Introduction Flashcards

1
Q

Why do we need dosage forms for drugs?

A
  1. Correct dosing for a predictable drug response
  2. Protect drug from degradation
  3. Ensure large scale manufacture and quality of the drug
  4. Patient’s acceptance and convenience for use
  5. Special/tailored drug release and localisation
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2
Q

What are the considerations in formulating a drug into a dosage form?

A
  1. Clinical indication to be treated and patient factors
  2. Physical and chemical properties of the drug substance
  3. Factors affecting the absorption of the drug from different administrative routes and dosage forms
  4. Good manufacturing practice and pharmacopoeia standards and tests to ensure quality
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2
Q

What are the various types of excipients used in liquids and semisolid preparations?

A
  1. Acidifying agent
  2. Alkalinizing agent
  3. Buffering agent
  4. Preservatives
  5. Colorant
  6. Flavorant
  7. Sweetening agent
  8. Tonicity agent
  9. Solvent
  10. Ointment base
  11. Humectant
  12. Surfactant
  13. Emulsifying agent
  14. Suspending agent
  15. Vehicle
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3
Q

What is the function of an acidifiying agent?

A

It is used in liquid preparations to provide an acidic medium for product stability.

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4
Q

What is the function of an alkalinizing agent?

A

Used in liquid preparations to provide an alkaline medium for product stability.

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5
Q

What is the function of a buffering agent?

A

Used to resist changes in pH upon dilution or addition of acid or alkali.

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6
Q

What is the function of preservatives?

A

Used in liquid and semisolid preparations to prevent growth of microorganisms like fungi and bacteria

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7
Q

What is the function of a colorant?

A

To impart colour to liquid and solid preparations.

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8
Q

What is the function of a flavorant?

A

To impart a pleasant flavor and often aroma to a preparation.

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9
Q

What is the function of sweetening agents?

A

To impart sweetness to a preparation.

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10
Q

What is the function of a tonicity agent?

A

To render a solution similar in osmolarity to physiologic fluids.

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11
Q

What is the function of a solvent?

A

Used to dissolve another substance in preparation of a solution.

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12
Q

What is the function of an ointment base?

A

It’s a semisolid vehicle for medicated ointments.

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13
Q

What is the function of a humectant?

A

Used to prevent drying of preparations, particularly ointments and creams.

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14
Q

Give some examples of an acidifying agent.

A

Citric acid, acetic acid, fumaric acid, hydrochloric acid, nitric acid

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15
Q

Give some examples of an alkalinizing agent.

A

Sodium bicarbonate, sodium borate, sodium carbonate, sodium hydroxide

16
Q

Give some examples of a buffering agent.

A

Potassium phosphate (monobasic), sodium acetate, sodium citrate (anhydrous and dihydrate)

17
Q

Give some examples of preservatives.

A

Antifungal: parabens (ethyl, methyl, propyl, etc), sodium benzoate
Antimicrobial: benzalkonium chloride

18
Q

Give some examples of colorants.

A

FD&C Red no.3
FD&C Yellow no.6
D&C Orange no.5

19
Q

Give some examples of flavorants.

A

Menthol, orange oil, peppermint oil, vanillin

20
Q

Give some examples of sweetening agents.

A

Aspartame, glycerin, mannitol, saccharin sodium, sorbitol, sucroseGive some examples of

21
Q

Give some examples of tonicity agents.

A

Sodium chloride, dextrose

22
Q

Give some examples of solvents.

A

Purified water, water for injection, mineral oil, alcohol

23
Q

Give some examples of ointment bases.

A

Petrolatum, hydrophilic petrolatum, white ointment, yellow ointment

24
Q

Give some examples of humectants.

A

Glycerin, propylene glycol, sorbitol

25
Q

What are the considerations for deciding the route of administering drug products?

A
  1. Are we aiming for local or systemic effects –> direct applicaton like eye drops for local effect and injection into the bloodstream for systemic effects
  2. Does the drug have significant first pass effect –> if yes then its hard to give as a tablet, may need to consider alternatives
  3. Does the drug have active metabolites –> it could mean a quicker therapeutic response, but that could get toxic
  4. Is there pre existing medical condition in the patient –> medical conditions that affect blood flow to the lover and kidney would affect metabolism and excretion which in turn affects drug conc. in the body.
26
Q

What does the area under the curve of a drug conc. vs time graph indicate?

A

The total amount of drug absorbed into the systemic circulation following the administration of a single dose.

27
Q

What is the onset time in a drug conc. vs time graoh?

A

The time taken for the drug to reach its minimum effective concentration (MEC).

28
Q

At what level can the peak concentration not exceed?

A

The minimum tox concentration (MTC)

29
Q

In which route of administration is the drug 100% bioavailable?

A

Intravenous

30
Q

What is absolute bioavailability?

A

The percentage of an administered drug that reaches the systemic circulation intact.

31
Q

How do you calculate absolute bioavailablity?

A

Absolute bioavailability = (AUCev/DOSEev) / (AUCiv/DOSEiv)

(pls check notes for better written ans.)

32
Q

What is bioavailabilty?

A

Bioavailability refers to the extent a substance or drug becomes completely available to its intended biological destination(s)

33
Q

What is relative bioavailability?

A

The bioavailability (AUC) of a test dosage form compared to that of a reference dosage form.

34
Q

Can bioavailability be higher than 100%?

A

Yes when it is relative bioavailability and the bioavailability of the test dosage form is higher than that of the reference dosage form.

35
Q

How do you calculate relative bioavailability?

A

Relative bioavailability = (AUCt/DOSEt) / (AUCstd/DOSEstd)

t = test, std = standard
(pls check notes for better written ans.)

36
Q

What is t max in a drug conc. vs time graph?

A

time to peak concentration

37
Q

What is C max in a drug conc. vs time graph?

A

Peak height concentration

38
Q

What is bioequivalence?

A

Two drugs are said to be bioequivalent when there is no significant difference between their Cmax, tmax and AUC