Recommended
More Related Content
What's hot
What's hot (20)
Similar to Dissolution test
Similar to Dissolution test (20)
Recently uploaded
Recently uploaded (20)
Dissolution test
- 1. Dissolution Test Presented by : Aqsa Sama
- 2. Dissolution Dissolution is the process by which a solid solute enters in to a solution i.e. , mass transfer from solid surface to liquid phase. Dissolution tests 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. Difference Between Drug Release & Dissolution Dissolution test is normally used to describe the testing of those forms such as immediate release oral tablets or capsules intended to dissolve rapidly in the test medium. For non-oral dosage forms such as semisolids, suppositories, topical and transdermal systems, the term “drug release” is normally employed.
- 4. What is the Dissolution Apparatus ? Tablet Dissolution is a standardized method for measuring the rate of drug release from a dosage form In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles.
- 5. Purposes of Dissolution Apparatus Test 1. Quality-control and quality-assurance purposes 2. In early phase drug development. 3. Assess product stability, monitor formulation changes over time. 4. Establish in-vitro–in-vivo correlations "IVIVC" 5. Regulatory perspective Particularly in the development and approval of generic dosage forms
- 7. Rotating Basket Apparatus (Apparatus 1) basically a closed-compartment beaker type apparatus comprising of a cylindrical glass vessel with hemispherical bottom of one liter capacity partially immersed in a water bath to maintain the temperature at 37oC. A cylindrical basket made of 22 mesh to hold the dosage form is located centrally in the vessel at a distance of 2 cm from the bottom and rotated by a variable speed motor through a shaft The basket should remain in motion during drawing of samples. All metal parts like basket and shaft are made of SS 316.
- 8. Rotating Paddle Apparatus (Apparatus 2) the rotating basket is replaced with a paddle which acts as a stirrer The dosage form is allowed to sink to the bottom of the vessel. Sinkers are recommended to prevent floating of capsules and other floatable forms. A small, loose, wire helix may be attached to such preparations to prevent them from floating.
- 9. Reciprocating Cylinder Apparatus (Apparatus 3) This apparatus consists of a set of cylindrical flat- bottomed glass vessels equipped with reciprocating cylinders The apparatus is particularly used for dissolution testing of controlled release bead-type (pellet) formulations.
- 10. Flow-Through Cell Apparatus (Apparatus 4) consists of a reservoir for the dissolution medium and a pump that forces dissolution medium through the cell holding the test sample. It may be used in either – Closed-mode where the fluid is recirculated and, by necessity, is of fixed volume, or Open-mode when there is continuous replenishment of the fluids. The material under test (tablet, capsules, or granules) is placed in the vertically mounted dissolution cell, which permits fresh solvent to be pumped (between 240 and 960 mL/h) in from the bottom Advantages of this apparatus include – 1. Easy maintenance of sink conditions for dissolution which is often required for drugs having limited aqueous solubility. 2. Feasibility of using large volume of dissolution fluid. 3. Feasibility for automation of apparatus
- 11. Paddle Over Disc Apparatus (Apparatus 5) used for evaluation of transdermal products and consists of a sample holder or disc that holds the product. The disc is placed at the bottom of apparatus and the apparatus operated in the usual way.
- 12. Cylinder Apparatus (Apparatus 6) Used for evaluation of transdermal products and is similar to apparatus 1 Instead of basket, a stainless steel cylinder is used to hold the sample. The sample is mounted on an inert porous cellulosic material and adhered to the cylinder.
- 13. Reciprocating Disc Apparatus (Apparatus 7) Used for evaluation of transdermal products as well as non disintegrating controlled-release oral preparations. The samples are placed on disc-shaped holders using inert porous cellulosic support which reciprocates vertically by means of a drive inside a glass container containing dissolution medium. The test is carried out at 320C and reciprocating frequency of 30 cycles/min
- 14. Dissolution test The test is designed to determine compliance with the dissolution requirements for solid dosage forms administered orally. Place the stated volume of the dissolution medium free from dissolved air into the vessel of the apparatus. Assemble the apparatus and warm the dissolution medium to 36.5 degree to 37.5 degree. Unless otherwise stated place one dosage unit in the apparatus taking care to exclude air bubbles from the surface of the dosage unit. For each of the tablet calculate the amount of dissolved active ingredient in solution as a percentage of the stated amount. Conventional-release dosage form. Unless otherwise specified the requirements are met if the quantities of active substance dissolved from the dosage units confirm to table1. If the results do not conform to the requirements as given in the table continue testing with additional dosage units through s2 and s3 unless the results confirm at stage 2.
- 15. *D is the amount of dissolved active ingredient specified in the individual monograph, expressed as percentage of labelled content **percentage of labelled content Level Number tested Acceptance criteria S1 6 Each unit is less than D*+ 5%** S2 6 Average of 12 units ( S1 + S2) is equal to or greater than D and no unit is less than D-15%** S3 12 Average of 24 units (S1 + S2 + S3) is equal to or greater than D not more than 2 units are less than D-15%** and no unit is less than D-25%**