Drug Dissolution Apparatus II USP (Paddle) 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.
What is the name of apparatus 2?
USP Dissolution Apparatus 2 – Paddle (37°C ± 0.5°C) USP Dissolution Apparatus 3 – Reciprocating Cylinder (37 °C ± 0.5°C)
What is S1 and S2 stage in dissolution?
The dissolved amount of each unit in S1 stage should not be less than Q+5%. It shows that each product should exceed 5% of the dissolved amount specified in the individual Manograph. If any of the units falls below the limit, then we have to reanalyse the sample in the next stage. i.e. S2 stage.
Which is type 1 dissolution apparatus as per IP?
1) Apparatus 1 (Basket Apparatus) A dosage unit is placed in a dry basket at the beginning of each test. 2) Apparatus 2 (Paddle Apparatus) The assembly from apparatus 1 is used, except that a paddle is formed from a blade and a shaft is used as the stirring element.
Why disintegration test is done?
The disintegration test is used to show how quickly the tablet breaks down into smaller particles, allowing for a greater surface area and availability of the drug when taken by a patient.
Why are prednisone tablets used for dissolution calibration?
Prednisone and Salicylic acid tablets USP were used for the calibration of dissolution test apparatus. Prednisone tablets were disintegration type and Salicylic acid tablets were non-disintegration type.
What is friability test apparatus?
Company’s Digital Friability Test Apparatus is a precision instrument for measuring obression strength of the tablets. The Friability Test Apparatus is designed as per IP/USP standards. The unit is equipped with two transparent acrylic drums which rotate at a speed of 25 . 1 rpm.
What is disintegration test apparatus?
Disintegration testers are used to test how a drug in pellet form will disintegrate in solution. Like dissolution testers, they permit researchers and medical practitioners to analyze the in vitro breakdown of powdered compounds for quality control purposes.
What is dissolution Q?
The dissolution specification is expressed in terms of the quantity (Q) of active substance dissolved in a specified time, expressed as a percentage of the content stated on the product label.
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.
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. 1 However, most dissolution results exhibit less variability than this.
What is dissolution limit?
The limit of Q may be different in different monographs according to the nature of the formulation and its active ingredients. Dissolution test is done using 6 units or dosage forms. … In S1 stage dissolved amount of each unit should not be less than Q+5%.
What is IP BP and USP?
IP stand For Indian Pharmacopoeia. BP stand for British Pharmacopoeia. USP stand for United State Pharmacopoeia.
What is difference BP and IP?
Drugs manufactured in India have to be labelled with the mandatory non-proprietary drug name with the suffix I.P. This is similar to the B.P. suffix for British Pharmacopoeia and the U.S.P. suffix for the United States Pharmacopeia.
What is dissolution and types?
There are seven USP-defined types of dissolution apparatus: baskets, paddles, reciprocating cylinders, flow through cells, paddle over disk types, cylinders, and reciprocating holders. Although USP 2 paddles are most widely used, most dissolution apparatus incorporate any number of each type (often all of them) .
What is DT in pharma?
Disintegration time is the time required for a dosage form to break up in to granules of specified size (or smaller) under carefully specified conditions. … In other words DT (disintegration time) is measuring the break down of a dosage form and dissolution is measuring the drug being solubilized in the media.
What is dissolution time?
The mean disintegration time (MDGT; mean time required for disintegration of tablets) and mean dissolution time (MDST; mean time required for drug dissolution) of water-soluble drugs from solid dosage forms were determined by moment analysis using microcalorimetric curves.
What is limit of friability in IP and USP?
A maximum loss of weight (from a single test or from the mean of the three tests) not greater than 1.0 percent is acceptable for most tablets.
How many types of dissolution are there?
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 is USP dissolution test?
A dissolution experiment evaluates the rate and extent that a compound forms a solution under carefully controlled conditions. The dissolution test in a USP drug product monograph helps evaluate the performance of a drug product (article) and indicates when the drug product performs in a substandard fashion.
How do you calibrate dissolution apparatus?
CALIBRATION FOR DISINTEGRATING TYPE PREDNISONE TABLETS 50 MG
- Ensure that mains of instrument and supply are “ON”.
- Set the time program for 30 minutes, temperature 37° C + 0.5° C and for 50 RPM. …
- Place 900 ml of deaerated water.
- After achieving the temperature place one tablet in each bowl and start the time program.
What is Roche Friabilator?
A new apparatus which measures resistance to abrasion and shock has been designed. A weighed sample of tablets is subjected in the apparatus to a tumbling action and to the shock resulting from a free-fall of six inches. The loss of weight suffered is a measure of the friability of the tablets.
What causes tablet sticking?
Sticking is caused when a machine having too deep concavity for granulation is used. The concavity should be reduced to the optimum in order to prevent tablet sticking. Too little pressure has also been found to cause tablet sticking.
How do you calculate friability?
Friability test procedure: Collect an equal amount of tablets from both sides of the chute and affix label on it. Take the tablet’s weight equal to or less than 6.5 g if the unit weight is equal to or less than 650 mg. If tablets having a unit weight of more than 650 mg, then collect ten tablets as a whole sample.
What is 5.3 disintegration test?
11. This test is provided to determine whether tablets or capsules disintegrate within the prescribed time. 12. when placed in a liquid medium under the experimental conditions presented below.
What is the difference between dissolution and disintegration?
Disintegration is a process of breaking down a substance into tiny fragments to improve its solubility in a solvent. … Dissolution, on the other hand, is a process through which solutes dissolve in a solvent.
What is disintegrating agent?
Disintegrating agents or disintegrators or disintegrants are the substances which are added to an oral solid dosage form such as tablet, beads, pellet, granule as well as capsule to promote its rapid disintegration or break down into small particles after administration for facilitating rapid dissolution into GI fluid.
How dissolution medium is selected?
The analytical target profile (ATP) and drug substance solubility are key factors in dissolution medium selection. The ATP should indicate the type of dosage form for which the test is being developed. Drug substance solubility should be characterized over the physiological range of pH values.
What is f1 and f2 value in 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 do we use 6 tablets for 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.
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