What is type 4 dissolution apparatus?

USP 4 is versatile and can be used for dissolution testing of both conventional dosage forms (powders, granules, tablets, capsules, enteric-coated tablets, suppositories, and injectable suspensions) and novel drug delivery systems, covering modified-release products, implant stents, drug coated medical devices, …

What is Type 3 dissolution 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.

What is Type 1 dissolution apparatus?

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.

Why are 6 units used in dissolution?

Six units are tested to provide the minimal statistical significance.

Why is 900mL 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?

What is S1 S2 S3 in dissolution?

Its a criteria / stage wise dissolution testing. S1 – dissolution testing of 6 units. check the acceptance criteria if failed proceed for S2 with additional 6 units. check the acceptance criteria for 12 units in total (S1+S2) if failed proceed for S3 with additional 12 units.

What is Q value for dissolution?

Answer: Q represents the targeted amount of active substance, expressed as a percentage of the label claim, which should be dissolved within a certain time. The ‘Q value’ should be seen as a “reference value” to which the dissolution results are compared.

What is limit of dissolution?

The amount of dissolved active ingredient is known as Q in the dissolution test. 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.

What is f1 and f2 in dissolution?

The fit factors can be expressed by two approaches: f1 (the difference factor) and f2 (the similarity factor). Two dissolution profiles to be considered similar and bioequivalent, f1 should be between 0 and 15 whereas f2 should be between 50 and 1006.

What is Apparatus 2 dissolution?

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.

Which is type 1 dissolution apparatus as per IP?

Note –Apparatus 1 and 2 according to IP is Paddle Apparatus and Rotating basket apparatus respectively.

How many types of DT are there?

Types of Dissolution Apparatus / DT Apparatus

Basket type (USP Dissolution apparatus 1) Paddle type (USP Apparatus types 2): Reciprocating cylinder: (USP Dissolution apparatus types 3) Flow-through cell:(USP Dissolution Apparatus 4)

What is USP 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 Q value for dissolution?

Answer: Q represents the targeted amount of active substance, expressed as a percentage of the label claim, which should be dissolved within a certain time. The ‘Q value’ should be seen as a “reference value” to which the dissolution results are compared.

What is difference between USP 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 are the two 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 is f1 and f2 in dissolution?

The fit factors can be expressed by two approaches: f1 (the difference factor) and f2 (the similarity factor). Two dissolution profiles to be considered similar and bioequivalent, f1 should be between 0 and 15 whereas f2 should be between 50 and 1006.

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 dissolution test is performed at 37 degrees?

The dissolution fluid is maintained at a constant temperature of 37°C to mimic physiological conditions. The volume of solvent used should maintain a sink condition at all time (generally, the final drug concentration of the dissolution fluid should be less than 10% of the solubility of the drug being tested).

What is Q dissolution?

Q, is the amount of dissolved active ingredient ✦specified in. the individual monograph✦, expressed as a percentage of. Proceed as described for Delayed-Release Dosage Forms, the labeled content of the dosage unit; the 5%, 15%, and. Method B under Apparatus 1 and Apparatus 2 using one row.

What is DD solver?

DDSolver is a freely available program which is capable of performing most existing techniques for comparing drug release data, including exploratory data analysis, univariate ANOVA, ratio test procedures, the difference factor f1, the similarity factor f2, the Rescigno indices, the 90% confidence interval (CI) of …

What does f2 value mean?

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.

What is f2 value in dissolution?

The factor f2, known as the similarity factor, measures the closeness between the two profiles:(1) f 2 = 50 · log 1 + 1 n ∑ t = 1 n ( R t – T t ) 2 – 0.5 × 100 where n is the number of time points, Rt and Tt are the dissolution value of the reference and test product at time t, respectively.