Capsules, Types, Gelatin , Preparation of capsules presentation.pptx

Capsules, Characteristics of capsules, Components of capsules, Gelatin, Manufacturing of gelatin, Types of gelatin capsules.

1. Capsules By DG. Davou (B.Pharm., unijos) BO/21A/0460.

2. Outline: Introduction Definition Advantages and disadvantages of capsule Types of capsule Gelatin and it’s properties Types of gelatin capsules Manufacturing processes of HGC and SGC Conclusion

3. Introduction to capsules The first patented in France by Pharmacist Joseph Gerard Dublanc and Francois Achille Barnabe Mothes (a pharmacy student) in 1834. The shells of these early capsules were not plasticized, such capsules likely would be classified today as soft gelatin capsules based on shape, contents, and other features.  In 1848, James Murdock invented the two-piece telescoping (hard gelatin) capsule patented in England in 1865.

4. Pharm. Joseph Dublanc and Francois Mothes

5. Capsules Capsules are solid preparations in which drug substance(s) and/or excipients are enclosed in either a soft or hard soluble shell. Capsules are defined as unit solid dosage form of medicaments available as small containers (shells) made up of gelatin enclosing accurately measured drug substances. The term capsule is derived from the Latin word capsula, meaning a small container.

6. Capsules continued… Depending on the composition of the capsule shell, capsules may be classified as either hard or soft capsule, with soft capsules possessing a flexible, plasticized gelatin film. The shells may be composed of two pieces in the form of cylinders closed at one end . The two-piece capsules and one-piece capsules are commonly referred to as hard-shell capsules and soft-shell capsules respectively.

7. Capsules continued… Capsules may be filled with a range of formulation types including dry powders, semisolids, nonaqueous liquids, and other dosage forms such as mini-tablets, and even mini capsules most of which are intended for oral administration. There are also applications such as capsules that can be loaded into dry-powdered inhalers, add reagents as part of a diagnostic kit, and occasionally soft-shell capsules intended for rectal or vaginal insertio n.

8. Mechanism of capsule absorption Drug absorption is the movement of a drug into the bloodstream after administration. Absorption affects bioavailability—how quickly and how much of a drug reaches its intended target (site) of action. Factors that affect absorpt ion include : Drug formulation Its physical and chemical properties Other ingredients it contains The physiologic characteristics of an individual.

9. Advantages of capsules Capsules mask the taste and odour of unpleasant drugs and can be easily administered. They are attractive in appearance . They are slippery when moist . They are economical . They are easy to handle and carry. The shells can be opacified (with titanium dioxide)or colored , to give protection from light .

10. Disadvantages of capsules Hygroscopic drugs absorb water from the capsule shell making it brittle and hence are not suitable for filling into capsules . The concentrated solutions which require previous dilution are unsuitable for capsules because if administered as such lead to irritation of stomach.

11. Types of capsules 1. Gelatin capsules : Gelatin capsules, informally called gel caps are composed of gelatin. 2. Non gelatin / Vegetable capsules : vegetable capsules are composed of hypromellose , a polymer formulated from cellulose.

12. Gelatins Gelatin is a product obtained by partial hydrolysis of collagen acquired from the skin, white connective tissue, and bones of animals. Gelatin is a protein which is soluble in warm (or hot) water, but insoluble in cold water . It’s the major raw material in capsule shell technology.

13. Gelatin properties It is non-toxic . widely used in foodstuffs . It is readily soluble in biological fluids at body temperature. It is good film-forming material . The gelatin films are homogeneous in structure, which gives them strength .

14. Types of gelatin capsules Hard gelatin capsule Soft gelatin capsule

15. Hard gelatin capsules (HGC) Majority of products are made of hard gelatin capsules. Hard gelatin capsules are made of two shells: the capsule body and a shorter cap. The cap fits snugly over the open end of the capsule body. The basic hard gelatin capsule shells are made from mixtures of gelatin, sugar, and water. They are clear, colourless, and essentially tasteless.

16. Manufacturing process of HGC Some of the major suppliers of empty gelatin capsules are: Eli Lilly and Company, WarnerLambert’s Capsugel (formerly Park Davis) and R. P.Scherer Corporation. The metal moulds at room temperature are dipped into a hot gelatin solution, which gels to form a film. The production procedures includes: dipping, spinning, drying, stripping, trimming, and joining the capsules.

17. Schematics of HGC production

18. Manufacture of HGC continued… T he size of the 000 capsule is the highest and that of the number 5 capsule is the smallest.

19. Hard gelatin capsules

20. Soft gelatin capsule (SGC) Soft gelatin (also called softgel or soft elastic) capsules consist of one-piece hermetically-sealed soft shells. Soft gelatin capsules are prepared by adding a plasticizer, such as glycerine or polyhydric alcohol (e.g., sorbitol), to gelatin.

21. Ideal properties of SGC Opt imize s the chemical stability of the active compound. Improves bioavailability of the active compound . Allows for an efficient and safe filling process . Helps to achieve a physically stable capsule product. Final product stability is related to shell compatibility.

22. Soft gelatin capsules continued… plasticizer makes gelatin elastic. Soft gelatin capsules come in various shapes such as spherical, elliptical, oblong, and special tube shapes . They can contain non-aqueous liquids, suspensions, pasty materials, or dry powders. They are especially important to contain volatile drug substances or drug materials susceptible to deterioration in the presence of air.

23. Manufacturing process of SGC In this process, two continuous gelatin ribbons are brought together between twin rotating dies. At the moment dies form pockets of the gelatin ribbons, metered-fill material is injected between the ribbons. Then the pockets of fill-containing gelatin are sealed by pressure and heat. The capsules are subsequently severed from the ribbon. The capsules are cut from the ribbons, they may be collected in a refrigerated tank to prevent capsules from adhering to one another and from getting dull.

24. Schematics of SGC production

25. Manufacturing process of SGC continued…

26. Soft gelatin capsules

27. Advantages of SGC Soft gels are easy to swallow, once swallowed, release their contents very quickly. Mask odors and unpleasant tastes . have an elegant appearance . readily dissolve in the gastric juices of the digestivetract . It can also be used for ophthalmic preparations, e.g. aplicaps, vaginal/rectal suppositories. Uniformity and precision dosage . Product Stability.

28. Disadvantages of SGC water soluble material are difficult to incorporate . H ighly moisture sensitive. Highly sensitive to heat . Efflorescent material can not be incorporated, theymay cause softening/leaching . Deliquescent materials cannot be incorporated. Theymay cause hardening or brittle capsule. Cost effective. Dietary restrictions.

29. Other forms of SGC Enteric soft gel Controlled released soft gel Chewable soft gel Gelatin free soft gel

30. References LA Augsburger “Hard and soft gelatin capsules” in Modern Pharmaceutics GS Banker & CT Rhodes, (1995) ,Eds., Marcel Dekker, Inc.: New York, NY, pp 395–440.14) http://en.wikipedia.org/wiki/Capsule(pharmacy)15 ) “HPMC capsules: an alternative to gelatin.” Pharm Tech Europe, 1998;10(11): 32-42.17) MS Patel, FSS Morton, & H Seager “ Jones D. (2008).  Fasttrack Pharmaceutics – Dosage Form and Design . London: Pharmaceutical Press.

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