Capsules

Question 1

Capsule

Answer 1

Solid dosage form in which the drug is enclosed within either hard of soft soluble shell

Question 2

Advantages of Capsules

Answer 2

Mask bitter and unpleasant taste
Increased bioavailability 
Easy to formulate
Protection to drug
Easy to swall and admin
Suitable for delivering liquids, semisolids, and solid drugs
Extemporaneous compound is easy
Adjustable to individual dosages

Question 3

Disadvantages of Capsules

Answer 3

Cannot be dispensed
Not suitable for highly soluble salts –> irritate the stomach
Not suitable for highly efflorescent (soften) or deliquescent (brittle) materials
Not suitable for children
Shell quality
Capsule filling is slower than tablet press

Question 4

Gelatin capsule

Answer 4

Glycine and alanine + other a.a.
Hydrolysis of collagen
- Combo of type A and B is the best

Question 5

Type A Gelatin

Answer 5

Produced by acid hydrolysis and is mainly manufactured from pork skin
- Plasticity and clarity

Question 6

Type B Gelatin

Answer 6

Produced by alkaline hydrolysis and is obtained from animal bones
- Firmness

Question 7

Colorants

Answer 7

Soluble synthetic dyes and insoluble pigments

- Product ID and patient compliance

Question 8

Opaquing agents

Answer 8

Titanium dioxide

Provide protection against light

Question 9

Preservatives

Answer 9

Parabens are used

- Water controlls viscosity

Question 10

Steps to make a hard gelatin capsule shell

Answer 10

Step 1/2: Mix gelatin and water in melting system and transfer to feed tanks
Step 3: Dyes, opacifiers and water are added
Step 4: Gelatin is fed in dipper sections and capsules are molded onto pin bars dipping
Step 5: Pin bars then rise to the upper deck allowing setting
Step 6: Pin bars are passed through a drying system
Step 7: Monitor humidity, temp and gelatin viscosity
Step 8/9: Capsule halves are stripped from the pin
Step 10: Trimmed
Step 11: Bodies are joined
Step 12/13: Packed and monitored
Step 14/15: Visual inspection and imprinted; ready to be sterilized

Question 11

Successful filling requires?

Answer 11

Lubricity
Compactibility
Flowability

Question 12

Fillers

Answer 12

Increase the bulk of the formulation

- Starch, lactose, dicalcium phosphate

Question 13

Glidants

Answer 13

Improve flowability
Coat powder particles
Fill surface irregularities and reduce the roughness, reduce attractive forces
Modify electrostatic charges
Act as moisture scavengers
Serve as ball bearing between host
- Colloidal silicas, talc, magnesium stearate

Question 14

Lubricants

Answer 14

Help ejects pluds
Reduce filming on pistons and adhesion of powders to metal surfaces
Reduce friction
Increase hydrophobic lubes, retard drug release
- Magnesium stearate, stearic acid

Question 15

Surfactants

Answer 15

Increase the wetting of powder mass and enhance dissolution

- Sodium lauryl sulfate, sodium docusate

Question 16

Hydrophilization

Answer 16

Hydrophilic polymers increase the wettability of poorly soluble drugs
- Metylcellulose, hydroxymethyl cellulose

Question 17

Capsule filing process

Answer 17

Blending ingredients (excipents and active)
Loading of capsules (body end downwards)
Separation of caps and body (vacuum separation)

Question 18

Automated filling process

Answer 18

Dosing of fill material (fill, replace the cap and eject)

Cleaning and polishing (remove powders adhere to shell)

Question 19

Quality assurance

Answer 19

Uniformity of mass and content
- Check for homogeneity in weights and chemical analysis for uniformity
Disintegration (will it break apart in a reasonable time)
Dissolution testing

Question 20

Dissolution testing

Answer 20

Measure the rate at which drug is released from the capsule

Question 21

Capsule from manufacturer to pharmacist?

Answer 21

Raw material/capsule shelf
Storage
Quality control
Weighing
Mixing
Packing
Quality control
Polishing
FIlling
Quality control
Finished capsules
Quality control
Storage
Delivery
Pharmacist

Question 22

Liquid filled hard gelatin capsules

Answer 22

Must not dissolve or alter the shell
Thixotropic formulation, thermal-Setting/thermosoftened
Mixed thermal-thixotropic system

Question 23

Thixotropic formulation

Answer 23

Shear thinning –> pumpable
Agitation stops, system rapidly reestablishes a gel structure –> avoid leakage
Liquid excipents and gell forming agent

Question 24

Thermal-setting/Thermosoftened formulation

Answer 24

Excipients used are liquid at filling temp but gel or solidifiy in the capsule
Contains PEG or poloxamer

Question 25

Mixed-thermal-Thixotropic systems

Answer 25

Improved resistance to leakage

Question 26

Sealing of liquid filled hard gelatin capsules

Answer 26

Sealed by coating the gap between the cap and body with a layer of gelatin called banding

Question 27

Soft gelatin capsules

Answer 27

Single unit dosage forms that contain liquid or semisolid fill enveloped by a one pience hermitically sealed elastic outer layer

Question 28

Composition of soft gelatin capsules

Answer 28

Gelatin Plasticizers (glycern, sorbitol, propylene glycol) Ratio of plasticizers to gelatin determine hardness + dyes, opacifiers, preservatives

Question 29

Filling composition?

Answer 29

Lipophilic solutions, suspensions, low melting point drugs (vit A, D, E) PEG Self emulsifying systems Micro-emulsions

Question 30

Advantages of soft gelatin capsules

Answer 30

``` Higher degree of content uniformity Easier Enhanced bioavailability Hermitically sealed Wide variety ```

Question 31

Disadvantages of soft gelatin capsules

Answer 31

More likely to interact with gelatin Proteolytic activity disrupt the shell Oily vehicles migrate to the shell

Question 32

Rotary Die Process

Answer 32

Shell material is converted into the liquid state in jacketed tanks Spreader boxes are fed with shell forming material from tank Shell ribbons are formed by a rotating casting drum Ribbons are then guided over counter rotating rolls containing sharp-edged dies Each die cavity has the size and shape of half of the capsule to be formed While passing through the rolls, the two ribbons form a sack like structure Sacks are filled with drug materials As the shell ribbon pass between the die rolls, the capsules will be fully sealed

Question 33

Defects for filled hard gelatin capsules

Answer 33

``` Presence of cracks, pinholes Uniformity Capsule is empty Surface spot and contamination Free from particulate substances Undesirable odor Void space of the container should be filled ```

Question 34

Minor defects filled hard gelatin capsules

Answer 34

Presence of pits and dents Surface of the capsules are not smooth Presence of particulate substance on the surface Presence of spots or blemishes