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  1. 1. Prepared by Mrs. Ashwini P . Shewale M.Pharm (PDEA’S Shankarrao Ursal Collegeof Pharmacy,Kharadi) 1
  2. 2. CAPSULES Unit solid dosage form thedrug is enclosed within watersoluble shell or an envelope either a hard or soft shell. Shell is typically made of gelatin primarily intended fororal delivery provide a rapid releaseof contents. 2
  3. 3. Advantages : 3 1.The drug having unpleasant odour & taste can be administered byenclosing them in a tasteless shell. 2.Smooth becomeveryslipperywhen moist &can beeasily swallowed. 3.They are economical. 4.Easy to handle & carry. 5.Release the medicamentas and when desired in GIT. 6.Theyare made up from gelatin hence theyare therapeutically inert. 7.Theyareattractive inappearance. 8.Available invarioussizes . 9. Microencapsulation provides thesustained release dosageform.
  4. 4. Disadvantages: 4 ⚫1. The hygroscopic drugs cannot be filled in capsules. Theyabsorbwaterpresent in thecapsuleshell & make itvery brittle, which ultimately breaks intopieces. ⚫2.Theconcentrated preparation which need previous dilution are unsuitable for capsules because it may lead to irritation in stomach if administered as such.
  5. 5. GELATINE protein, prepared from hydrolysis of collagen (animal bones and skin) type A : PH = 7-9, pig skin type B : PH = 5, animal bones TYPEA - Derived from acid treated precursor that exhibits an iso electric point at pH-9. It is manufactured mainly from pork skin. TYPE B - Derived from alkali treated precursor that exhibits an iso electric point at pH-4.7. It is manufactured mainly from animal bones. POSSESSES 4 ESSENTIAL PROPERTIES •stablewhen dry •subject to microbial degradationwhen moist •digested • absorbed 5
  6. 6. MANUFACTURE OF EMPTY GELATIN CAPSULES: Steps involved in making empty gelatin capsules… ⚫ Dipping ⚫ Spinning ⚫ Drying ⚫ Stripping ⚫ Trimming ⚫ Joining ⚫ Polishing 6
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  8. 8. • Once raw materials have been received and released by Quality Control, the gelatin and hot demineralized water are mixed under vacuum in Stainless Steel Gelatin Melting System. • From receiving tanks, the gelatin solution is transferred to stainless steel feed tanks. • Dyes, opacifants, and any needed water are added to the gelatin in the feed tanks to complete the gelatin preparation procedure. • From the feed tank, the gelatin is gravity fed to Dipper section. 8
  9. 9. 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 50º 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, Here gently moving air which is precisely controlled for volume, temperature, and humidity, removes the exact amount of moisture from the capsule halves. 9
  10. 10. Stripping : Aseries 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. After trimming to the right length, the cap and body portion are joined. ⚫Finished capsules are pushed onto a conveyer belt which carries them out to a container. ⚫Capsule quality is monitored throughout the production process including size, moisture content, single wall thickness, and color. ⚫ Capsules are sorted and visually inspected on specially designed Inspection Stations. ⚫Perfect capsules are imprinted with the client logo on high-speed 10
  11. 11. Types of Capsules 1.Hard gelatin capsules 2.Soft gelatin capsules 3.modified-release capsules: 1.delayed-release capsules gastroresistant / enteric capsules) 2.sustained-release capsules (extended-/prolonged release capsules). 11
  12. 12. Hard Gelatin Capsules contain 12 - 16 % moisture typically filled with dry solids powders granules pellets tablets alsocontain gelatin, titanium dioxide Colorant ,preservatives SIZE Capacity in mg VOLUME (cm3 ) 000 950 1.37 00 650 0.95 0 450 0.68 1 300 0.50 2 250 0.37 3 200 0.30 4 150 0.21 5 100 0.13 12
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  14. 14. Excipients used in the filling of capsules: 14 1. Diluents: e.g. Lactose, mannitol , sorbitol , starch 2.Absorbents: e.g. magnesiumoxides, magnesium carbonates, Calciumoxides, Calciumcarbonates, Kaolin 3.Glidants: Talc, magnesium stearate, calcium stearate 4. Antidusting agents: inertedibleoil.
  15. 15. Hard Gelatin Capsules 15 ⚫ Advantages ⚫ tastelessand odorless ⚫ swallowing iseasy ⚫ flexibility in formulating ⚫ uniquely suitable for blinded clinical trials ⚫ useful forextemporaneouscompounding by pharmacist ⚫ Disadvantages ⚫ tend to be moreexpensive toproduce than tablets ⚫ not suitable for highly solublesalts Processing of capsules: 1.Filling of capsules 2. Cleaning & polishing 3. Sealing of capsules
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  17. 17. Capsule filling machine (Hand operated) Itconsists 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 200-300 pins 5. A sealing plate having a rubbertop 6. A lever 7. A cam handle Polishing Pan Polishing : Acela-cota pan is used todustand polish. Cloth Dusting : Capsule are rubbed with cloth. Brushing : Capsuleare feed undersoft rotating brush. 17
  18. 18. Locking and 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 Thermal welding – Applying wetting sol. At the meeting points which causes lowering of M.P at applied area. Finally they are sealed at a temp. 40-45ºc. By using Coni-snap capsules – Grooves help to lock the caps with the bodies. Storage: Finished capsules normally contain an equilibrium moisture content of 13-16%. To maintain a relative humidity of 40-60% when handling and storingcapsules 18
  19. 19. Soft Gelatin Capsules (Softgels) • consist of acontinuous gelatin shell surrounding a liquid core • formed, filled, and sealed in one operation • shells are softened platizised by addition of glycerin or polyhydric alcohol (ex. sorbitol), Maycontain preservetive. • oblong, spherical, elliptical in shape. Enclosed oils,suspention,food concentarate,opthalmic products. 19
  21. 21. Soft Capsules 21 ⚫ADVANTAGES ⚫maycontain liquids, suspensions, pastes ⚫rapid releaseof contents ⚫useful fordrugs prone tooxidation ⚫DISADVANTAGES ⚫have agreater tendency toadhere to each other ⚫more expensive ⚫increased possibilityof interactions between drug and shell
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  23. 23. ROTARY DIE MACHINE: 23
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  25. 25. Sr.No. Hard Gelatin Capsule Soft gelatin capsule 1. Hard Gelatin Capsule shell consists of two parts 1. Body 2. Cap Soft gelatin capsule shell become a single unit after sealing the two halves of the capsules 2. They are cylindrical in shape They are available in round , oval & tube like shapes 3. The contents of a hard gelatin capsules usually consist of the medicaments is the form of powder, beads or granules The contents of soft gelatin capsules usually consists of liquids or solids dissolved or dispersed in suitable excipients to give a paste like consistency . 4. These are prepared from gelatin ,Titanium dioxide, coloring agents and Plasticizer These are prepared from gelatin plasticizer (Glycerin or Sorbitol ) and a preservative 5. Capsules are sealed after they are filled to ensure that the medicaments may not come out of the capsule due to rough handling Filing and sealing of soft gelatin capsules are done in a combined operation on machines 25
  26. 26. EVALUTION OF CAPSULES: (1) Content uniformity (2) Disintegration test . (3)Weight variation test (4)Dissolution test. (5)Moisture permeation test: 26
  27. 27. Content uniformity: 27 The amount of active ingredient should be within the range of 85% to 115% of the label amount for 9 of 10 capsules, with no unit outside the range of 70% to 125% of label amount.
  28. 28. Disintegration test for capsules: Place 1 capsule in each of the 6tubes of the basket & suspend the assembly in water at 37℃ ± 2ºC,which is repeatedly immersed 30 times per minute. The capsules pass the test if no residue of drug or other than fragments of shell remains on No. 10 mesh screen of the tubes. 28
  29. 29. ⚫ Weight variation test: 20 capsules are taken at random and weighed. Their average weight is calculated, then each capsule is weighed individually and their weight is noted. The capsule passes the test if the weight of individual capsule falls with in 90-110% of the average weight. ⚫ Moisture permeation test: ⚫ Acc. to U.S.P the unit dose container is packed along with dehydrated pellets, which have the property of changing color in the presence of moisture. The weight of test capsule is compared with the under test capsules. Diff. in weights gives the amount of moisture absorbed. 29
  30. 30. Dissolution test for capsules:  Place 1000ml of water having a temp. of 36.5º to 37.5º into the vessel. Place specified number of capsules in basket 7 adjust the speed to 100 rpm.  Withdraw req. volume for every 10min time interval. Filter and determine the amount of active ingredient.  The sample passes the test if the amount of active ingredients in the solution is not less than 70% of the stated amount. 30
  31. 31. PACKING & STORAGE OF CAPSULES: 31 Capsules should be packed well closed glass & plastic container & stored at temp. not exceeding 30ºc. Capsules are individually protected by enclosing in strip & blister packaging. In strip packing the capsule is hermetically sealed within the strips of an aluminum or plastic film. In blister packs, a press on the blister forces the capsule through the backing strip. .
  32. 32. Special applications of capsules 32 1.Enteric Coated Capsules:- a Coating of cellacephate (cellulose acetate phthalate) and mixture of waxes with fatty acids or their esters is given. 2. Sustained release capsules :- Finely powdered drug first converted to pellets .pellets are coated with protective coating that delay the release of drug.30% uncoated pellets 30% coated pellets that release drug at 4 hr & 8 hr interval & 10% neutral pellets to fill the capsule. 3.Rectal Capsules:-soft gelatin capsules as substitute for rectal & vaginal suppositories. Pear shaped 4. Capsule containing ophthalmic ointments:- Ophthalmic ointments are sterile to keep that ointment sterile during their storage & later use it is required to be filled in a single dose container. Intended for single application to eye. The capsule is puncture with sterile needle a& instilled into eye & shell is discarded
  33. 33. Angle of repose The maximum angle between the surface of pile of powder and the horizontal surface is called as angle of repose. tan θ = 2h D tan θ = 25O tan θ= 50O h D 33
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