Which apparatus used for dissolution?
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. General chapter <711> Dissolution includes 4 standardized apparatus: basket, paddle, reciprocating cylinder, and flow-through cell.
What is Apparatus 2 dissolution?
The paddle apparatus (Apparatus II) consists of a special, coated paddle that minimizes turbulence due to stirring. The paddle is attached vertically to a variable-speed motor that rotates at a controlled40 speed. Drug Dissolution Apparatus II USP (Paddle)
What is dissolution Apparatus 1?
Drug Dissolution Apparatus-I USP (Rotating Basket) The rotating basket apparatus (Apparatus 1) consists of a cylindrical basket held by a motor shaft. The basket holds the sample and rotates in a round flask containing the dissolution medium. The entire flask is immersed in a constant-temperature bath set at 37°C.
What is the temperature of dissolution apparatus?
37°C
The device with the drug substance disk is immersed in the dissolution fluid and maintained at a constant temperature of 37°C, with the same arrangement as that of the rotating basket of the USP method.
What are types of dissolution?
Currently, there are seven different types of dissolution apparatus defined in the United States Pharmacopeia (USP)-basket type, paddle type, reciprocating cylinder, flow through cell, paddle over disc, rotating cylinder, and reciprocating disc.
What does Q stand for in dissolution?
The quantity, Q is the amount of dissolved active. Dissolution Medium—Proceed as directed for Immediate- ingredient. specified in the individual monograph, expressed Release Dosage Forms under Apparatus 1 and Apparatus 2.
What is RSD in dissolution?
Dissolution results may be considered highly variable if the relative standard deviation (RSD) is greater than 20% at time points of 10 minutes or less and greater than 10% RSD at later time points.
Why is 900 ml dissolution media?
Most likely, the volume was lowered to 900mL to account for volume displacement from the product and stirring shaft. This gives some wiggle room in the test, so that the vessel doesn’t spill over during the dissolution. On the low end, why 500mL?
What is f2 factor in dissolution?
Conclusions: The similarity factor f2 is a simple measure for the comparison of two dissolution profiles. But the commonly used similarity factor estimate f2 is a biased and conservative estimate of f2. The bootstrap approach is a useful tool to simulate the confidence interval.
Why are 6 units used in dissolution?
Six units are tested to provide the minimal statistical significance. *Mean & Standard deviation (SD)* of any in-process or finished product CQA represents *Accuracy & Precision* of any Statistically Contolled Stable Process or Method.
Why surfactant used in dissolution?
Addition of surfactant to the dissolution medium improves the dissolution of pure drug by facilitating the drug release process at the solid/liquid interface and micelle solubilization in the bulk[6].
What is f1 and f2 dissolution?
Factor f1 indicates the percentage difference (dissimilarity) between two dissolution profiles; f2 is the logarithm of the reciprocal square root transformation of the sum squared error. It indicates the average percentage of similarity between two dissolution profiles.
Why phosphate buffer is used in dissolution?
The higher buffer capacity of phosphate maintains the pH at the solid-liquid interface lower than, but closer, to the basic environment of the bulk, in relative to the bicarbonate system. Thus, a greater extent ionization of acidic drugs and the subsequent increase of drug dissolution in the phosphates are present.
Why SLS is used in dissolution media?
Abstract. Purpose: Sodium lauryl sulfate (SLS) is a commonly used surfactant in dissolution media for poorly water soluble drugs. However, it has occasionally been observed that SLS negatively impacts the dissolution of drug products formulated in gelatin capsules.
What is QC media in dissolution?
To serve the QC purpose, a dissolution medium is designed to provide a sink condition; for development purpose, the dissolution medium is required to simulate the physiological conditions in the gastrointestinal tract as far as possible.
What is f1 and f2 value in dissolution?
The f1 value is 0 when the test and the reference profiles are identical and increases proportionally with the dissimilarity between the two profiles. The f2 value is between 0 and 100. The value is 100 when the test and the reference profiles are identical and approaches zero as the dissimilarity increases 6, 11, 12.
Why do we use 6 tablets for dissolution?
The use of six dosage units as the basic sample size in dissolution is partially due to the configuration of the dissolution test assembly with six positions.