Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

3117 > preformulation_5 > Flashcards

preformulation_5 Flashcards

1
Q

why is preformulation necessary

A

to identify critical material attributes (CMAs) that could impact the critical quality attributes (CQAs) of a product

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

example of CMA (critical material attributes)

A
  1. solid state form
  2. particle size distribution
  3. hygroscopicity (tendency to absorb water from air)
  4. solubility
  5. moisture content
  6. residual solvent
  7. process impurity
  8. chemical stability
  9. flow properties
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

example of CQA critical quality attribute

A
  1. assay
  2. content uniformity
  3. dissolution
  4. degradation products
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

purpose of preformulation studies

A
  • involve primary characterisation of drug substance and/or excipients for certain fundamental physical and chemical properties
  • confirm supplier’s information and ensure quality, especially of raw materials
  • provide important data that may dictate many of the subsequent events
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

assumptions made in preformulation studies

A
  • operate in optimum capacity

- process control managed by good healthy workers

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

reason for preformulation studies (API)

A
  • to predict viability of various formulations and methods of manufacture
  • to provide clues as to how to achieve the desired performance of finished product
  • to confirm stability and bioavailability, reduce probability of formulation failure
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

cost are associated with preformulation studies but studies

A
  • significantly minimise the risk of product failure

- increase the likelihood of producing a better quality product

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

use of data from preformulation studies

A
  • detect batch to batch variations of starting materials
  • enable better specifications to be drawn up for procuring materials
  • an excellent database for the assessment of suppliers who can provide materials of consistent quality
  • retrospective study of process or product, improve specifications for raw materials
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

benefits from conducting preformulation studies

A
  1. setting specifications for API, to ensure consistent successive batches of finished product
  2. minimising development cost, ensure optimal product development before commencing costly bioavailability and bioequivalence studies
  3. avoiding failures during long-term stability; by accurate predictions of chemical and physiochemical stability of API, compatibility with excipients, other actives and container
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

class I

A

high solubility and permeability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

class II

A

low solubility and high permeability

focus on in vitro dissolution

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

class III

A

high solubility and low permeability

optimise absorption/route

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

class IV

A

low solubility and permeability

molecule modification

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

non-chemical characteristics that can change on aging

A
  • particle size (in suspensions, large particles grow while small particles shrink/dissolve)
  • polymorphic form
  • dissolution rate (especially with polymorphic transformation)
  • preservative efficacy of multidose suspension, both sterile and non-sterile
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

important factors to consider when developing dosage form

A
  1. manufacturability
  2. stability
  3. bioavailability
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

manufacturability

A
  • scalability
  • reproducibility
  • cost-effectiveness
17
Q

stability

A
  • during manufacture
  • shelf life- ideally 2yr or more (in ambient)
  • in GIT
18
Q

bioavailability

A
  • acceptance for biological activity- therapeutic action

- convenience, for compliance

19
Q

particle shape factor

A
  1. sphericity (4 pi x area/ perimeter ^2)

2. aspect ratio (length/breadth)

20
Q

surface area measurement and determination methods

A

by either gas permeability or adsorption
methods:
1. BET- specific surface are (v small pores determined)
2. estimation by size - shape factor not taken into account (tend to underestimate)

21
Q

the technology of specific surface area by gas adsorption technique

A
  • performed by addition of small known volume of gas (adsorbate, typically N2) to a solid at cryogenic temp (liq nitro temp -298)
  • at cryogenic temp, weak molecular attractive forces will cause gas molecules to be adsorbed
  • direct relationship between the pressure and volume of gas, by ideal gas law, measuring pressure, can determine volume of gas adsorbed (adsorption isotherm)
  • from cross-sectional area of adsorbed gas molecule, surface area and pore size distribution can be derived
22
Q

Brunauer-emmett teller (BET) theory

A

first isotherm: assume a random distribution of sites that are empty or that are covered with by one monolayer, two and so on

23
Q

apparent density

A
  • poured (bulk); freely settled
  • tapped: post-tapped
  • enveloped: bulk density without inter-agglomerate voids
24
Q

envelope density

A

involves the determination of geometric space occupied within the envelope of solid material or aggregate (like interior voids, cracks, pores)
- particle size should ideally exceed 2mm for best results

25
Q

what is the displacement measurement technique for envelope density

A

quasi-fluid composed of small, rigid spheres, freely flowing and referred as free-flow filler
(note: displacement vol = equivalent vol of sample)

26
Q

equation of gas pycnometer

A

Vs = Vc + Vr / (1 - P1/P2)

sample volume= volume of empty sample chamber + ref vol / (1 - first pressure/ pressure after expansion of gas)

27
Q

what does solubility affect

A

bioavailability, rate of drug release, therapeutic effect

28
Q

factors that determine solubility

A
  • technique/ methodology
  • temperature control
  • eqm point (can take long time to establish)
  • supersaturation (crystal form)
  • impurities
29
Q

mercury intrusion porosimetry

A

analytical technique to quantify material’s porous microstructure, in particular, pore entrance size distribution, pore shape, and tortuosity (total pore vol involving the intrusion of non-wetting mercury at high pressure, forcing mercury into the porous structures of material

30
Q

DVS (dynamic vapor sorption)

A
  • predict whether microbial growth will be possible

- predict whether product a soften/ cake w time

31
Q

advantage of DVS

A
  1. minimal sample size required (10mg)
  2. rapid analysis due to faster eqm ( few days)
  3. higher accuracy and precision (enclosed environment and sensitive microbalance)

3117 (15 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions