Capsule: A small container

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Presentation transcript:

Capsule: A small container A soluble gelatin case containing a dose of medicine A solid oral dosage form consisting of a shell and a filling.  The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band.  Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials. There are two forms of capsules, Hard capsules Soft capsules. Hard capsules are for powders or semi-solid preparations and soft capsules for liquids. Hard capsules were invented in 1833 in France. They were (and are today) made of gelatin and consist of two parts, a body and a cap. While soft gelatin capsule is single sealed enclosure.

Gelatin: Gelatin is a protein produced by partial hydrolysis of collagen extracted from the bones, connective tissues, organs, and some intestines of animals such as the domesticated cattle, and horses . The manufacturing processes of gelatin consists of three main stages: Pretreatments to make the raw materials ready for the main extraction step and to remove impurities which may have negative effects on physicochemical properties of the final gelatin product. The main extraction step, which is usually done with hot water or dilute acid solutions as a multistage extraction to hydrolyze collagen into gelatin. The refining and recovering treatments including filtration, clarification, evaporation, sterilization, drying, grinding, and sifting to remove the water from the gelatin solution, to blend the gelatin extracted, and to obtain dried, blended and ground final gelatin. Types of Gelatin There are two types of gelatin Type A Gelatin 2. Type B Gelatin

Type A gelatin is derived from acid treated precursor and have the isoelectric pH of 9. Type B gelatin is derived from acid treated precursor and have the isoelectric pH of 4.7 Method of production

Capsule Sizes with capacity

Advantages of capsules Bioavailability Enhancement and Stability. Versatile - oral, rectal, vaginal and topical applications. To deliver powders. Superior means of delivery liquids. Masking of bad odors and tastes. Precise dosage control. Reduces potential of cross contamination of powders in production. Protects Contents from contamination, oxidation and light. Patient Preference Studies - Demonstrate appeal to consumers. Available in wide ranges of Colours, Shapes and Sizes. Outstanding Visual appeal. Easy to swallow. Patent protection and Line Extension. Tamper-evident / tamper resistant characteristics. High accuracy for Lower Dose of active ingredients. High degree of product elegance & differentiation for a Marketing Edge

2.Open capsules once again to ensure the capsule to be opened. 1.After capsules arranged and oriented, put capsule into the mold and open it by vacuum. 2.Open capsules once again to ensure the capsule to be opened. 3.Eject the unopened capsule and the faulty into a collection box. 4.&5.Both Stations are reserved for pellet or granule filling

6. Put dosing tube into powder plate 6.Put dosing tube into powder plate. The powder will be compressed into slug. Then eject the powder slug into the open capsule. 7.Reclaim the powder which not being filled into the capsules from the collector. 8.Join capsules together by upper and lower closing pins.

9.Eject the filled capsule into the collection container. 10.Clean the residue powder attached to cap and body mold by suction for next cycle use.

can handle powder, pellets Company Model Rated Out put/Hr Remarks Formatic 2000/15 40,000 Dosator filling 200/30 80,000 2000/60 160,000 Zanasi LZ-64 4000 BZ-40, 70, Z-5000-R1, Z-5000-R2 and Z-5000-R3 can handle powder, pellets and tablets AZ-20 9000-20,000 BZ-40 30,000 BZ-72 60,000 BZ-110 110,000 BZ-115 115,000 Z-5000-R1 70,000 Z-5000-R2 Z-5000-R3 150,000 Mecofar MT12, MT13/1,MT13/2 35,000, 5000 and 10,00 mG2 G36/4, G36/2, G-36, G37N, G38 9000, 18,000, 36,000, 96,000 and 60,000 can handle powder, pellets Osaka R-180 70,000-165,000 Perry Accofil Powder feeding through suction

Soft Gelatin Capsules The soft gelatin capsule is composed of Gelatin Plasticizer Water Other ingredients (Preservative, colorants, opacifiers, flavours, sugar, acids and medicaments). The most common plasticizer used are sorbitol, glycerin or combination of these. The common ratio of plasticizer to gelatin (dry basis) is 0.4-0.8 :1. The gelatin must be checked for specification other than pharmacopoeia, these include bloom strength, viscosity and iron content 1.Bloom or gel strength: it is the measure of cohesive strength of the cross linking that occurs between gelatin molecule and is proportional to the molecular weigh of gelatin. It is determined by measuring the weight in grams required to move plastic plunger of 0.5 inches in diameter 4 mm into a 6.66% gelatin solution held at 10oC for 17 hours. The range for bloom strength is 150-250 g. 2. Viscosity: it is determined using 6.66% aqueous gelatin solution at 60oC. The range for viscosity is 25-45 millipoise. 3.Iron content: gelatin used for soft gelatin capsule should not contain iron more than 15 ppm. The most common size for human is oblong 20 minims, oval 16 minims and round 9 minims

Filling Equipment Plate Rotary die Reciprocating die Accogel