Preformulation of Solid Dosage Forms

Question 1

What is the aim of a dosage form?

Answer 1

To facilitate the delivery of Therapeutic Drugs

Question 2

What is a preformulation?

Answer 2

The first step in the ‘rational approach’ to developing a drug into a medicine

Question 3

What must a dosage form be?

Answer 3

Safe
Efficient
Reproducible
Convenient

Question 4

What does In-vivo mean?

Answer 4

In a living organism

Question 5

What does In-vitro mean?

Answer 5

In a lab environment

Question 6

What is a preformulation exercise?

Answer 6

generates mathematical and statistical data, that helps the development of a dosage form.

Question 7

What is the aim of a preformulation exercise?

Answer 7

To create a mathematical model for drug behaviour in the dosage form being studied.

Question 8

If a drug is given by GI…

Answer 8

The drug MUST permeate the gut epithelium

Question 9

Controlling factors of GI dosage forms

Answer 9

dissolution and solubility

Question 10

Optimal solubility for GI dosage forms

Answer 10

10mg/ml

Question 11

What should be done if the solubility is less than 1mg/ml

Answer 11

Put in a salt form

Question 12

How do you determine the dissolution rate

Answer 12

Noyes Whitney equation

Question 13

Is Solubility a Constant or a Variable

Answer 13

Constant

Question 14

Is dissolution a constant or variable

Answer 14

Variable

Question 15

What affects dissolution rate?

Answer 15

diffusion layers
concentration of drug solution

Question 16

How many classes are in the Biopharmaceutical Classification?

Answer 16

4 Classes

Question 17

Which Biopharmaceutical Class has high solubility, high permeability?

Answer 17

Class 1

Question 18

Which Biopharmaceutical Class has high solubility low permeability?

Answer 18

Class 3

Question 19

Which Biopharmaceutical Class has low solubility, high permeability?

Answer 19

Class 2

Question 20

Which Biopharmaceutical Class has low solubility and low solubility

Answer 20

`Class 4

Question 21

How are drugs with low solubility described

Answer 21

Brick Dust

Question 22

How to fix low solubility?

Answer 22

Make it a Salt
Polymorph (change the structure)
Reduce the particle size

Question 23

When do you convert a drug to its salt?

Answer 23

When it has a poor aqueous solubility
it is a weak acid
Or a weak base

Question 24

The equation to find the pH of a drug?

Answer 24

Henderson Hasselbach Equation

Question 25

What are the solid-state forms?

Answer 25

Crystalline, Chiral, Habits, Amorphs.

Question 26

What does the physical form of the Drug affect?

Answer 26

performances, development patentability manufacturing profitability

Question 27

What are the 3 most common primitive structures

Answer 27

monoclinic triclinic orthohombic

Question 28

What is enantiopolymorphism?

Answer 28

Changing a chiral crystalline form to its enantiomer

Question 29

What is pseudopolymorphism?

Answer 29

When solvent molecules form a crystal lattice

Question 30

What does enantiotropic mean?

Answer 30

Reversible transitions to a different form that does not undergo a phase change.

Question 31

What does monotropic mean?

Answer 31

Irreversible transitions to a different form that undergo a state change first,

Question 32

What does changing polymorphic form affect?

Answer 32

Melting point Density Stability Compressibility and more

Question 33

Where are hydrates most stable?

Answer 33

Water

Question 34

Where are hydrates least stable?

Answer 34

GI environment

Question 35

What are the 3 types of Amorphous forms?

Answer 35

Solid, Lipophillized, Oral Fast dissolving Tablets