Oral Drug Delivery 2 Flashcards

1
Q

What is osmotic technology

A

Controlled delivery of a drug using an osmotic pump
Tablet contains an osmotic-agent which causes an influx of water to the inside of the tablet
Can release drugs with zero order kinetics, independent of concentration

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2
Q

How does osmotic technology work

A

Osmotic agent acts to draw water from surrounding environment through a semi-permeable membrane

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3
Q

Factors which influence osmotic drug release

A

Osmotic pressure
Membrane area
Permeability coefficient
Membrane thickness
Drug solubility

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4
Q

What is the relationship between osmotic pressure and drug release

A

As osmotic pressure increases the rate of drug release of the drug increases

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5
Q

Describe an elementary osmotic pump (EOP)

A

An EOP is a single layer compressed tablet coated with a semi-permeable polymer (cellulose acetate)
Has one laser drilled hole

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6
Q

How does an elementary osmotic pump (EOP) work

A

Water is driven into the tablet core through the membrane by the soluble drug
Drug is then released as a soloution

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7
Q

Describe a push-pull osmotic system

A

Two chamber osmotic pump
Bilayer - push layer and drug layer
Water is drawn in through semi-permeable membrane

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8
Q

When is a push-pull osmotic system used

A

Used for less soluble drugs or high drug loadings

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9
Q

How does a push-pull system work

A

Expansion of osmotic ‘push’ layer begins when water is drawn in
This pushes the active drug through the orifice in the tablet

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10
Q

Function of the push layer in a push-pull system

A
  1. Generate osmotic potential
  2. Generate hydrostatic pressure via swelling (to push drug out)
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11
Q

What is a push layer made of?

A

A highly swellable polymer ( high MW PEO)
An osmogen (NaCl)

There is also option for an immediate or delayed release coating

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12
Q

What are the parts of an OROS

A

Bilayer (push-pull system)
Semi-permeable membrane
Laser drilled orifice
Aesthetic coating

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13
Q

Commercial example of an OROS

A

Methylphenidate hydrochloride
CNS stimulant
Used for treat of ADHD
Can be used orally as IR or ER

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14
Q

Advantages of Push-Pull systems

A

1.Release rate is independent of hydrodynamics
- Release rate is only controlled by osmotic pressure + thickness/permeability of coating
- Therefore fed and fasted states in the stomach do not effect release rate

  1. Release is not pH dependant
    • Avoids problems with establishing in vitro in vivo correlation models for ionisable drugs
  2. In vitro & in vivo correlation
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15
Q

What is in vitro in vivo correlation (IVIVC)

A

Predictive model describing the relationship between and in vitro property of a dosage form and an in vivo response
It allows a dissolution test to act as a surrogate for human studies

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16
Q

Disadvantages of Push-Pull systems (manufacturing)

A

Require Bilayer tablet press
Drug load limited to 25% of the tablet weight
Limited number of excipients available to use
Laser drilling required to create orifice

17
Q

Disadvantages of push-pull systems (clinical)

A

Local irritation if trapped in the GI tract
Unmodified tablet is eliminated in faeces (patient distrust)
Risk of drug dumping if patient breaks the tablet