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Stability Testing > Stability of ASD > Flashcards

Stability of ASD Flashcards

1
Q

Definition of ASD

A

Amorphouse Solid dispersion

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2
Q

Physical formulation methods to enhance the solubility

A

Amorphous Solid Dispersion and Nanosuspensions

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3
Q

ASD improved dissolution profile

A

Faster dissolution and Supersaturation

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4
Q

What are the main differences between amorphous and crystalline API

A

Near order, Tg and thermodyanmic instable amorphous

Near and Far order, Melting point and thermodynamic stableare

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5
Q

What are the properties of polymers

A

usally high glass transition temperature and high viscosity

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6
Q

What are the steps during the dissolution of crystalline APIs

A

Disruption of crystal lattic, solvation or hydration of molecules, breakage of solvent/hydrogen bonds to accomadate molecules,

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7
Q

the disruption of crystal lattice is

A

endothermic

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8
Q

solvation of molecules is

A

exothermic

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9
Q

Breakage of solvent

A

endothermic

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10
Q

engery in disolution

A

endo or exothermic depending on the dominant energies

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11
Q

when do we have poor solubility

A

high lactic engergy and/ or poor solvatioan

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12
Q

What does it means if there is no lattic energy

A

better solbility

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13
Q

What is the driving force for crystallization?

A

the higher supersooling

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14
Q

what does supercooled glasses have?

A

they have a higher Gibbs energy in comparison with crystalline materiall

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15
Q

Why are amorphous API thermodynamically instable?

A

Due to their high free energy

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16
Q

How can amorphous API be stabiliziert

A

with Polymer

increasing the solubility, Miscibility and Kinetic stability

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17
Q

What is mix tg line

A

it is the tg of the API and that of the polymer, mixture in einer molecule level

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18
Q

when can the mix tg be formed

A

when the APT has a good solubility in the polymer and mixability

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19
Q

What happend if the solubility of the API is low

A

it will lead to phase separtaion, due to the different tg

20
Q

When the ASD kinetic stable

A

When it is stored below its tg

21
Q

What happend if the drug load is higher than the solubility line

A

is will be thermodynamic stable, reducing the solubility

22
Q

what happend if the drug load is high

A

it could lead to kinetic stability, but is shouldn’t go above the mix tg , which will lead to the thermodynamic instable state

23
Q

what does Spring means?

A

Amorphous API have a high energy state, which leads to a high apparent solubility. Without a stabilizing agent, precipitation will occur

24
Q

Describe the word parachut in respects of the ADS

A

Due to adding of the Polymers as a stabilizing agent, there will be an temporary inhibition of precipitation

25
Q

What’s the different between the apparent solubility and the true solubility

A

the treu solubility is in the thermody.equilibrium to most stable solid form, whereby the apparent solubility is the unstable form

26
Q

Which parameters are influnces by the Polymer excipients

A

API solubility, degree of supersaturation, viscosity, molecular mobility, nucleation, configurational entropy and free energy of ASD

27
Q

how does the polymer excipient influnces the parameters of the ASD?

A

API solubility (increase), degree of supersaturation (Decrease), viscosity (increase), molecular mobility (Decrease), nucleation (decrease), configurational entropy (increase )and free energy of ASD (decrease)

28
Q

What are the effect of the ADS parachut interactions?

A

Higher activation energy for nucleation

slow crystal growth due to adsorption on crytal surface

29
Q

API with high tg

A

they are good so solubilized

30
Q

Name 4 effects on physical stability of ASD

A

Glass transition temperature of amorphose drugs and polymers
drug-polymer miscibility
solid solubility of drugs in the polymers
molecular weight of drugs

31
Q

What are the preparation process, ASD?

A

Different thermal histories and mechanical stresse.

Using different degrees of drug-polymer mixing and drug mobility in ASD

32
Q

Production of ASDs

A

Melting and dyring processes

33
Q

what affects the stability of the ASD exstrusion

A

the resistence time, the high temperature

34
Q

What is the disadvantages of the spray drying ASD?

A

difficult to fine sovent for both API and polymer

35
Q

characterization Methods for crystallinity

A

DCS, XRPD, FTIR-Spectroscopy

36
Q

characterization Methods for Homogenity

A

FTIR, NMR

37
Q

characterization Methods for Interactions

A

FTIR

38
Q

Describe how the differential scanning calorimetry works (phases)

A

Power compensating DSC, Heat flux DSC Measurment

39
Q

Power compensating DSC

A

Recording of differential power signal, which is a function of actual sample temperature

40
Q

Heat flux DSC

A

Temperature differrents between the sample and reference and it is plotted gainst time
Integration of differences
Transfer into heat flux

41
Q

Measurement in the DSC

A

Sample filled up, reference and sample are heated or colled–> temperature diagram

42
Q

x-ray powder diffraction different between crystalline and amorphous state

A

Crystalline state: Angle dependent high x-ray intensities detected
Amorphous state: no Bragg Peaks detected

43
Q

FTIR-spectroscopy used for?

A

Crystallinity

44
Q

which other method can be used to check Crystallinity

A

DSC, XRPD, FTIR spectroscopy

45
Q

FTIR-spectroscopy advantages

A

improved signal to noise ratio
faster detection of spectra
improved wave numer accuracy
API-polymer interaction

Stability Testing (5 decks)

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