Hard Capsules

Question 1

what are capsules

Answer 1

solid preparations with hard or soft shells of various shapes and capcities, usually containing a single dose of active substance. They are intended for oral administration.

Question 2

what are the two types of capsules

Answer 2

soft “twopiece”

hard “onepiece”

Question 3

what raw materials are used in the manufacture of capsules

Answer 3

gelatin
water
colourants
optional materials
plasticizers

Question 4

what are the two ways in which gelatin forms

Answer 4

acidic or alkaline process

Question 5

describe the acidic process of gelatin formation

Answer 5

acidification to pH4

heating from 50 degrees to boiling

elimination of fat

filtration

vacuum evaporation

drying

Gelatin

Question 6

describe the alkaline process of gelatin formation

Answer 6

Treatment with NaOH

Removing NaOH

Treatment with acid to adjust pH

Heating from 50 degrees to boiling

Demineralisation

Filtration

Vacuum Evaporation

Drying

Question 7

what are the 3 main ingredients to form gelatin

Answer 7

pig skin
bovine hide
bones

Question 8

what are the properties of gelatin

Answer 8

non toxic
soluble at body temperature
has good film forming properties
solutions of high concentration 40% W/V are mobile at 50
changes from gel to sol at temperatures just above room temp

Question 9

what is bloom strength

Answer 9

measure of gel rigidity

Question 10

what is the issue with gelatin

Answer 10

unacceptable product to vegetarians as it is a by product of the slaughterhouse industry, being made of protein derived from animal bones, cartilage tendons and other tissues such as pig skin

Question 11

what is an alternative to geletain

Answer 11

hydroxypropylmethylcellulose

Question 12

what do hard capsules consist of

Answer 12

two piece shell which lock together known as cap

the capsules body and the powder mixture

Question 13

what types of material for filling into hard capsules

Answer 13

dry solids

• powders
• pellets
• granules
• tablets

semisolids

• thermosoftening mixtures
• thixotropic mixtures
• pastes

Liquids
- non aqueous liquids

Question 14

The sequence of two piece hard gelatin capsules shell manufacture

Answer 14

capsulre is dipped then 
spinned 
drying 
stripping
cutting
joining

Question 15

what should storage conditions be for empty capsules

Answer 15

moisture content between 13-16%

store at controlled temperature and humidity

Question 16

how are capsules are filling process

Answer 16

the two halves of the capsules are separated an exact

exact dose is placed into the smaller half

cap is then locked onto the smaller half

the filled capsule is removed from the machine

Question 17

Formulation advantages of capsules

Answer 17

typically requires fewer excipients

commonly used for clinical trials

versatility

reduces stability problems with sensitive drugs and combination products

more efficient pharmaceutical development means faster speed to market