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What is USP dissolution?

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.

What is dissolution of drug?

Definition- • Dissolution is a process in which a solid substance solubilizes in a given solvent i.e. mass transfer from the solid surface to the liquid phase.

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 are the different 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?

amount of dissolved active ingredient

What is difference between assay and dissolution?

“In my experience the differences you are seeing are not that unusual afterall the tests are designed for different purposes, CU is a check on the reproducibility of a production run as is dissolution which also ensures that the formulation will release the drug over the required timeframe so limits are usually wider …

What is the difference between assay and content uniformity?

The main difference between content uniformity and assay is that content uniformity is a test in which evaluation units are done individually whereas assay is a test in which multiple units are done simultaneously. Furthermore, the evaluation procedure of content uniformity tests is the same for all units.

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.

How do you perform a dissolution?

Warm the dissolution medium to 36° to 37°. Place one dosage unit in the apparatus, cover the vessel and operate the apparatus at the specified rate. After 2 hours of operation in the acid medium, withdraw an aliquot of the liquid and proceed immediately as directed under Buffer stage.

How do you calculate dissolution?

Formula for determination of percentage of release of drug from in vitro dissolution testing

  1. Concentration of drug (µg/ml)= (slope × absorbance) ± intercept.
  2. Amount of drug = Concentration × Dissolution bath volume × dilution factor.

What is Q point in dissolution?

What is Q? Q, as it relates to dissolution is commonly used in the USP for immediate release and delayed release dosage forms. The quantity of Q is the amount of dissolved active ingredient specified in the individual monograph expressed as a percentage of the labeled content.

Why sinkers are used in dissolution?

Capsule Sinkers. Floating dosage forms rarely dissolve at a reproducible rate. Using a sinker in Apparatus 2 fixes the dosage form to a certain point and aids reproducibility. Sinkers can also be useful where dosage forms may stick to the sides of the vessel.

Why dissolution test is important?

Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness. Dissolution and drug release are terms used interchangeably.

How do you select rpm in dissolution?

The selection of RPM depends upon type of formulation, solubility characteristics of active substances and apparatus used for dissolution study. For capsules (both soft gel and hard gel), USP-I i. e. Basket apparatus is recommended, rotation speed for paddle shall be 50 to 75 RPM.

How do you start a dissolution method?

  1. Manufacture product variants with different release. characteristics.
  2. Determine dissolution rates resulting in. similar in vivo performance.
  3. Dissolution specifications chosen to ensure similar (BE) product performance.
  4. Determine bioavailability for. product variants.
  5. Select optimal dissolution method.

How do you select dissolution media?

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).

How do you prepare a dissolution media?

What Is a Dissolution Media Preparation System? These instruments can simultaneously process multiple vessels using a combination of heating (for example, ambient to 45 °C), vacuum, circulation, and dispensing. The appropriate volumes of acid, buffer, or surfactant are also added automatically if required.

What are the media used in dissolution test?

Conventional dissolution media, such as simple US Pharmacopeia (USP) buffers (e.g., hydrochloric acid, 50-mM phosphate, acetate, and citrate) have been used for solubility and dissolution assessment for decades and are referenced in the majority of USP monographs (1,2).

How do you determine sink conditions for dissolution?

Sink condition is the ability of the dissolution media to dissolve at least 3 times the amount of drug that is in your dosage form.

What is meant by OGD media for dissolution?

A discriminative dissolution method has to be developed to exhibit different results when the manufacture of a product changes. Discrimination in dissolution having dissolution test which will show a difference between one formulation and another. A discriminating medium is one part of discriminating dissolution test.

Why 900mL dissolution media is used?

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.

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. Conclusions: SLS interacts with gelatin to form a less-soluble precipitate at pH < 5. The use of SLS in dissolution media at acidic pH should be carefully evaluated for gelatin capsule products.

What is f2 value in dissolution?

An f2 parameter is commonly used to establish similarity of two dissolution profiles. The formula and procedure to obtain f2 value is described in one of the publications. In short, two profiles are considered identical when f2=100. An average difference of 10% at all measured time points results in a f2 value of 50.

How do you calculate f2 for dissolution?

When the two profiles are identical, f2=100. 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 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.

What is mean dissolution time?

K-1/n Mean dissolution time (MDT) value is used to characterize the drug release rate from the dosage form and the retarding efficiency of the polymer. A higher value of MDT indicates a higher drug retaining ability of the polymer and vice-versa.

What is dissolution efficiency?

Dissolution efficiency (D.E.), the area under a dissolution curve between defined time points, and the fit factors (f1 and f2) have been compared for the characterisation of dissolution profiles, using data from three batches of a product in nine different packs stored under two conditions.

How do you calculate dissolution efficiency?

The parameter of dissolution efficiency (DE) was calculated using the dissolved percentage curves of the drug versus time, using the reason between the area above the curve (ASC) and the total area of the graph (surface), and expressed in percentage (Khan and Rodhes, 1975).

What is asymptote in dissolution?

An asymptote is basically the point in a dissolution curve (or really any curve) where it is no longer increasing. An asymptote in dissolution is when you have had 2 or more timepoints in a row which have the same or almost the same % dissolved, and you are at or near the full dissolution for that product.