How many apparatus are official for dissolution in IP?
In United States Pharmacopeia (USP) General Chapter <711> Dissolution, there are four dissolution apparatuses standardized and specified.
How do you select dissolution apparatus?
The selection of an appropriate dissolution medium is a fundamental stage of the dissolution test….* TEMPERATURE:
- The standard temperature for the dissolution medium is 37±0.5°C for oral dosage forms.
- Slightly increased temperatures such as 38±0.5°C have been recommended for dosagesforms such as suppositories.
Why do we use 900 ml in dissolution apparatus?
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. At these volumes, you can achieve success with most products as well.
How many 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.
Which is type 1 dissolution apparatus as per IP and BP?
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 dissolution is performed on 6 tablets?
Dissolution test is done to verify the release of drug in the solution from the tablet because of binders, granulation, mixing and the coating may affect the release of drug from tablets. Dissolution test is done using 6 units or dosage forms.
In which dissolution apparatus IP basket is used?
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….AN OVERVIEW OF APPROACHES IN DISSOLUTION TESTING: A REVIEW.
| Characteristic | USP | BP |
|---|---|---|
| Cap Air hole | 3.9 ± 1 | 3.9 ± 1 |
How dissolution medium is selected?
The selection of a dissolution medium should be based on drug substance and formulation characteristics as well as on interactions among components. include acidic solutions, buffers, surfactants, and surfactants with acid or buffers (1). Surfactants exist as monomers at low concentration in solutions.
Why SLS is used in dissolution media?
Purpose: Sodium lauryl sulfate (SLS) is a commonly used surfactant in dissolution media for poorly water soluble drugs. Results: SLS significantly slowed down the dissolution of gelatin shells at pH < 5. Visually, the gelatin shells transformed into some less-soluble precipitate under these conditions.
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.
How many types of dissolution apparatus are there?
There are seven USP-defined types of dissolution apparatus: baskets, paddles, reciprocating cylinders, flow through cells, paddle over disk types, cylinders, and reciprocating holders.
What is mesh size of DT apparatus?
The holes are equidistant from the center of the plate and are equally spaced from one another. Attached to the underside of the lower plate is a woven stainless steel wire cloth with a plain square weave with 2.0 ± 0.2 mm mesh apertures and with a wire diameter of 0.615 ± 0.045 mm.
What are the different types of Dissolution Apparatus?
Different Types of Dissolution Apparatus. 1 1. Basket Type. 2 2. Paddle Type. 3 3. Reciprocating Cylinder. 4 4. Flow Through Cell. 5 5. Paddle Over the Disk.
How to maintain calibration schedule for dissolution apparatus?
Maintain the third party calibration schedule and the Internal calibration schedule for the Dissolution Apparatus as per SOP “Preparation of Internal and External (Third Party) Calibration Schedule and Calibration Practices”. In case of noticing any calibration results not within the specified limit, follow the SOP of “Handling Out of Calibration”.
What is a dissolution specification?
The dissolution specification is expressed as the quantityQof the active substance as a percentage of the content statedon the product label, which is dissolved in a specified timeframe.
What is a closed system dissolution test?
The closed system, on the other hand, is where the dissolution medium is pumped into the circle but not replaced by a fresh medium. It is normally used for drugs with a low dosage and the test is conducted in small volumes. The flow through the cell apparatus is designed like a reservoir and is commonly used for implants.