Dosage Forms Exam 3

Question 1

What are the advantages/disadvantages of Tablets and Capsules dosage forms?

Answer 1

-stable
-accurate dose
-easy to use (patient compliance)
-low cost
-taste masking/controlled release
DISADVANTAGES
-hard for infants/children
-not suitable for non-oral medications

Question 2

What are the advantages/disadvantages of IV solution?

Answer 2

-fast
-avoids GI tract environment
-for patients that cant swallow
DISADVANTAGES
-expensive
-not convenient
-associated with pain

Question 3

What are the advantages/disadvantages of transdermal patches?

Answer 3

-mostly for local treamtment

Question 4

What are the advantages/disadvantages of Intranasal spray?

Answer 4

-mostly for local treatment
-can be used for systemic drug delivery

Question 5

What is the difference between solid state versus solution?

Answer 5

Solution
-faster to act
-less stable
-more for parenteral administration (not by mouth)
Solid state
-slower to act
-more stable
-more convenient
-common for oral administration

Question 6

What is preformulation?

Answer 6

-determining the physiochemical properties necessary to formulate the compound

Question 7

What is formulation?

Answer 7

determining the route and composition of the final dosage form

Question 8

What is manufacturing?

Answer 8

What unit operations are necessary for final dosage preparation

Question 9

What are some roles/types of excipients?

Answer 9

-diluents
-disintegrants
-binders
-lubricants
-glidants
-controlled release (functional)
-preservative
-solubility enhancer
-stability enhancer
-taste masker

Question 10

What do Diluents do?

Answer 10

-bulking agents
-needed to make practical weight for tablet and keep it together, enhances powder flow (for manufacturing)
ex. lactose, starch, compressible sugar

Question 11

What do Disintegrants do?

Answer 11

-breaks up tablet, enhancing dissolution
-works by either water uptake and/or swelling
ex. sodium starch glycolate, starch, croscarmellose sodium

Question 12

What do binders do?

Answer 12

-gives tablet mechanical strength, creates granules in wet milling
-water uptake/swelling
ex. Polyvinylpyrrolidone, Starch, Polymers, microcrystalline cellulose

Question 13

What do lubricants do?

Answer 13

-prevents tablet from sticking to the press
-overlubrication can affect dissolution
ex. Magnesium stearate, stearic acid

Question 14

What do glidants do?

Answer 14

-improves powder flow, stops inter-particle friction
-very fluffy
ex. Fumed Silica (collodial silicon dioxide), Talc (has issues with asbestos)

Question 15

What do controlled release/Protection excipients do?

Answer 15

-extends the release of drug from a matrix
-coats a tablet for specified release
ex. HPMC, hypromellose, Xanthan gum
protection- Eudragits- poly(meth)acrylates

Question 16

What do coloring agents do?

Answer 16

-improve esthetics, identification to use, control product, help in case of poisoning
-can be combined with sugars, starches

Question 17

What is polymorphism?

Answer 17

-ability of a molecule to adopt two or more conformations/arrangements of molecules in the crystal lattice

Question 18

what does modified-release mean?

Answer 18

-the time course, location of drug release or both are altered to accomplish therapeutic objectives not achieved by conventional dosage forms

Question 19

What are the types of modified release?

Answer 19

Zero-order-releases drug at a constant and known rate
variable-release drug at variable rates so as to match circadian rhythms (useful when changes in blood concentration are necessary)
Bio-responsible- drug release triggered by a change in biological stimulus such as pH, temperature, or concentration of some disease marker (insulin)
-delayed-release delivery system
-Extended-release delivery system (sustained, controlled, prolonged, etc.)

Question 20

What are diffusion systems?

Answer 20

-release rate of the drug is determined by diffusion through a poorly water-soluble polymer
-reservoir device: core of drug surrounded by a poorly water-soluble polymeric membrane
-Matrix device: dissolved or dispersed drug is distributed uniformly throughout a polymer matrix. diffusion through the matrix is rate-limiting step

Question 21

What is Flux?

Answer 21

mass of drug that moves through a membrane per unit time. Fick’s law
-Zero-order release kinetics has a constant flux (reservoir system)
-Matrix device is not zero order and release rate is proportional to t-1/2

Question 22

What is Fick’s law of diffusion?

Answer 22

-for steady state diffusion

Question 23

What factors affect permeability?

Answer 23

-lipophilicity, solubility
-properties of membrane (hydration state, pH, penetration enhancers)
-dictated by diffusion

Question 24

What is a syrup?

Answer 24

a drug solution containing sugar or a sugar subsititute

Question 25

What is an Elixir?

Answer 25

clear sweetened solution containing a drug and alcohol

Question 26

Which has a higher blood level: Oral solution or Oral tablet?

Answer 26

The oral solution
-both have slow elimination rates

Question 27

The solution dosage form reaches higher blood levels than the solid dosage form because:
a. The drug is already in solution
b. it takes longer for a solid to dissolve
c. both a and b

Answer 27

c. both a and b

Question 28

What are the ingredients of solution formulas of biologicals?

Answer 28

-Drug
-buffer (pH control)
-stabilizer
-solubilizer
-tonicity modifier
-insulin ingredients

Question 29

How much faster is solution degradation than solid state degradation (dry solid)?
a. about 1000 times
b. about 100 times
c. about 1000000 times

Answer 29

b. about 100 times

Question 30

What is biotechnology?

Answer 30

-technology based on biology that harnesses cellular and biomolecular processes to develop medicines

Question 31

What is a master and working cell bank?

Answer 31

Master Cell bank- collection of uniform cells derived from selected cell clone containing the expression vector (contains genome that makes the drug)
Working cell bank- Derived from vials from the MCB

Question 32

What is synthetic Post-translational Modification?

Answer 32

PEGylation- polyethylene glycol (PEG) is attached to a protein to prolong its half-life, increase solubility, reduce immunogenicity, increase resistance to proteolysis

Question 33

What is an Analytical Target Profile?

Answer 33

combination of all performance criteria required to adequately describe what a method has to measure

Question 34

What type of vaccine was the polio vaccine?

Answer 34

-A whole killed virus vaccine