Capsules

Question 1

Hard gelatin capsule structure

Answer 1

Two pieces, cap and body

Question 2

Soft gelatin capsule structure

Answer 2

One piece

Question 3

Advantages of capsules

Answer 3

Avoid many steps of tablet manufacture, may improve bioavailability of poorly water soluble drugs, convenient way to administer some liquids, difficult to counterfeit, stability of drug may be improved, diversity of filling, ideal for clinical trials and drug studies

Question 4

Disadvantages of capsules

Answer 4

Require specialised equipment, potential stability problems if containing liquid fills, problems related to homogeneity of fill weight and content, slower than tablet manufacture

Question 5

Benefits of gelatin

Answer 5

Non toxic, worldwide acceptance, readily soluble in biological fluids, good film forming material, changes from solid to gel a few degrees above ambient temperature

Question 6

Water soluble colourants

Answer 6

Azo or non-azo dyes

Question 7

Insoluble pigments

Answer 7

Iron oxide, titanium dioxidesW

Question 8

What colourants are more commonly used in capsules and why

Answer 8

Insoluble pigments as they are not absorbed

Question 9

What is the largest capsule size

Answer 9

000

Question 10

What is the smallest capsule size

Answer 10

5

Question 11

Ways of sealing hard gelatin capsule

Answer 11

Gelatin band sealing, hydro-alcoholic solvent seal

Question 12

How does gelatin band sealing work

Answer 12

Dilute solution of gelatin applied to centre of capsules, when dry produces seal

Question 13

How does hydro-alcoholic solvent seal work

Answer 13

Solution of equal parts ethanol and water applied to centre of capsule, soften capsule, heat to 45 degrees, interface fuses to produce seal

Question 14

Steps in filling hard gelatin capsules

Answer 14

Rectification, separation, filling, joining, ejection

Question 15

Methods for powder filling on an industrial scale

Answer 15

Dependent method, independent dosing systems

Question 16

Dependent method of capsule fillin

Answer 16

Lower half capsule in revolving turntable, rotated under hopper containing powder, flow and homogeneity maintained by circular movement, at end of operation two halves bought together

Question 17

Independent dosing systems

Answer 17

Tube containing spring loaded piston depressed in powder bed, enables plug to enter tube, tube with plug elevated out of powder bed, rotated, put over lower half of capsule, powder plug dispensed

Question 18

What are softgels

Answer 18

Capsules whose mechanical properties have been manipulated by adding plasticisers, more flexible

Question 19

Components of softgels

Answer 19

Gelatin (normally type B), plasticising agents, water, opacifiers (titanium dioxide), colorants, may contain flavor

Question 20

Fills in softgels

Answer 20

Primarily liquid, sometimes powder, lipophilic liquids, self emulsifying systems, microemulsions, water miscible liquids

Question 21

Advantages of softgels

Answer 21

Improved drug absorption, easy to swallow, no taste issues, avoid dust handling problems for cytotoxic drugs, overcomes problems with manufacture of compressed tablets, liquid flow more precise which increases dose uniformity, drugs protected against oxidation- more stable

Question 22

Manufacture of softgels

Answer 22

Two sheets of gelatin ribbon between pair of matched dies, ribbon pressed into dies and medication placed, pressure between two plates enables individual capsules to be cut

Question 23

What 2 subprocesses are required prior to softgel encapsulation process

Answer 23

Gel mass and liquid matrix