Test 4-Capsules and Tablets (check answers)

What are empty hard gelatin capsule shells made from?

1) A mixture of gelatin, sugar and water (water 13-16%) 2) Various FD&C and D&C dyes 3) Preservatives are also added

Name 2 examples of enteric coating polymeric material

1) Cellulose acetate phthalate 2) Polyvinyl acetate phthalate

What are some advantages of capsules as a dosage form?

1) Elegance 2) Masks taste 3) Administration ease 4) Protect from air and humidity

What can overdrying of capsules result in?

1) Film split from shrinkage 2) Films become too brittle for the later trimming operation

What advantage does a film coated tablet have compared with a sugar coated tablet?

1) Film: a) covered by a thin layer of film of water soluble or insoluble polymer b) less bulky, protect from abrasion 2) Sugar: a) susceptible to microorganisms b) large size c) conceals odor and taste of medication

What is the difference between a hard gelatin capsule and a soft gelatin capsule?

1) Hard -encapsulated between .65 mg - 1 g of powdered materials; good for solid drugs 2) Soft - rapidly release contents which increase bioavailability; good for liquid drugs

What are some reasons that tablets are coated?

1) Mask the tastes of medications 2) For the course of action (ER, dissolve in SI) 3) Appearance 4) Protect from air and humidity

What is one difference between USP apparatus 1 and USP apparatus 2 that are used principally for dissolution testing of immediate release solid oral dosage forms.

1) USP apparatus 1 - basket 2) USP apparatus 2 - paddle

What are 2 differences between buccal and sublingual tablets?

1) buccal - in cheek (slower onset) 2) sublingual - under tongue (faster onset)

What is the order of processing materials for the manufacture of compressed tablets?

1) communition 2) blending 3) granulation 4) wet sieving 5) drying 6) dry sieving 7) bolting the lubricant 8) compression

Give two types of tablet coating in pharmaceutical industry

1) film coating 2) sugar coating

What are the 2 main ingredients in dipping solution?

1) gelatin 2) water

What are the purposes of binder in tablet formulation?

1) promotes granulation 2) maintains integrity of final tablet 3) makes sure that the tablet stays together (intact) after compression

What are 2 disadvantages of capsules?

1) rapid release of the highly soluble salt 2) capsules can become lodged in the throat

If gelatin and water are the 2 main ingredients in dipping solutions what is the weight by weight requirement for gelatin?

30%-40% w/w

The medium for tablet dissolution testing is usually placed in the vessel and allowed to come to ______

37 degrees Celsius +/- 0.5 degrees Celsius

What is the isoelectric point range for Type B gelatin?

4.8-5.0

What is the isoelectric point range for Type A gelatin?

7-9

What is the difference between dispensing and hypodermic tablets?

A hypodermic tablet is a molded tablet ....

Arrange these methods of tablet manufacture in DECREASING order of complexity A) Wet granulation B) Direct compression C) Dry granulation

A) Wet granulation (most) B) Direct compression C) Dry granulation (least)

The official tests for ensuring the quality of drug products in tablet form include which of the following? A. Disintegration B. Dissolution C. Hardness D. Content uniformity E. Weight variation F. Friability G. Tablet thickness

A. Disintegration B. Dissolution D. Content uniformity E. Weight variation

Capsules are A) liquid dosage forms with medicinal agents B) solid dosage forms with medicinal agents C) inert substances enclosed within a shell of gelatin D) b & c

B & C solid dosage forms with medicinal agents and inert substances enclosed within a shell of gelatin

Which of the following methods of tablet manufacture can be used for preparing Aspirin tablets? A) Wet granulation method B) Dry granulation method C) Geometric dilution method D) Fluidized drying method

B) Dry granulation method

Which of the following types of capsule can be used by the pharmacist for extemporaneous compounding in a community or retail pharmacy? A) Soft gelatin capsule B) Hard gelatin capsule C) None of the above D) All of the above

B) Hard gelatin capsule

Soft gelatin capsule shells contain shell glycerin, sorbitol, or propylene glycol as A) Lubricating agent B) Plasticizers C) Polyhydric alcohols D) surfactants

B) Plasticizers

Which statement is true about the manufacture of compressed tablets? A) Direct compression method of compressed tablet manufacture B) Dry granulation followed by compression method of compressed tablet manufacture C) Wet granulation followed by compression method of compressed tablet manufacture D) Slugging method of granulation followed by compression

C) Wet granulation followed by compression method of compressed tablet manufacture

Gelatin capsule shells may be A) hard B) soft C) both

C. both

Pick the most correct answer for the manufacture of soft gelatin capsules A) Plate process B) Rotary die process C) Acogel process D) All are correct

D) All are correct

Pick the test for tablet quality that approximates bioavailability of tablets. A) Friability test B) Hardness test C) Test for tablet thickness D) Dissolution test

D) Dissolution test

Which of the following is NOT the purpose of binder in tablet formulation? A) Promote the adhesion of the particles of the formulation, enabling a granulation to be prepared B) Maintains the integrity of the final tablet C) Imparts cohesiveness to the tablet formulation which ensures that the tablet remains intact after compression D) Promotes the breakup of the tablets after administration to the smaller particles for dissolution and availability

D) Promotes the breakup of the tablets after administration to the smaller particles for dissolution and availability

True/False: Sodium carboxylmethyl cellulose is often added when making empty hard gelatin capsule shells

False

True/False: The upper punch of the tableting machine controls the weight of the tablets.

False

True/False: chewable tablets are an example of a molded tablet

False

What group of lubricant promotes fluidity or flowability of granulation during tableting?

Glidants

True/False: Preservatives can be added to capsules

True

True/False: Soft gelatin capsules have the advantage of being suitable for the preparation of liquid drugs or drug solutions

True

True/False: Stripping uses bronze jaws which are softer than stainless steel.

True

True/False: The capsule process takes about 45 minutes and the 2/3 of this time is spent during the drying process?

True

True/False: The lower punch controls the tablet weight in a single punch tabletifng machine.

True

True/False: The upper punch controls the tablet hardness and thickness in a single punch tableting machine

True

Does Type A or B gelatin offer firmness?

Type B; B stands for bone gelatin

What temperature are the pins before dipping?

about 22 degrees Celsius and the dipping solution is 50 degrees Celsius

What is type A gelatin obtained from?

acid hydrolysis of pork skins

What is type B gelatin obtained from?

alkali hydrolysis of animal bones

The USP directs that nitroglycerin tablets be preserved in tight containers, at controlled room temperature, preferably made of ________

glass

What type of capsules are 1) used to manufacture most of the commercially medicated capsules 2) employed in clinical drug trials to compare the effects of an investigational drug to another drug product and 3) used by pharmacist in the compounding ?

hard gelatin capsules

Comment on the MOA of starch as a disintegrant in the tablet formulation ( which means how does starch break down tablets)

high water uptake and breakup of the tablet

What are empty hard gelatin capsules made from?

mixture of gelatin, sugar, and water

stopped at question 33 ...

of exam 4 2000

How do you obtain gelatin?

partial hydrolysis of collagen obtained from skin, white connective tissues and bones from animals

What can underdrying of capsules result in?

pliable and sticky films

When the pairs of stainless steel pins are dipped into the dipping solution they are lubricated with a _____________

proprietary mold release agent

After the pins are dipped in the solution they are withdrawn and rotated 2.5 times. What is the purpose for the rotation?

rotation distributes the gelatin over the pins uniformly and avoids the formation of a bead at the capsule end.

What is the hardness of the tablet controlled by?

the upper punch

Why is the vacuum applied to the gelatin water mixture in the large stainless steel tanks?

to remove access air

What type of tablet requires water maintained at 37 degrees Celsius as the immersion fluid in the disintegration test unless another fluid is specified in the individual monograph in the USP?

uncoated tablets

Which punch remains stationary at the time of compression in a single punching tableting machine?

upper

True statements about the function of excipients used in tablet formulations include 1) Binders impart cohesiveness to granules during the wet granulation process of tablet manufacture 2) Glidants help to promote the flow of the tablet granulation during manufacture 3) True lubricants help the patient to swallow the tablet

1 & 2 are true 3 is false

3 examples of molded tablets

1) hypodermic tablet 2) dispensing tablet (DT) 3) tablet triturate (TT)

What are 2 reasons for tablet coating?

1) mask taste 2) protect active ingredient

What are 3 manufacturing variables that may likely affect the dissolution of a prednisone tablet?

1) the amount and type of binder added 2) the amount and type of disintegrant added 3) the force of compression used during tableting

How long are pins cast in the dipping solution?

12 seconds; more for larger pins

Manufacturing variables that may likely affect the dissolution of prednisone tablet in the body include A) The amount and type of binder added B) The amount and type of disintegrant added C) The force of compression used during tableting

A) The amount and type of binder added B) The amount and type of disintegrant added C) The force of compression used during tableting

How are the pins dried after rotation? A) moist air B) through 4 ovens by dehumidification ie. large volumes of dry air over the pins C) pins are shaken until all the water is removed

B) through 4 ovens by dehumidification ie. large volumes of dry air over the pins

All of the following capsule sizes are for veterinary use except: A) 10 B) 11 C) 6 D) 12

C) 6

Which of the following capsule sizes has the largest capacity? A) 4 B) 0 C) 1 D) 000

D) 000

What does DSDS-TJ stand for?

DIP SPIN DRY STRIP TRIM JOIN

True/False: Buccal tablets are softer than sublingual tablets.

False

True/False: Methylcellulose and glucose are enteric coating polymeric material

False

What is the purpose of binder in tablet formulation?

Impact cohesiveness to granules during wet granulation

What type of tablet is easily susceptible to microbial attack?

Sugar coated tablets

True/False: Capsules are used for incorporation of drug liquids and solutions

True

True/False: Capsules may be opened or crushed to mix with food or drink?

True

True/False: In the compression cycle of rotary press or tablet machine, the upper punches enter a fixed distance into dies, while the lower punches are raised to squeeze and compact the granulation within the dies.

True

What do you understand by the term mottling in tableting?

Uneven distribution of color on the surface of the tablet

How are hard gelatin capsules made opaque?

by adding agents like titanium diaoxide

What happens if capsules dry too rapidly?

case hardening

What does Type A gelatin offer?

clarity and plasticity

Once a portion of the gelatin stock mixture is removed from the large stainless steel tanks additional ingredients are added to make the dipping solution. After that the viscosity is measured. What does the measured viscosity control?

controls the thickness of capsule walls