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Making drugs into medicines ☆ > Pharmaceutical product stability > Flashcards

Pharmaceutical product stability Flashcards

1
Q

What is Shelf-life (1)

A

Period that a product retains acceptable chemical, physical and microbiological stability (if stored correctly!)

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2
Q

What is the Expiry date (1)

A

Given on the product package indicates the end of the shelf-life

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3
Q

What is Drug degradation in vivo (3)

A
  1. After the patient takes the product
  2. breakdown in stomach acid
  3. first-pass metabolism by the liver
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4
Q

What are the stability profiles (4)

A
  1. Extremely stable - more than 5 years
  2. Stable - 2 – 5 years
  3. Moderately stable - approximately two years
  4. Unstable - less than 1 year
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5
Q

What is the rough guideline for stability (1)

A

Stable = can be stored at RT for 2-3 years after manufacture and at least 1 month after dispensing.

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6
Q

What are the causes of instability of pharmaceutical products (7)

A
  1. The active pharmaceutical ingredient (API)
  2. chemically reactive molecule
  3. An ‘active’ excipient
  4. preservative, suspending agent, etc.
  5. vehicle, colour, capsule shell, etc.
  6. A component or part of the packaging
  7. material in contact with the formulation
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7
Q

What are the Active Pharmaceutical Ingredients (API) (3)

A
  1. Drugs are complex polyfunctional molecules.
  2. Contain chemically reactive functional groups.
  3. Primary chemical change can lead to secondary physical or biological effects (Water/oxygen + heat/light)
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8
Q

What can Deterioration of API lead to (2)

A
  1. Loss of API function → ineffective medication
  2. Formation of toxic degradants (e.g. Aspirin → Salicylic acid).
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9
Q

What are Excipients (3)

A
  1. Included in pharmaceutical dosage forms to aid manufacture, administration or absorption
  2. Pharmacologically inert. However, it can react chemically or physically with other/active ingredients.
  3. Compromise product stability
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10
Q

What can the Deterioration of excipients lead to (6)

A
  1. Loss of excipient functionality (E.g. degradation of suspending agent)
  2. Insoluble active accumulates at the bottom of the bottle
  3. Underdose/overdose
  4. Microbial proliferation (e.g. degradation of antimicrobial preservative in multi-dose eye-drop)
  5. Microbial contamination
  6. eye infection
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11
Q

What are examples of Drug-excipients incompatibility (2)

A
  1. Mg+2 Ions from magnesium stearate can catalyse the degradation of fosinopril (ACE inhibitor)
  2. Lactose interacts with compounds containing amine groups (phenytoin), Maillard reaction.
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12
Q

What is Pharmaceutical packaging (9)

A
  1. Primary - Direct contact with formulation
  2. Secondary - Protection and presentation
  3. Tertiary - Storage and transport

Should:

  1. Present the product
  2. Identification & selection
  3. Provide information and aid compliance.
  4. Label & PIL
  5. Protect the formulation
  6. Climatic, biological, chemical & physical damage
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13
Q

What can Deterioration of the packaging lead to (4)

A
  1. Loss of protection (e.g. Defective blister pack)
  2. Moisture uptake by a tablet can increase friability & disintegration.
  3. Chemical changes (e.g. Leaching of Na+ from a glass container)
  4. increased pH of injectable can increase degradation
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14
Q

What is pharmaceutical testing used to find out (6)

A
  1. The weaknesses in the stability of the drug
  2. What the drug can be combined with
  3. How stable the drug is during the manufacturing process
  4. How long its properties are retained during storage & use

Information can be used to determine:

  1. Recommended storage conditions
  2. Shelf-life (expiry date)
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15
Q

Definition of Retest Date (1)

A

The date on which the material should be examined to ensure it still complies with its quality specification

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16
Q

Definition of Expiry Date (1)

A

The last date on which the product can be expected to comply with its quality specification if stored under the specified conditions (calculated from the manufacturing date)

17
Q

Definition of Shelf-life (1)

A

Period which elapses after manufacture when the product can be expected to comply with its quality specification if stored under the specified conditions

18
Q

What is Stability testing (6)

A
  1. Accelerated stability - studies on drug substance
  2. Pre-formulation studies - Excipients incompatibilities, IV compatibility
  3. Process development - stability in mixing, autoclaving, transportation, etc.
  4. Clinical supplies - stability of initial clinical formulations
  5. Marketing authorisation stability studies - formal studies on commercial formulation and pack
  6. Post-marketing studies - on commercial production batches for sale
19
Q

How are changes evaluated qualitatively or quantitatively (5)

A
  1. Test the sample at the start (T0)
  2. Store the sample for several hours/days/weeks/months.
  3. Test the sample at specified time points (Tn)
  4. Repeat steps 2 & 3 until sufficient data is available.
  5. Evaluate the data & make a decision.
20
Q

What factors are considered when designing a stability study (6)

A
  1. Storage conditions (stressed/accelerated / real-time)
  2. Tests (methodology/replicates)
  3. Test times (& post-test storage)
  4. Packs
  5. Temperature cycling
  6. Photostability
21
Q

What are the storage conditions (4)

A
  1. Deep freezer → -70 degrees
  2. Freezer (domestic) → -20 degrees
  3. Refrigerator → 5-15 degrees
  4. Room temperature → 15-30 degrees
22
Q

What are the levels of drug substance stability testing (3)

A
  1. Stress testing - Identify likely degradation products, degradation mechanisms & intrinsic stability of the molecule and develop a stability-indicating methodology
  2. Accelerated testing - Early estimate of retest period & ‘safety net’
  3. Long-term testing - Establishes retest period & storage conditions & shelf life.
23
Q

What is long-term & accelerated stability testing for drug substances (2)

A
  1. Specification is typically 98 – 102%
  2. Retest date typically 2 – 4 years
24
Q

What is long-term & accelerated stability testing for drug products (2)

A
  1. Specification is typically 90 – 110%
  2. Shelf life is typically 3 – 5 years but varies greatly, e.g. parenteral, biologics, powders for reconstitution.
25
Q

What is Shelf-life prediction (2)

A
  1. Drug X has undergone accelerated stability testing at storage temperatures of 30, 40, 50 and 75 °C.
  2. Based on the data obtained, estimate the shelf-life of the drug at 20 °C and 4 °C.
26
Q

How is Stability predicted (4)

A
  1. Use raw data to plot % drug vs time.
  2. Observe the trend and determine the reaction order.
  3. The plot is non-linear – the reaction is not in zero order.
  4. Use logarithms of % drug values to calculate reaction rates.
27
Q

How is the Linear relationship calculated – 1st order process (3)

A
  1. Add trendlines to obtain straight-line equations in the form y = mx + c
  2. The reaction rate (k) at each temperature is determined from the gradient:
    𝐿𝑛 % 𝐷𝑟𝑢𝑔𝑡 = −𝐾𝑡 + 𝐿𝑛 % 𝐷𝑟𝑢𝑔0
  3. Logarithms of the reaction rates (ln k) can be plotted against 1/T (K)

Making drugs into medicines ☆ (13 decks)

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