In-Vitro Dissolution Apparatus USP.pptx

The objective of in vitro dissolution testing is to evaluate the variables that effect the rate and extent of release of a drug substance from the finished dosage form, and in turn, the in vivo performance of the drug product.

1. IN-VITRO DISSOLUTION AND DRUG RELEASE TESTING Submitted By: Prachi Pandey*, Rahul Pal Submitted To: Dr. Tejpal Yadav M. Pharm (Pharmaceutics), IInd Sem. Department of Pharmaceutics, NIMS Institute of Pharmacy, NIMS University, Jaipur Rajasthan, India In-vitro dissolution testing is a very powerful tool to easily and effectively obtain information about the performance of drug products.

2. DEFINITION Dissolution is a process in which a solid substance solubilizes in a given solvent (mass transfer from the solid surface to the liquid phase.) Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment , etc. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness.

3. DISSOLUTION RATE : Dissolution rate is defined as the amount of solid substance goes into solution per unit time under standard conditions of temperature, pH and solvent composition and constant surface area. ABSOLUTE OR INTRINSIC SOLUBILITY: It is defined as the maximum amount of solute dissolved in a given solvent under standard conditions of temperature, pressure and pH. DISSOLUTION

4. When a immediate release tablet or other solid drug form is introduced into a beaker of water or into the gastrointestinal tract, the following steps take place. Disintegration: Breaking of tablet into granules. Deaggregation: Breaking of these granules into individual particles. Dissolution: Finally, particles dissolve, releasing the active drug into solution. Dissolution is a time dependent process that represents the final step of drug release, which is ultimately required before a drug can be absorbed or exert a pharmacologic effect DISSOLUTION OF TABLETS AND CAPSULES

5. Types of Dissolution apparatus

6. USP DISSOLUTION APPARATUS

7. Cylindrical basket of 22mesh. Rotating speed-100 rpm. As per IP, height of dissolution jar is 168+8 mm and internal diameter is102+4 mm and height of basket36.8+3 mm and diameter is 25.4+3 mm. Temp. maintained at 37°C. Calibration tablets of Prednisone-for disintegrating tablets. Salicylic acid calibration tablets-for non disintegrating tablets. For capsules & dosage forms that tend to float. I. ROTATING BASKET APPARATUS Figure (a) Basket type

8. II. PADDLE METHOD It consists of a special coated paddle formed from a blade and a shaft that minimizes turbulence due to stirring. The coated material is inert. The paddle is attached vertically to a variable -speed motor that rotates at a controlled speed As per IP, diameter of the paddle is 74.5+0.5 mm. The tablet or capsule is placed into a round-bottom dissolution flask and the apparatus is housed in a constant temperature water bath maintained at 37°C. Figure (b) Paddle type

9. II. PADDLE METHOD Most common operating speeds are 50rpm for solid oral dosage forms and 25 rpm for suspensions. A sinker, such as few turns of platinum wire may be used to prevent a capsule or tablet from floating Used for film coated tablets that stick to the vessel walls or to help to position tablet/capsule under the paddle Figure (b) Paddle type

10. Set of cylindrical, flat-bottomed glass vessels equipped with reciprocating cylinders. temp. 37°C Place the stated volume of dissolution medium in each vessel of the apparatus, assemble the apparatus, equilibrate the dissolution medium to 37±0.5°C and remove the thermometer. Place one dosage form unit in each of the cylinders taking care to exclude the air bubbles from the surface of each dosage unit and immediately operate the apparatus as specified in the monograph. III. RECEPROCATING CYLINDER TYPE Figure (c) Receprocating cylinder type

11. During the upward and downward stroke, the reciprocating cylinder moves through a total distance of 9.9 to 10.1cm. Within the time interval specified raise the cylinders and withdraw a portion of the solution under test from a zone midway between the surface of the dissolution medium and bottom of each vessel. III. RECEPROCATING CYLINDER TYPE Figure (c) Reciprocating cylinder type

12. VI. FLOW THROUGH CELL METHOD The flow through cell is transparent & inert mounted vertically with filters. Standard cell diameters are 12 & 22.6 mm. The bottom cone usually filled with glass beads of 1 mm diameter. Place the glass beads into the cell as specified in the monograph. Place one dosage unit on top of the beads or on a wire carrier Tablet holder used for positioning special dosage form e.g. inlay tablets. Figure (d) Flow through cell Method

13. VI. FLOW THROUGH CELL METHOD Assemble the filter head and fix the parts together by means of a suitable clamping device. Introduce by the pump of the dissolution medium warmed to 37±0.5°C through the bottom of the cell to obtain the flow rate specified and measured with an accuracy of 5%. Flow rate is maintained from 4 to 16 mL/min. Collect the eluate by fractions at each of the times stated For modified release dosage forms, containing active ingredients with limited solubility. Figure (d) Flow through cell Method

14. V. PADDLE OVER DISK METHOD For testing the release of drug from transdermal products. Stainless steel disk assembly is used for holding the transdermal system at the bottom of the vessel. The distance between the paddle and the surface of the disk is kept 25±2.... The release surface of the trans dermal patch is kept such that it's release surface faces upward and parallel to the edges of the blade. The transdermal system may be attached to the disk assembly by applying a suitable adhesive. • TEMP.- 32+ 0.5 °C. Sample is drawn midway between the surface of the dissolution medium and the top of the paddle blade. Figure (e) Paddle over disk method

15. VI. Rotating cylinder method Here, basket and shaft are replaced by the cylinder stirring elements made up of stainless steel. The dosage unit is kept on the cylinder. The distance between the inside bottom of the vessel and the cylinder is kept at 25 ± 2 mm. TEMP.- 32+ 0.5 °C. Sample is mounted on to cuprophan. Volume - 900 ml Temperature 32°C For testing transdermal preparations. Figure (f) Rotating Cylinder Method

16. VII. RECIPROCATING DISK METHOD It consist of a set of volumetrically calibrated or tared containers of glass or other suitable inert material, a motor and a set of sample holders. A motor drive assembly is used to reciprocate the system vertically. Samples are placed on disk shaped holders using cuprophan supports. Capacity - 50-200 ml Temperature 32°C. Reciprocating frequency is about 30cylces per minute. It is useful for assessing the in vitro dissolution of extended release tablets and transdermal drug delivery systems. Figure (g) Reciprocating disk method