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DDS > Solid Oral Modified-Release Dosage Forms and Drug Delivery System > Flashcards

Solid Oral Modified-Release Dosage Forms and Drug Delivery System Flashcards

1
Q
  • release their medication in a controlled manner, at a predetermined rate, duration, and location
  • to achieve and maintain optimum the therapeutic blood levels of drug
A

Extended-release products

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2
Q
  • most delayed-release products
  • designed to pass through the stomach unaltered, releases their medication within the intestinal tract
A

Enteric-coated tablets or capsules

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3
Q
  • commonly taken only once or twice daily
  • provide an immediate release of drug that produces the desired therapeutic effect, followed by gradual release of additional amounts of drugs to maintain this effect over a predetermined period
  • provides sustained plasma drug levels, oftentimes eliminate the need for night dosing
A

Extended-release tablets and capsules

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4
Q
  • ranges in duration from 24 hours for most transdermal patches to 3 months for the estradiol vaginal ring insert
A

Nonoral Rate-controlled drug delivery system

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5
Q
  • Loss of flexibility in adjusting the drug dose
  • Risk of sudden and total drug, or dose dumping, due to a failure of technology
A

Disadvantages of Extended-Release Systems

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6
Q

Advantages of Extended-Release Dosage Forms Over Conventional Forms

* Controlling rate of release eliminates peaks and valleys of blood levels.
A

Less fluctuation in drug blood levels

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7
Q

Advantages of Extended-Release Dosage Forms Over Conventional Forms

* Extended-release products frequently deliver more than a single dose, hence may be taken less often than conventional forms.
A

Frequency reduction in dosing

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8
Q

Advantages of Extended-Release Dosage Forms Over Conventional Forms

* With less frequency of dosing, a patient is less apt to neglect taking a dose; also greater convenience with day and night administration
A

Enhanced convenience and compliance

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9
Q

Advantages of Extended-Release Dosage Forms Over Conventional Forms

* Because of fewer blood level peaks outside therapeutic range and into toxic range, adverse side effects are less frequent.
A

Reduction in adverse side effects

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10
Q

Advantages of Extended-Release Dosage Forms Over Conventional Forms

  • Although initial cost of extended-release dosage forms may be greater than for conventional forms, overall cost of treatment may be less because of enhanced therapeutic benefit, fewer side effects, and reduced time for health care personnel to dispense and administer drugs and monitor patients.
A

Reduction in overall health care costs

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11
Q

SR

A

sustained release

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12
Q

SA

A

sustained action

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13
Q

PA

A

prolonged action

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14
Q

CR

A

controlled release

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15
Q

ER

A

extended release

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16
Q

TR

A

timed release

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17
Q

LA

A

long acting

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18
Q
  • applied to certain types of drug delivery systems
  • the rate of the delivery is controlled by features of the device rather than by physiologic or environmental conditions (e.g. gastrointestinal pH or drug transit time thru the GI tract)
A

Rate-Controlled Delivery

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19
Q
  • use to describe dosage forms having drug-release features based on time, course, and location
  • designed to accomplish therapeutic or convenience objectives not offered by conventional or immediate-release forms
A

MODIFIED RELEASE

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20
Q
  • the USP differentiates the modified-release forms as:
A

EXTENDED RELEASE AND DELAYED RELEASE

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21
Q

allows a reduction in dosing frequency from that necessitated by a conventional dosage forms (such as solution of an immediate-release dosage form)

A

extended-release dosage forms (Extended Release)

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22
Q
  • to release the drug at a time other than promptly after administration
      * delay may be time based or based on influence of environmental conditions (e.g. GI pH)
A

delayed-release dosage form (Delayed Release)

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23
Q
  • contain two single doses of medication: one for immediate release and one for delayed release
  • ex: two-later tables, one layer of drug for immediate release with the second layer designed to release drug later as either a second dose of in an extended-release manner
A

Repeat-Action Forms (Repeat Action)

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24
Q
  • describes drug release directed toward isolating or concentrating a drug in a body region, tissue, or site for absorption or for drug action
A

Targeted Release

25
Q
  • the most widely used measure of the margin of a drug’s safety
      * the median toxic dose divided by the median effective dose
A

Therapeutic Index

26
Q

Fill in the blanks:

the larger the therapeutic index, the ____ the drug

A

safer

27
Q
  • extended drug action is achieved by affecting the rate at which the drug is released from the dosage form, and/or by slowing the transit time of the dosage form thru the GI Tract
A

Oral Administered Dosage Forms

28
Q

Using __________ or _________, a solution of the drug substance is placed on a small _______________ made of sugar and starch or on microcrystalline cellulose spheres

A

conventional pan coating or air suspension coating

inert nonpareil seeds or beads

29
Q
  • most often range from 425 to 850 mm
A

Nonpareil seeds

30
Q
  • ranges from 170 to 600 mm
  • more durable during production than sugar-based cores
A

Microcrystalline Cellulose Spheres

31
Q

True or False

the THICKER the coat, the MORE RESISTANT to penetration and the MORE DELAYED will be the drug release and dissolution

A

True

32
Q
  • 1mm in diameter
  • combined to have three or four release groups among more than 100 beads contained in the dosing unit
  • the release groups provide the different desired rates of sustained or extended release and —
  • the targeting of the coated beads to the desired segments of the GI tract (e.g. spansule)
A

Coated Beads

33
Q
  • compressed tablets to 3 or 4 mm in diameter to have varying drug-release characteristics
  • placed in gelatin capsule shells to provide the desired pattern of drug release
  • each capsule may contain 8 to 10 minitablets, coated for immediate-release and others coated for extended-drug release
A

Small Spheroid

34
Q
  • a process by which solids, liquids, or gases may be enclosed in microscopic particles by formation of thin coatings of wall material around the substance
A

Microencapsulation

35
Q
  • a common wall-forming material
A

Gelatin

36
Q
  • a common wall-forming material that may also be used aside from Gelatin
A

Synthetic Polymers

37
Q
  • concentrates of gelatin by the additive materials
  • forms a film or coat around the particles of the substance to be encapsulated so that a continuous tight film coating remains on the particle
A

Coacervate

38
Q

True or False
Advantage of Microencapsulation

The administered dose of a drug is subdivided into small units that are spread over a large area of the GI Tract, which enhances absorption by diminishing local drug administration.
Ex: Potassium Chloride

A

True

39
Q
  • commonly used as the excipient base in tablet matrix systems
A

Hydrophilic cellulose polymers

40
Q
  • a free-flowing powder
  • commonly used to provide the hydrophilic matrix
  • 20% of the HPMC results in satisfactory rates of release for an extended-release tablet formulation
A

Hydroxypropyl methylcellulose (HPMC)

41
Q
  • Drug is granulated with an _______, and the granulation is compressed into tablets
  • The drug is slowly released from the inert plastic matrix by _____
A

inert plastic material

diffusion

42
Q

Release is GREATER in the ACIDITY of stomach than in the LESS acidic environment of the small intestine.

A

True

43
Q
  • Drug substances when combined with chemically with other chemical agents form ______ that maybe only slowly soluble in body fluids, depending on the pH of the environment
  • This slow dissolution rate provides ER (extended release) of the drug
A

COMPLEXES

44
Q
  • A solution of a cationic drug may be passed thru a column containing an _______, forming a complex by the replacement if hydrogen atoms
  • The release of drugs depends on the pH and electrolyte concentration in the GI tract
A

ion-exchange resin

45
Q
  • composed of a core tablet surrounded by a semipermeable membrane coating having a 0.4-mm-diameter hole produced by laser beam
  • It operates on the principle of osmotic pressure
A

OROS SYSTEM

46
Q

-OROS SYSTEM core tablet has two layers: a) _______, containing the drug b) _______, containing a polymeric osmotic agent

A

active layer

the push layer

47
Q

The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as __________

A

an insoluble shell

48
Q
  • prepared so that an initial dose of drug is released immediately and a second dose follows later
A

Repeat-Action Tablets

49
Q
  • are best suited for treatment of chronic conditions requiring repeated dosing
A

Repeat-Action dosage forms

50
Q
  • capsules and tablets specially coated to remain intact in the stomach and to yield their ingredients in the intestine
A

Enteric Coated

51
Q

Uniformity of Dosage units may be demonstrated by either of two methods: _______ or ______

A

weight variation or content uniformity

52
Q
  • FDA published a guidance document: EXTENDED RELEASE ORAL DOSAGE FORMS: DEVELOPMENT, EVALUATION, AND APPLICATION OF IN VITRO/IN VIVO CORRELATIONS
A

True

53
Q

a predictive mathematical model for the relationship between the entire in vitro dissolution and release time course and the entire in vivo response time course

A

Level A

54
Q

A predictive mathematical model of the relationship between summary parameters that characterize the in vitro and in vivo time courses

A

Level B

55
Q

A predictive mathematical model of the relationship between the amount dissolved in vitro at a particular time and a summary parameter that characterizes the in vivo time course

A

Level C

56
Q
  • critical to the development of oral extended-release products
A

In Vitro-In Vivo Correlations (IVIVCs)

57
Q

The most common process for developing an IVIVC model (Level A)

A

True

58
Q

What are the Advantages of Extended-Release Dosage Forms Over Conventional Forms?

A
  • Less fluctuation in drug blood levels
  • Frequency reduction in dosing
  • Enhanced convenience and compliance
  • Reduction in adverse side affects
  • Reduction in overall health care costs
59
Q

Complete the order:

Powder -> ______ -> granules -> _______

A

Powder -> slug -> granules -> tablet

DDS (5 decks)

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