What is dissolution test apparatus?
A Dissolution Test is used for in vitro testing of the tablets and capsules. Dissolution apparatus are used through the product development life cycle, from Product release to stability testing in the Quality Control department.
What is paddle dissolution apparatus?
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.
How many types of dissolution apparatus are there?
Defined dissolution apparatus and development of new tools 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.
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?
Why dissolution is performed on 6 tablets?
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 baskets are used in dissolution?
This apparatus is called a basket. It is cylindrical in shape and is constructed from non-reactive mesh to prevent any unwanted chemical reactions that may alter the final result. The pores in the mesh allow the dissolving drug to move from the basket into the holding vessel, creating a uniform solution.
What is USP apparatus?
USP Apparatus 3 (reciprocating cylinder) is a very versatile device for the in vitro assessment of release characteristics of solid oral dosage forms, because it enables the product to be subjected to different dissolution media and agitation speeds in a single run.
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 D value in dissolution?
The value of D in Table 4 is 75 percent dissolved unless otherwise specified. The quantity, D, is the specified total amount of active substance dissolved in both the acid and buffer stages, expressed as a percentage of the labeled content.
Why are 6 bowls used in dissolution?
Why is prednisone used in 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 SOTAX dissolution system?
Sotax Dissolution System. The design of SOTAX dissolution systems is compliant with all harmonized pharmacopeia requirements for paddle and basket methods. From set-up (fixed position vessels and auto-centering) through the complete dissolution test to mechanicalcalibration (executed with the SOTAX MQD): all requirements are fulfilled.
What makes SOTAX different?
From the world’s first fully automated self-cleaning dissolution testing system more than 25 years ago to pioneering release testing of novel dosage forms, SOTAX is driving innovation since 1973. Today, thousands of SOTAX instruments are in daily operation at Pharmaceutical companies all over the world. ATF – Fully automated dissolution tester
What is the history of SOTAX?
Dissolution Experts. From the world’s first fully automated self-cleaning dissolution system more than 25 years ago to pioneering release testing of novel dosage forms, SOTAX is driving innovation since 1973. Today, thousands of SOTAX instruments are in daily operation at Pharmaceutical companies all over the world.
Where can I buy an automatic dissolution system?
Sotax has a wide variety of manual and automatic dissolution systems. Find yours today for sale or through online auction at LabX. The AT MD is a fully automated bench-top dissolution system and can handle basket and paddle methods as well as sinkers including Japanese Sinkers.