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OU Pharmaceutics > Exam 2 Spring 2017 > Flashcards

Exam 2 Spring 2017 Flashcards

1
Q

What are other names for size reduction?

A
  • comminution

- micronization

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2
Q

What are examples of small scale size reduction?

A
  • mortar and pestle
  • levigation (semi-solid dosage forms)
  • ball milling
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3
Q

What are examples of large scale size reduction?

A
  • hammer mill
  • fitzmill
  • airject mill (attrition)
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4
Q

Properties of ball milling

A
  • batch process
  • capacity of 100g to a few kg (maybe 5)
  • reduces size to 50microm
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5
Q

What are factors that influence ball milling?

A
  • # of balls
  • rotation speed
  • mass of powder
  • length of milling time
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6
Q

Properties of hammer milling

A
  • continuous process

- reduce size to 50microm

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7
Q

What are factors that influence hammer milling?

A
  • feed rates
  • milling speed
  • screen size
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8
Q

Properties of Fitzmill

A
  • like hammer mill
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9
Q

What are factors that influence Fitzmill?

A
  • speed
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10
Q

Properties of air jet milling

A
  • continuous process
  • opposing air jets that operate at 100psig
  • reduce particle size to 1-5microm (DPI)
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11
Q

What are factors that influence air jet milling?

A
  • pressure

- velocity

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12
Q

What is another name for air jet milling?

A

attrition

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13
Q

What are the appropriate methods for different sizes particles?

A
  • 1-40microm definitely air jet mill

- 40 and above, can use all the other techniques

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14
Q

The most common procedure for mixing is tumbling but there are some limitations to that. What are they?

A
  • powder segregation
  • sifting or percolation
  • air entrapment (fluidization)
  • particle entrapment (dusting)
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15
Q

What are the different types of blends?

A
  • segregated mixture
  • perfect mixture
  • random mixture
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16
Q

What are the different types of mixers/blenders and what would you use them for?

A
  • Dry ingredients: V-mixer, double cone, rotating cube

- Liquid ingredients: ribbon blender

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17
Q

What are the purposes of size enlargement?

A
  • to make materials free-flowing
  • to prepare uniform mixtures that don’t separate
  • improve compression characteristics of the drug
  • improve appearance of dosage form
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18
Q

What are the different size enlargement methods?

A
  • dry granulation
  • wet granulation
  • spray drying
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19
Q

Describe dry granulation

A
  • usually used when one of your ingredients may be composed of water (lec 2-6 @ 35:20)
  • used for powders that are sensitive to moisture
  • powder is condensed into a sheet or tablet-like block
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20
Q

Describe wet granulation

A
  • used for moist powders

- spray powder with a liquid binder, liquid bridges formed, solid bridges formed, snowball structure formed

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21
Q

Describe spray drying

A
  • droplets formed and compressed air comes together and forms particles, goes in a chamber where liquid is dried out
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22
Q

What are the different types of capsules?

A
  • Gelatin
  • Methyl cellulose (HPMC) [best to use in DPI]
  • Calcium alginate
  • DRcaps™ Gastro Resistant Capsules
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23
Q

What are the steps for gelatin manufacturing?

A
  • Derived from skin or bone
  • Acid or alkali treatment
  • Extended treatment periods
  • Filter
  • Vacuum concentration
  • Cool to solidify
  • Air dry
  • Mill to size
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24
Q

How can capsules be closed?

A
  • welded with heated metal pin
  • bonded with molten gelatin
  • snap fit
  • coni-snap
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25
Q

Properties of soft gelatin capsules

A
  • Shells of gelatin, glycerin or sorbitol added to induce plasticity
  • Oblong, elliptical or spherical shape
  • Used to encapsulate liquids, suspensions, pastes or dry powders
  • Must be prepared filled and sealed in one continuous operation
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26
Q

What are the ways in which you can manufacture soft gelatin capsules?

A
  • plate process

- die process

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27
Q

What does the die process consists of?

A
  • a process which to manufacture soft gelatin capsules
  • rotary process
  • reciprocating process
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28
Q

What is the plate process?

A
  • a process which to manufacture soft gelatin capsules

- molds

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29
Q

What types of formula is suitable for soft gelatin capsules?

A
  • Water immiscible, volatile and nonvolatile liquids
  • Oily, non-volatile liquids
  • Not suitable for low molecular weight compounds that can easily pass through the capsule
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30
Q

What are the different types of coating for coated tablets?

A
  • Sugar
  • Film (make tablet more sturdy)
  • Gelatin
  • Enteric
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31
Q

What are the types of specialized tablets?

A
  • chewable
  • effervescent
  • CR, ER
  • sublingual
  • buccal
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32
Q

What are the essential ingredients for tablets?

A
  • diluent
  • binder
  • lubricant
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33
Q

Why would any ingredient be essential to tablets?

A

give the formula specific characteristics needed to be compressed

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34
Q

What are the ingredients to give tablets desirable characteristics?

A
  • disintegrant
  • color
  • flavor
  • sweetening agent
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35
Q

What is the purpose of a glidant?

A
  • needed for formulations with poor flow
  • not needed if lubricant is enough for flow
  • improves flow characteristics of powder mixture
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36
Q

Define diluent

A

inert substance added to increase bulk to make a tablet of practical size for compression, or to adjust its size

37
Q

What are examples of diluent?

A
  • lactose
  • calcium phosphate
  • microcrystalline cellulose (Avicel®)
38
Q

There needs to be a compatibility test between diluent and active ingredient. Give an example of an incompatibility.

A

Calcium salts interfering with absorption of tetracycline in the GI tract

39
Q

How can a diluent affect bioavailability?

A

water soluble diluents can increase bioavailability of drugs that have low solubility; can enhance dissolution

40
Q

Define binder

A

glues ingredients together and helps with compression; improves powder flow-ability

41
Q

What are examples of binders?

A
  • starch (10-20% paste)
  • gelatin (10-20% solution)
  • acacia
  • CMC
  • PVP
42
Q

What is the purpose of a lubricant?

A

generally hydrophobic; to prevent adhesion of the powder formulation to the surfaces of the dice and punches of tableting machine; improves rate of flow of granulate; should be added after granulation

43
Q

What are examples of lubricant?

A
  • talc (1-5%)

- magnesium stearate

44
Q

Why does talc undergo testing?

A

it may contain metals

45
Q

What happens if you add too much lubricant?

A
  • your tablet may become waterproof and it will affect wetting of the tablet
  • lead to poor tablet disintegration
  • poor dissolution
  • decreased solubility
46
Q

Give an example where talc needs to be purified.

A

if talc is not pure enough, it may have a high Ca concentration and will act as a decomposing agent towards ASA

47
Q

What is an example of a glidant?

A

talc

48
Q

Define disintegrant

A

substance or mixture of substances added to a tablet to facilitate its break-up or disintegration after oral ingestion

49
Q

What are examples of distinegrants?

A
  • starch

- celluloses

50
Q

How can you tell the difference between the roles that starch plays?

A
  • dilute/dissolve starch = binder
  • mixed with diluent = used as disintegrant
  • starch used as a binder usually has a lesser proportion
51
Q

Why doesn’t effervescent tablets need disintegrants?

A

because the sodium bicarbonate, tartaric or citric acid effervescence will cause tablets to disintegrate

52
Q

Which are the steps that we can add coloring agents and why?

A
  • wet granulation: dissolved in binding solution prior to granulation
  • dry granulation: blended in dry with other ingredients
53
Q

What are examples of flavoring agents?

A
  • Cyclamates and saccharine (banned)

- Aspartame

54
Q

What does it mean when you have talc and magnesium stearate in the same compound?

A

one will act as the glidant and one will act as the lubricant

55
Q

What are the purpose of tablet coating?

A
  • cover unpleasant taste, odor, color
  • physical and chemical protection
  • DR or EC
  • identification
  • ease process of blistering
56
Q

What are the different kinds of coatings?

A
  • sugar coated
  • film coated
  • gelatin coated
  • enteric coated
  • compression coated
57
Q

Purposes of sugar coating

A
  • protection from air and humidity

- improve taste and smell

58
Q

What can be used to waterproof tablets?

A

Shellac

59
Q

What is used to smooth tablets?

A

dibasic calcium phosphate, titanium oxide, starch

60
Q

Purposes of film coating

A
  • improve presentation
  • increase stability
  • improve taste
61
Q

What are examples of plasticizers and how are they used in tablets?

A
  • used for film coating

- castor oil, diethyl phtalate, propylen glycol

62
Q

What are examples of enteric coating materials?

A
  • cellulose acetate phtalate
  • poly(methacrylic acid-co-methyl-methacrylate)
  • poly(vinyl acetate phtalate)
63
Q

What are some commercially available for use enteric coating solutions?

A
  • Aquateric®
  • Caoteric®
  • Eudragits™
64
Q

Explain how enteric coating tablets allow the API to be released in the intestine instead of the stomach.

A
  • At low pH, carboxyl groups remain protonated (not water soluble)
  • At high pH, carboxyl group is ionized (becomes water soluble)
65
Q

Describe ingredients in sublingual tablets

A

lactose or mannitol and saccharine is massed with 60% ethanol

66
Q

What are ingredients in buccal tablets?

A
  • lactose or mannitol
  • HPMC
  • silica gel
67
Q

With respect to the film theory, what is a stagnant film?

A

a layer of solution which is saturated with the drug

68
Q

Define sink condition

A

one-third times that of the maximum solubility of the drug

69
Q

What are factors that influence dissolution from solid dosage forms?

A
  • dosage form
  • solubility
  • dissolution media
  • partition coefficient
  • diffusivity
  • diffusional path thickness
70
Q

What are three interaction forces that occur in powder samples?

A
  • capillary forces
  • mechanical interlocking
  • electrostatic charges
71
Q

What are the main reasons to granulate pharmaceutical powders?

A
  • make particle size more uniform
  • improve powder flow
  • improve compression characteristics of the drug
  • densify materials
72
Q

What are examples of plasticizers and how are they used in soft gelatin capsules?

A
  • used to soften gelatin and make it more maleable

- sorbitol, glycerin

73
Q

What are the ways in which tablets can disintegrate?

A
  • wicking: disintegrant forms pored and water enters the pores which reduces the physical bonding forces between powder particles
  • swelling: disintegrant particles swell inside tablet breaking the tablet from the inside
74
Q

What are the advantages of a film coating over sugar coating?

A
  • simpler process
  • less ingredients in coating solution
  • can provide thinner coats
75
Q

Causes of capping / lamination

A
  • insufficient binder
  • undermixing of tablets ingredients
  • fast speed of compression
76
Q

Causes of sticking / picking

A
  • insufficient amount of lubricant

- improper application of coating or insufficient drying time

77
Q

Causes of erosion / chipping

A
  • tablets are friable
  • fast pan rotation during coating
  • ## poor choice of plasticizer
78
Q

Causes of bridging

A
  • high viscosity of solid content in coating solution
  • improper atomization pressure
  • insufficient drying time
  • slow pan rotation during coating
79
Q

What are different types of media for dissolution?

A
  • water
  • solution with buffer
  • simulated gastric fluid (SGF)
  • simulated intestinal fluid (SIF)
80
Q

What does SGF consists of?

A
  • 0.2% NaCl in 0.7% HCl

- pepsin

81
Q

What does SIF consists of?

A
  • Phosphate buffer, pH=6.8

- pancreatin

82
Q

Apparatus 1

A
  • rotating basket
  • less than 4h dissolution test
  • standard volume 900-1000mL (also 1, 2, and 4L)
    used for
  • tablets coated, IR, DR, EC
  • capsules
  • beads
  • suppositories
  • floating dosage forms
83
Q

Apparatus 2

A
  • paddle
  • makes up about 80% of dissolution tests performed
  • less than 4h dissolution test
  • standard volume 900-1000mL
    used for
  • tablets coated, IR, DR, EC
  • capsules
  • beads
  • floating dosage form
84
Q

Apparatus 3

A
  • reciprocating cylinder
  • 4-12h dissolution test
  • standard volume 200-250mL
    used for
  • controlled release tablets & beads
85
Q

Apparatus 4

A
  • flow-through cell
  • designed for poorly soluble compounds
  • flow rate: 10-100mL/min
    used for
  • low solubility drugs
  • microparticles
  • implants
  • suppositories
  • controlled release formulations
86
Q

Advantages and disadvantages to Apparatus 4

A
  • Advantages: easy to change pH, pH profile, sink conditions maintained at all times, open and closed system, can be automated
  • Disadvantages: de-aeration necessary, high volumes of media needed
87
Q

Apparatus 5

A
  • paddle over disk
  • standard volume = 900m L
  • used for transdermal patches
88
Q

What should the time period be for an IR tablet to be dissolved?

A

15 - 60 minutes

OU Pharmaceutics (9 decks)

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