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type of dissolution apparatus(usp)

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DISSOLUTION TEST APPARARTUS: 

RESEARCH GUIDE: Dr. ABHA DOSHI MET Institute Of Pharmacy (Deg ree) DISSOLUTION TEST APPARARTUS Presented by : AAKASH SAHU M-PHARM DATE 13/03/2013

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Is the process by which a solid or liquid forms a homogeneous mixture with a solvent Tablet dissolution is a standardized method for measuring the rate of drug release from a dosage form Concept & Importance of Dissolution Definition- Dissolution is defined as the process by which a known amount of drug substance goes into solution per unit of time under standardized condition.

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Concept & Importance of Dissolution Tablet / capsule Drug – Blood- Tissue Fine Particles Solution of drugs Granules Disintegration Deagreegation Dissolution Dissolution Diffusion Dissolution

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Routine assessment of production quality to ensure uniformity between production lots. Its not only a QC tool but also its important in bioavailability study. Prediction of ‘in-vivo’ availability, i.e. bioavailability. Assessment of ‘ bioequivalence’. Optimization of therapeutic effectiveness during product development and stability assessment.

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Why location plays with dissolution..???

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Beaker methods Rotating Basket/paddle apparatus Open flow-through compartment system flow through cell apparatus. Dialysis concept Rotating filter method Rotating flask disc method Rotating & static disc method Official apparatus Non official apparatus

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IP USP BP EP Type I paddle apparatus basket apparatus basket apparatus paddle apparatus Type II basket apparatus paddle apparatus paddle apparatus basket apparatus Type III Reciprocating cylinder flow through cell apparatus flow through cell apparatus Type IV flow through cell apparatus Type V Paddle over disk Type VI cylinder Type VII reciprocating holder

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Fig . Flow through cell along with sample holder Fig . Dissolution apparatus Fig. Basket and Paddle Fig . Rotating Cylinde r

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DOSAGE FORM Speed APPARATUS (USP) Capsules, Beads, Delayed release / Enteric Coated dosage forms, Floating dosage forms 50 – 120 rpm Type 1-basket Type 2-paddle Tablets , Capsules 20 – 50 rpm Type3-Reciprocating cylinder Tablets, Beads, controlled release formulations 6 – 35 rpm Type4-flow through cell apparatus Soft gelatin capsules, suppositories, poorly soluble drugs N/A or 25 – 50 rpm Type 3 & 4 Transdermal dosage form N/A Type5-Paddle over disk Type6-cylinder Non disintegrating oral modified dosage form as will as traditional dosage form 30 rpm Type7-reciprocating holder

Rotating basket apparatus : 

Rotating basket apparatus shaft vessel basket 160 – 210mm 98 – 106 mm 1. VESSEL CYLINDRICAL WITH HEMISPHERICAL BOTTOM CAPACITY : 1 TO 4 LITERS COVER MAY BE USED TO RETARD EVAPORATION 2. A MOTOR, METALLIC DRIVE SHAFT NOT MORE THAN 2MM FROM VERTICAL AXIS OF THE VESSEL Stainless steel

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ROTATING BASKET APPARATUS Gold coating 0.0001 inch (2.5 µm) All metal parts like basket and shaft are made of stainless steel 316

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ADVANTAGE 1. Full pH change during the test 2. Can be easily automated which is important for routine investigation. There is no physical abrasion of solids. Perfect sink conditions can be maintained DISADVANTAGE 1. Disintegration-dissolution interaction 2. Hydrodynamic Dead zone under the basket. 4. Limited volume-sink condition for poorly soluble drugs.

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ROTATING PADDLE APPARATUS The dosage unit is allowed to sink to the bottom of the vessel before rotation of the blade is started. Few turns of wire helix may be attached to dosage units that would otherwise float. PADDLE VESSEL SHAFT

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Sinker types

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OD : 22.2±1.0 mm ID:20.2±1.0 mm 25.0±3.0 mm 37.0±3.0 mm 27.0±1.0 mm 2.0±1.0 mm vent hole 5.1±0.5 mm 6.3 to 6.5 mm/ 9.4 to 10.1 mm 42.0 mm 74.5 ±0.5 mm 19.0± 0.5 mm Dia: 9.4 to 10.1 mm Thickness: 4.0± 1.0 mm BASKET PADDLE DIAMENTION OF DISOOLUTION APPARATUS

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ADVANTAGE Easy to use . Robust . Can be easily adapted to apparatus 5 . pH change possible . Can be easily automated which is important for routine investigations. DISADVANTAGE Media change is often difficult Hydrodynamics are complex, they vary with site of the dosage form in the vessel (sticking, floating) and therefore may significantly affect drug dissolution.

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RECIPROCATING CYLINDER SET OF CYLINDRICAL FLAT BOTTOMED GLASS VESSEL SCREEN (PP) EVAPORATING CAP FILTER

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Programmed for dissolution in various media for various time, Prevents the cone formation May start at pH 1 and then pH 4.5 and then at pH6.8 and Attempts to mirror pH changes and transit times in the GI tract Disintegrating dosage forms show too low result Surfactants cause foaming and Volume of dissolution media is too small ADVANTAGE DISADVANTAGE

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Flow cell Fresh Medium PISTON PUMP OPEN FLOW THROUGH CELL TYPE FLOW THROUGH CELL TYPE

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Flow cell PISTON PUMP CLOSED FLOW THROUGH CELL TYPE Volume240 to 960 ml FLOW RATE (4,8.16 ml/min) 12 mm or 22.6 mm depending upon the tablet size. A filter chamber is attached to the top of the cell to prevent escape of un dissolved particles. The bottom part of the cell is conical provided with a 1mm tube. Also a holder assembly is provided to hold the dosage form in place.

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TYPE FLOW THROUGH CELL TYPE

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PADDLE OVER DISK TYPE Borosilicate Glass 17 mesh is standard (others available) Accommodates patches of up to 90mm The disk holds the system flat and is positioned such that the release surface is parallel with the bottom of the paddle blade

ROTATING CYLINDER TYPE: 

ROTATING CYLINDER TYPE This method adopts the USP disintegration “basket and rack” assembly for the dissolution test. The disks are not used. This method is less suitable for precise dissolution testing due to the amount of agitation and vibration involved.

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RECIPROCATING HOLDER

Media for dissolution : 

2. De-aeration Air bubble can : Interfere with result Can cause particle to cling to apparatus and vessel wall . Point to be remember while selecting the media Physical and chemical data Solubility and stability . Release mechanism Media for dissolution De-aeration can be done by Heating Filtering vacuum

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water HCL Buffers (PH 1.2 – 7.5)

manual sampling: 

manual sampling Syringe Plastic or glass Cannula /needle Stainless steel Bent or straight Filter - end of probe, in line, after sampling Pipettes-not good unless filter at tip

Time point: 

Time point Five minute Disintegration occurring May give profile information especially Suspensions 10, 15, or 20 minutes 30, 45, 60 Can eliminate later points Fast stir or infinity point to compare with content uniformity results

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Physical calibration To minimize erroneous results in dissolution test calibration of the dissolution apparatus is required to be performed on routine basis. Calibration to be performed as per EOP No. E-158 Chemical calibration CALIBRATION

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Calibration parameters Frequency Std. Limit RPM Monthly 50 48-52 ( 4% ) 100 97-103 150 145-155 Bath temperature Monthly 37°C 36.5-37.5°C Wobble Paddle Monthly NMT 0.5 mm Basket Monthly NMT 1.0 mm Timer Monthly 30 29 min 24 sec – 30 min 36 sec 60 58 min 48 sec – 61 min 12 sec PHYSICAL CALIBRATION

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PHYSICAL CALIBRATION Calibration parameters Frequency Std. Limit Distance of paddle/basket from bottom of jar Monthly 25 mm ±2 mm Distance between shaft axis and vertical axis of the vessel Monthly Less than 2 mm NA Head co planarity Monthly Exactly horizontal Spirit level should be ok Integrity check of basket Monthly Should be intact NA # size of the basket Monthly 40/Linier inch NA

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Digital techometer Vibration meter

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CHEMICAL CALIBRATION Calibration parameters Frequency Dissolution with non disintegrating type tablets (Salicylic Acid 300 mg tablet) Half yearly Dissolution with disintegrating type tablets (Prednisone 10 mg tablet) Half yearly

Calibration with Salicylic acid tablets 300 mg: 

Calibration with Salicylic acid tablets 300 mg The performance of the dissolution apparatus can be checked by performing the test on Salicylic acid tablets 300 mg. For USP type I / II Dissolution medium : 0.05 m phosphate buffer ( pH 7.40± 0.05) Duration : 30 minutes Temperature : 37°C ±0.5 °C Speed : 100 RPM Volume : 900 ml Measurement : by using class A Volumetric flask

Calibration with Salicylic acid tablets 300 mg: 

Calibration with Salicylic acid tablets 300 mg USP I APPARATUS Sample collected and absorbance is checked at 296 nm . % release is calculated Calibration is satisfactory if the release is 23-30% of salicylic acid. USP II APPARATUS Sample collected and absorbance is checked at 296 nm . % release is calculated Calibration is satisfactory if the release is 17-25 % of salicylic acid.

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The performance of the dissolution apparatus can be checked by performing the test on Prednisone tablets 10 mg. For USP type I Dissolution medium : Purified water Duration : 30 minutes Temperature : 37°C ±0.5 °C Speed : 50 RPM Volume : 500 ml Measurement : by using class A Volumetric flask Calibration with prednisone tablets 10 mg

Calibration with Salicylic acid tablets 300 mg: 

Calibration with Salicylic acid tablets 300 mg USP I APPARATUS Sample collected and absorbance is checked at 242 nm . % release is calculated Calibration is satisfactory if the release is 47 -82 % of salicylic acid. USP II APPARATUS Sample collected and absorbance is checked at 242 nm . % release is calculated Calibration is satisfactory if the release is 30 - 57 % of salicylic acid.

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MANUFACTURING COMPANY APPARATUS NAME CALEVA TYPE I AND II ERWEKA ALL DISSOLUTION APPARATUS DISTECT TYPE 4 AND 5 HANSON RESEARCH ALL TYPE OF DISSOLUTION APPARATUS LAB INDIA TYPE I AND II AGILENT TECHOLOGIES VK 7010 (TYPE I ) EXAMPALE

REFERENCE: 

REFERENCE Pharmaceutical Dissolution Testing, Edited by Jennifer Dressman And Johannes Kramer, Published in 2005 by Taylor & Francis Group, LLC 6000 Broken Soubd Parekway NW, Suite 300. Dissolution, Bioavailability and Bioequivalence; by Hamed M. Abdou , Mack publishing company, eston pennslvania , International Journal of Current Biomedical and Pharmaceutical Research, Riaz Uddina *, Nadia Saffoonb and Kumar Bishwajit Sutradhara Physical pharmacy And Pharmaceutical sciences by MARTIN’S, Fifth Edition. The Science And Practice of Pharmacy by REMINGTON , 21 st Edition.

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