of the product

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7
Q

A solubility of 1mg/ml indicates what?

A

The need for a salt, particularly if the dosage form is a tablet or a capsule

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8
Q

The crystal structure of a compound determines what properties

A

Solubility and dissolution rates
Crystal hardness (compressibility for tablets)
Chemical stability
Other: colour, heat capacity etc

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9
Q

Define habit

A

The external shape of a crystal is termed the habit

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10
Q

What 4 things does crystal habit influence

A

Flow
Compaction
Stability
Solubility

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11
Q

What does the Miller index provide information about?

A

The molecular ordering of the surface of a crystal face

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12
Q

How many types of crystal structure are there?

A

7

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13
Q

Define crystal structure

A

Crystal structure is composed of periodical aligned building blocks, unit cells

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14
Q

Define unit cell

A

Are the smallest building unit and reveals crystal structure and symmetry specific for each substance

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15
Q

Name the seven types of crystal structure

A 
Cubic
Tetragonal
Orthorhombic
Rhombohedral
Monoclinic 
Triclinc
Hexagonal
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16
Q

Molecules arrange themselves into how many bravais lattices?

A

14

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17
Q

What does crystal form mean

A

Means ordering of atoms and molecules to form crystal structure

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18
Q

What is polymorphism

A

When the same chemical compounds exist in different crystal forms

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19
Q

Special cases of polymorphisms are known as what? Give two examples

A

Pseudopolymorphs

Solvates and hydrates

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20
Q

What is enantiomorphism

A

When chiral molecules crystallise as mirror images of one another

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21
Q

What’s the objective of pharmaceutical research and development

A

Convert synthesised chemical compounds into candidate drugs for development

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22
Q

What’s an excipients

A

All the other components of a formulation other than the active drug

23
Q

What’s a diluent

A

(Bulking agent) inert substances which are added to the active ingredient to make a reasonable sized tablet

24
Q

What’s the principle diluent and why?

A

Lactose

Pleasant taste, rapidly dissolves, is not hygroscopic

25
Q

What’s the BEST diluent

A

Microcrystalline cellulose

26
Q

Name 4 diluents

A

Lactose
Dicalcium phosphate
Starches
Microcrystalline cellulose

27
Q

Is microcrystalline cellulose sensitive to lubricants?

A

YEAH

28
Q

What’s the role of lubricants in tablets

A

Necessary to prevent adherence of the formulations to punches and dies

29
Q

Name the 2 most effective PUNCH lubricants

A

Talc

Magnesium stearate

30
Q

Name the most effective DIE lubricant?

A

Stearic acid

31
Q

What’s the role of glidants (flow agents)

A

Added to improve flow properties of granules

32
Q

What’s the most effective/common glidant?

A

Fumed silica- a synthetic amorphous colloidal silicon dioxide

33
Q

What is silicified MCC

A 
(Two in one) MCC and silicon dioxide 
One supplier (pen west) very expensive
34
Q

How many disintegrants should you add to a tablet?

A

Two

35
Q

What does a disintegrant do?

A

Act to promote break up of tablets in vivo

36
Q

Give a key example of a disintegrant

A

STARCH

37
Q

Name a super disintegrant

A

Modified starch- sodium starch glycollate

38
Q

What’s the role of binders?

A

Bind powders together in the wet granulation process or granules during direct compression

39
Q

Should liquid additives be removed prior to compression?

A

Yes

40
Q

Name three binding agents

A

Starch mucilage
Gelatin
Polyvinylpyrrolidine (PVP)

41
Q

What’s an adsorbent?

A

Substances which are capable of holding quantities of fluid in an apparently dry state

42
Q

Name 4 common adsorbents

A

Fumed silica
Microcrystalline cellulose
Kaolin
Magnesium carbonate

43
Q

Name the 8 steps to the tabletting process

A 
Weighing 
Mixing 
Granulation 
Tabletting 
QA check 
Dissolution 
Coating 
QC check
44
Q

Name two types of tablet presses

A

Single (eccentric)

Rotary presses

45
Q

Commercial manufacture of tablets is performed almost exclusively on what?

A

Rotary tablet machines

46
Q

Name 4 ways to process tablets

A

Mounded tablets
Compressed tablets
Sintered tablets
Effervescent tablets

47
Q

Name two dry methods of compressing tablets

A

Dry methods

Wet methods

48
Q

Name two types of dry methods for compressing tablets

A 
Direct compression 
Dry granulation (slugging, roller compaction)
49
Q

Do you add lubricant last?

A

YES

50
Q

Name 4 types of blender used in dry mixing

A

V-cone
Double cone blender
Ribbon blender
Bin blender

51
Q

What diluent is often used in wet granulation?

A

Dicalcium phosphate (insoluble in water)

52
Q

Name 7 diluents

A 
Dicalcium phosphate 
Alpha-lactose mono hydrate 
Mannitol
MCC
sodium chloride
Sucrose
Starch
53
Q

Name 3 anti friction excipients

A

Starch
Talc
Colloidal silica

54
Q

Name two fillers used in the direct compression of chewable tablets

A

Mannitol

sorbitol

Med Design 2 (3 decks)

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