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Medicines design II - solid dosage forms > Pharmacopoeia > Flashcards

Flashcards in Pharmacopoeia Deck (17)
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0
Q

EU P on solid dosage forms…

A

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

1
Q

P Contains monographs for…

A

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

2
Q

Requirements of in vitro systems

A

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

3
Q

EU set specifications on…

A
Dissolution apparatus
Medium (compulsion, temp, vol)
Rotational speed/flow rate
Time, method, amount, monitoring conditions
Methods of analysis
Acceptance criteria
4
Q

Advantage of rotating basket or paddle

A
Simple, robust
Standardised
Experience
Possible pH change during
Automation
5
Q

Disadvantage specific to paddle

A

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

(Also floaters and sinker variation is an issue)

6
Q

Disadvantages of rotating cylinder and paddle?

A
Deaertion
Single container - difficult to change pH
Floaters/sinkers
Limited volume
Special dosage forms?
7
Q

Reciprocating cylinder apparatus advantages

A

pH changes during
Control dip rate to control hydrodynamics
Avoids cloning

8
Q

Disadvantages of recip cylinder ap

A

Small volume
Limited experience
Limited data

9
Q

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

A

Pretty much anything

10
Q

Advantages if flow through

A

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

11
Q

Disadvantages of flow through

A

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

12
Q

How to decide type of app?

A

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

13
Q

EU recommends with regards to medium?

A

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

14
Q

EU P recommends with regard to agitation conditions

A

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

15
Q

Acceptance criteria

A

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

16
Q

There are different levels of acceptance criteria?

A

True