HARD GELATIN

CAPSULES
 History
Capsules were invented by Mothes &
DuBlanc in 1834

The two part hard gelatin empty

capsules were invented by J. Clehuby
(Parisian pharmacist)
 Capsules
 Latin word
 Two types ‘Hard’ & ‘Soft’
 Hard- Body & Cap
 Soft- ‘Soft gels’
 Advantages of Capsules
 Elegance
 Ease of use
 Portability
 Smooth, slippery, can be easily
swallowed
 Odour and taste masking
 Can be economically produced on a
large scale
 Disadvantages of Capsules
 Water soluble material are difficult to
incorporate
 Moisture sensitive
 Efflorescent material causing
‘softening’
 Deliquescent material causing
‘hardening’
 Raw Materials for Capsules
 Gelatin (Most popular and Widely
used till date
 Plasticizers
 Colours
 Flavours
 Preservative
 Gelatin
 Gelatin is heterogeneous product derived from
irreversible hydrolytic extraction of treated
animal collagen and as such never occurs
naturally.
 It is also defined as “Gelatin is a generic term for
a mixture of purified protein fractions obtained
either by partial acid hydrolysis (type A gelatin) or
by partial alkaline hydrolysis (type B gelatin) of
animal collagen. Gelatin may be a mixture of both
types. The protein fractions consist almost
entirely of amino acids joined together by amide
linkages to form linear polymers, varying in
molecular weight from 15 000-250 000.
Methods of Mfg. of Gelatin
 Basic Properties of Gelatin
 Non toxic
 Soluble in biological fluid at body
temp.
 Good film forming agent
 Solution of high concentration
40%w/v mobile at 500c.
 Features of Capsule shell mfg.
machine

 Two rows of Trays with blocks of 150 pins

 Dipped in different coloured Gelatin
solution
 Air dried to stabilize (gel)
 Hot dried to shape
 Trimming to size
 Locking to form two piece capsule and
ejection
Manufacture of capsule
shells
Drying under
hot air

Blasting to cool

Trimming Dipping Area

Dipping of Gelatin
 Empty capsule capacity
Size Volume Fill weight (g) at
0.8 g/cm3 powder density

000 1.37 1.096

00 0.95 0.760
0 0.68 0.544
1 0.50 0.400
2 0.37 0.296
3 0.30 0.240
4 0.21 0.168
5 0.13 0.104
 Excipients used

 Active ingredients ( medicaments)

e.g. aspirin, amoxicillin etc.

 Fillers
-To increase bulk formulation
- e.g. starch, lactose, dicalcium
phosphate
 Contd.
 Glidants
- To improve flow property
a) reducing roughness with
surface
b) reducing attractive forces
c) modifying electrostatic charges
d) acting as moisture scavengers
e) serving as ball bearing
e.g. corn starch, talc, mg
 Contd.
 Lubricants
- ease the ejection of pings
- reduce filming on pistons
- reduces adhesion of powder to
metal
surface
- reduces friction
 Contd.
 Disintegrants
- role not exactly known
- involved in hand filling
- ‘Super disintegrants’ such as
croscarmellose type A, soidium
starch
glycolate, crospovidone
 Contd.
 Surfactants
- To increase powder mass
- enhance drug dissolution
 Semi automatic Capsule filling
Machine
Features :
 Better approach than hand filling

 Better capsule output approx.

200000 per shift

 Fewer worker required

 Better tolerances of weight variation,

filled weight, capsule length etc.

 Lilly/Parky Davis
 20,000 capsules per day
 Automatic Capsule Filling
Machines
 Features
- Automatic filling from 60 to 1000
capsules per min
- Different models available
- Better accuracy
Automatic Capsule filling
Machine
1. Empty capsule
storage hopper
2. Rectification
stations
3. Removal of un-
separated
capsules
4. Powder hopper
5. Dosing unit
assembly
6. Capsule closing
station
7. Ejection of filled
capsules
8. Cleaning station
for capsules
Osaka

70,000 to
165,000
capsules

per hour
 Zanasi

9,000 to
20,000
capsules per
hour
 Table: Representative Automatic Capsule-Filling Machines:-
Make/model Dosing principle Rated capacity
(capsules/hr)
Hofliger-Kargc Tamping/dosing disk 24,000
GKF 400 48,000
GKF 1200 180,000
GKF 3000

Zanasid Tamping/dosator 6,000

Zanasi 6 40,000
Zanasi 40 120,000
Matic 120

MG2e Tamping/dosator 36,000

Futura 60,000
G38/N 100,000
G100

Dott. Bonapace & Cof. Tamping/dosator 30,000

RC530

Harro Hofligerg Tamping/dosing disk 18,000

KFM III
 Dose adjustment
 Dosing disc machine
- disc containing holes similar to cavities
of tablet press.

 Piston tamp principle

- automatic fillers in which individual
dose of powder tamp into slugs
 Manufacturing Layout
Workers entry
Finished goods outlet

Fresh
room PACKING
& BONDED HALL
Wash Change Room STORE
separate for both Blister
room ROOM
Sex Packing
(FINISHED
GOODS STORE)

Air IPQC
RECG
BAY Lock

DEDUSTIN CONTROL PASSAGE Filled Caps

G (FOR MOVEMENT OF MEN IN 1ST CHANGE) Quarantine
ROOM
Sampling Goods
Rejected
Goods Area Under
Area (rLAF) Test Storage Approved Filling
Goods Sifting Room
Storage and
DEDUSTIN Blending
G Room
ROOM Packing
Material
Storage Quarantine
Area Dispensing office
RECG Area
BAY (rLAF)

= Pass Box = Air Lock / 2nd chg

 Quality control parameters
 Content of active ingredient
 Uniformity of weight
 Uniformity of content
 Disintegration
 Sorting & Printing
 Sorting
- Defected capsules are removed

 Printing
- empty capsules r easy to handled
- printed before filling
 Sealing & Self locking
 Prevents separation
 Self locking by forming grooves
 Storage & Stability
 Moisture content 13-16%
 Avoid extreme temp. Humidity 40-
60%
 Over removal of moisture may cause
cracking
 Packaging
 Bulk packaging
 Unit dosage form packaging
- Strip (glassine/alu foil)
- Blister packaging
. Hot Forming (PVC PVDC- alu)
. Cold Forming (Alu-Alu)