What is dissolution S1 S2 S3?

What is dissolution S1 S2 S3?

What Are S1 S2 And S3 stages In Dissolution in pharmaceutical? In the pharmaceutical industry, it is a very important test to know the drug dissolution rate in the defined medium. Dissolution is an in-vitro test (Outside body) to predict the invivo (In body) results of the drug.

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 are the types of dissolution apparatus?

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 are the types of dissolution?

What is BCS Class II drug?

BCS Class IIa drugs, typically carboxylic acids with a pKa in the range of 4 to 5, are insoluble at typical, fasted, gastric pHs but soluble at intestinal pHs and, hence, are classified as BCS Class II or IV depending on intestinal jejunal permeability at pH = 6.5 or fraction dose absorbed determination in humans.

Which type of apparatus is used for the dissolution capsules?

It is used for capsules or tablets, suppositories, floating dosage forms and a delayed release. This apparatus is specially made and it comes with a coated paddle that reduces the disturbance from the stirring….Follow Pharmaguideline.

Why do we use dissolution apparatus?

A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product.

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. However, it has occasionally been observed that SLS negatively impacts the dissolution of drug products formulated in gelatin capsules.

What is f2 value in dissolution?

An average difference of 10% at all measured time points results in a f2 value of 50. FDA has set a public standard of f2 value between 50-100 to indicate similarity between two dissolution profiles.

What is dissolution apparatus?

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 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.

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.

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.

What is f2 factor in dissolution?

The factor f2 measures the closeness between the two profiles. Because of the nature of measurement, f1 was described as difference factor, and f2 as similarity factor (2).