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Pharmacology > Biopharmaceuticals > Flashcards

Biopharmaceuticals Flashcards

1
Q

Components of a drug

A
  1. Active pharmaceutical ingredient (API)
  2. Excipients- everything else
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2
Q

Different routes of ingestion

A

-Oral
-Parenteral (IM/SC/IV)
-Topical vs. transdermal
-intra-mammary
-intranasal
-rectal
-buccal

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3
Q

Oral route

A

-can be solid, semi-solid (paste/suspensions), oral solution, feed premix (powder)
>think about different timing of drug release and absorption
>solids=longer expiry dates; liquids= short expiry dates

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4
Q

How much API gets absorbed?

A

-depends on how much of drug gets into the blood stream… Route will effect this (IV greater vs. oral)
**effects bioavailability

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5
Q

Parenteral (IM/SC/IV) route

A

-usually solution (water-soluble)
-sometimes non-aqueous
-must be sterile
-often irritating; companies will try to modify it the best they can

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6
Q

Topical vs. transdermal routes

A

-Topical: on top of skin; Transdermal: drug goes through skin into blood
-creams, liquids, gels, patches
-intended for local effect only

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7
Q

Intra-mammary route

A

-suspension
-stay in the teat/udder

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8
Q

Intranasal route

A

-liquid, aerosolize/nebulize (convert liquid to fine particles)
-drug either stays in nostril/head vs. nebulizer results in drugs reaching alveoli

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9
Q

Rectal route

A

-suppository

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10
Q

Buccal route

A

-fast dissolving tablet or paste
-absorbed through cheek epithelium which helps to avoid first pass through the hepatic metabolism
-need to make sure that it isn’t swallowed (difficult in animals)

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11
Q

Why do drugs need excipients?

A

-Can be used to change Cmax, Tmax, AUC. Can be used to modulate levels that reach systemic circulation
-avoid poor taste and irritation of GI mucosa
-can be used to modulate levels that reach systemic circulation
-stability of API in dose form
-help API stay on skin in topical route
-help API penetrate the skin in transdermal

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12
Q

Excipients of oral drugs

A

-binding agent
-coating or capsule
-flavouring agent

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13
Q

Binding agent purpose in oral meds

A

-delays disaggregation (break down tablet) and dissolution (solubilizes aPI) which ensures it makes it into the intestinal cell

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14
Q

Coating/capsule in oral meds

A

-protect API from stomach acid
-decrease irritation in proximal GI tract
-delay timing of absorption

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15
Q

Flavouring agent in oral meds

A

increase palatability

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16
Q

Excipients in parenteral injected meds

A

-pH adjuster
-salt or chelating agent
-preservative

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17
Q

pH adjuster in parenteral meds

A

-makes injection less irritating
-increases solubility of API allowing for smaller injection volume
-enhances stability of the API in solution

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18
Q

Salt or chelating agent in parenteral injection

A

-alters API solubility
-determines how long before APi is released
-vasoconstriction

19
Q

Preservative in parenteral drugs

A

-maintain sterility

20
Q

What is the difference between longer release drugs and other drugs on the market?

A

Longer release drugs will often have more of the active ingredient present than any other drug form (higher dose 100mg compared to slower release 50mg)

21
Q

Pioneer drugs

A

-the original drug that came to market
-high cost
-requires all clinical, safety and efficacy studies
-Patent allows for exclusive marketing and when patent runs out, price will drop

22
Q

Generic drugs

A

-copies of the pioneer drug
>proven safety and efficacy of pioneer drug so the generic drugs don’t need to reproduce studies but still need to prove quality

23
Q

Compounded drugs

A

-pharmacy makes up the drug product… but not an approved drug product

24
Q

Generic drug approval process

A
  1. Test for manufacturing and chemistry/drug product quality. Requires same potency (strength or concentration), purity (API, no excess impurities), stability and sterility
  2. Clinical efficacy and safety- must be same strength and dosage form, and demonstrate bioequivalence
25
Q

Bioequivalence between pioneer and generic

A

Generic drug has equal plasma concentrations to pioneer drug resulting in clinical efficacy and safety (bioavailability and absorption)

26
Q

Bioequivalence

A

When the rate and extent of absorption of two pharmaceutically equivalent formulations of drugs (pioneer or generic) are sufficiently similar, within allowable limits, when administered under similar experimental conditions

27
Q

Clinically interchangeable

A

When a generic drug has the same strength, dosage form, and bioequivalence!

28
Q

Drugs with equal amounts of identical medicinal ingredients in comparable dosage forms

A

Does not mean they have the same non-medicinal ingredients- as long as varying non medicinal ingredients doesn’t influence the absorption characteristics of the active ingredient

29
Q

How to prove bioequivalence?

A

-Blood level Crossover study (2 groups, 2 treatments) to compare generic and pioneer products
>each animal gets both products with a washout period in between (10x half life)
>collect multiple blood samples (need early and late times) to determine plasma concentrations
>create concentration-time profiles (AUC, Cmax, Tmax)

30
Q

What times do blood samples need to be collected over time?

A

Early: enough to capture absorption/Cmax

Late: At least 3x half life beyond Tmax

31
Q

Compounding

A

-combining or mixing multiple ingredients (at least one has to be a drug) to create a final product in an appropriate dosing form

32
Q

Why use compounded drugs?

A

1.available formulations are not appropriate for a specific patient- diluted formulation for very small animals

  1. Improve client compliance (palatability; non-oral formulation)
  2. no approved drug product commercially available (requires bulk ingredients)
    -Ex. Cisapride, apomorphine, KBr
33
Q

FDA rules on compounded drugs

A

-used to treat an unmet therapeutic need or reduce animal suffering
-cause no harm to treated animal
-do not result in therapeutic failures
-do not result in violative drug residues (food animals)

34
Q

Order of drug choice

A
  1. approved vet drug on label
    2.approved vet drug extra label
    3.approved human drug
    4.compounded drug- from approved vet drug
  2. compounded drug- from approved human drug
  3. compounded drug from active pharmaceutical ingredient
35
Q

Compounding concerns

A
  1. purity
  2. potency
  3. Stability of compounded formulation
  4. Pharmacokinetic changes due to formulation
36
Q

Purity of compound drug

A

-quality of drug- drug that is present is supposed to be there, no other drugs should be there

37
Q

Potency of compounded drug

A

-quantity of drug need to line up with accuracy of label quantity

**manufactured drug concentration must be within 10%

38
Q

Meloxicam compounding example

A

-looked at 19 compounded products
-actual concentrations of meloxicam was from 37-132%
-majority of them did not meet drug potency!

39
Q

Stability of compounded formulation

A

-hydrolysis- if it comes dry, needs to stay dry

-oxidation-change due to light or O2

-consistency- precipitates

-expiry date- 25% of time left on original expiry date. Usually very short.
*water-based compounds: 14 days
*Oil-based compounds: 180 days

40
Q

Pharmacokinetic changes due to formulation

A

Compounded drugs can have alterations in terms of:
-Absorption (oral, transdermal)
-bioavailability

41
Q

Compounded Transdermal products

A

-just because a pharmacy can make a gel or patch, but it does not mean it will be absorbed
>results can vary between individuals
>not uniform between pharmacies

**need to explain efficacy

42
Q

What to tell clients about compounded drug products?

A
  1. Explain use for specific patient (different strength or route of administration is needed OR no approved drug is available)
  2. Have a method of assessing efficacy of compounded drug
    3.Get informed consent from client, and document in medical record

**Compound and generic are not the same thing!!!
**do not use because it is cheaper!!

43
Q

DIN

A

Drug ID number= approved drug

Pharmacology (19 decks)

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