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  2. 2. INTRODUCTION The term capsule is derived from the Latin word capsula, meaning a small container. The first capsule prepared from gelatin was a one- piece capsule patented in France by Mothes and Du Blanc in 1834. Capsules are solid dosage forms in which the drug substance is enclosed within either a hard or soft soluble shell, usually formed from gelatin. DESIGN & FORMULATION OF CAPSULES 2
  3. 3.  Today capsules may be classified as either hard or soft, depending on the nature of the shell. Most capsules of both types are intended to be swallowed whole; however, some soft gelatin capsules are intended for rectal or vaginal insertion as suppositories. TYPES OF CAPSULES 1) Hard gelatin capsules 2) Soft gelatin capsules DESIGN & FORMULATION OF CAPSULES 3
  5. 5. ADVANTAGES  Tasteless, odorless and can easily be administered.  Combination of powders we can use  These are attractive in appearance.  The drugs having un-pleasant odor and taste are enclosed in a tasteless shell.  They can be filled quickly and conveniently.  Physician can change the dose and combination of drug according to patient requirement.  They are economical.  They are easy to handle and carry. DESIGN & FORMULATION OF CAPSULES 5
  6. 6. DISADVANTAGES  Hygroscopic drugs are not suitable for filling into capsules, because they absorb water present in capsule shell makes shell very brittle and ultimately lead to crumble into pieces.  The concentrated solutions which require previous dilution are unsuitable for capsules because if administered as such lead to irritation into stomach. DESIGN & FORMULATION OF CAPSULES 6
  7. 7. HARD GELATIN CAPSULE  The hard gelatin capsule consists of two pieces in the form of cylinders closed at one end. The shorter piece is called the cap. This cap fits over the open end of longer piece called body.  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(the shorter part) The drug substance is placed in the body and the caps are slided over it, hence enclosing the drug substance. DESIGN & FORMULATION OF CAPSULES 7
  8. 8. CAPSULE SIZES For human use,empty capsules ranging in size from 000(the largest)to 5 (the smallest)are commercially available. DESIGN & FORMULATION OF CAPSULES 8
  9. 9. HGC •HGC typically are filled with powders, granules & pellets. •Contain body & cap. •They are cylindrical in shape. •Less amount of plasticizers. DESIGN & FORMULATION OF CAPSULES 9
  10. 10. FORMULATION OF HARD GELATIN SHELL :  GELATIN: It is prepared by the hydrolysis of collagen obtained from animal connective tissue, bone and pork skin. There are two types of gelatin  Type A (Acid hydrolysis of pork skin)  TypeB (Alkaline hydrolysis of bones) The two types of gelatin can be distinguished by iso electric point as:  Type A iso electric point near to PH 9  Type B iso electric point near to PH 4.7 DESIGN & FORMULATION OF CAPSULES 10
  11. 11. The physiochemical properties of gelatin of most interested to the shell manufactures are-  1) Bloom strength  2) Viscosity Bloom strength It is measured in a bloom gelometer which determine the weight in grams required to depress a standard plunger a fixed distance in to the surface of a 6.66 % w/v gel under standard condition. Bloom strength in the range of 150-280 is considered suitable for capsule. DESIGN & FORMULATION OF CAPSULES 11
  12. 12. Viscosity- The viscosity of the gelatin is vital to control the thickness of the cast film. Viscosity is measured on a standard 6-2/3%w/w solution at 600 C in a capillary pipette & generally in the range of 30-60 milli poise. PLASTICIZER Sorbitol & glycerol is used. DESIGN & FORMULATION OF CAPSULES 12
  13. 13.  COLORANTS:  Colour approved by D & C act.  Soluble synthetic dye(coaltar dyes) & insoluble dyes(iron oxide).  Colorant plays an important role in improving patient compliance.  Thus the color of drug product may be selected in consideration of the disease state for which it is intended. e.g. White – analgesics. Orange/Yellow – stimulants & anti depressants  OPACIFIERS: It provide protection against light or or conceal the contents. Eg.Titanium dioxide. DESIGN & FORMULATION OF CAPSULES 13
  14. 14.  WATER Demineralised water is used. Finished capsule contain an equilibrium moisture content of 12-16%.  Preservatives: Propyl and Methyl Parabens.  Flavouring agents If needed flavouring agent may be added to the capsule shell. Eg. Ethyl vanillin, essential oil. DESIGN & FORMULATION OF CAPSULES 14
  15. 15. GELATIN CAPSULE FORMULATION The formulation of hard gelatin capsule includes different substances which promote the release of drug constituent from the hard gelatin capsule these include:-  Active ingredients.  Fillers (diluents).  Glidents.  Lubricants.  Disintegrants.  Surfactants.  Hydrophilic agents.  Protectives.  Anti-dusting agents DESIGN & FORMULATION OF CAPSULES 15
  16. 16. 1) ACTIVE INGREDIENTS :- The amount and type of active ingredients influence capsule size and the nature and amount to be used in the formulation. Active ingredients tends to make up to the high percentage of the contents of a capsule as compared to tablet. Smaller the size of active ingredients, larger will be the surface area of the active ingredients, hence greater will be the rate of dissolution of the active ingredients. DESIGN & FORMULATION OF CAPSULES 16
  17. 17. Granulation of the active ingredient in the case of hard gelatin capsule is carried out to  Increase the flow properties.  Increase Drug dissolution. 2) FILLERS(DILUENTS):- Fillers are used to increase the bulk of the formulation. The most common capsule diluents are starch, lactose & dicalcium phosphate. These substances improve flow properties and compatibility. DESIGN & FORMULATION OF CAPSULES 17
  18. 18. 3) GLIDENTS:- Glidants are used to improve the fluidity of powders. Glidants include the colloidal silica, corn starch, talc and magnesium stearate. They are fine particles that appear to coat the surface of the bulk powder and enhance fluidity by reducing roughness by filling surface irregularities reducing attractive force by ….  Physically separating the host particles.  Modifying electrostatic charges.  Acting as moisture scavengers. DESIGN & FORMULATION OF CAPSULES 18
  19. 19. Optimum concentration for flow is less then 1% & typically lies between 0.25-0.50 percent. Exceeding this concentration will result in no further improvement in flow. 4)LUBRICANTS:- Capsule formulation usually requires lubricants :  To ease the ejection of plugs.  To reduce filming on piston and adhesion of powders to metal surface.  Reduce the friction between sticking surfaces in contact with powder. Ex:- magnesium stearate and stearic acid. DESIGN & FORMULATION OF CAPSULES 19
  20. 20. 5) DISINTEGRANTS:- In capsule formulation, the substances which have superior swelling or moisture absorbing properties are generally used as disintegrants. Such disintegrants are called “super disintegrants”. E.g. croscarmellose sodium, sodium starch glycolate and crospovidone. 6) SURFACTANTS:- Surfactants are used in capsule formulation to increase the wetting of the powder mass and enhance drug dissolution. DESIGN & FORMULATION OF CAPSULES 20
  21. 21.  Commonly used surfactants are sodium lauryl sulphate and sodium docusate. Surfactant in concentration range of 0.1-0.5% is usually used. 7) HYDROPHILIC AGENTS:- Hydrophilic agents are used to improve the wettability of poorly soluble drug present in hard gelatin capsule. E.g.:- Both wettability of the drug and the rate of dissolution of hexobarbital from hard gelatin capsule could be enhanced if the drug is treated with methyl cellulose or hydroxyl ethyl cellulose.(hydrophilic agents). DESIGN & FORMULATION OF CAPSULES 21
  22. 22. SOFT GELATIN CAPSULES  Made from a more flexible plasticized gelatin film than hard gelatin capsules.  Most capsules of either type is intended to be swallowed whole.  Some soft gelatin capsules are intended for rectal or vaginal insertion as suppositories.  Most capsules product manufactured today are of the hard gelatin type.  On the basis of shape, content & other features intended to make the taste of certain unpleasant tasting medication, they quickly gained popularity. DESIGN & FORMULATION OF CAPSULES 22
  23. 23. S.G.C •SGC are filled with solution or suspension of drug in liquids that will not solubilize the gelatin shell. • Consist of single unit after sealing. •Available in ROOT shapes i.e. round,oval,oblong & tubular • Plasticizers & preservatives are more. •Most accurate & precise of all solid oral dosage form. • More flexible plasticized gelatin film. DESIGN & FORMULATION OF CAPSULES 23
  25. 25. Composition of the shell The basic component of soft gelatin shell is gelatin; however, the shell has been plasticize The ratio of dry plasticizer to dry gelatin determines the “hardness” of the shell and vary from 0.3-1.0 for very hard shell to 1.0-1.8 for very soft shell Up to 5% sugar may be included to give a “chewable” quality to the shell The residual shell moisture content of finished capsules will be in the range of 6-10%. DESIGN & FORMULATION OF CAPSULES 25
  26. 26. II. Formulation : Formulation for soft gelatin capsules involve liquid. Materials generally formulated to produce the smallest possible capsule consistent with maximum stability, therapeutic effectiveness and manufacture efficiency. The liquids are limited to those do not have adverse effect on gelatin walls. Emulsion can not be filled because water will be released that will affect the shell. The pH of the liquid can be between 2.5 and 7.5. DESIGN & FORMULATION OF CAPSULES 26
  27. 27. CAPSULE SHELL  Gelatin  Plasticizer  Preservatives  Colorants  Opacifier  Flavoring agents  Sugar CAPSULE CONTENT  Liquids or a combination of a miscible liquid, a solution of solid in liquid or a suspension of solid in liquid. DESIGN & FORMULATION OF CAPSULES 27
  28. 28. VEHICLES USED IN SOFT GELATIN CAPSULES Two main groups : 1. Water - immiscible, volatile & non volatile liquids as: Vegetable , aromatic oils & mineral oil, Aromatic & aliphatic hydrocarbons, Acetylated glycerin, esters, and organic acids. 2. Water - miscible, nonvolatile liquids as: Polyethylene glycols (PEG) with low molecular weight used more recently because of their ability to mix with water and accelerate dissolution of dissolved or suspended drugs, Nonionic surface active agents(Polysorbate 80) & Propylene glycol DESIGN & FORMULATION OF CAPSULES 28
  29. 29. HARD GELATIN CAPSULE SOFT GELATIN CAPSULE 1)Two pieces (large body & short cap) 2) Cylindrical shape. 3) Powder drug or pellets coated with drug are encapsulated. 4) Gelatin in Hard form is used. 5) Capsules sealed after filled to ensure that medicaments not come out of capsule due to rough handling. 6) 8 different type of sizes are available 1) One piece & hermetically sealed. 2) Available in round , oval & tube like shapes. 3) Liquid & Semi liquid fill & unstable substances are encapsulated. 4) Molten gelatin are used. 5) Filling & sealing of soft gelatin capsules are done in a combined operation on machine. 6) No specific sizes are available DESIGN & FORMULATION OF CAPSULES 29
  30. 30. REFERENCES 1)Aulton’s Pharmaceutics The design and manufacture of medicines Fourth edition,by Michael.E.Aulton &Kevin M.G.Taylor,pg no:583-607. 2)The theory and practice of industrial pharmacy By Leon Lachman , Herbert .A .Libermann , Joseph.L.Kanig, Third edition Published by Varghese publishing house DESIGN & FORMULATION OF CAPSULES 30

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