Price

Question 1

What does product development involve

Answer 1

Converting candidate drugs into dosage forms for registration and sale

Question 2

Define generic drug

Answer 2

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

Question 3

Preformulation and bio pharmaceutical studies will highlight what

Answer 3

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

Question 4

What is preformulation

Answer 4

The physicochemical characterisation of the properties of the compounds

Question 5

What does preformulation provide

Answer 5

Critical information for formulation development and scale up

Question 6

For dosage form there must be a clear understanding of what

Answer 6

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

Question 7

A solubility of 1mg/ml indicates what?

Answer 7

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

Question 8

The crystal structure of a compound determines what properties

Answer 8

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

Question 9

Define habit

Answer 9

The external shape of a crystal is termed the habit

Question 10

What 4 things does crystal habit influence

Answer 10

Flow
Compaction
Stability
Solubility

Question 11

What does the Miller index provide information about?

Answer 11

The molecular ordering of the surface of a crystal face

Question 12

How many types of crystal structure are there?

Answer 12

7

Question 13

Define crystal structure

Answer 13

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

Question 14

Define unit cell

Answer 14

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

Question 15

Name the seven types of crystal structure

Answer 15

Cubic
Tetragonal
Orthorhombic
Rhombohedral
Monoclinic 
Triclinc
Hexagonal

Question 16

Molecules arrange themselves into how many bravais lattices?

Answer 16

14

Question 17

What does crystal form mean

Answer 17

Means ordering of atoms and molecules to form crystal structure

Question 18

What is polymorphism

Answer 18

When the same chemical compounds exist in different crystal forms

Question 19

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

Answer 19

Pseudopolymorphs

Solvates and hydrates

Question 20

What is enantiomorphism

Answer 20

When chiral molecules crystallise as mirror images of one another

Question 21

What’s the objective of pharmaceutical research and development

Answer 21

Convert synthesised chemical compounds into candidate drugs for development

Question 22

What’s an excipients

Answer 22

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

Question 23

What’s a diluent

Answer 23

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

Question 24

What’s the principle diluent and why?

Answer 24

Lactose

Pleasant taste, rapidly dissolves, is not hygroscopic

Question 25

What's the BEST diluent

Answer 25

Microcrystalline cellulose

Question 26

Name 4 diluents

Answer 26

Lactose Dicalcium phosphate Starches Microcrystalline cellulose

Question 27

Is microcrystalline cellulose sensitive to lubricants?

Answer 27

YEAH

Question 28

What's the role of lubricants in tablets

Answer 28

Necessary to prevent adherence of the formulations to punches and dies

Question 29

Name the 2 most effective PUNCH lubricants

Answer 29

Talc | Magnesium stearate

Question 30

Name the most effective DIE lubricant?

Answer 30

Stearic acid

Question 31

What's the role of glidants (flow agents)

Answer 31

Added to improve flow properties of granules

Question 32

What's the most effective/common glidant?

Answer 32

Fumed silica- a synthetic amorphous colloidal silicon dioxide

Question 33

What is silicified MCC

Answer 33

``` (Two in one) MCC and silicon dioxide One supplier (pen west) very expensive ```

Question 34

How many disintegrants should you add to a tablet?

Answer 34

Two

Question 35

What does a disintegrant do?

Answer 35

Act to promote break up of tablets in vivo

Question 36

Give a key example of a disintegrant

Answer 36

STARCH

Question 37

Name a super disintegrant

Answer 37

Modified starch- sodium starch glycollate

Question 38

What's the role of binders?

Answer 38

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

Question 39

Should liquid additives be removed prior to compression?

Answer 39

Yes

Question 40

Name three binding agents

Answer 40

Starch mucilage Gelatin Polyvinylpyrrolidine (PVP)

Question 41

What's an adsorbent?

Answer 41

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

Question 42

Name 4 common adsorbents

Answer 42

Fumed silica Microcrystalline cellulose Kaolin Magnesium carbonate

Question 43

Name the 8 steps to the tabletting process

Answer 43

``` Weighing Mixing Granulation Tabletting QA check Dissolution Coating QC check ```

Question 44

Name two types of tablet presses

Answer 44

Single (eccentric) | Rotary presses

Question 45

Commercial manufacture of tablets is performed almost exclusively on what?

Answer 45

Rotary tablet machines

Question 46

Name 4 ways to process tablets

Answer 46

Mounded tablets Compressed tablets Sintered tablets Effervescent tablets

Question 47

Name two dry methods of compressing tablets

Answer 47

Dry methods | Wet methods

Question 48

Name two types of dry methods for compressing tablets

Answer 48

``` Direct compression Dry granulation (slugging, roller compaction) ```

Question 49

Do you add lubricant last?

Answer 49

YES

Question 50

Name 4 types of blender used in dry mixing

Answer 50

V-cone Double cone blender Ribbon blender Bin blender

Question 51

What diluent is often used in wet granulation?

Answer 51

Dicalcium phosphate (insoluble in water)

Question 52

Name 7 diluents

Answer 52

``` Dicalcium phosphate Alpha-lactose mono hydrate Mannitol MCC sodium chloride Sucrose Starch ```

Question 53

Name 3 anti friction excipients

Answer 53

Starch Talc Colloidal silica

Question 54

Name two fillers used in the direct compression of chewable tablets

Answer 54

Mannitol | sorbitol