1
Q
What is one of the most established dosage forms in pharmaceuticals?
A
Oral, Solid
2
Q
What do Oral Solid Dosage Forms include?
A
tablets and gelatin capsules
3
Q
What % of ALL pharmaceutical preparations consist of tablets and gelatin capsules?
A
80% of all
4
Q
What are capsules?
A
Unit doses of powder, semisolid or liquid drugs enclosed within either an edible hard or a soft envelope, or shell
5
Q
What was the basic idea of a capsule?
A
to enclose the drug or active pharmaceutical ingredient (API) in an easy-to-fill shell
6
Q
What are the types of capsules?
A
Gelatin Capsules and Vegetable capsules
7
Q
What does a Hard Gelatin Capsule include/components?
A
- body and cap
- Gelatin, Sugar, H3O - 13-16%
8
Q
What does a Soft Gelatin Capsule include/components?
A
- elastic shell + liquid/semi-solid core
- Gelatin
- Plasticizers
- Colorants/Opaquants
- H2O: 6-13%
- Preservatives to prevent microbial growth
9
Q
What materials are used in gelatin production?
A
27% bones, 28% bovine hides, 44% pig skin
10
Q
What are the advantages of Capsules?
9
A
- Convenience compared to a liquid
- Easy to identify - colors and markings
- No need for spoons or other measuring devices
- Tasteless
- flexibility in dosing
- Easy to transport
- Easy to take – oral
- Manufacturing cost is low with minimal breakage compared to liquid packaging,
- Longer stability than liquid dosage forms
11
Q
How are capsules identified?
A
- Size, shape and color
- Brand identification
- Quality perception
- Counterfeit prevention
12
Q
What are the Disadvantages of Capsules?
A
- 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
13
Q
What can some drugs in the form of capsules cause when exposed to the GI?
A
nausea, vomiting, and diarrhea
14
Q
What does iron in prenatal supplements and fish oil capsules cause (in terms of GI)?
A
an unpleasant “burp back” effect - reduces patient compliance
15
Q
What kind of drugs in capsule form are not good because of GI?
A
drugs that are readily degraded in the GI tract -stomach acids or enzymatic degradation
16
Q
What is the coloration of Hard gelatin capsules?
A
May be colored, May be opaque
17
Q
How are opaque Hard gelatin capsules made?
A
Titanium dioxide
18
Q
How are colored Hard gelatin capsules made?
A
FD&C + D&C dyes
19
Q
What is Gelatin soluble in?
A
hot water and gastric fluid
20
Q
What do Hard gelatin capsules protect against? How?
A
moisture - use of desiccants in the packaging
21
Q
What are some examples of desiccants?
A
dried silica, clay, charcoal
22
Q
What are the Empty Capsule Manufacturing Steps (10)?
A
- Material inspection
- Gelatin melting
- Color blending
- Capsule production
- Cutting
- Joining
- Printing
- Inspection
- Testing
- Packing
23
Q
What are Dyes?
A
a chemical that shows color when it is dissolved in an aqueous base, not oil base (Artificial colors)
24
Q
What are the 3 classifications of dyes?
A
FD&C (Food, Drugs and Cosmetics), D&C (Drugs and Cosmetics), External D&C
25
What can dyes do to another product?
bleed or migrate from one part of a product to another
26
For liquids, what is the concentration of dyes used?
0.001% to 0.0005%
27
For powders, what is the concentration of dyes used?
0.1%
28
What are some coloring agents (2)?
Caramel, Ferric oxide: Red/yellow
29
What are the Capsule Preparation Steps?
1. Comminution
2. Blending
3. Determine capsule size
4. Add additional diluent prn
5. Encapsulate
6. Clean
7. Quality control
8. Package and label
30
What is the Pre-locked position of Con-Snap Capsules?
Dimples of the cap engage gently with the indented ring of the body
31
Do empty capsules stay closed in transit?
Yes
32
What does the consistent low pre-stock force reduce?
opening and rectification problems
33
Why is there a wide choice of capsule sizes available?
For compatibility with all type and models of capsule filing machines
34
What does the selection of capsule size depend on (3)?
1. amount of material
2. compressibility
3. density
35
What is the relationship between Capsule # & Content (mg) within them?
Lower the capsule #, higher the amount of content
36
What are the 4 Common Capsule Excipients?
Wetting agents, Glidants, Disintegrants, Diluents or adsorbents
37
What type of excipient can provide bulk to the formulation & reduce moisture?
Diluents or adsorbents
38
What are some examples of Diluents or adsorbents?
lactose, cellulose
39
What type of excipient assists the break-up and distribution of the capsule contents?
Disintegrants
40
What are some examples of Disintegrants?
pre-gelatinized starch
41
What are some examples of Glidants?
silicon dioxide, talc
42
What type of excipients enhance the flow properties of the powder mix?
Glidants
43
What type of excipients facilitate wetting of the dry powder?
Wetting agents
44
What are some examples of wetting agents?
surfactants – Sodium dodecyl sulfate (SDS)
45
What is the goal in Developing the Formulation of Capsules?
Prepare capsule with accurate dosage, good bioavailability, ease of filling and production, stability, and elegance
46
What are some Physicochemical Considerations when Developing the Formulation of Capsules?
Potential incompatibilities: Drug-Drug, Drug-Excipient, Hygroscopic or Deliquescent drugs, Eutectic mixtures
47
What are some Special Applications of capsules?
Capsule within a capsule, tablet within a capsule, Altered-release capsules
48
What are Altered-release capsules designed to do?
provide modified release
49
When is a Capsule within a capsule?
For potent, small dose powders, For separation of incompatible ingredients
50
How are Hard Capsule Shells filled?
Extemporaneous compounding, Manufacturing via Automated machines
51
What are some types (2) of Extemporaneous compounding?
Punch method, Capsule machines (100 count, 300 count, etc.)
52
How are Alternative to Locking-caps made by?
Extemporaneous Compounding
53
What are (4) alternatives to locking caps sealing?
1. hydroalcoholic solution
2. Hot pin Manufacturing
3. gelatin band - KAPSEALS
4. Heat welded or thermally coupled
54
What is the manufacturing rate of capsules/hour?
60,000-150,000/hr
55
What is the main difference between hard & soft gelatin capsules?
Plasticizers
56
What are some types (2) of Plasticizers?
Glycerin, Polyhydric alcohol: Sorbitol
57
What are some preservatives to retard microbial growth in soft gelatin capsules?
Methylparaben, Propylparaben
58
What do soft gelatin capsules encapsulate & seal?
1. liquids
2. suspensions
3. pasty materials
4. powders
5. granules
6. preformed tablets
59
Are soft gelatin capsules easily swallowed?
Yes
60
What kind of dosage forms are soft gelatin capsules?
Oral dosage forms, suppository dosage form
61
What is the shape of soft gelatin capsules?
Can be oblong, oval or round
62
What are some (3) materials you can advantageously encapsulate in Soft Gelatin Capsules?
1. Water-immiscible volatile and non-volatile liquids
2. Water-miscible non-volatile liquids
3. Water-miscible, relatively non-volatile compound
63
What are some (3) materials you CANNOT encapsulate in Soft Gelatin Capsules?
1. Liquids that can easily migrate through the capsule shell
2. Materials with > 5% water content
3. Low molecular weight water soluble and volatile organic compounds
64
What are 3 examples of Commercially prepared soft gelatin capsules?
DIGOXIN, ACETAZOLAMIDE, Cyclosporine
65
What is the Trade name for Cyclosporine?
sandimune, neoral
66
What commercially prepared soft gelatin capsules is an immunosuppressive, slightly soluble powder, corn oil, polyoxyethylated glycolyzed glycerides?
Cyclosporine
67
What is the Trade name for ACETAZOLAMIDE?
DIAMOX SEQUELS
68
What commercially prepared soft gelatin capsules is a carbonic anhydrase inhibitor, slightly water-soluble powder?
ACETAZOLAMIDE
69
What type of Commercially prepared soft gelatin capsules contain coated pellets of sustained-release drugs?
ACETAZOLAMIDE
70
What is the trade name of DIGOXIN?
LANOXICAPS
71
What Commercially prepared soft gelatin capsules is a Cardiac glycoside, water insoluble powder, PEG 400, ethyl alcohol, propylene glycol, water?
DIGOXIN
72
What are the USP Capsule compendial requirements?
Content Uniformity and Weight Variation <905>, Dissolution Tests <711>, Disintegration Tests <701>
73
What are the Disintegration Tests <701> defined as?
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
74
Does Disintegration imply complete dissolution of drugs from the dosage unit?
No
75
What are the Dissolution Tests <711>?
Measures the rate of drug release from the dosage form that is achieved using the USP apparatuses
76
According to the Content Uniformity and Weight Variation <905>, what must the containers be like?
1. tight
2. well closed
3.light resistant
77
According to the Content Uniformity and Weight Variation <905>, what do the weight variations determine?
content uniformity
78
For hard capsules, how is the Content Uniformity and Weight Variation <905> compliance determined?
10 capsules are weighed, and their contents removed, then the shells are weighed, and the balance is the amount in each capsule
79
For soft capsules, how is the Content Uniformity and Weight Variation <905> compliance determined?
10 capsules are weighed, cut open and the contents are removed. The shells are weighed to determine the content weight
80
What must be the uniformity according to the Content Uniformity and Weight Variation <905> be?
Uniformity 85-115% of the labeled claim for 9 out of 10 dosage units assayed
81
What must the labeling include according to the Content Uniformity and Weight Variation <905>?
each active ingredient in each dosage unit
82
What must there be stability testing for according to the Content Uniformity and Weight Variation <905>?
expiration date
83
According to the Content Uniformity and Weight Variation <905>, when can added substances be used?
If they’re harmless in quantity used
84
How to tell if the added substance in capsules is harmless in quantity according to the Content Uniformity and Weight Variation <905>?
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
85
FPS Exam 2
flashcards
Decks in class (12)
# Cards
