Capsules

about capsules and manufacturing of capsules

1. CAPSULES presented by S.Nandhini 1

2. DEFINITION Capsules are a solid dosage form in which the drug substance is enclosed in a water soluble shell or an envelope. A capsule shell is made up of gelatin Primarily intended for oral delivery. 2

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 stomach. They are attractive in appearance 3

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. 4

5. TYPES OF CAPSULES Capsules are available in two types: 1.Hard gelatin capsules 2.Soft gelatin capsules. 5

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. 6

7. Hard gelatin capsules These are used for administration of solid medicaments. It consists of two parts i.e. body and cap. Example : omeprazole 7

8. Filling of Capsules POWDERS w/ capsules GRANULES BEADS TABLETS

9. CAPSULE NUMBER AND ITS APPROXIMATE CAPACITY Capsule number Approximate capacity in mg 000 950 00 650 450 1 300 2 250 3 200 4 150 5 100 9

10. MANUFACTURING OF HARD GELATIN CAPSULE. 10

11. 11 MANUFACTURE OF EMPTY HARD GELATIN CAPSULES Steps involved in making empty gelatin capsules… Dipping Spinning Drying Stripping Trimming and Joining

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13. METHODS OF FILLING THE HARD GELATIN CAPSULES Capsule filling machine ( hand operated) 13

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 5.A lever 6. A cam handle. 14 rubber top

15. 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 ↓ 15

16. 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 16

17. SEALING OF CAPSULES 17

18. CLEANING OF CAPSULES Accela-cota tablet coating pan may be used to clean and polish capsules. A polyurethane or cloth liner is placed in the pan,the liner is used to trap the removed dust as well as to import a gloss the capsule 18

19. ACCELA- COTA COATING PAN 19

20. SOFT GELATIN CAPSULES 20

21. 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 - Cyclosporine capsules . 21

22. SHAPE OF CAPSULE 22

23. MANUFACTURING OF SOFT GELATIN CAPSULES. Soft gelatin capsules may be prepared by Plate process Die process 23

24. PLATE PROCESS A warm sheet of gelatin is placed on the bottom plate of the mold. The liquid medication is poured on it Then the second sheet of the prepared gelatin is carefully laid in place on top of the medication,and the top plate of the mold is put in place The entire mold is then subjected to a press where pressure is applied to form fill and seal the capsules simultaneously. Then the capsule is removed. 24

25. DIE PROCESS Rotary machine In rotary die machine ,the soft gelatin capsules are prepared and then filled immediately with the liquid medicaments. 25

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27. The warm liquid gelatin flows over the two chilled drums which are located at both sides of the machine through a spreader box that sits over each drum and this transforms the liquid gelatin into two solid ribbons of gel. The left and the right ribbons pass over rollers which feed them through two die rolls. These die rolls determine the shape and size of soft gels and cut the soft gel shell from the ribbon as they turned around Simultaneously, displacement pump delivers the fill materials into the heated wedge which sits between the rotary dies. The wedge injects the fill material into die cavities between ribbons just right before the die rolls cut the ribbons and seal the two halves together. 27

28. 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. 28

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30. 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. . 30

31. 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 31

32. 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 . 32

33. 33 THANK YOU