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PHRM 828 > Final Exam > Flashcards

Final Exam Flashcards

1
Q

What are different types of pharmacy innovations?

A
  • Oros
  • Prodrugs
  • Combination products
  • Abuse deterrent
  • ADHD
  • Oral vaccines
  • Sustained release
    – Pulsatile
  • Enteric
  • Inhaleable
  • Fentanyl Buccal
  • Fentana Patch
  • Solid Lipid
    Nanoparticles
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2
Q

What are the different types of vaccine innovations for Covid-19?

A
  • mRNA
  • vector
  • protein subunit
  • whole, killed
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3
Q

What are the 3 different types of ADHD drugs?

A
  • amphetamine (adderall/vyvanse)
  • methylphenidate (Ritalin/concerta)
  • non stimulant (intuniv)
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4
Q

What is one of the five main methods for ensuring the quality of tablets/capsules?

A

Dissolution Testing
(others: assay, impurities, content uniformity, water)

only one linked to BLOOD LEVELS and BIOAVAILABILITY

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5
Q

What must come before dissolution?

A

Disintegration

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6
Q

What happens to drugs with low water solubility?

A

The dissolution rate determines the absorption rate.

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7
Q

What drugs require a dissolution test?

A

RIGOROUS for HIGH solubility, HIGH permeability drugs

MORE RIGOROUS for HIGH solubility, LOW permeability drugs

MOST RIGOROUS for LOW solubility, HIGH permeability (BCS Class 2)

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8
Q

What does any change in experimental dissolution % show about the same drug?

A

Experimental Error

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9
Q

What are the steps in film coating?

A

1) spray solution
2) solution wets and spreads on surface
3) solvent evaporates
4) polymer molecules entangle
5) film forms through coalescence
6) adhesion between coating and surface

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10
Q

What are examples of coating pans?

A
  • accelacota
  • grover
  • vector
  • fluid bed coating
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11
Q

What are some NONENTERIC polymers?

A
  • HPMC
  • Methylhydroxyethylcellulose
  • Ethylcellulose
  • HPC
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12
Q

What are some ENTERIC polymers?

A
  • (in small intestine)
  • OMEPRAZOLE
  • acrylate polymers (eudragit L and S)
  • CAP
  • HPMCP
  • PVAP
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13
Q

What is a matrix tablet?

A

a drug embedded in a polymer matrix

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14
Q

What is the difference between a DISSOLUTION graph and a BLOOD level graph?

A

blood levels are decreasing due to metabolism, goes to zero

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15
Q

What is a process innovation?

A

improvement in method or platform, levitated drop

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16
Q

What is a product innovation?

A

improvements in things such as insulin or ADHD treatments

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17
Q

How did they fix the problem of Ritalin having to stimulate 2x per day?

A

changed formulation and copied Oors controlled releases by combining DIFFERENT RELEASE BEADS

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18
Q

What is viread/tenofovir?

A

a prodrug,
polymorphic (water and heat)
(turn active once it enters the body)

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19
Q

What is the HepC lifecycle?

A

a) ENTERS body (neutralizing antibodies)
b) FUSION and UNCOATING
c) TRANSLATION into polyprotein
d) CLEAVAGE of polyprotein
e) FORMATION of membrane rep. complex
f) REPLICATION
g) VIRION packaging and assembly
h) virion MATURE and RELEASE

20
Q

What are the costs of untreated HepC?

A

HepC: $24k
liver disease: $60k
liver cancer: $112
liver transplant: $500k

21
Q

How does COVID-19 enter the body and how does paxlovid and molnupriavir stop it?

A

1) attach and enter
2) translate bad proteins
3) proteolysis (PAXLOVID)
4) RNA replication (MOLUN.)
5) transcription and translation of accessory proteins
6) assemble and release

22
Q

What are some characteristics of antiviral drugs?

A
  • insoluble/poor bioavailability
  • prodrugs (sofosbuvir)
  • made by MELT EXTRUSION (amorphous dosage form) and spray-drying
23
Q

What kind of vaccine was the polio vaccine?

A

whole virus vaccine
in 1955 by lilly
made until 1968, drop to 53 cases

24
Q

How are RNA Vaccines manufactured?

A

by CMOs
(Contract Manufacturing Organizations)

25
Q

What is the drug substance step in making a vaccine?

A

Plasmid linearization: produce DNA template

26
Q

What is the drug substance manufacture 2 step?

A

In vitro transcription (IVT): enzymatic synthesis and capping of mRNA

27
Q

What is drug substance manufacture 3 step?

A

Buffer exchange: prepare feed for the purification step

28
Q

What is drug substance manufacture step 4?

A

Capture: mRNA purification

29
Q

What is drug substance manufacturer part 5?

A

Concentration: Volume reduction and change to stable salt condition

30
Q

Drug product part 11?

A

LNP formation: lipid nanoparticles formation as an mRNA drug delivery vehicle

31
Q

What is Mounjaro?

A

Dual agonist
- GLP-1 receptor agonist
- GIP receptor agonist
weight loss, blood sugar control
cardiovascular benefits
reduced hypoglycemia
pancreatic beta-cell reservation
appetite suppression

32
Q

What are the ICH Q10 Objectives?

A
  • ACHIEVE product realization
  • ESTABLISH control
  • FACILITATE continuous improvement
33
Q

What are typical drug SUBSTANCE specifications?

A
  • AB1234 content by HPLC
  • drug-related impurities
  • residual palladium by ICP
  • loss of drying
34
Q

What are typical drug PRODUCT specifications?

A
  • AB1234 content
  • Degradation products
  • Dissolution
35
Q

What’s in the Common Technical Document (CTD)?

A
  • Module 2: content, intro etc.
  • Module 3: Quality
  • Module 4: Nonclinical study
  • Module 5: Clinical study
36
Q

What’s not in the CTD?

A

Module 1 regional administrative information

37
Q

What are the components of an NDA?

A
  1. table of contents
  2. Summary
  3. evaluation of safety and effectiveness
  4. copies of label and all other labeling to be used for drug
  5. statement as to whether the drug is or not limited in its labeling and by this application to use under the professional supervision of a practitioner licensed by law to administer it
  6. full list of the articles used as components of the drug
  7. full statement of the composition of the drug
  8. full description of the methods used in and the facilities and controls used for the manufacture processing and packaging of drug
  9. samples of the drug and articles used as components
  10. list of investigators
  11. full reports of preclinical investigators that have been made to show whether or not the drug is safe for use and effective
  12. full reports of clinical investigations that have
    been made to show whether or not the drug is safe for use and effective in use
  13. If this is a supplemental application. full
    information on each proposed change concerning
    any statement made in the approved application
38
Q

What are ANDAs?

A

approvals for generics, must show scientific bioequivalence, and have 24 to 36 healthy human volunteers

39
Q

Generic drugs require a __________ for approval
a) NDA
b) IND
c) ANDA

A

C – an Abbreviated NDA

40
Q

Which is not true about specifications
a) Specifications are based on the quality overall summary
b) It’s ok if specifications are not met as long as you feel the drug is of good quality
c) Specifications are binding quality standards. If a drug fails specifications it can’t be sold or must be recalled

A

Answer b
The firm set the specifications they must meet them

41
Q

Which method is not used to enforce quality
a) Seizures
b) Recalls
c) Warning letters
d) Tasers on offending parties

A

Answer:
d) At least not usually

42
Q

What are the 6 systems?

A

QUALITY SYSTEM
1) packaging and labeling system
2) production system
3) facilities and equipment system
4) laboratory controls system
5) materials system

43
Q

What is an impurity?

A

Any component of a drug substance that is not the chemical entity defined as the drug substance
Impurities are unwanted coexisting components in bulk pharmaceutical
chemicals that arise during manufacture and/or subsequent storage

44
Q

What’s an impurity profile?

A

Description of the identified and unidentified impurities present in a new drug substance

45
Q

What are impurity profiles?

A

Monitored on an ongoing basis through stability studies
 Determined at the time of
 IND filing
 NDA filing
 Post NDA approval
 ANDA filing
Reconfirmed after changes in
 Synthesis of the bulk drug substance
 Drug product process or formulation

46
Q

What are types of organic impurities?

A
  • Process-related and drug-substance-related
     The last step intermediates
     Reagents (carried over as trace impurities)
     Side reactions (incomplete reaction, overreaction, isomerization, rearrangement)
     Impurities in starting materials (positional isomers) or their reaction products
     Degradation products
47
Q

What are inorganic impurities?

A
  • Reagents, ligands, and catalysts
     Heavy metals or other residual metals
     Inorganic salts
     Other materials (eg, filter aids, charcoal)

PHRM 828 (2 decks)

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