logging in or signing up Capsule dosage forms goutham.atla Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 1026 Category: Science & Tech.. License: All Rights Reserved Like it (2) Dislike it (0) Added: March 05, 2011 This Presentation is Public Favorites: 3 Presentation Description No description available. Comments Posting comment... By: shaileshrich (8 month(s) ago) plz mail me this ppt on shaileshrich@yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close By: jaganlal (9 month(s) ago) good ppt send to me friend for e mail jagan.bhukya@yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close By: nagesh4660 (9 month(s) ago) very nice ppt.... pls send to me thalluri_nagesh@yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close By: nagesh4660 (9 month(s) ago) very nice ppt.....pls send to me thalluri_nagesh2yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close By: jayaagnihotri (9 month(s) ago) plz send me this at email id arnapadii@yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close loading.... See all Premium member Presentation Transcript Slide 1: CAPSULES Dr J RajuIntroduction: Introduction Capsules are solid dosage forms in which medicinal agents and/or inert substances are enclosed within a shell of gelatin. Gelatin capsule shells may be hard or soft depending on their composition.Advantages: Advantages Elegance, ease of use, easily swallowed, tasteless shells Conveniently carried (portable) and readily identified Prescribing flexibility, Efficiently and productively manufactured Packaged and shipped at lower cost and with less breakage More stable and have a longer shelf-life Empty hard gelatin capsules are often used in the extemporaneous compounding of prescriptions. Capsules are a convenient method by which liquids may be orally administered to patients as a unit dosage form.Disadvantages: Disadvantages Not useful for extremely soluble materials such as KCl, KBr sudden release may cause irritation. Not useful for efflorescent or deliquescent materials. Efflorescent cause capsules to soften & Deliquescent may dry the capsule shell to brittleness. More costlier than tablets. Cheaper than coated tablets.Types of capsules: Types of capsules Hard gelatin capsules Soft gelatin capsulesHard Gelatin Capsules: Hard Gelatin Capsules The application of hard gelatin capsules Used to manufacture most medicated agents Employed in clinical trials Used in the extemporaneous compounding Empty capsule shells consist of Gelatin, sugar, water, colorants (various dyes), and opaquants (titanium dioxide).Shell Composition: Shell Composition GELATIN - Protein, prepared from hydrolysis of collagen (animal bones and skin) Type A : acid treated precursor Isoelectric pH 9, pig skin Type B : alkali treated Isoelectric pH 4.7, animal bones Bone gelatin produces tough, firm film but tends to be hazy and brittle. Pork skin gelatin produce plasticity and clarity thus reduce haziness of finished product. Either type can be used but combination is used to optimize shell characteristics.Slide 8: Schematic for the production of GelatinContd..: Contd.. Gelatin’s chemical, physical and physiological properties make it an ideal substance for capsulation. Stable when dry Subject to microbial degradation when moist Digested and Absorbed Bloom Strength – Cohesive strength of the cross linking that occurs between gelatin molecules and is proportional to the molecular weight of the gelatin. Determined by measuring the weight in gm required to move a plastic plunger that is 0.5 inches in diameter 4 mm into a 6.66 %w/w gelatin gel that has been held at 10 ° C for 17 h.Slide 10: BS within the range of 150-280 are suitable for capsules. Higher the BS, more physically stable is the capsule shell. Viscosity of the gel can vary from 25 to 45 millipoise. Iron is always present in raw gelatin and used in soft gelatin capsule should not contain more than 15 ppm. Opaquing agents like titanium dioxide to render the shell opaque. - to protect from light or to conceal the contents Preservatives, parabens can be used if employed. Contd..Shell Manufacture: Shell Manufacture Entire cycle lasts for 45 minSlide 12: Dipping Stainless steel pins Pins at ambient temperature (22°C) Dipping solution at 50°C Length of time to cast the film is 12 seconds Rotation Elevated and rotated 2 1/2 times until they face upward To distribute gelatin evenly on the pins Avoid formation of bead at the capsule ends After rotation, blast of cool air to set the film. Drying Dehumidification, passing large volumes of dry air over the pins Drying must not be too rapid, to prevent case hardening Overdrying causes the films to split from the pins & brittle, Underdrying leaves film, too sticky for subsequent operations Contd..Slide 13: Stripping Bronze jaws (softer than steel) strip Caps and Bodies from pins Trimming Delivered to collets and firmly held Collets rotate, knives trim them to the required length Joining Cap and Body aligned concentrically in two channels, and two portions are slowly pushed together. Sorting Printing Thickness of capsule controlled by viscosity of gelatin solution, speed and time of dipping. Precise drying, for ultimate quality of film. The Caps are slightly larger in diameter than the bodies. Contd..Slide 14: Normally, hard gelatin capsules contain between 13 to 16% of moisture. Additional moisture absorption: capsules become distorted and lose their rigid shape Lose their contained moisture: become brittle and crumble when handled Solubility property of gelatin Insoluble in cold water, soften through the absorption of up to ten times its weight of water; soluble in hot water and warm gastric fluid. Gelatin, being a protein, is digested by proteolytic enzymes. Contd..Capsule Size: Capsule Size How to select capsule size? Amount of fill material to be encapsulated Density and compressibility of the fill Final determination largely may be on the result of trial. Human use: 0, 1, 2, 3, 4, 5 (the smallest) Veterinary use: 000 (the largest), 00, Larger capsules are available.Slide 16: Size Volume Fill weight (g) at 0.8 g/cm 3 powder density 000 1.37 1.096 00 0.95 0.760 0 0.68 0.544 1 0.50 0.400 2 0.37 0.296 3 0.30 0.240 4 0.21 0.168 5 0.15 0.104Slide 17: Sealing of Hard Gelatin Capsules Gelatin band sealing . In this method a dilute solution of gelatin is applied to the centre of the capsule (between the two halves) which, once dried, produces a hermetic seal. Hydroalcoholic solvent seal. A hydroalcoholic solution (1:1 water/ethanol) is applied to the centre of the capsule (between the two halves). This softens the capsule and, following heating to 45°C, the interface fuses to produce a seal. Soft welding. Two hot metal jaws are brought into contact with the area where the cap overlaps the filled body.Diagram of the Conisnap capsule, illustrating the locking mechanism between the two capsule halves.: Diagram of the Conisnap capsule, illustrating the locking mechanism between the two capsule halves.Formulation types for filling into hard capsules: Formulation types for filling into hard capsulesPowders: Homogeneity of mix Flow properties Compatibility between formulation components and capsule. Diluents/Fillers – Lactose, starch, MCC Lubricants & Glidants Disintegrants Wetting agents Hydrophilization and granulation PowdersLiquids/Semisolid fills : Lipophilic liquids/oils containing dissolved or dispersed therapeutic agent. Vegetable oils (e.g. sunflower, arachis, olive) Fatty acid esters (e.g. glyceryl monostearate). Water-miscible liquids containing dissolved/dispersed therapeutic agent. Polyethylene glycols (PEGs) that are solid at room temperature but will liquefy upon heating (high Mol wt) Liquid polyoxyethylene-polyoxypropylene block co-polymers (Pluronics). Surface active agents & Viscosity modifying agents A major concern in the choice of solvents for liquid fill formulations is the effect of the formulation on the stability of the capsule. Equilibrium moisture content of hard gelatin capsules - 13–16% Liquids/Semisolid fillsCapsule filling: Capsule filling You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
Capsule dosage forms goutham.atla Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 1026 Category: Science & Tech.. License: All Rights Reserved Like it (2) Dislike it (0) Added: March 05, 2011 This Presentation is Public Favorites: 3 Presentation Description No description available. Comments Posting comment... By: shaileshrich (8 month(s) ago) plz mail me this ppt on shaileshrich@yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close By: jaganlal (9 month(s) ago) good ppt send to me friend for e mail jagan.bhukya@yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close By: nagesh4660 (9 month(s) ago) very nice ppt.... pls send to me thalluri_nagesh@yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close By: nagesh4660 (9 month(s) ago) very nice ppt.....pls send to me thalluri_nagesh2yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close By: jayaagnihotri (9 month(s) ago) plz send me this at email id arnapadii@yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close loading.... See all Premium member Presentation Transcript Slide 1: CAPSULES Dr J RajuIntroduction: Introduction Capsules are solid dosage forms in which medicinal agents and/or inert substances are enclosed within a shell of gelatin. Gelatin capsule shells may be hard or soft depending on their composition.Advantages: Advantages Elegance, ease of use, easily swallowed, tasteless shells Conveniently carried (portable) and readily identified Prescribing flexibility, Efficiently and productively manufactured Packaged and shipped at lower cost and with less breakage More stable and have a longer shelf-life Empty hard gelatin capsules are often used in the extemporaneous compounding of prescriptions. Capsules are a convenient method by which liquids may be orally administered to patients as a unit dosage form.Disadvantages: Disadvantages Not useful for extremely soluble materials such as KCl, KBr sudden release may cause irritation. Not useful for efflorescent or deliquescent materials. Efflorescent cause capsules to soften & Deliquescent may dry the capsule shell to brittleness. More costlier than tablets. Cheaper than coated tablets.Types of capsules: Types of capsules Hard gelatin capsules Soft gelatin capsulesHard Gelatin Capsules: Hard Gelatin Capsules The application of hard gelatin capsules Used to manufacture most medicated agents Employed in clinical trials Used in the extemporaneous compounding Empty capsule shells consist of Gelatin, sugar, water, colorants (various dyes), and opaquants (titanium dioxide).Shell Composition: Shell Composition GELATIN - Protein, prepared from hydrolysis of collagen (animal bones and skin) Type A : acid treated precursor Isoelectric pH 9, pig skin Type B : alkali treated Isoelectric pH 4.7, animal bones Bone gelatin produces tough, firm film but tends to be hazy and brittle. Pork skin gelatin produce plasticity and clarity thus reduce haziness of finished product. Either type can be used but combination is used to optimize shell characteristics.Slide 8: Schematic for the production of GelatinContd..: Contd.. Gelatin’s chemical, physical and physiological properties make it an ideal substance for capsulation. Stable when dry Subject to microbial degradation when moist Digested and Absorbed Bloom Strength – Cohesive strength of the cross linking that occurs between gelatin molecules and is proportional to the molecular weight of the gelatin. Determined by measuring the weight in gm required to move a plastic plunger that is 0.5 inches in diameter 4 mm into a 6.66 %w/w gelatin gel that has been held at 10 ° C for 17 h.Slide 10: BS within the range of 150-280 are suitable for capsules. Higher the BS, more physically stable is the capsule shell. Viscosity of the gel can vary from 25 to 45 millipoise. Iron is always present in raw gelatin and used in soft gelatin capsule should not contain more than 15 ppm. Opaquing agents like titanium dioxide to render the shell opaque. - to protect from light or to conceal the contents Preservatives, parabens can be used if employed. Contd..Shell Manufacture: Shell Manufacture Entire cycle lasts for 45 minSlide 12: Dipping Stainless steel pins Pins at ambient temperature (22°C) Dipping solution at 50°C Length of time to cast the film is 12 seconds Rotation Elevated and rotated 2 1/2 times until they face upward To distribute gelatin evenly on the pins Avoid formation of bead at the capsule ends After rotation, blast of cool air to set the film. Drying Dehumidification, passing large volumes of dry air over the pins Drying must not be too rapid, to prevent case hardening Overdrying causes the films to split from the pins & brittle, Underdrying leaves film, too sticky for subsequent operations Contd..Slide 13: Stripping Bronze jaws (softer than steel) strip Caps and Bodies from pins Trimming Delivered to collets and firmly held Collets rotate, knives trim them to the required length Joining Cap and Body aligned concentrically in two channels, and two portions are slowly pushed together. Sorting Printing Thickness of capsule controlled by viscosity of gelatin solution, speed and time of dipping. Precise drying, for ultimate quality of film. The Caps are slightly larger in diameter than the bodies. Contd..Slide 14: Normally, hard gelatin capsules contain between 13 to 16% of moisture. Additional moisture absorption: capsules become distorted and lose their rigid shape Lose their contained moisture: become brittle and crumble when handled Solubility property of gelatin Insoluble in cold water, soften through the absorption of up to ten times its weight of water; soluble in hot water and warm gastric fluid. Gelatin, being a protein, is digested by proteolytic enzymes. Contd..Capsule Size: Capsule Size How to select capsule size? Amount of fill material to be encapsulated Density and compressibility of the fill Final determination largely may be on the result of trial. Human use: 0, 1, 2, 3, 4, 5 (the smallest) Veterinary use: 000 (the largest), 00, Larger capsules are available.Slide 16: Size Volume Fill weight (g) at 0.8 g/cm 3 powder density 000 1.37 1.096 00 0.95 0.760 0 0.68 0.544 1 0.50 0.400 2 0.37 0.296 3 0.30 0.240 4 0.21 0.168 5 0.15 0.104Slide 17: Sealing of Hard Gelatin Capsules Gelatin band sealing . In this method a dilute solution of gelatin is applied to the centre of the capsule (between the two halves) which, once dried, produces a hermetic seal. Hydroalcoholic solvent seal. A hydroalcoholic solution (1:1 water/ethanol) is applied to the centre of the capsule (between the two halves). This softens the capsule and, following heating to 45°C, the interface fuses to produce a seal. Soft welding. Two hot metal jaws are brought into contact with the area where the cap overlaps the filled body.Diagram of the Conisnap capsule, illustrating the locking mechanism between the two capsule halves.: Diagram of the Conisnap capsule, illustrating the locking mechanism between the two capsule halves.Formulation types for filling into hard capsules: Formulation types for filling into hard capsulesPowders: Homogeneity of mix Flow properties Compatibility between formulation components and capsule. Diluents/Fillers – Lactose, starch, MCC Lubricants & Glidants Disintegrants Wetting agents Hydrophilization and granulation PowdersLiquids/Semisolid fills : Lipophilic liquids/oils containing dissolved or dispersed therapeutic agent. Vegetable oils (e.g. sunflower, arachis, olive) Fatty acid esters (e.g. glyceryl monostearate). Water-miscible liquids containing dissolved/dispersed therapeutic agent. Polyethylene glycols (PEGs) that are solid at room temperature but will liquefy upon heating (high Mol wt) Liquid polyoxyethylene-polyoxypropylene block co-polymers (Pluronics). Surface active agents & Viscosity modifying agents A major concern in the choice of solvents for liquid fill formulations is the effect of the formulation on the stability of the capsule. Equilibrium moisture content of hard gelatin capsules - 13–16% Liquids/Semisolid fillsCapsule filling: Capsule filling