Capsules

capsules and its types are discussed in this slide. along with their uses and their advantages over one another. preparation of each type is well explained in these slides.

1. CAPSULES…. A PRESENTATION BY: SALONI GOYAL HIMANSHI KAUSHIK

2. Contents Introduction Classification Soft gelatin capsules Capsule shell Capsule content Production Hard gelatin capsules Structure Manufacturing Principle Filling of hard gel capsule Comparison

3. INTRODUCTION…. Capsule is derived from a Latin word “ capsula” means small container  solid dosage forms in which drug is enclosed within a hard or soft soluble shell. The casing of capsule is made up of gelatin. First capsule from gelatin was one piece capsule by mothes and dublanc in France in 1834.

4. CLASSIFICATIONS Hard gelatin capsules Soft gelatin capsules

5. Soft gelatin capsules primarily used for oils and for active ingredients that are dissolved or suspended in oil Can be used orally or as suppositories. They are one in piece, containing suspension or a semisolid. Are called soft-gels or softules They are formed, filled & sealed in one operation. Available in round, oval, oblonged form

6. Pros and cons Easy to manufacture Enhanced drug stability Extended release Portable Liquids can be encapsulated (non aqueous substances) Easy to swallow Water soluble materials are difficult to incorporate Moisture sensitive Efflorescent material cannot be incorporated (when some substances are exposed to air, they lose water) Deliquescent materials (when exposed to air absorb water, enough to form solutions)cannot be incorporated, they may cause hardening or brittle capsules Costly and stick together

7. CAPSULE SHELL Gelatin with water- 45% w/w the ratio by weight of water to dry gelatin can vary from 0.7 to1.3(water) to 1.0(dry gelatin) depending on the viscosity of the gelatin being used a plasticizer- Used to make the soft gel shell elastic like glycerol or sorbitol. ratio of dry plasticizer to dry gelatin determines the “hardness” of the shell and can vary from 0.3-1.0 for very hard shell to 1.0-1.8 for very soft shell preservatives Coloring Used in shell has to be darker than color of encapsulating material colors may be natural or synthetic opacifying agents Titanium dioxide, may be added to produce an opaque shell ,when the fill formulation is a suspension or to prevent photo degradation of light sensitive fill ingredients. Conc. taken is 0.5% flavorings, sugars, acids & medicaments to achieve desired effects

8. Capsule content Content can be liquid or combination of miscible liquids Solution of solid in a liquid (solid is mixed and dissolved) Suspension of solid in liquid (solid is mixed not dissolved) Solid insoluble in liquids or in combination of liquids are capsulated as Suspension. Suspending agents used are Lecithin, Soybean oil, yellow wax. Suspension agents reduces sedimentation of the solids and keep them mixed in the liquid.

9. PRODUCTION The gel is prepared in a 300-litre stainless steel vessel. Gelatin powder is mixed with water and glycerine. Heating at 80°C Stirring. The molten gelatin mass is formed. It is decanted into 200-kg mobile vessels. Turbine mixing where colors and flavors can be added. It ensures consistency of gelatin mass. This mass is kept at a constant temperature until it is needed for the next stage of the process

10. the gel and fill mobile vessels are then taken to the encapsulation bays. Where each encapsulation machine is segregated in individual bays. The molten gel is pumped to the machine. Two thin ribbons of gel are formed, one either side of the machine. These ribbons then pass over a series of rollers and over a set of dies that determine the size and shape of the capsules Tumble Drying:- Dry, sterile air is forced across the tumbler and removes the moisture from the outer surface of the capsules. Supplemental Drying (curing):- After the tumbler dryers, the soft capsules are placed on special trays for final drying in the drying room. For a period up to 48 hrs.

11. sizing:- Automatic capsule sizing machine eliminates undersized and oversized capsules. Inspection:- includes visual inspection to check malformed, damaged or improperly filled capsules. Packaging:- capsule may be packaged in glass or plastic containers or may be strip-packaged, so long as such packaging involves tight closures ingredient specifications: all ingredients of a soft gel are controlled and tested. E.g. Impurities such as aldehydes & peroxides which may be present in polyethylene glycols. Presence of high levels of these impurities gives rise to cross- linking of the gelatin polymer, leading to insolubilization through further polymerization.  filling temperature is maintained around 35°C and sealing temp is around 37-40°C.

12. In-process testing During the encapsulation process the four most important tests are:- The gel ribbon thickness, Soft gel seal thickness at the time of encapsulation, Fill matrix weight & capsule shell weight, Soft gel shell moisture level and soft gel hardness at the end of the drying stage.  Finished product testing includes Capsule appearance, Active ingredient assay ,Related substances assay ,Fill weight ,Content uniformity, Microbiological testing. This is how its made!!

13. HARD GELATIN CAPSULES DEFINITION:- These are solid dosage form of medicaments, in which drug is enclosed within the shells made up of gelatin. CAPSULE SHELL:- These capsules are made up of gelatin blends, small amount of certified dyes, opaquants, plasticizers and preservatives . In hard gelatin capsule the plasticizer and gelatin ratio is 0.4 : 1

14. STRUCTURE OF CAPSULE CAP BODY

15. MANUFACTURING The process of capsule shell production with the peg/pin method: dipping→ spinning→ drying→ stripping→ trimming→ joining→ polishing The thickness of the gelatin walls must be strictly controlled. The caps are slightly larger in diameter than the bodies.

16. Dipping : Pairs of the stainless steel pins are dipped into the dipping solution to simultaneously form the caps and bodies for 12sec. The dipping solution is maintained at a temperature of about 50 º C in a heated, jacketed dipping pan & pins are at 22ºc. Spinning : The pins are rotated to distribute the gelatin over the pins uniformly and to avoid the formation of a bead at the capsule ends it is rotated 2½ times by moving upward. Drying : The gelatin is dried by a blast of cool air to form a hard shells. The pins are moved through a series of air drying kilns.

17. Stripping : A series of bronze jaws strip the cap and body portions of the capsules from the pins.  Trimming and joining: The stripped cap and body portions are trimmed to the required length by stationary knives. The cap and body lengths are precisely trimmed to a ±0.15 mm tolerance. The cap and body portions are aligned concentrically in channels, and the two portions are slowly pushed together. Hard gelatin capsules are made self locking by forming indentations or grooves on the inside of the cap and body portions.

18. Principle of capsule filling Auger Fill principle: empty capsules – rectifying unit Rectifier descends the capsules such that caps are turned up and bodies down. From rectifying unit these are placed one by one in filling ring kept on rotating mode. The lower ring is rotated with a suitable speed and the hopper containing powdered drug is held over this ring. The auger drives the drug into bodies. Vibratory Fill Principle: The feed is placed in the feed hopper and the capsule bodies are passed under it. A perforated resin plate is placed in the feed hopper. Due the vibrations of the resin plate, the powder flows freely through the pores into bodies. - Osaka machines follows this principle.

19. Filling of Hard Gelatin C apsules Punch Method or Manual filling: - Powder is placed on a sheet of a clean paper or porcelain plate using spatula which is formed into a cake having a depth of approximately one-fourth to one-third the length of the capsule body. - Then empty capsule body is held between the thumb and forefinger and punched vertically into the powder cake repeatedly until filled .

20. Hand filling or semi automatic machine: - Consists of couple of plates

21. Locking & Sealing of Capsules Banding – Placing gelatin color bands at the meeting point of caps and the bodies. Moistening – Moistening the inner surface of caps with lukewarm gelatin solution. Spot Welding – Spot welding the joints which leaves a ring like appearance at the point of sealing

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