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PPD > Secondary Manufacturing > Flashcards

Secondary Manufacturing Flashcards

1
Q

What are primary pharmaceutical processes

A

The Reactions and separations involved in the manufacturing of the pure API

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2
Q

What are secondary pharmaceutical prcesses

A

The blending and formulation steps required to formulate the dosage form of the product

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3
Q

Why are tablets not jsut pure API?

A

Need the tablet to be large enough to be taken by a person so even if only a very small amount of API is required, bulking agents etc are required

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4
Q

Differentiate between sustained release and immediate release

A

Immediate release is ensuring the API reaches the desired area asap
Sustained release is attempting to maintain as constant as possible levels of the API over a long period

These are influenced more by the formulation of the drug than the API itself

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5
Q

6 drug Administration routes

A
  • Oral
  • Pulmonary (e.g. inhaler)
  • Transdermal (e.g. cream)
  • Intravenous
  • “Direct Application” (e.g. eye drops)
  • Implantable controlled-release devices
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6
Q

Define Pharmacokinetics

A

The rate at which the API is released from dosage form, absorbed into the system ciruclation, metabolised and excreted

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7
Q

Define the minimum toxic concentration (MTC)

A

The [API] that once exceeded will begin to result in undesirable side effects and (potentially irreversible) toxicity (e.g. liver damage) being observed

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8
Q

Define minimum effective concentration (MEC)

A

[API]min that has a measureable pharmaceutical effect on a statistically representative group of patients

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9
Q

Define Therapeutic Index (TI)

A

The [API] window rhar we want to maintain for the duration of the treatment

TI = MTC - MEC

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10
Q

Define the LADME model

A
  1. Liberation
  2. Absorption
  3. Distribution
  4. Elimination
    4a. Metabolism
    4b. Excretion
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11
Q

Define Bioavailability (F)

A

The fraction of the administered dose that reaches the systemic circulation as the parent drug (not as metabolites)

  • Tells us to what extent API was dissolved and already metabolised absorption
  • If low either need to change the route of administration or the physical/chemical properties of the API
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12
Q

Bioavailability Equation

A

F = AUC/Dose

AUC = Area Under Curve
F = Value between 0 & 1
The lower it is the more waste there is

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13
Q

Define Apparent Volume Distribution

A

V = Total Amount of drug in the body/ Plasma Concentration

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14
Q

Partition Coefficient Equation

A

P = [Octanol]/[Water]

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15
Q

Uses of the Partition Coefficient

A
  • Gives the ability of the API to be liberated, absorbed and distributed
  • if substance is lipophilic conc in plasma wil be low but amount in body will be high as it will have accumulated in lipophilic tissues
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16
Q

Biopharmaceuticals Classification System

A

I) High solubility & High Permeability
II) Low Solubility & High Permeability
III) High Solubility & Low Permability
IV) Low Solubility & Low Permeability

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17
Q

Methods of improving solubility

A
  • Milling the API it so it is well distributed in the tablet

- Change the form of the API to amorphous or metastable crystal

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18
Q

Dissolution rate of particles equation

A

dm/dt = D/delta x A(c* - c_bulk)

Delta = thickness of the boundary layer

c* dependent on pH, Temperature & solid phase form

19
Q

Typical Components of a tablet

A
  • API
  • Filler (bulking agent)
  • Binder
  • Disintergrant or Matrix-forming polymer
  • Lubricant/glidant
  • Coating Polymer + Pigment
20
Q

Role of a filler/bulking agent

A
  • No active role
  • Usually for low dose APIs
  • Usually sugars

Must be:

  • Tolerated by population
  • Soluble
  • Easy to handle, compress, blend etc
  • Be of a specific grade (differing properties)
21
Q

Role of a binder

A

Increase adhesion between particles

22
Q

Role of Disintergrant or Matrix forming polymer

A

Disintergrant - Swells in contact with liquid to help break up the tablet

Matrix forming polymer - Forms gel upon contact with liquid; helping tablet keep together to slow dissolution

23
Q

Roe of lubricant/glidant

A

Reduce friction between tablet particle and walls of the process equipment

24
Q

Role of Coating polymer or pigment

A
  • Increase shelf life
  • May prevent acid hydrolysis so that tablet is absorbed in intestine not stomach
  • May add a visual appeal
25
Q

Why is milling required

A

Crystalline form of the API may not have sufficient distriution rate so will need to reduce its size/increase its surface area

26
Q

Give 3 types of milling

A
  • Stirred media or wet milling (particles suspended in solvent then pumped through agitated chamber) - gives smallest sizes
  • Impact/Jet milling (Particles broken up by impact with other particles or compressed gas)
  • Attrition milling
27
Q

In tabletting what are the types of compaction behaviour

A
  • Rearrangement
  • Elastic Deformation
  • Plastic Deformation
  • Viscous Flow
  • Brittle Failure
  • Elastic Recovery
28
Q

What type of deformation is desirable in tabletting?

A
  • Plastic deformation as the increase in contact area increases the strength of VdW holding the tablet together increase
29
Q

Measure of mixedness equation

A

sigma^2 = SUM{(w_i - w_avg)/n}

30
Q

Define mixing number

A

Number of unit mixing operations required for the system to reach a given state of mixedness

31
Q

Define segregation

A

Natural tendency of powders to de-mix (due to difference in particle size, shape, density or surface properties)

32
Q

What are the quality attributes of tablets

A
  • Hardness
  • Attrition
  • Weight Uniformity
  • Content Uniformity
  • Disintegration Time
  • Release Kinetics
33
Q

What are the aims of tablet coating

A
  • Tase Masking
  • Visual appeal (Colouring)
  • Protective layer
  • Delayed release effect
  • Functional coating of carrier particles (e.g. sometimes one API is in tablet core and another is in the coating)
34
Q

What is the criteria required for agglomeration?

A

Stv < Stv*
(Viscous Stokes Number)

Stv = 8mu/(3pi x mu x D^2)

Stv* = 2ln(lambda/h_a)

35
Q

Sequence of processes for wet granulation

A

Wet Granulation -> Mix/Dissolve/Suspend -> Dry -> Mill/Size -> Blend

36
Q

Sequence of processes for dry granulation

A

Dry granulation -> Blend -> Compact -> Mill/Size -> Blend

37
Q

Sequence of processes for direct compression

A

Direct Compression -> Blend

38
Q

Sequence of processes for melt granulation

A

Melt Granulation -> Mix/Melt/Dissolve -> Congeal -> Mill/Size -> Blend

39
Q

Sequence of processes for Spray Drying

A

Spray Drying -> Dissolved/Suspend -> Spray/Dry -> Blend

40
Q

Sequence of processes for Freeze Drying

A

Freeze Drying -> Dissolve -> Freeze -> Vacuum/Dry -> Blend

41
Q

Sequence of processes for Tabletting

A

Tabletting -> Compact -> Coating -> Dissolve/Suspend -> Spray/Dry

42
Q

Why does granulation need to perform

A

To turn elastic material into elastoplastic granules to aid in tablet formation
- Change material behaviour + flow properties. Therefore increase production rate

43
Q

What is the principles of wet granulation

A

Contact powder with a liquid binder, wet powder particles become cohesive, agglomeration occurs during particle collisions, binder sers to form mechanically stable granules

44
Q

Steps in extrusion

A
  • product extruded as a long noodles
  • It is then broken up by contact with high speed rotating disk
  • It then spheronises over time
  • It is finally dried to form spherical pellets

PPD (7 decks)

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