Chap 7

Question 1

solid dosage forms which medicinal agents
and or inert substances are enclosed in a small edible shell usually made of gelatin

Answer 1

CAPSULES

Question 2

obtained by the PARTIAL HYDROLYSIS OF COLLAGEN obtained from the skin, white connective tissue and bones of animals and seaweeds.

Answer 2

GELATIN

Question 3

TYPES OF GELATIN

Answer 3

TYPE A
TYPE B

Question 4

. TYPE A is made through

Answer 4

acid hydrolysis

Question 5

TYPE B is made through

Answer 5

alkali hydrolysis

Question 6

Hard gelatin capsules has a

Answer 6

Body
Cap

Question 7

CHARACTERISTICS OF GELATIN

Answer 7

Stable in air
Soften in cold water
Soluble in hot water
Digested by proteolytic enzymes.

Question 8

Employed in clinical drug trials to compare the effects of an investigational drug with those of another drug product or placebo; It is Employed in the extemporaneous compounding of
prescription in community setting

Answer 8

HARD GELATIN CAPSULES (HGC)
(DRY-FILLED CAPSULES)

Question 9

COMPONENTS OF HGC:

Answer 9

1. Gelatin
2. Sugar
3. Water
4. FD&C and D&C dyes (color)
5. Titanium dioxide (opaque)
6. Sulfur dioxide 0.15% (preservative)

Question 10

CHARACTERISTICS: of HGC

Answer 10

Moisture content: 13% -16%

Question 11

Storage condition & difficulties encountered of HGC

Answer 11

HIGH HUMIDITY: distorted and lose their rigid shape
EXTREME DRYNESS: Brittle and crumble

Question 12

Are made of gelatin to which glycerin or
polyhydric alcohol such as sorbitol or has been added and is Elastic

Answer 12

SOFT GELATIN CAPSULES

Question 13

CHARACTERISTICS of SGC

Answer 13

Moisture content: 6%-10%
Physical appearance:
 Oblong, oval or round
 Single-colored or two-tone

Question 14

ENCAPSULATED WITH SGC

Answer 14

1. Pumpable solutions
2. Suspensions
3. Pastry materials
4. Powders
5. Liquids

Question 15

Types of liquid used

Answer 15

Water-immiscible volatile & non-volatile liquids (vegetables and aromatic
oils)
Water- miscible non-volatile liquids
(polyethylene glycols)
Water-miscible & relatively non-volatile
(isopropyl alcohol)

Question 16

CAPSULE SHELL PRODUCTION:

Answer 16

1. Dipping
2. Drying
3. Trimming
4. Removing
5. Joining

Question 17

MANUFACTURE OF HGC SHELLS

Answer 17

1. Capsule body
2. Shorter cap

Question 18

shells are produced industrially by the
mechanical dipping of PINS OR PEGS
(made of manganese bronze) of the desired shape and diameter into temperature and controlled reservoir of melted gelatin.

Answer 18

Shorter cap

Question 19

Soft gelatin capsules may be prepared by:

Answer 19

Plate process (molder)
Rotary die process
Reciprocating die process

Question 20

hard gelatin capsules may be prepared by:

Answer 20

PIN METHOD (CENTRIFUGAL CASTING)

Question 21

Preparation of Filled Hard Gelatin
Capsules

Answer 21

1. Developing and preparing the formulation
   and selecting the capsule size.
2. Filling the capsule shells
3. Capsule sealing (optional)
4. Cleaning and polishing the filled capsules

Question 22

Each capsules is weighed individually after filling through punch method to ensure accuracy

Answer 22

PUNCH METHOD

Question 23

Used in regular or extensive basis of filling capsule

Answer 23

HAND OPERATED FILLING MACHINE

Question 24

FILLING OF EMPTY HGC
(LARGE SCALE)

Answer 24

1. SUPPLY
2. RECTIFICATION
3. SEPARATION
4. JOINING
5. POLISHING AND CLEANING

Question 25

Capacities ranging from and when efficiently operated can produced about 200 –2,000 capsules per hour.

Answer 25

24 – 300 capsules

Question 26

Capsules may be clean individually or in a small numbers by rubbing them with a clean gauze or cloth.

Answer 26

SMALE-SCALE PRODUCTION

Question 27

Capsule-filling machines are fixed with a cleaning vacuum that removes any extraneous material from the capsules as they exit the equipment

Answer 27

LARGE-SCALE PRODUCTION

Question 28

Capsules may be sealed through:

Answer 28

a) Distinct design b) Colored band of gelatin c) Heat welding d) Liquid wetting agent that lowers the melting point in the contact areas of the capsule's cap and body. e) Lightly coating the inner surface of the cap with a warm gelatin solution.

Question 29

Added substances is needed i capsules to

Answer 29

to enhance their stability, usefulness, or elegance or to facilitate their manufacture may be used only if they

Question 30

CONTAINERS FOR DISPENSING CAPSULES

Answer 30

1. Tight container 2. Well-closed container 3. Light resistant container

Question 31

1. Capsules are placed in the basket rack assembly 2. Immersed for 30x/minute into thermostatically controlled fluid at 37 C.

Answer 31

DISSOLUTION & DISINTEGRATION TEST

Question 32

Capsules disintegrate completely into soft mass having no palpably firm core and only some fragments of the gelatin shell.

Answer 32

Endpoint:

Question 33

The amount of active ingredient, determined by assay, is within the range of ____-_____ of the labelled claim for 9 to 10 dosage units assayed with no unit outside the range of _____ - _______ of the labelled claim

Answer 33

85% - 115% 70% to 125%

Question 34

To determine the intrinsic stability of the active drug molecule and the influence of environmental factors such as temperature, humidity, light, formulative components, and the container and closure system

Answer 34

STABILITY TESTING

Question 35

TYPES of STABILITY TESTING

Answer 35

Long-term stability Accelerated stability

Question 36

To ensure their suitability for packaging the capsules

Answer 36

MOISTURE PERMEATION TEST

Question 37

MOISTURE PERMEATION TEST is determined by

Answer 37

Degree and rate of moisture penetration.

Question 38

Containers for dispensing capsules

Answer 38

Tight container well-closed container Light resistant container

Question 39

HGC & SGC

Answer 39

10 Capsules

Question 40

In SGC, solvent is allowed to evaporate at room temperature for ___ minutes

Answer 40

30 minutes