Pharmacopoeia

Question 0

EU P on solid dosage forms…

Answer 0

Place in tide of basket
37+/- 2
At the end of epic five time all must dissolve
If not release with additional units (12)
No less than 16 of 18 must disintergrate

Question 1

P Contains monographs for…

Answer 1

Active substances and dosage forms.
Qualitative and quantitative composition of medicines
Text converting excipients, preparations, chemicals, herbals etc.

Question 2

Requirements of in vitro systems

Answer 2

Experimentally sound
Precise, accurate, repeatable results
Sufficient knowledge if in vivo relevance of data obtained

Question 3

EU set specifications on…

Answer 3

Dissolution apparatus
Medium (compulsion, temp, vol)
Rotational speed/flow rate
Time, method, amount, monitoring conditions
Methods of analysis
Acceptance criteria

Question 4

Advantage of rotating basket or paddle

Answer 4

Simple, robust
Standardised
Experience
Possible pH change during
Automation

Question 5

Disadvantage specific to paddle

Answer 5

Cloning
Bit under paddle does to move - instead use peaked vessel

(Also floaters and sinker variation is an issue)

Question 6

Disadvantages of rotating cylinder and paddle?

Answer 6

Deaertion
Single container - difficult to change pH
Floaters/sinkers
Limited volume
Special dosage forms?

Question 7

Reciprocating cylinder apparatus advantages

Answer 7

pH changes during
Control dip rate to control hydrodynamics
Avoids cloning

Question 8

Disadvantages of recip cylinder ap

Answer 8

Small volume
Limited experience
Limited data

Question 9

Flow through cell app can be used for what dosage form?

Answer 9

Pretty much anything

Question 10

Advantages if flow through

Answer 10

Achieve sink conditions
Media and/or flow rate chages
More effective simulations interlumenal hydrodynamics
Long runs with no evaporation
Carry over effects, IVIVC
formulation ru busyness to various GI physiologies

Question 11

Disadvantages of flow through

Answer 11

High vol of media
More training than standard
Labour intensive
Filtration issues in some cases

Question 12

How to decide type of app?

Answer 12

-Purpose?
QC - batch homogenicity
R&D - formulation, development, IVIVC
-Alternative models/ appropriate modifications: superiority in compression with standardise ap?

Question 13

EU recommends with regards to medium?

Answer 13

Sink conditions are 3-10 times saturation volume.
pH 1-6.8
Conventional buffers, UPP media, bio relevant media
May contain enzymes/surfactants
De aeration for removal of dissovled gas

Question 14

EU P recommends with regard to agitation conditions

Answer 14

Rotational speed 50-100r/min
Dip rate not specific (eg 10-15/min)
Flow rate 4-59 ml/min

Question 15

Acceptance criteria

Answer 15

Specification is expressed as quantity (Q) of the active substance dissolved in a specific time as a percentage of the content stated in the label

Question 16

There are different levels of acceptance criteria?

Answer 16

True