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SOFT GELATIN CAPSULES

SOFT GELATIN CAPSULES. DEPARTMENT OF PHARMACEUTICS CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES. INTRODUCTION FORMULATION OF SOFT GELS MANUFACTURE OF SOFT GELS QUALITY CONTROL TESTS REFERENCES. INTRODUCTION

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SOFT GELATIN CAPSULES

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  1. SOFT GELATIN CAPSULES DEPARTMENT OF PHARMACEUTICS CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES

  2. INTRODUCTION • FORMULATION OF SOFT GELS • MANUFACTURE OF SOFT GELS • QUALITY CONTROL TESTS • REFERENCES

  3. INTRODUCTION • Capsules are solid dosage forms in which medicinal agents are enclosed within hard or soft soluble shell. The shells are generally formed from gelatin. • The capsule is regarded as container drug delivery system that provides a tasteless/ odorless dosage form without need for secondary coating step. • Capsule may classified depending on nature of shell • Hard gelatin • Soft gelatin capsules, also called as soft gels

  4. GELATIN CHARACTERISICS: • Type A gelatin produced by acid hydrolysis, is manufactured mainly from pork skin • Type B gelatin produced by alkaline hydrolysis, is manufactured mainly from animal bones • The two types are differentiated by isoelectric points (4.8-5.0 for type B and 7.0-9.0 for type A) and their viscosity building properties and film-forming characteristics. • Bone gelatin contributes firmness, where as pork skin gelatin contributes plasticity clarity

  5. SOFT GELATIN CAPSULES • Soft Gelatin Capsules are one-piece forms that encase a predetermined dose of liquid or semi liquid fill. • Filled and hermetically sealed in a single operation • Soft gelatin capsules offer the capability of delivering a liquid in a solid dosage form. • Soft gels ability to enhance the bioavailability not only makes it the preferred dosage form with poor bioavailability owing to poor aqueous solubility but also for reformulation of marketed drugs with the purpose of life cycle extension

  6. Hard vs soft gelatin Capsules

  7. WHY SOFT GELS AS DOSAGE FORM?

  8. Soft gels drug delivery systems:

  9. FORMULATION OF SOFT GELS • Excipients of Soft gels • a. GELATIN • b. SOFTENER (plasticizer): sorbitol, xylose, maltitol, glycerin, PEG, water) • c. PRESERVATIVES: Methyl paraben, propyl paraben, butylated hydroxyaniline, EDTA, sodium benzoate • d. DYES AND PIGMENTS • e. SOLVENT • Polar: glycerin, PEG, PEG 400, PEG 3350, ethanol, propylene glycol, water • Nonpolar: beeswax, coconut oil, triglycerin, corn oil, mineral oil, soybean oil, D,L-α-tocopherol • f. FLAVOR AND FRAGRANCE • g. PIGMENT: Titanium oxide, ferric oxide • h. ANTICAKING AGENT: Silicone dioxide • i. HUMECTANTS:Polyol, glycerin

  10. NATURE OF CAPSULE (GELATIN) SHELL • Bloom Strength: • measure of the cohesive strength of the cross linking that occurs between gelatin molecules • proportional to molecular weight of gelatin • Determined by measuring weight in grams required to move a plastic plunger i.e. 0.5 inches in diameter 4mm into a • 62/3 % gelatin gel that has been held at 10°C for 17 hours • Value ranges from 150 – 250g • Higher the bloom strength - more physical stability to the capsule shell • - more costly

  11. VISCOSITY Set sealing temperature Drying conditions Standard gelatin formulation Firm, nontacky, nonbrittle, elegant product

  12. Iron – depends on the concentration of iron in water used. shouldn't be more than 15ppm PLASTICIZER

  13. ADDITIONAL COMPONENTS OF THE GELATIN SHELL

  14. DYES AND PIGMENTS: • Color of the capsule shell should never be lighter in hue than • capsulated material. • Darker colors are more appropriate for large size • (14 to 20 minim oblong) • Interaction between colorants and shell additives must be • studies. • Clear colors are employed for clear type fill materials. • Opaque colors are used for suspensions.

  15. CRITERIA OF A FORMULATION: • Capacity to dissolve the drug • Rate of dispersion in the gastro intestinal tract after rupture of the soft gel shell • Ruptures and releases the fill matrix • Capacity to retain the drug in solution in the gastro intestinal tract • Compatibility with the soft gel shell • Ability to optimize the rate ,extent and consistency of drug absorbed.

  16. LIQUID:

  17. Aromatic and aliphatic hydrocarbons, chlorinated hydrocarbons and high molecular weight alcohols ,esters and organic acids are used as solvents for veterinary cosmetic and industrial products. • The most commonly used liquids for human use are: oily active ingredients (Clofibrate), vegetable oils(soyabean oil), mineral oil, nonionic surface active agents(polysorbate 80) and polyethylene glycols(400,600) FILLING CONDITIONS • Sample must be air free. • Should flow by gravity at room temperature. • pH - 2.5 and 7.5 if more acidic – hydrolysis and leakage of shell if more alkaline – tanning solubility of shell

  18. CAPSULATION OF SUSPENSIONS

  19. BASE ADSORPTION • is expressed as the no of grams of liquid base required to produce a capsulatable mixture when mixed with 1g of solid. • Base adsorption is influenced by • Size and shape • Physical state – fibrous, amorphous or crystalline • Density • Moisture content • Oleophilic or hydrophilic nature

  20. Procedure for determining base adsorption 40g of solid in 150ml beaker 100g of liquid base in 150ml beaker Add small equivalents of base to solid with spatula Stir the base into the solid until the solid is properly wetted Continue to add base until a free flowing mixture is obtained

  21. SELF EMULSIFYING OILS: • Combinations of pharmaceutical oil and a non-ionic surfactant such as Polyoxyethylene sorbitan mono oleate can provide an oily formulation which disperses rapidly in the gastro intestinal fluid. The resulting oil/surfactant Droplets enable rapid transfer of drug to the absorbing mucosa and subsequent drug absorption. • MICROEMULSION AND NANOEMULSION SYSTEMS: • A micro emulsion of a lipid-surfactant-polar liquid system is a characterized by its translucent single phase appearance. • A nanoemulsion is a similar system but contains the emulsion droplets in the 100nm size range. • Micro emulsion and nanoemulsion systems have the advantage of a high capacity to solubilize drug compounds and to retain the drug in solution even after dilution in gastrointestinal fluids

  22. Capsule manufacture, processing and control:

  23. OPERATING CONDITIONS • Plant temperature – 20 to 22°C • Operating areas – 40% RH • Drying areas – 20 -30% RH • Gelatin film Preparation • Required gelatin weighed • Chilled to 7°C • In melting tanks 29.5Hg at 93°C (for 3hrs) • Mixing for 25mins • Colorants added and maintained at 57 - 60°C

  24. Fill preparation Stainless steel jacketed tanks (10 – 450 gallons) (for initial blending with liquid base) Milling or homogenized (not to reduce the size but to break the agglomerates) Wetted with liquid carrier to form smooth homogenous mixture Dearation (to achieve uniform capsule fill weight and to prevent loss of potency by oxidation) If ingredients are volatile, added after dearation and if suspensions/ liquids, vacuum 29.5Hg Dearation can be achieved by heating at 60°C

  25. IN PROCESS TESTING • Ingredient assay • Specific gravity • Test for homogeneity • Moisture content • Air entrapment

  26. Manufacturing of soft gels:

  27. Plate process: • Oldest commercial process • Semi automatic process • Equipment is no longer available • Procedure: • Placing the upper half of a plasticize gelatin sheet over a die plate • containing numerous die pockets • Application of vacuum to draw the sheet into the die pockets • Filling the pockets with liquid or paste • Folding the lower half of the gelatin sheet back over the filled pockets • And inserting the sandwich under a die press where the capsules are formed and cut out

  28. ACCOGEL PROCESS • Is a continuous process (powders or granules) • Is an another rotary process involving • measuring roll • die roll • sealing roll • The measuring roll and die roll rotates, the measured doses are transferred to gelatin lined pocket and second gelatin sheet is applied to form other half of the capsule

  29. BUBBLE METHOD • One piece soft gelatin capsules are made by this • Molten gelatin and liquid content are discharged simultaneously from outer and inner annulus respectively • The liquids are discharged into chilled oil as droplets, gelatin congeals on cooling • Finished capsules are degreased and dried

  30. Rotary die process: • First continuous process invented by R.P.Scherer in 1933 • Reduced manufacturing losses • Content variation to a±1-3% range • Procedure: • Die cavities are machined into the outer surfaces of die dollars • Die pockets on the left hand roller form the left side of the capsule • The die pockets on the right hand roller form the right side of the capsule • The die pockets on the two rollers match as the rollers rotate • Two plasticized gelatin ribbons are continuously and separately fed with liquid or paste fill between the rollers of the rotary die mechanism • Forceful Injection of the feed material between the two ribbons causes the gelatin to swell into the left and right hand die pockets as they converge • . • As the die roll rotates the convergence of the matching die pocket seals and cuts out the filled pockets.

  31. AFTER MANUFACTURING

  32. INSPECTION AND QC STEPS • Seal thickness • Total or shell moisture tests • Capsule fragility or rupture tests • Determining freezing and high temperature effects • FINISHING DEPARTMENT • Heat branding or ink painting for identification purpose. • Diameter sorting: Capsules with ±0.020 inch of theoretical diameter of particular capsule is tested. • Over fills, under fills, foreign capsules are discarded

  33. Color sorter • Pneumatic conveyor – capsule color that doesn't conform to reference color standard is discarded • Passed to electronic counting and packaging unit • Electronic counting can count as many as 8000capsules/min

  34. Shape Fixing And Drying Process Preparation room Capsule making process Gelatin Melting Part Capsule Air Drying Process Capsule Inspection Process Inner Packed Process Capsule Cleaning Process

  35. Outside Packing Process Storage

  36. Quality control tests • Content uniformity • Weight variation • Contents of the packaged dosage form • Disintegration test • Dissolution test

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