In the changing scenario of pharmacy practice in India, for successful practice of Hospital Pharmacy, the students are required to learn various skills like drug distribution, drug dispensing, manufacturing of parenteral preparations, drug information, patient counselling, and therapeutic drug monitoring for improved patient care

1. DOCTOR OF PHARMACY
IV YEAR
CAPSULES
CHAPTER-6 c
MANUFACTURING OF PHARMACEUTICAAL P
REPARATIONS
Dr.V.Chanukya Pharm D

2. Definition
• Capsules are a solid dosage form in which the drug substance is
enclosed in a water soluble shell made up of gelatin
• The term capsule is derived from the latin word’’ capsula’’ meaning a
‘’samll container’’
• Capsules are of two types
• Soft gelatin capsules
• Hard gelatin capsules
• Gelatin a protein, digested by proteolytic enzymes obtained by partial
hydrolysis of collagen obtained from bone, skin, and connective tissue
of animals.
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3. Advantages
• The drug having unpleasant odour and taste can be
administered by enclosing them in a tasteless shell.
• They are smooth, become very slippery when moist and can be
easily swallowed.
• The ready solubility of gelatin at gastric pH provides rapid
release of medicament in the stomac
• They are attractive in appearance
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4. Disadvantages
• The hygroscopic drugs cannot be filled in capsules.
• The concentrated preparations which need previous
dilution are unsuitable for capsules because it may lead to
irritation in stomach if administers as such.
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5. Types of capsules
Soft gelatin capsules
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Hard gelatin capsules

6. Gelatin
• Gelatin is heterogeneous product derived by hydrolytic
extraction of animal's collagen.
• The sources of gelatin including animal bones, and frozen pork
skin.
Types
• Type A: gelatin is mainly derived from pork skin by acid
treatment
• Type B : gelatin is derived from bones and animal skin by
alkaline process.
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7. Hard gelatin capsules
• These are used for administration of solid medicaments.
• It consists of two parts i.e. body and cap.
• Example : omeprazole, rabeprazole
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8. Filling of capsules
Powders with Capsules Granules with Capsules
BEADS with Capsules Tablets with Capsules

9. Capsule number and its approximate capacity
Capsule number Approximate capacity in mg
000 950
00 650
0 450
1 300
2 250
3 200
4 150
5 100
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10. MANUFACTURING OF HARD GELATIN
CAPSULE.
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11. Manufacture of empty hard gelatin capsules
• Hard gelatin capsules are also known as dry filled capsules or two
piece capsules.
• Hard gelatin capsules consists of two parts known as capsule body
(Longer part) and the capsule cap (shorter part).
• The drug substance is placed in the body and the cap is slided over
it. Hence enclosing the drug substance.
MANUFACTURE:
• The Manufacturing equipment consist of pins and pegs made up of
stainless steel to produce to produce capsule shells of desired shapes
and sizes. About 50 of these pins are attached to the plates which
are movable. Both caps and bodies are prepared simultaneously

12. Manufacture of empty hard gelatin capsules
Steps involved in making empty gelatin capsules…
• Dipping and Spinning
• Drying
• Stripping
• Trimming/ Cutting
• Joining 12

13. Dipping:
Gelatin solution of required viscosity is taken in a reservoir. The plate
holding the pins is lowered into the reservoir to the suitable depth for
the certain period of time. This helps in achieving proper length and
thickness of shells.
Drying:
The plate holding the pins is slowly raised from the gelatin solution
and is subjected to blow drying with air having controlled temperature
and humidity. During this period the gelatin sets over pins.

14. Stripping:
The desired capsule shells are then stripped (removed)off from the pins
by using jaws made up of bronze.
Trimming:
The stripped capsules shells are then trimmed (shortened) by stationary
knives to the required length.
Joining of capsule caps and bodies:
Finally, the trimmed caps and body parts are joined and released from
the machines.

15. 12

16. METHODS OF FILLING THE HARD
GELATIN CAPSULES
• Capsule filling machine ( hand operated)
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17. 14
• It consists of:
1.A bed having 200-300 holes
2.A loading tray having 200-300 holes
3.A powder tray
4.A pin plate having a rubber top
5.Alever
6.A cam handle.

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The empty capsules are filled in the loading tray .
↓
and it is placed over the bed
↓
The cam handle is operated to separate the capsule caps from their
bodies.
↓
The powder tray is placed in a proper position and filled with an
accurate quantity of powder with scraper.
↓
The excess of powder is collected on the plat for of the powder tray
↓
The pin plate is lowered and the filled powder is pressed by moving
the pin downwards
↓

19. After pressing ,the pin plate is raised and the remaining powder is
filled into the bodies of the capsules
↓
The powdered tray is removed after its complete filling
↓
The cap holding tray is again placed in position
↓
The plate with the rubber top is lowered and the lever is operated
to lock the caps and bodies
↓
The loading tray is then removed and the filled
capsules are collected
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20. Heat-welding process
Fuse the cap & body through
double wall thickness at their
juncture
Distinctive ring around the
capsule where heat welded
Sealing of capsules
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21. CLEANING OF CAPSULES
• Accela-cota tablet coating pan may be used to clean and
polish capsules.
• Apolyurethane or cloth liner is placed in the pan,the liner is
used to trap the removed dust as well as to import gloss look
to the capsule
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22. ACCELA- COTA COATING PAN
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23. Soft Gelatin Capsules
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24. Soft gelatin capsules
• These are used for administration of liquid
medicaments.
• Soft gelatin are used to enclose liquid medicaments-
oils,suspension,semi solid,ophthalmic products.
• Example – vitamin-D, vitamin-E capsules .
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25. Shape of capsules
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26. Manufacturing of soft gelatin capsules.
Soft gelatin capsules may be prepared by
•Plate process
•Die process
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Plate process
• It is a semi autonomic process in which a warm sheet of soft gelatin is
laid over a plate having die pockets.
• Vacuum is applied from underside of this plate to pull the gelatin sheet
into the pockets.
• The liquid medication is poured into these dies and another sheet of
soft gelatin of similar or a different colour is laid over it.
• Finally, a die press which upon application of pressure seals and cuts
off the capsules simultaneously.
• The capsules are removed and washed with a volatile solvent.
• Washing is done to removed the adhering oil from the capsules.

28. Die process
Rotary machine
• The capsule prepared by this process have uniformly filled
medications with accurate doses.
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30. • It is fully automatic continuous process in which the liquid gelatin is made to
flow from an overhead tank to form two gelatin sheets on two different
rotating drums.
• These gelatin sheets are conveyed between two rotating dies from opposite
direction.
• As the sheets comes in between the dies, the metered filling materials is
injected which creates pockets in the sheets.
• Simultaneously , these formed pockets are sealed by pressure and heat and
are cut off from the sheets as capsules.
• The capsules so formed are adhered with mineral lubricants applied on gelatin
sheets for ease in movement. These lubricants can be removed by passing the
capsules through naphtha bath.
• The capsules are then passed through air dryers under pressure to rinse off the
excess moisture. Finally they are proceeded for packaging 27

31. Drying:
• After the soft gels are formed through the die rolls,they contain around
20 % of water.
• This process is divided into two stages:
Stage 1:
• Performed by tumble dryer .
• This equipment tumbles the soft gelatin around 30-40 minutes .
• It removes approximately 25 % of water content in the soft gelatin
capsules.
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33. Stage 2:
• Soft gelatin capsules are spread on stackable trays and transferred to
the drying room or tunnel where high air flows exists and they stay
around 24-48 hours or until the soft gels become hard enough. This
process is called natural manual drying.
Inspection
• Any damaged and/or not fully filled capsules are removed
manually in small batch size production.
• Fully automatic soft gel sorting machine equipped with electronic
sensors can be used to sort and remove the damaged gelatin capsules.
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Polishing
• The final step before packing is to clean and polish the soft
gel capsule to remove any mineral oil or glycerine that the
capsules may have on their outer skin.
Storage
• Finished soft gelatin capsule product should be stored in
the temperature around 20-24 ⁰c .