logging in or signing up Dissolution bharatrbh 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: 1344 Category: Science & Tech.. License: All Rights Reserved Like it (2) Dislike it (0) Added: July 11, 2010 This Presentation is Public Favorites: 3 Presentation Description No description available. Comments Posting comment... By: Anushakusuma (15 month(s) ago) hello mam your presentation is good,can u send copy to my mail.anushakusuma9@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: nikhilbhowalu (15 month(s) ago) hi mam yr ppt is good please sent copy of ppt on my email bhowalu.nikhil@rocketmail.com Saving..... 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Edit Comment Close Premium member Presentation Transcript DISSOLUTION : DISSOLUTION SWAPNA MASURKAR ARDL - I WHAT IS DISSOLUTION? : WHAT IS DISSOLUTION? the process by which a solid or liquid forms a homogeneous mixture with a solvent Tablet Dissolution is a standardised method for measuring the rate of drug release from a dosage form FUNCTIONS OF DISSOLUTION : FUNCTIONS OF DISSOLUTION • Optimisation of therapeutic effectiveness during product development and stability assessment • Routine assessment of production quality to ensure uniformity between production lots • Assessment of ‘bioequivalence’, that is to say, production of the same biological availability from discrete batches of products from one or different manufacturers • Prediction of ‘in-vivo’ availability, i.e. bioavailability (where applicable) TYPES OF APPARATUS : TYPES OF APPARATUS BASKET APPARATUS PADDLE APPARATUS RECIPROCATING CYLINDER FLOW-THROUGH CELL PADDLE OVER DISK CYLINDER RECIPROCATING HOLDER BASKET APPARATUS : BASKET APPARATUS VESSEL A MOTOR, METALLIC DRIVE SHAFT CYLINDRICAL BASKET VESSEL : VESSEL CYLINDRICAL WITH HEMISPHERICAL BOTTOM CAPACITY : 1 TO 4 LITERS FOR 1 LIT : HEIGHT – 160 TO 210 MM INNER DIAMETER – 98 TO 106 MM COVER MAY BE USED TO RETARD EVAPORATION SHAFT : SHAFT POSITIONED IN SUCH A WAY THAT ITS AXIS IS NOT MORE THAN 2MM FROM VERTICAL AXIS OF THE VESSEL SHOULD ROTATE SMOOTHLY WITHOUT SIGNIFICANT WOBBLE BASKET : BASKET PADDLE APPARATUS : PADDLE APPARATUS METALLIC, SUITABLY INERT, RIGID BLADE AND SHAFT COMPRISING OF SINGLE ENTITY SINKERS (A SMALL, LOOSE PIECE OF NON-REACTIVE MATERIAL) MAY BE ATTACHED TO DOSAGE UNIT TO AVOID FLOATING MEDIA FOR DISSOLUTION : MEDIA FOR DISSOLUTION POINTS TO BE REMEMBERED WHILE SELECTING A MEDIUM VOLUME DEAERATION EXAMPLES OF TYPICAL MEDIA POINTS TO BE REMEMBERED WHILE SELECTING A MEDIUM : POINTS TO BE REMEMBERED WHILE SELECTING A MEDIUM PHYSICAL AND CHEMICAL DATA SOLUBILITY AND STABILITY AS A FUNCTION OF pH FOR POORLY SOLLUBLE – SURFACTANTS SUCH AS SLS, POLYSORBATE RELEASE MECHANISM VOLUME OF MEDIUM : VOLUME OF MEDIUM 500 TO 1000 ml 900 ml IS GENERALLY USED CAN BE RAISED TO 2 TO 4 LIT DEAERATION : DEAERATION AIR BUBBLES CAN : INTERFERE WITH THE RESULT CAN CAUSE PARTICLES TO CLING TO THE APPARATUS AND VESSEL WALLS DEAERATION CAN BE DONE BY: HEATING FILTERING VACUUM EXAMPLES OF TYPICAL MEDIA : EXAMPLES OF TYPICAL MEDIA WATER DILUTE HCl BUFFERS OF pH RANGE 1.2 TO 7.5 Slide 16: APPARATUS AGITATION TIME POINTS SAMPLING FILTERS ASSAY APPARATUS : APPARATUS FOR SOLID ORAL DOSAGE FORMS, BASKET OR PADDLE METHOD IS USED IN CASE OF BASKET, MESH SIZE RANGING FROM 10 TO 80 CAN BE USED SINKERS CAN BE ADDED IN PADDLE METHOD AGITATION : AGITATION RANGE : 25 TO 100 RPM FOR BASKET METHOD : 100 RPM FOR PADDLE METHOD : 50 TO 75 RPM BELOW 25 RPM : INCONSISTENCY OF HYDRODYNAMICS ABOVE 150RPM :TURBULANCE TIME POINTS : TIME POINTS FOR IMMEDIATE RELEASE : 15 TO 60 MINS FOR EXTENDED RELEASE : AT LEAST THREE TEST TIME POINTS ARE SELECTED SAMPLING : SAMPLING MANUAL : USING PLASTIC OR GLASS SYRINGE, A STAINLESS STEEL CANNULA AUTOSAMPLING : BEST FOR SEVERAL TIME POINTS CAN BE SEMI OR FULLY AUTOMATIC FILTERS : FILTERS USED TO PREVENT UNDISSOLVED DRUG PARTICLES FROM ENTERING THE ANALYTICAL SAMPLE USED TO REMOVE INSOLUBLE EXCIPIENTS WHICH MAY CAUSE TURBIDITY PORE SIZE MAY RANGE FROM 0.45 TO 70 µM APPARATUSAGITATIONTIME POINTSSAMPLINGASSAY : SPECTROPHOTOMETRY OR HPLC SPECTROPHOTOMETRY IS PREFERRED BECAUSE : ANALYSIS IS SIMPLE AND FASTER FEWER SOLVENTS ARE USED APPARATUSAGITATIONTIME POINTSSAMPLINGASSAY SPECTROPHOTOMETRY : SPECTROPHOTOMETRY CELLS WITH PATHLENGTHS 0.02 TO 1 CM CAN BE USED ALIGNMENT OF CELLS MUST BE PROPER SMALLER PATHLENGTHS ARE USED TO AVOID DILUTING THE SAMPLE A TYPICAL BLANK, STANDARD AND SAMPLE ARE ANALYSED IN A SEQUENCE TYPICAL RSD IS NOT MORE THAN 2 % HPLC : HPLC COMPATIBILITY OF DISSOLUTION MEDIA AND MOBILE PHASE MUST BE EXAMINED SINGLE INJECTION OF EACH VESSEL TIME POINT WITH STANDARDS THROUGH-OUT THE RUN CONSTITUTE A TYPICAL RUN Slide 25: THANK YOU You do not have the permission to view this presentation. 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Dissolution bharatrbh 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: 1344 Category: Science & Tech.. License: All Rights Reserved Like it (2) Dislike it (0) Added: July 11, 2010 This Presentation is Public Favorites: 3 Presentation Description No description available. Comments Posting comment... By: Anushakusuma (15 month(s) ago) hello mam your presentation is good,can u send copy to my mail.anushakusuma9@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: nikhilbhowalu (15 month(s) ago) hi mam yr ppt is good please sent copy of ppt on my email bhowalu.nikhil@rocketmail.com Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript DISSOLUTION : DISSOLUTION SWAPNA MASURKAR ARDL - I WHAT IS DISSOLUTION? : WHAT IS DISSOLUTION? the process by which a solid or liquid forms a homogeneous mixture with a solvent Tablet Dissolution is a standardised method for measuring the rate of drug release from a dosage form FUNCTIONS OF DISSOLUTION : FUNCTIONS OF DISSOLUTION • Optimisation of therapeutic effectiveness during product development and stability assessment • Routine assessment of production quality to ensure uniformity between production lots • Assessment of ‘bioequivalence’, that is to say, production of the same biological availability from discrete batches of products from one or different manufacturers • Prediction of ‘in-vivo’ availability, i.e. bioavailability (where applicable) TYPES OF APPARATUS : TYPES OF APPARATUS BASKET APPARATUS PADDLE APPARATUS RECIPROCATING CYLINDER FLOW-THROUGH CELL PADDLE OVER DISK CYLINDER RECIPROCATING HOLDER BASKET APPARATUS : BASKET APPARATUS VESSEL A MOTOR, METALLIC DRIVE SHAFT CYLINDRICAL BASKET VESSEL : VESSEL CYLINDRICAL WITH HEMISPHERICAL BOTTOM CAPACITY : 1 TO 4 LITERS FOR 1 LIT : HEIGHT – 160 TO 210 MM INNER DIAMETER – 98 TO 106 MM COVER MAY BE USED TO RETARD EVAPORATION SHAFT : SHAFT POSITIONED IN SUCH A WAY THAT ITS AXIS IS NOT MORE THAN 2MM FROM VERTICAL AXIS OF THE VESSEL SHOULD ROTATE SMOOTHLY WITHOUT SIGNIFICANT WOBBLE BASKET : BASKET PADDLE APPARATUS : PADDLE APPARATUS METALLIC, SUITABLY INERT, RIGID BLADE AND SHAFT COMPRISING OF SINGLE ENTITY SINKERS (A SMALL, LOOSE PIECE OF NON-REACTIVE MATERIAL) MAY BE ATTACHED TO DOSAGE UNIT TO AVOID FLOATING MEDIA FOR DISSOLUTION : MEDIA FOR DISSOLUTION POINTS TO BE REMEMBERED WHILE SELECTING A MEDIUM VOLUME DEAERATION EXAMPLES OF TYPICAL MEDIA POINTS TO BE REMEMBERED WHILE SELECTING A MEDIUM : POINTS TO BE REMEMBERED WHILE SELECTING A MEDIUM PHYSICAL AND CHEMICAL DATA SOLUBILITY AND STABILITY AS A FUNCTION OF pH FOR POORLY SOLLUBLE – SURFACTANTS SUCH AS SLS, POLYSORBATE RELEASE MECHANISM VOLUME OF MEDIUM : VOLUME OF MEDIUM 500 TO 1000 ml 900 ml IS GENERALLY USED CAN BE RAISED TO 2 TO 4 LIT DEAERATION : DEAERATION AIR BUBBLES CAN : INTERFERE WITH THE RESULT CAN CAUSE PARTICLES TO CLING TO THE APPARATUS AND VESSEL WALLS DEAERATION CAN BE DONE BY: HEATING FILTERING VACUUM EXAMPLES OF TYPICAL MEDIA : EXAMPLES OF TYPICAL MEDIA WATER DILUTE HCl BUFFERS OF pH RANGE 1.2 TO 7.5 Slide 16: APPARATUS AGITATION TIME POINTS SAMPLING FILTERS ASSAY APPARATUS : APPARATUS FOR SOLID ORAL DOSAGE FORMS, BASKET OR PADDLE METHOD IS USED IN CASE OF BASKET, MESH SIZE RANGING FROM 10 TO 80 CAN BE USED SINKERS CAN BE ADDED IN PADDLE METHOD AGITATION : AGITATION RANGE : 25 TO 100 RPM FOR BASKET METHOD : 100 RPM FOR PADDLE METHOD : 50 TO 75 RPM BELOW 25 RPM : INCONSISTENCY OF HYDRODYNAMICS ABOVE 150RPM :TURBULANCE TIME POINTS : TIME POINTS FOR IMMEDIATE RELEASE : 15 TO 60 MINS FOR EXTENDED RELEASE : AT LEAST THREE TEST TIME POINTS ARE SELECTED SAMPLING : SAMPLING MANUAL : USING PLASTIC OR GLASS SYRINGE, A STAINLESS STEEL CANNULA AUTOSAMPLING : BEST FOR SEVERAL TIME POINTS CAN BE SEMI OR FULLY AUTOMATIC FILTERS : FILTERS USED TO PREVENT UNDISSOLVED DRUG PARTICLES FROM ENTERING THE ANALYTICAL SAMPLE USED TO REMOVE INSOLUBLE EXCIPIENTS WHICH MAY CAUSE TURBIDITY PORE SIZE MAY RANGE FROM 0.45 TO 70 µM APPARATUSAGITATIONTIME POINTSSAMPLINGASSAY : SPECTROPHOTOMETRY OR HPLC SPECTROPHOTOMETRY IS PREFERRED BECAUSE : ANALYSIS IS SIMPLE AND FASTER FEWER SOLVENTS ARE USED APPARATUSAGITATIONTIME POINTSSAMPLINGASSAY SPECTROPHOTOMETRY : SPECTROPHOTOMETRY CELLS WITH PATHLENGTHS 0.02 TO 1 CM CAN BE USED ALIGNMENT OF CELLS MUST BE PROPER SMALLER PATHLENGTHS ARE USED TO AVOID DILUTING THE SAMPLE A TYPICAL BLANK, STANDARD AND SAMPLE ARE ANALYSED IN A SEQUENCE TYPICAL RSD IS NOT MORE THAN 2 % HPLC : HPLC COMPATIBILITY OF DISSOLUTION MEDIA AND MOBILE PHASE MUST BE EXAMINED SINGLE INJECTION OF EACH VESSEL TIME POINT WITH STANDARDS THROUGH-OUT THE RUN CONSTITUTE A TYPICAL RUN Slide 25: THANK YOU