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Year 3 - Pharmaceutical Analysis > 5 - Epinephrine > Flashcards

5 - Epinephrine Flashcards

1
Q

MOA of epinephrine

A
  • Acts on alpha and beta receptors
  • Increases BP by stimulating cardiac muscle
  • Increases contractility, HR, and causes constriction of arterioles
  • Relaxes bronchial SM
  • Increases blood sugar
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2
Q

Epinephrine is rapidly degraded in the body by ______

A

Liver enzymes

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3
Q

Epinephrine uses

A
  • Bronchospasm (anaphylactic reactions)

- Prolong anesthetics

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4
Q

What dosage forms is epinephrine available as?

A

Injection, inhalation, nasal, ophthalmic (always in a liquid medium)

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5
Q

What is pharmaceutical stability?

A

The extent to which a product retains, within specified limits, and throughout its period of storage/use, the same properties it possessed at the time of manufacture

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6
Q

What causes chemical instability and examples

A
  • Degradation results from reactions between the active ingredients, excipients, and the environment
  • Hydrolysis, oxidation, photolysis, dehydration
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7
Q

____ is the most significant problem that shelf-life is based upon

A

Chemical stability

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8
Q

Physical stability definition and examples of instability

A
  • Changes in physical properties of the dosage form
  • Transition between polymorphs, vaporization of volatile components, adsorption to packaging, “aging” of polymers, separation of suspensions/ emulsions/ creams/ ointments
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9
Q

What dosage forms is microbiological stability used for? How is it achieved?

A
  • For injections, emulsions, ointments, and creams

- Achieved through complete enclosure, filtration, sterilization, additions of preservatives/antimicrobial agents

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10
Q

What determines microbiological stability?

A

Sterility or resistance to microbial growth should be maintained and additives should be effective for the duration of storage/ administration

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11
Q

What is therapeutic stability? What can compromise it?

A
  • Effectiveness of an active ingredient in vivo

- Compromised by changes in chemical, physical, and microbiological stability

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12
Q

Toxicological stability

A
  • Potential toxicity in vivo due to physicochemical or microbiological changes
  • No significant increase in SEs/toxicity should be produced during normal storage/application period
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13
Q

Examples of environmental factors that can influence stability of pharmaceutical preparations

A

Temperature, radiation, sunlight, air (oxygen, carbon dioxide, water vapor), humidity

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14
Q

Characteristics of dosage forms that can influence stability of pharmaceutical preparations

A

Particle size, size distribution, pH, water/solvents, package materials, excipients/additives

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15
Q

What is accelerated stability testing?

A

Exposing the test preparation to a high stress scenario to detect instabilities (eg. temperature, humidity, light intensity)

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16
Q

What is accelerated stability testing used for?

A
  • To predict pharmaceutical stability under normal conditions
  • Allows selection of the most optimal formulation/packaging material, storage condition, and expiration date
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17
Q

What determines the design of accelerated stability testing and what does the testing determine?

A
  • Product and manufacturer requirements
  • Determine effects of temperature, light, air, pH, moisture, trace metals, and common excipients on the active ingredient
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18
Q

What temperature, humidity, and length of time should be used in testing for solid dosage forms?

A
  • 25 or 37 C
  • Relative humidity of 60% or 75%
  • 30 day testing period
19
Q

What environment should light-sensitive products be tested in?

A

Natural or artificial light sources

20
Q

What temp is used to test liquids?

A

Higher temps of 40-90 C are needed to increase degradation

21
Q

What rules should be followed in community pharmacy?

A
  1. Dispense oldest stock first and record expiration date
  2. Store under proper conditions
  3. Check for evidence of drug instability
  4. Properly treat/label repackaged/diluted/mixed preparations
  5. Dispense in proper containers
  6. Educate patients about storage/ administration
22
Q

Signs of deterioration in solid dosage forms

A
  • Fog
  • Liquid droplets, clumping
  • Presence of desiccant indicates care should be taken in dispensing to avoid humidity instability
23
Q

Signs of deterioration in uncoated tablets

A
  • Excessive powder or pieces of tablet at the bottom of bottle
  • Cracks/chips
  • Swelling
  • Discolouration
  • Fused tablets
  • Crystals
24
Q

Signs of deterioration in coated tablets

A
  • Cracks
  • Mottling
  • Clumping
25
Q

Signs of deterioration in dry powders/ granules for reconstitution

A
  • Caking
  • Discolouration
  • For reconstitution – caking, fog, liquid droplets, unpleasant odour
26
Q

Signs of deterioration in effervescent tablets/ granules/ powders

A

Swelling (due to moisture)

27
Q

Signs of deterioration in hard/ soft gelatin capsules

A
  • Change in consistency

- Hardening/ softening

28
Q

Signs of deterioration in liquid dosage forms

A
  • Microbial growth is a primary concern (discolouration, turbidity, gas formation)
  • Cloudiness
  • Precipitation
  • Breaking of an emulsion
  • Non-resuspendable caking of a suspension
29
Q

Signs of deterioration in solutions/ elixirs/ syrups

A
  • Precipitation

- Gas formation

30
Q

Signs of deterioration in emulsions

A

Breaking (irreversible)

31
Q

Signs of deterioration in suspensions

A
  • Caked solid phase that cannot be resuspended by shaking

- Large particles

32
Q

Signs of deterioration in sterile products

A
  • Haziness
  • Colour change
  • Surface film
  • Particulate
  • Gas formation
  • Damage to enclosure
33
Q

Signs of deterioration in semisolid dosage forms

A
  • Discolouration

- Changes in consistency/ odour

34
Q

Signs of deterioration in creams (w/o, o/w)

A
  • Breakage
  • Crystals
  • Water evaporation
  • Microbial contamination
35
Q

Signs of deterioration in ointments

A
  • Change in consistency
  • “Bleeding” (liquid)
  • Grittiness
36
Q

Signs of deterioration in supppositories

A
  • Store in fridge
  • Excessive softening/ hardening
  • Oil stains on packaging
37
Q

What is prediction of shelf-life based on?

A
  • Arrhenius equation
  • Effect of temp on rate constant of decomposition
  • Linear correlation between rate constant (ln k) and temp (1/T)
38
Q

Describe the methods for this experiment

A
  • Epinephrine injection contains epinephrine bitartrate 10 mg/mL
  • Describe any colour changes or precipitation of solids
  • Filter 40 mL and seal in vials completely
  • Subject to temp for 3 days
  • Take HPLC-UV readings at sampling times
39
Q

How can you determine epinephrine content?

A

(Peak of sample/ peak of standard)(1 mg/mL)

40
Q

What are the results of this lab?

A
  • Approximate shelf-life should be 23.6 days

- Degrades to quinones via oxidation and also undergoes methylation and deamination

41
Q

Define shelf life

A

Time for an active ingredient to chemically degrade by 10% in its potency at 25 C

42
Q

What needs to be done for a product to maintain satisfactory chemical stability?

A

Retain its chemical integrity and labelled potency

43
Q

What is considered satisfactory physical stability?

A

Original physical characteristics in appearance, palatability, uniformity, disintegration, dissolution, and suspenability

44
Q

___ is a compromising factor to solid dosage forms

A

Humidity

Year 3 - Pharmaceutical Analysis (8 decks)

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