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Pharmaceutics > T1 - Week 5 > Flashcards

T1 - Week 5 Flashcards

1
Q

What is the difference between acids and bases?

A

Acids donate protons, bases gain protons

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2
Q

What is a buffer?

A

An aqueous solution that has the ability to resist a change in pH

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3
Q

What are the components of a buffer?

A
  1. Weak acid and conjugate base (salt of acid)
  2. Weak base and conjugate acid (salt of base)
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4
Q

What is a buffer capacity?

A

The ability of a buffer solution to resist changes in pH upon addition of acid and bases

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5
Q

How are buffers used in pharmaceutical products?

A
  1. To control the pH of the formulated products
  2. To optimize the physicochemical performance of the product enhancing solubility and stability of products
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6
Q

What are examples of pharmaceutical buffers?

A
  1. Acetates
  2. Citrates
  3. Phosphates
  4. Borates
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7
Q

What are factors for selecting a buffer system?

A
  1. Nontoxic
  2. Nonirritating
  3. No disagreeable odor or taste
  4. pH range of 4-8
  5. Buffer capacity is less than 0.05 is optimal
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8
Q

Describe the steps of preparing a buffer solution?

A
  1. Determine the optimal pH for the product
  2. Select a weak acid with a pKa near the desired pH
  3. Calculate the salt to acid ratio using Henderson-Hasselbach
  4. Specify the desire buffer capacity of the product
  5. Calculate buffer concentration for buffer capacity using Van Slyke
  6. Determine the pH and buffer capacity of solution by using a pH meter or paper
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9
Q

What buffers would you use for acidic solutions?

A
  1. HCl (1-3)
  2. Citrate buffer (2.5-6.5)
  3. Acetate buffer (3.6-5.6)
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10
Q

What buffers would you use for neutral solutions?

A

Sorenson’s phosphate buffer (6-8)

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11
Q

What buffers would you use for basic solutions?

A
  1. Sodium bicarbonate (8-9)
  2. Sodium bicarbonate/sodium carbonate (9-11)
  3. NaOH (11-13)
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12
Q

What are the desirable properties of salts in drugs?

A
  1. Increase solubility
  2. Increase stability
  3. Reduce toxicity
  4. Improve absorption
  5. Improve manufacturing process
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13
Q

How do you select counterions based on pKa for acidic and basic drugs?

A
  1. Acidic: pKa of counterion must be 2 pH units higher than pKa of drug
  2. Basic: pKa of counterion must be 2 pH units lower than pKa of drug
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14
Q

What is the relationship between solubility and dissolution rate?

A

Salt formation may improve solubility and dissolution rate

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15
Q

What are examples of counterions for weak base drugs?

A
  1. Hydrochloride
  2. Mesylate
  3. Hydrobromide
  4. Acetate
  5. Fumarate
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16
Q

What are examples of counterions for weak acid drugs?

A
  1. Sodium
  2. Calcium
  3. Potassium
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17
Q

What are the characteristics influencing selection of counterions?

A
  1. pKa rule
  2. Solubility and dissolution rate
  3. Lipophilicity
  4. Hygroscopicity
  5. Chemical stability
  6. Flowability
  7. Corrosiveness of counterions
  8. Compatibility with excipients
  9. Route of administration
  10. Controlled release dosage forms
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18
Q

How can lipophilicity decrease water solubility?

A
  1. Increase chemical stability with certain APIs
  2. Hydrophobic salts may increase membrane permeability of hydrophilic molecules
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19
Q

What is hygroscopicity?

A

The ability of a material to absorb and retain moisture at various temperature and humidity conditions

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20
Q

Would drugs have a low or high hygroscopicity?

A

Low to easily degrade in the presence of water

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21
Q

What counterions are used to avoid hygroscopicity?

A

Very polar and hydroscopic salts of mineral acids

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22
Q

What degrades hydrolyzable drugs?

A

pH alterations in the salt

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23
Q

In regards to chemical stability pH changes can cause APIs to do what?

A
  1. Reactivity of API with excipients
  2. Instability, degradation, or impurities
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24
Q

What is flowability?

A

The ability of the powder blend to easily flow with consistency into the manufacturing equipment is essential

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25
Q

How can poor flowability affect final products?

A
  1. Unacceptable uniformity content
  2. Weight variation
  3. Physical inconsistency
26
Q

What structures are preferred for flowability?

A

Crystalline

27
Q

What is used to mask the corrosiveness of drugs?

A

Salts such as HCl and methanesulfonate

28
Q

Should counterions interact with excipients?

A

No

29
Q

What is the main issue of using injectable drugs?

A

Poor solubility of drugs in a limited number of solvents

30
Q

What are common anions for injectables?

A
  1. Maleate
  2. Chloride
  3. Sulfate
  4. Acetate
31
Q

What are common cations for injectables?

A
  1. Sodium
  2. Potassium
  3. Calcium
32
Q

What are common anions for oral drugs?

A
  1. Chloride
  2. Sulfate
  3. Maleate
33
Q

What are common cations for oral drugs?

A
  1. Sodium
  2. Potassium
  3. Calcium
34
Q

What are the properties of salts in regards to controlled release dosage forms?

A

May alter dissolution rate and release from formulation

35
Q

How do you decrease GI tract irritation and side effect from a drug?

A

Salts

36
Q

Define excipient

A

Any substance other than the active drug or pro-drug that is included in the manufacturing process or is contained in finished pharmaceutical dosage forms

37
Q

What is the general purpose of excipients

A
  1. Protect, support, or enhance stability of formulation
  2. Add bulk to formulation
  3. Improve patient acceptance
  4. Help improve bioavailability of API
  5. Enhance overall safety and effectiveness
38
Q

Excipients are classified based on what?

A
  1. Origin (animal, vegetable, mineral, synthetic sources)
  2. Pharmaceutical formulation type (liquids, solids, and semi-solids
  3. Function (sweetener, humectant, wetting agent)
39
Q

What makes an excipient ideal?

A
  1. Chemically stable
  2. Non-reactive
  3. Low equipment and process sensitive
  4. Inert to human body
  5. Non-toxic
  6. Acceptable taste and smell
  7. Economical
  8. Efficient with regards to intended use
40
Q

What are examples of drug-excipient interactions?

A
  1. Physical
  2. Chemical
  3. Biopharmaceutical
41
Q

What are the physical interactions of drug-excipient interactions?

A
  1. Rate of dissolution
  2. Dosage uniformity
  3. Difficult to detect
  4. No chemical changes
  5. May be beneficial
42
Q

What are examples of physical interactions?

A
  1. Complexation
  2. Adsorption
  3. Solid dispersion
43
Q

What are the chemical interactions of drug-excipient interactions?

A
  1. Formation of unstable compounds
  2. Generally try to avoid these interactions
44
Q

What are examples of chemical interactions?

A
  1. Hydrolysis
  2. Oxidation
  3. Racemization
  4. Polymerization
  5. Maillard reactions
  6. Photolysis
45
Q

What are the biopharmaceutical interactions of drug-excipient interactions?

A
  1. Effects observed after administration
  2. Cause alteration of rate of absorption
46
Q

What are examples of bio pharmaceutical interactions?

A
  1. Premature breakdown of enteric coating
  2. Interactions with adjunct therapy
  3. Increase GI motility
47
Q

How important are excipient-excipient interactions?

A
  1. Rare but important
  2. May be desirable or undesirable
48
Q

What is the importance of package-excipient interactions?

A

Excipients must undergo same testing as API’s in terms of reactions with packaging, stability, and safety

49
Q

What are the general types of excipients?

A
  1. Fillers/Diluents
  2. Binders
  3. Disintegrants
  4. Lubricants
  5. Glidants
  6. Wetting agents and surfactants
  7. Colorants
  8. Sweetners
  9. Flavorings
  10. Coatings materials
50
Q

What are fillers/diluents for?

A

65-85% of oral formulations that bulks the drug

51
Q

What are examples of fillers/diluents?

A
  1. Lactose
  2. Mannitol
  3. Cellulose
52
Q

What is the purpose of binders?

A

Holds API and inactives together, 2-5%

53
Q

What are examples of binders?

A
  1. HPC
  2. HPMC
54
Q

What is the purpose for disintegrants?

A

Reduce cohesive forces and speed time for tablet to break apart, 2-5%

Has an affinity for water to draw water into tablet

55
Q

What are examples of disintegrants?

A
  1. Starches
  2. Clay
  3. Cellulose
56
Q

What are lubricants for?

A
  1. Hydrophobic
  2. Used to aid manufacturing process that can slow dissolution
57
Q

What are glidants for?

A
  1. Used in manufacturing to improve flow of powder blends
  2. Some lubricants can also be glidants
58
Q

What is the purpose for wetting agents and surfactants?

A

2-4%, if API is hydrophobic, these improve wettability and facilitate dissolution

59
Q

What is the purpose for coating?

A
  1. Ease of swallowing
  2. Protection
  3. Taste masking
  4. Aesthetics
60
Q

List advanced uses of excipients

A
  1. Enhancement of oral absorption
  2. Enhancement of absorption sites other than oral
  3. Drug targeting
  4. Manufacturing process aids

Pharmaceutics (27 decks)

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