logging in or signing up Soft gelatin capsules final 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: 996 Category: Science & Tech.. License: All Rights Reserved Like it (2) Dislike it (0) Added: March 05, 2011 This Presentation is Public Favorites: 2 Presentation Description No description available. Comments Posting comment... By: vinaybpham (4 month(s) ago) hi urs preformulation slide is nice,if u dont mind plz mail vinaybpham@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: escandonjl (5 month(s) ago) Would be great to have a copy, thanks!!! pepillomx@hotmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: nagesh4660 (7 month(s) ago) sir kindly send my mail id thalluri_nagesh@yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close By: prasandeep (9 month(s) ago) its a stunning presentation............i am very happy.............thanks Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript Slide 1: Soft Gelatin Capsules - Dr J RajuIntroduction: Introduction Soft gelatin capsules are one piece, hermetically sealed, containing a liquid, suspension, or a semisolid. The nomenclature for this dosage form has now been changed to soft gel. They have long been preferred dosage form for those, taking health & nutritional supplements. Soft gelatin capsules unique advantages over traditional dosage forms such as tablets, hard gelatin capsules and liquids. However due to economic, technical and patent constraints there are relatively a few manufacturers of soft gels in the world.Advantages: Advantages Easy to administer, Manufacture Liquids can be encapsulated (non water soluble) Small to large sizes possible Elegance & Portable Odour and taste masking Ready availability of drug hence faster action. Specialised dosage forms can be made Can be used for ophthalmic preparations e.g. aplicaps, vaginal/rectal suppositoriesDisadvantages: Disadvantages Water soluble material are difficult to incorporate. Highly moisture sensitive Efflorescent material cannot be incorporated, they may cause softening / leaching Deliquescent materials cannot be incorporated, they may cause hardening or brittle capsules .Shapes of Capsules: Shapes of Capsules Oval Round OblongAnatomy of a Softgel: Anatomy of a SoftgelFormulation of Softgels: Formulation of Softgels Composition of the shell: Basic component of soft gelatin shell is gelatin; however, the shell has been plasticized ex glycerol, sorbitol. The ratio of dry plasticizer to dry gelatin determines the “hardness” of the shell and can vary from 0.3-1.0 for very hard shell to 0.8-1.0 for very soft shell. 5% sugar to give a “chewable” quality to the shell. The residual shell moisture content of finished capsules will be in the range of 6-10%. Iron is always present in raw gelatin, & should not contain iron more than 15 ppm.Slide 8: Formulation for soft gelatin capsules involves liquid, rather than powder technology. Materials are generally formulated to produce the smallest possible capsule consistent with maximum stability, therapeutic effectiveness and manufacture efficiency. The liquids are limited to those that do not have an adverse effect on gelatin walls. The pH of the liquid can be between 2.5 and 7.5. Emulsion cannot be filled because water will be released that will affect the shell.Slide 9: Vehicles used in soft gelatin capsules Water immiscible, volatile or more likely volatile liquids such as vegetable oils, mineral oils, medium-chain triglycerides and acetylated glycerides. Water miscible, nonvolatile liquids such as low molecular weight PEG have come into use more recently because of their ability to mix with water readily and accelerate dissolution of dissolved or suspended drugs. All liquids used for filling must flow by gravity at a temperature of 35 ° C or less. The sealing temperature of gelatin films is 37-40 ° C.Slide 10: Viscosity-modifying agents Surface-active agents Colours Co-solvents (and other solubilising agents)Slide 11: Plate process : The process involved Placing the upper half of a plasticized gelatin sheet over a die plate containing numerous die pockets, Application of vacuum to draw the sheet in to the die pockets, Filling the pockets with liquor or paste, Folding the lower half of gelatin sheet back over the filled pockets, and Inserting the “sandwich” under a die press where the capsules are formed and cut out. Formulation of SoftgelsSlide 12: Rotary die press: In this process, the die cavities are machined into the outer surface of the two rollers. The die pockets on the left hand roller form the left side of the capsule and the die pockets on the right hand roller form the right side of the capsule. Two plasticized gelatin ribbons are continuously and simultaneously fed with the liquid or paste fill between the rollers of the rotary die mechanism. As the die rolls rotate, the convergence of the matching die pockets seals and cuts out the filled capsules.Manufacturing method for soft gelatin capsules.: Manufacturing method for soft gelatin capsules.Slide 14: Bubble method: The Globex Mark II capsulator produces truly seamless, one-piece soft gelatin capsules by a “bubble method”. A concentric tube dispenser simultaneously discharges the molten gelatin from the outer annulus and the liquid content from the tube. By means of a pulsating pump mechanism, the liquids are discharged from the concentric tube orifice into a chilled-oil column as droplets that consists of a liquid medicament core within a molten gelatin envelop. The droplets assume a spherical shape under surface tension forces and the gelatin congeals on cooling. The finished capsules must be degreased and dried.In Process testing: In Process testing During the encapsulation process the four most important tests are:- - The gel ribbon thickness; - Soft gel seal thickness at the time of encapsulation; - Fill matrix weight & capsule shell weight; - Soft gel shell moisture level and soft gel hardness at the end of the drying stage.Finished product testing: Finished product testing Capsule appearance, Active ingredient assay & related substances assay Fill weight Content uniformity and Microbiological testing.Vegicaps: Vegicaps Vegicaps®Soft capsules are an alternative animal free capsule. The shell is made from seaweed extract and gluten free starch, and contains no modified sugars or artificial ingredients. The shell can be clear or colored and there is a wide range of shapes, sizes and colors available. You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
Soft gelatin capsules final 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: 996 Category: Science & Tech.. License: All Rights Reserved Like it (2) Dislike it (0) Added: March 05, 2011 This Presentation is Public Favorites: 2 Presentation Description No description available. Comments Posting comment... By: vinaybpham (4 month(s) ago) hi urs preformulation slide is nice,if u dont mind plz mail vinaybpham@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: escandonjl (5 month(s) ago) Would be great to have a copy, thanks!!! pepillomx@hotmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: nagesh4660 (7 month(s) ago) sir kindly send my mail id thalluri_nagesh@yahoo.com Saving..... Post Reply Close Saving..... Edit Comment Close By: prasandeep (9 month(s) ago) its a stunning presentation............i am very happy.............thanks Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript Slide 1: Soft Gelatin Capsules - Dr J RajuIntroduction: Introduction Soft gelatin capsules are one piece, hermetically sealed, containing a liquid, suspension, or a semisolid. The nomenclature for this dosage form has now been changed to soft gel. They have long been preferred dosage form for those, taking health & nutritional supplements. Soft gelatin capsules unique advantages over traditional dosage forms such as tablets, hard gelatin capsules and liquids. However due to economic, technical and patent constraints there are relatively a few manufacturers of soft gels in the world.Advantages: Advantages Easy to administer, Manufacture Liquids can be encapsulated (non water soluble) Small to large sizes possible Elegance & Portable Odour and taste masking Ready availability of drug hence faster action. Specialised dosage forms can be made Can be used for ophthalmic preparations e.g. aplicaps, vaginal/rectal suppositoriesDisadvantages: Disadvantages Water soluble material are difficult to incorporate. Highly moisture sensitive Efflorescent material cannot be incorporated, they may cause softening / leaching Deliquescent materials cannot be incorporated, they may cause hardening or brittle capsules .Shapes of Capsules: Shapes of Capsules Oval Round OblongAnatomy of a Softgel: Anatomy of a SoftgelFormulation of Softgels: Formulation of Softgels Composition of the shell: Basic component of soft gelatin shell is gelatin; however, the shell has been plasticized ex glycerol, sorbitol. The ratio of dry plasticizer to dry gelatin determines the “hardness” of the shell and can vary from 0.3-1.0 for very hard shell to 0.8-1.0 for very soft shell. 5% sugar to give a “chewable” quality to the shell. The residual shell moisture content of finished capsules will be in the range of 6-10%. Iron is always present in raw gelatin, & should not contain iron more than 15 ppm.Slide 8: Formulation for soft gelatin capsules involves liquid, rather than powder technology. Materials are generally formulated to produce the smallest possible capsule consistent with maximum stability, therapeutic effectiveness and manufacture efficiency. The liquids are limited to those that do not have an adverse effect on gelatin walls. The pH of the liquid can be between 2.5 and 7.5. Emulsion cannot be filled because water will be released that will affect the shell.Slide 9: Vehicles used in soft gelatin capsules Water immiscible, volatile or more likely volatile liquids such as vegetable oils, mineral oils, medium-chain triglycerides and acetylated glycerides. Water miscible, nonvolatile liquids such as low molecular weight PEG have come into use more recently because of their ability to mix with water readily and accelerate dissolution of dissolved or suspended drugs. All liquids used for filling must flow by gravity at a temperature of 35 ° C or less. The sealing temperature of gelatin films is 37-40 ° C.Slide 10: Viscosity-modifying agents Surface-active agents Colours Co-solvents (and other solubilising agents)Slide 11: Plate process : The process involved Placing the upper half of a plasticized gelatin sheet over a die plate containing numerous die pockets, Application of vacuum to draw the sheet in to the die pockets, Filling the pockets with liquor or paste, Folding the lower half of gelatin sheet back over the filled pockets, and Inserting the “sandwich” under a die press where the capsules are formed and cut out. Formulation of SoftgelsSlide 12: Rotary die press: In this process, the die cavities are machined into the outer surface of the two rollers. The die pockets on the left hand roller form the left side of the capsule and the die pockets on the right hand roller form the right side of the capsule. Two plasticized gelatin ribbons are continuously and simultaneously fed with the liquid or paste fill between the rollers of the rotary die mechanism. As the die rolls rotate, the convergence of the matching die pockets seals and cuts out the filled capsules.Manufacturing method for soft gelatin capsules.: Manufacturing method for soft gelatin capsules.Slide 14: Bubble method: The Globex Mark II capsulator produces truly seamless, one-piece soft gelatin capsules by a “bubble method”. A concentric tube dispenser simultaneously discharges the molten gelatin from the outer annulus and the liquid content from the tube. By means of a pulsating pump mechanism, the liquids are discharged from the concentric tube orifice into a chilled-oil column as droplets that consists of a liquid medicament core within a molten gelatin envelop. The droplets assume a spherical shape under surface tension forces and the gelatin congeals on cooling. The finished capsules must be degreased and dried.In Process testing: In Process testing During the encapsulation process the four most important tests are:- - The gel ribbon thickness; - Soft gel seal thickness at the time of encapsulation; - Fill matrix weight & capsule shell weight; - Soft gel shell moisture level and soft gel hardness at the end of the drying stage.Finished product testing: Finished product testing Capsule appearance, Active ingredient assay & related substances assay Fill weight Content uniformity and Microbiological testing.Vegicaps: Vegicaps Vegicaps®Soft capsules are an alternative animal free capsule. The shell is made from seaweed extract and gluten free starch, and contains no modified sugars or artificial ingredients. The shell can be clear or colored and there is a wide range of shapes, sizes and colors available.