3. hISTORY
• In 1730, the Pharmacist De PAULI from Vienna
developed oval shaped capsules for covering up the unpleasant taste of the
pure turpentine used for the treatment of gout
• In 1834, the Pharmacist JOSEPH DUPLANC from FRONCOIS MOTHES
were granted Patent which covered a method for the producing , single piece ,
olive shaped , gelatin capsules which were closed after filling by a drop of
concentrated warm gelatin solution
• In 1846, the Frenchman JULES LEHUBY
first to suggest Tow- Piece Capsule produced by dipping silver coated metal
pins into a gelatin solution and then drying them quickly
• In 1931, the author COLTON
Designed a machine to manufacture bodies and caps and fitted them to form
hard gelatin capsule.
5. cAPSulES
• These are solid dosage forms in which the
medication is enclosed within a gelatin
shells.
• The medication may be a powder, a liquid
or a semisolid mass.
• Capsules are usually intended to be
administered orally by swallowing them
whole. Occasionally, capsules may be
administered rectally or vaginally.
7. RARAWW M MAATTEERRIAIAlSlS
1. Gelatin
2. FD & C and D & C colorant
3. Sugar
4. Water - 12 to 16 % (may vary depending on the storage condition )
5. Sulfur dioxide (15%) - prevent decomposition during manufacture
6. Colorants / Opacifying agent : There are two types
A) water soluble dyes – e.g. erythrosine
B) pigments – e.g. iron oxides , titanium dioxide
(make the capsule opaque to provide protection against light)
7. Preservatives: To prevent microbial growth
during manufacture
9. RAW MATERIAlS
GELATIN
• It is a protein substance derived from collagen, a natural protein
present in the tendons, ligaments, and tissues of mammals.
It is produced by boiling the connective tissues, bones and skins of
animals, usually cows and pigs.
• It is the major component of the capsule. The reason for this is that
gelatin possesses five basic properties:
A- Non-toxic.
B- Soluble in biological fluids at body temperature.
C- It is a good film-forming material.
D- Solutions of high concentration, 40% w/v, are mobile at 50°C.
E- A solution in water changes from a sol to a gel at
temperatures only a few degrees above ambient
(Others require volatile solvents or large quantities of heat).
10. gElATIN
Type A Type B
- Obtained from bone - Obtained pork skin
- Derived from acid treated - Derived from alkali treated
precursor precursor
- Isoelectric point in the - Isoelectric point in the
region of pH 9 region of pH 4.7
15. Hard gelatin capsules
• It consists of two pieces in the form of cylinders which is closed
at one end and open from the other:
- the shorter piece “cap” and
- the longer piece “body”.
• The shells consist largely of gelatin, sugar and
water.
CAP
BODY
Capsule shell filling:
- typically filled with dry solids (powders, granules, pellets, tablets) and
semisolids.
- Fixed oils and other liquids that do not dissolve gelatin may be filled
into hard gelatin capsules with a pipette or calibrated dropper, then
capsules are sealed by moisturizing the lower part of the caps with
water.
- Liquids may often be sorbed onto inert carrier powders to form dry
powders suitable for capsule filling.
17. general cHaracteristics OF gelatin
1 Bloom value
- is a measurement of the gelling power and the strength of the resulting gel.
- Gelatin generally falls between 50 and 300 bloom strength.
2 Gelling power
- the key function of gelatin.
- The gelling power varies depending on the grade of gelatin
- its measured in terms of bloom value. The higher the bloom value, the greater the
ability to form gels & the stronger the gel strength.
3 Viscosity
- In general the higher the bloom, the greater the viscosity
- Beef bone grades tend to have higher viscosity.
- Viscosity is determined by measuring the flow time of a 6.67% solution of gelatin
through a U-tube viscometer at 60 °C. Viscosity measurement is given in millipoise
units and varies between 20 and 70 mps.
4. Foamability
- In general pigskin grades tend to have better foaming properties
- Gelatin lowers the surface tension, allowing for the incorporation of air, and stabilizes
the foam once aerated
- Gelatin will also prevent crystal formation of sugars in the foam and maintain smoothness
in texture.
18. general cHaracteristics OF gelatin
5. Melting point
- Lower melting point gelatins dissolve faster in the mouth, therefore
releasing the flavors more quickly for an instant taste sensation.
-Lower bloom grades tend to have lower melting points.
6. Color and odor
-The gelatin should be as clear as possible in solution.
- Clarity is measured using a turbidimeter .
-The gelatin should be without odor.
7. Conductivity
- is a key parameter in photographic applications and grades of the highest purity
with minimal or no conductivity are required. De-ionized grades have an
advantage because of their low conductivity.
8. pH
-. pH is measured using a pH meter on a 1% solution and typically for gelatin
solutions falls between ph 4.5 and 6.5.
20. emptY capsule sHell prOductiOn
The process of capsule shell production with the pin method:
Dipping→ Drying → Stripping→ Trimming→ Joining → Polishing
23. Filling eQuipments
cOmpanies manuFacturing Filling eQuipments
•Eli lilly and company, indianapolis
•Farmatic snc, bologna, italy
•Hoflinger and karg, germany
•Mg2 s.p.a, bologna ,italy
•Osaka, japan
•Parke davis and copany, detroit
•Perry industries, green bay
•Zanasi nigris, bologna ,italy
24. Hard capsule Filling
1) Bench scale filling
•For small scale filling
•Manual filling machine
2) Industrial scale-filling
•Comes in varying shapes and sizes
- semi automatic machine
- fully automatic machine
25. Bench scale filling
Pin plate with 200-300 holes
Bed – 200-300 holes
Powder tray
Sealing plate with rubber top
loading tray lever
with 200-300
scraper
holes
Cam handle
27. semi automated capsule filling machine
FEATURES:
•Suitable for filling capsules of all sizes with powder, granules and
pellets.
•minimizes operator attention and ensures maximum production.
•Choice of four auger speed with variable speed of filling table
•Auto drug hopper in feed mechanism, reduces weight variation and
improves productivity.
•easy to maintain and clean.
•Quality and precision manufacturing meets the requirement of CGMP.
•Both, PLC controlled panel or digital controlled panel, with auto capsule
loader closing system available to meet customers requirement.
28. fullY automated capsule
filling machine
1. Empty Capsule hopper
2. Rectifying roller
3. Magazine
4. Cap Segment
5. Body disc
6. Powder filling hopper
7. Unopened Capsules rejection
unit
8. Joining station
9. Discharge chute
10.Segment cleaning
11.Weight Control unit
12.Control station
13.Auger Motor
14.Auxiliary powder hopper
32. soft gelatin capsules
DEFINITION
•Soft Gelatin capsules are one piece, hermetically sealed, soft gelatin
shells containing a liquid, a suspension, or a semisolid.
•They have long been preferred dosage form for those, taking Health &
Nutritional supplements
ADVANTAGES
33. soft gelatin capsules
composition
• A typical gel mass formula for making soft
gelatine capsules would be:
• Gelatine 35-45%
• Plasticizer 15-25% (glycerine or sorbitol)
• Water ~40%
• Dye / Pigment as needed
• Opacifier as needed
• Other (flavour, sugar,) as needed
41. eValuation of capSuleS
1.UNIFORMITY OF WEIGHT
2.CONTENT OF THE API IN CAPSULES
3.DISINTEGRATION TEST
4.DISSOLUTION TEST
42.
43.
44. DISINTIGRATION
•T PElaSceT one capsule in each basket
• Set the temperature of water to 37 +/- 2
•Use disc if HGC floats whereas for soft gelatin use the disc
•Operate the apparatus for 30 min for HGC and 60 min for SGC
• The test is said to pass if no residue is left on the screen of the
apparatus
•Repeat the test for 12 capsules if more than 1 or 2 capsules fails
to disintegrate
•The test passes if 16 out of 18 capsules disintegrate or else fail
45. DISSOLUTION TEST
• Place 1000ml of watr free from disolevied air having temp. of
36.5 to 37.5
•Place specified no. of capsules in each basket
•Start motor and adjust speed 100 rpm as per monograph
•Withdraw the required volume of solution after 45 min or as
specified in the monograph.
•Filter and weigh the amt of active ingredient by the method
specified in the mongraph
•Repeat four times
• The test is said to pass ifthe amt of actve ingredient is not less
than 70% of the stated amt given in the monograph
