Capsules

Question 1

What is one of the most established dosage forms in pharmaceuticals?

Answer 1

Oral Solid Dosage Forms

Question 2

What do Oral Solid Dosage Forms include?

Answer 2

tablets and gelatin capsules

Question 3

What % of ALL pharmaceutical preparations consist of tablets and gelatin capsules?

Answer 3

80% of all

Question 4

What are capsules?

Answer 4

Unit doses of powder, semisolid or liquid drugs enclosed within either an edible hard or a soft envelope, or shell

Question 5

Describe the invention of gelatin capsules (date, patent, & people)?

Answer 5

Original patent was issued in 1834 to a pharmacist and pharmacy student, the invention and manufacture of gelatin capsules

Question 6

What was the basic idea of a capsule?

Answer 6

to enclose the drug or active pharmaceutical ingredient (API) in an easy-to-fill shell

Question 7

What are the types of capsules?

Answer 7

Gelatin Capsules and Vegetable capsules

Question 8

What are the types of Gelatin Capsules?

Answer 8

Hard Gelatin Capsules and Soft Gelatin Capsules

Question 9

What does a Hard Gelatin Capsule include?

Answer 9

body and cap

Question 10

What does a Soft Gelatin Capsule include?

Answer 10

elastic outer shell and liquid/semi-solid core

Question 11

What materials are used in gelatin production?

Answer 11

27% bones, 28% bovine hides, 44% pig skin

Question 12

What are the advantages of Capsules?

Answer 12

Convenience compared to a liquid, Easy to identify with colors and markings, No need for spoons or other measuring devices, Tasteless, Allows flexibility in dosing, Easy to transport, Easy to take – oral administration, Manufacturing cost is low with minimal breakage compared to liquid packaging, Longer stability than liquid dosage forms

Question 13

How are capsules identified?

Answer 13

Size, shape and color are visual characteristics used to differentiate products to the consumers, Brand identification, Quality perception, Counterfeit prevention

Question 14

What are the Disadvantages of Capsules?

Answer 14

Exposes the drug to the GI tract and the GI tract to the drug, Storage conditions - Humidity is a problem, Can be a problem during clinical research

Question 15

What can some drugs in the form of capsules cause when exposed to the GI?

Answer 15

nausea, vomiting, and diarrhea

Question 16

What does iron in prenatal supplements and fish oil capsules cause (in terms of GI)?

Answer 16

an unpleasant “burp back” effect, which reduces patient compliance

Question 17

What kind of drugs in capsule form are not good because of GI?

Answer 17

drugs that are readily degraded in the GI tract, either due to stomach acids or enzymatic degradation

Question 18

What happens during clinical research of medications?

Answer 18

when one wants a blinded placebo or to make a comparison to a particular formulation or existing product

Question 19

What are the components of Hard gelatin capsules?

Answer 19

Gelatin, Sugar, H3O - 13-16%

Question 20

What is the coloration of Hard gelatin capsules?

Answer 20

May be colored, May be opaque

Question 21

How are opaque Hard gelatin capsules made?

Answer 21

Titanium dioxide

Question 22

How are colored Hard gelatin capsules made?

Answer 22

FD&C + D&C dyes

Question 23

What is Gelatin soluble in?

Answer 23

hot water and gastric fluid

Question 24

What does gelatin protect from?

Answer 24

Moisture

Question 25

What do Hard gelatin capsules protect against?

Answer 25

moisture

Question 26

How do Hard gelatin capsules protect against moisture?

Answer 26

Via use of desiccants in the packaging

Question 27

What are some examples of desiccants?

Answer 27

dried silica, clay, charcoal

Question 28

What are the Empty Capsule Manufacturing Steps (10)?

Answer 28

Material inspection, Gelatin melting, Color blending, Capsule production, Cutting, Joining, Printing, Inspection, Testing, Packing

Question 29

What are Dyes?

Answer 29

a chemical that shows color when it is dissolved in an aqueous base, not oil base (Artificial colors)

Question 30

What are the 3 classifications of dyes?

Answer 30

FD&C (Food, Drugs and Cosmetics), D&C (Drugs and Cosmetics), External D&C

Question 31

What can dyes do to another product?

Answer 31

bleed or migrate from one part of a product to another

Question 32

For liquids, what is the concentration of dyes used?

Answer 32

0.001% to 0.0005%

Question 33

For powders, what is the concentration of dyes used?

Answer 33

0.1%

Question 34

What are some coloring agents (2)?

Answer 34

Caramel, Ferric oxide: Red/yellow

Question 35

What are the Capsule Preparation Steps?

Answer 35

1. Comminution, 2. Blending, 3. Determine capsule size, 4. Add additional diluent prn, 5. Encapsulate, 6. Clean, 7. Quality control, 8. Package and label

Question 36

What is the Pre-locked position of Con-Snap Capsules?

Answer 36

Dimples of the cap engage gently with the indented ring of the body

Question 37

Do empty capsules stay closed in transit?

Answer 37

Yes

Question 38

What does the consistent low pre-stock force reduce?

Answer 38

opening and rectification problems

Question 39

What is the Sealed position of capsules?

Answer 39

The full-circumference locking rings of the cap and the body interlock to form a secure, leak-free closure

Question 40

Why is there a wide choice of capsule sizes available?

Answer 40

For compatibility with all type and models of capsule filing machines

Question 41

What does the selection of capsule size depend on?

Answer 41

amount of material, compressibility, and density

Question 42

What is the relationship between Capsule # & Content (mg) within them?

Answer 42

Lower the capsule #, higher the amount of content

Question 43

What are the 4 Common Capsule Excipients?

Answer 43

Wetting agents, Glidants, Disintegrants, Diluents or adsorbents

Question 44

What type of excipient can provide bulk to the formulation & reduce moisture?

Answer 44

Diluents or adsorbents

Question 45

What are some examples of Diluents or adsorbents?

Answer 45

lactose, cellulose

Question 46

What type of excipient assists the break-up and distribution of the capsule contents?

Answer 46

Disintegrants

Question 47

What are some examples of Disintegrants?

Answer 47

pre-gelatinized starch

Question 48

What are some examples of Glidants?

Answer 48

silicon dioxide, talc

Question 49

What type of excipients enhance the flow properties of the powder mix?

Answer 49

Glidants

Question 50

What type of excipients facilitate wetting of the dry powder?

Answer 50

Wetting agents

Question 51

What are some examples of wetting agents?

Answer 51

surfactants – Sodium dodecyl sulfate (SDS)

Question 52

What is the goal in Developing the Formulation of Capsules?

Answer 52

Prepare capsule with accurate dosage, good bioavailability, ease of filling and production, stability, and elegance

Question 53

What are some Physicochemical Considerations when Developing the Formulation of Capsules?

Answer 53

Potential incompatibilities: Drug-Drug, Drug-Excipient, Hygroscopic or Deliquescent drugs, Eutectic mixtures

Question 54

What are some Special Applications of capsules?

Answer 54

Capsule within a capsule, tablet within a capsule, Altered-release capsules

Question 55

What are Altered-release capsules designed to do?

Answer 55

provide modified release

Question 56

When is a Capsule within a capsule?

Answer 56

For potent, small dose powders, For separation of incompatible ingredients

Question 57

How are Hard Capsule Shells filled?

Answer 57

Extemporaneous compounding, Manufacturing via Automated machines

Question 58

What are some types (2) of Extemporaneous compounding?

Answer 58

Punch method, Capsule machines (100 count, 300 count, etc.)

Question 59

How are Alternative to Locking-caps made by?

Answer 59

Extemporaneous Compounding

Question 60

What are some types (4) of Extemporaneous Compounding sealing?

Answer 60

hydroalcoholic solution, Hot pin Manufacturing, gelatin band - KAPSEALS, Heat welded or thermally coupled

Question 61

What is the manufacturing rate of capsules/hour?

Answer 61

60,000-150,000/hr

Question 62

What are the components of Soft Gelatin Capsules?

Answer 62

Gelatin, Plasticizers, Colorants/Opaquants, H2O: 6-13%, Preservatives to retard microbial growth

Question 63

What is the main difference between hard & soft gelatin capsules?

Answer 63

Plasticizers

Question 64

What are some types (2) of Plasticizers?

Answer 64

Glycerin, Polyhydric alcohol: Sorbitol

Question 65

What are some preservatives to retard microbial growth in soft gelatin capsules?

Answer 65

Methylparaben, Propylparaben

Question 66

What do soft gelatin capsules encapsulate & seal?

Answer 66

Encapsulate and hermetically seal liquids, suspensions, pasty materials, powders, granules, and preformed tablets

Question 67

Are soft gelatin capsules easily swallowed?

Answer 67

Yes

Question 68

What kind of dosage forms are soft gelatin capsules?

Answer 68

Oral dosage forms, suppository dosage form

Question 69

What is the shape of soft gelatin capsules?

Answer 69

Can be oblong, oval or round

Question 70

What are some (3) materials you can advantageously encapsulate in Soft Gelatin Capsules?

Answer 70

Water-immiscible volatile and non-volatile liquids, Water-miscible, non-volatile liquids, Water-miscible, relatively non-volatile compound

Question 71

What are some (3) materials you CANNOT encapsulate in Soft Gelatin Capsules?

Answer 71

Liquids that can easily migrate through the capsule shell, Materials with > 5% water content, Low molecular weight water soluble and volatile organic compounds

Question 72

What are 3 examples of Commercially prepared soft gelatin capsules?

Answer 72

DIGOXIN, ACETAZOLAMIDE, Cyclosporine

Question 73

What is the Trade name for Cyclosporine?

Answer 73

sandimune, neoral

Question 74

What are the contents of Cyclosporine?

Answer 74

immunosuppressive, slightly soluble powder, corn oil, polyoxyethylated glycolyzed glycerides

Question 75

What is the Trade name for ACETAZOLAMIDE?

Answer 75

DIAMOX SEQUELS

Question 76

What are the contents of ACETAZOLAMIDE?

Answer 76

Carbonic anhydrase inhibitor, slightly water-soluble powder

Question 77

What type of Commercially prepared soft gelatin capsules contain coated pellets of sustained-release drugs?

Answer 77

ACETAZOLAMIDE

Question 78

What is the trade name of DIGOXIN?

Answer 78

LANOXICAPS

Question 79

What are the contents of DIGOXIN?

Answer 79

Cardiac glycoside, water insoluble powder, PEG 400, ethyl alcohol, propylene glycol, water

Question 80

What are the USP Capsule compendial requirements?

Answer 80

Content Uniformity and Weight Variation <905>, Dissolution Tests <711>, Disintegration Tests <701>

Question 81

What are the Disintegration Tests <701> defined as?

Answer 81

a state in which the dosage unit exists as a soft mass w/ no palpably firm core present and only fragments of the insoluble coating or capsule shell remaining

Question 82

Does Disintegration imply complete dissolution of drugs from the dosage unit?

Answer 82

No

Question 83

What are the Dissolution Tests <711>?

Answer 83

Dissolution testing to measure the rate of drug release from the dosage form is achieved using the USP apparatuses

Question 84

According to the Content Uniformity and Weight Variation <905>, what must the containers be like?

Answer 84

Containers need to be tight, well closed and light resistant (or a combination of these)

Question 85

According to the Content Uniformity and Weight Variation <905>, what do the weight variations determine?

Answer 85

content uniformity

Question 86

For hard capsules, how is the Content Uniformity and Weight Variation <905> compliance determined?

Answer 86

10 capsules are weighed, and their contents removed, then the shells are weighed, and the balance is the amount in each capsule

Question 87

For soft capsules, how is the Content Uniformity and Weight Variation <905> compliance determined?

Answer 87

10 capsules are weighed, cut open and the contents are removed. The shells are weighed to determine the content weight

Question 88

What must be the uniformity according to the Content Uniformity and Weight Variation <905> be?

Answer 88

Uniformity 85-115% of the labeled claim for 9 out of 10 dosage units assayed

Question 89

What must the labeling include according to the Content Uniformity and Weight Variation <905>?

Answer 89

each active ingredient in each dosage unit

Question 90

What must there be stability testing for according to the Content Uniformity and Weight Variation <905>?

Answer 90

expiration date

Question 91

According to the Content Uniformity and Weight Variation <905>, when can added substances be used?

Answer 91

If they’re harmless in quantity used

Question 92

How to tell if the added substance in capsules is harmless in quantity according to the Content Uniformity and Weight Variation <905>?

Answer 92

Do not exceed the minimum amounts required to provide their intended effect, Do not impair the product’s bioavailability, efficacy or safety, Do not interfere with the required assays and tests