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914 > Solid Dosage Forms > Flashcards

Solid Dosage Forms Flashcards

1
Q

What does GRAS stand for and what does it describe?

A

Generally Regarded as Safe, refers to excipients that have been used for a long time safely even if they haven’t been tested by the FDA

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2
Q

GRAS refers only to what kind of doses?

A

Oral doses

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3
Q

What does PCID stand for?

A

Physico-chemical Identifiers

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4
Q

These would allow you to accurately identify that the drug you have is correct and would prevent counterfeiting of the drug

A

PCIDs

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5
Q

Elimination is the sum of which two processes?

A

Metabolism and excretion

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6
Q

Buccal tablets are meant to be used where?

A

Between the cheek and the gum

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7
Q

Certain drugs are very highly 1st pass metabolized; what are three oral dosage forms designed to get around that?

A

Orally disintegrating tablets, Sublingual tablets, Buccal tablets

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8
Q

Why does it take 25 minutes for conventional tablets to reach the minimum effective concentration in the blood?

A

There is a 3-step process to release: Disintegration of the tablet to granules, Dissolution of the tablet into solution (rate determining step) and absorption of the drug into the bloodstream so it can be circulated.

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9
Q

What is the ONLY WAY for a drug to pass through a biological membrane?

A

In a solution

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10
Q

Should tablets be kept in the bathroom cabinet?

A

No, because the tablets absorbs moisture from the air and starts to break apart

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11
Q

What should you tell your pt who is receiving tablets?

A

Take them with water (necessary for disintegration/dissolution) and keep them away from excessive moisture

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12
Q

What are some concerns about oral delivery of drug products?

A

If molecule too big or poorly soluble, it may not be able to be absorbed by the GI tract; there are often side effects from having the drug in the blood, because there is no way to control which tissues the blood w/ drug travels too; not all drugs can handle the acidity and enzymes of the stomach/intestines; it can take drugs a long time to dissolve and permeate the body

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13
Q

This solid dosage form is geared toward children, the elderly, and the infirm…

A

Chewable tablets

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14
Q

Why do chewable tablets need to be highly flavored?

A

Because most drugs have a bad taste, and since the pt is chewing the tablets, the taste must be improved so the pt will be willing to take it

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15
Q

What do you need to tell a patient receiving chewable tablets?

A

Make sure to chew the whole tablet and swallow, do not swallow whole (can affect drug action in some cases)

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16
Q

At what pH will enteric-coated tablets start to break apart?

A

Around pH 4

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17
Q

What is the difference between enteric-coated and conventional tablets?

A

Enteric-coated tablets are coated so that at low pH (ie, in the stomach) the pills will not dissolve, while conventional tablets do not have any protection from the acidity of the stomach

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18
Q

What do you need to tell a patient receiving enteric-coated tablets?

A

Do not take the tablet with antacids (it would raise the pH of the stomach and make the tablet dissolve too quickly)

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19
Q

What do you need to tell a person receiving sublingual or buccal tablets?

A

Don’t take the tablet with liquid or drink for about 10 minutes after taking (will wash drug into stomach and defeat the plan to avoid 1st pass metabolism as much as possible)

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20
Q

What are effervescent tablets?

A

Tablets designed to be dissolved into a solution and then drunk

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21
Q

What are some advantages of effervescent tablets?

A

Helps mask the taste of the drug, helps solubize some drugs (ie aspirin)

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22
Q

What do you need to tell a pt receiving effervescent tablets?

A

Wait til the entire tablet has dissolved before drinking (tablets themselves usually quite large, so would be difficult to swallow)

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23
Q

What are some differences between tablets and capsules?

A

Capsules have their drug product encases in a thin gelatin shell, while tablets have their drug and excipients compressed together; capsules have fewer ingredients (less need for excipients to add bulk)

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24
Q

What few excipients do capsules contain?

A

Diluents (increase capsule volume), Lubricants (make powders flow in filling machines easier), Colors (to make capsule shell easier to identify)

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25
Q

Why would a capsule be preferable to a tablet in some cases?

A

Easy to handle/swallow, tasteless and odorless so no need for extra coating, fewer ingredients so can be cheaper to make

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26
Q

What are some problems with capsules?

A

They cannot be “split” to change the dose, are sensitive to too much moisture, are 1st pass metabolized, might be poorly absorbed by GI tract

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27
Q

Instead of a disintegration step, what is the first step in the activation of a capsule?

A

The capsule rupture step (water softens the shell so enzymes can act to break open the capsule)

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28
Q

Is the capture rupture step or the disintegration step slower?

A

The capsule rupture step is slower than the disintegration step for tablets

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29
Q

What promotes cross-linking of gelatin in capsules?

A

Moisture and age of the proteins (as proteins age they cross link)

30
Q

What does cross-linking affect (on the concentration-time graph)

A

Tmax, Cmax, and AUC (area under the curve)

31
Q

What are some advantages of modified release drugs?

A

Patient compliance increases when fewer doses must be taken, constant blood levels are important for therapy of some conditions, and for SOME drugs bioavailability better for slowly-released drug

32
Q

What are different ways to create extended-release drugs?

A

Matrix diffusion, matrix erosion, encapsulation, and encapsulation (osmotic system)

33
Q

Where is the drug located in matrix diffusion and what is the rate determining step?

A

Particles of the drug are dispersed throughout an insoluble polymer matrix, and the diffusion of the drug out of the matrix is the rate-determining step

34
Q

What are some factors that affect the rate in matrix diffusion?

A

Molecular weight of polymer and cross linking of the matrix

35
Q

Where is the drug located in matrix erosion and what is the rate-determining step?

A

Particles of the drug are dispersed in the polymer matrix, and the erosion of the polymer is the rate-determining step

36
Q

Where is the drug located in encapsulation and what is the rate-determining step?

A

The drug is the core and coated with insoluble polymer, and the slow diffusion of the drug through the polymer shell is the rate-determining step

37
Q

How is the rate modified in encapsulation?

A

Controlling the thickness of the shell

38
Q

Where is the drug located in osmotic system encapsulation and what is the rate-determining step?

A

The drug is the core surrounded by a semi-permeable polymer with a laser-formed hole in the film, and the rate-determining step is the diffusion of the water into the film that dissolves the drug

39
Q

What does semi-permeable mean?

A

Only water can pass through but nothing else

40
Q

What does “zero order” release mean?

A

It means there is a constant rate of release

41
Q

Which of the modified release technologies have a zero-order release?

A

Osmotic system encapsulation

42
Q

What is dose-dumping?

A

When the controlled release mechanism fails for some reason and most or all of the drug is released quickly

43
Q

How should you counsel patients to lower risk of dose-dumping?

A

Tell patients not to chew capsules or take the drug with alcohol

44
Q

Divided powders are also called what?

A

Chartules

45
Q

What are target populations for divided powders?

A

Small children and those who have trouble swallowing

46
Q

What is the difference between bulk powders and divided powders?

A

Divided powders are packaged in “unit of use” envelopes while bulk powders are packaged in multi-dose containers

47
Q

Do divided powders or tablets/capsules enter the blood faster? Why?

A

Divided powders are slightly faster because there is only one step before absorption (dissolution) as opposed to the two-step process for tablets/capsules

48
Q

What are some concerns of divided powders?

A

They are expensive and must be protected from moisture

49
Q

What are some advantages of “gum” dosage forms?

A

They avoid 1st pass metabolism, although some drugs can be absorbed both orally and by the GI tract

50
Q

Why would a drug be made into gum form (like nicotine gum)?

A

The drugs tend to be highly first-pass metabolized

51
Q

Are troches and lozenges the same?

A

No, troches have a stick and are meant to be left between the gum and cheek to dissolve over 10-15 minutes

52
Q

What should you tell a patient receiving a lozenge or troche?

A

Do not drink for about 10 minutes after taking the lozenge (will wash the drug into the stomach and defeat the purpose)

53
Q

What is the Cmax value?

A

The highest concentration of drug acheived

54
Q

What is the Tmax value?

A

Time necessary to attain peak concentration in blood

55
Q

The area under the curve (AUC) is proportional to the amount of ____ absorbed in body

A

drug

56
Q

What are the four steps of ADME?

A

Absorption, distribution, metabolism, excretion

57
Q

What is a xenobiotic?

A

Something foreign to the body

58
Q

Which organ usually changes the chemical structure of a xenobiotic to make excretion easier?

A

Liver

59
Q

Are the four ADME steps sequential (one after another) or all they all going on at the same time?

A

All happening at same time (at different speeds)

60
Q

Why are the absorption and distribution steps initially faster than metabolism and excretion steps?

A

Because when the drug first enters the body, there is very little circulating in the blood to be metabolized; most of it still must be broken down and absorbed into the blood

61
Q

Define First-Pass metabolism

A

When drug passes through the portal vein into the liver, the vast majority is metabolized and sent to be excreted; the remaining amount is distributed throughout the body

62
Q

Which vein drains the intestine and will have the highest concentration of drug ever seen in the body?

A

The portal vein

63
Q

What makes up a drug product?

A

Drug + dosage form

64
Q

What is a dosage form?

A

System designed to deliver a well-defined amount of medicine to a specific location in the body at a certain time and in a way to maximize the therapeutic effect and minimize side effects

65
Q

What are five required features of dosage forms?

A

Delivers proper amount of medicine at proper rate at action site, provides reproducible dose in each unit, maintains drug in chemically stable state (avoids incompatibilities between drug and excipients), has acceptable pharmaceutical qualities (smell, taste, etc.), and is suitable for large scale manufacturing

66
Q

What are four ways to classify dosage forms?

A

Physical state, Point of Application/Delivery Route, Delivery mode, Technology of Release

67
Q

What are the two delivery modes?

A

Systemic (whole body) or local (usually not going to blood first, delivery to specific place)

68
Q

What is the difference between conventional and modified technology of release?

A

In conventional, release rate is rapid and limited only by rate at which drug substance dissolves; in modified, release rate designed to be controlled and slower than rate of drug dissolution would normally be

69
Q

What are the excipients in a tablet?

A

diluents, binding agent, disintegrating agents, lubricants, colors/coatings

70
Q

What is the purpose of a diluent in a tablet?

A

To give bulk to the tablet

71
Q

What do disintegrating agent excipients in tablets do?

A

Attract water from the GI tract to swell/disintegrate tablet

914 (4 decks)

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