What are the various methods of dissolution testing?
What are the various methods of dissolution testing?
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 comparative dissolution testing?
DISSOLUTION TESTING AND OTHER BIOWAIVERS FOR GENERIC DRUG PRODUCTS—PREAPPROVAL. Comparative dissolution testing can be used to grant biowaivers for different strengths for IR dosage forms as long as certain conditions are met (8,9).
What is Case B dissolution testing?
b) Case B. Dissolution testing should be conducted as a multipoint test in the application/compendial medium, for the proposed and currently registered formulations, at intervals such as 10, 15, 20, 30, 45, 60 and 120 minutes, or until an asymptote is reached for the proposed and currently registered formulation.
What is acceptance criteria for immediate release tablet?
For immediate release solid oral drug products containing a high solubility drug substance (as defined herein), the dissolution criterion is Q=80% in 30 minutes.
What is the principle of dissolution test?
The principle function of the dissolution test may be summarised as follows: Optimisation of therapeutic effectiveness during product development and stability assessment. Routine assessment of production quality to ensure uniformity between production lots.
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.
What is bioequivalence study?
Bioequivalence studies are special type of studies where two drugs or two sets of formulation of the same drug are compared to show that they have nearly equal bioavailability and PK/PD parameters. These studies are often done for generic drugs or when a formulation of a drug is changed during development.
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 f1 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.
Why dissolution test is required?
Dissolution testing is a requirement for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability testing. It is a pivotal analytical test used for detecting physical changes in an active pharmaceutical ingredient and formulated product.
What is F value in dissolution?
FDA has set a public standard of f2 value between 50-100 to indicate similarity between two dissolution profiles. For a dissolution profile comparison: · At least 12 units should be used for each profile determination.
What is bioequivalence testing?
15.5. Bioequivalence studies are special type of studies where two drugs or two sets of formulation of the same drug are compared to show that they have nearly equal bioavailability and PK/PD parameters. These studies are often done for generic drugs or when a formulation of a drug is changed during development.
What is a dissolution test procedure?
The general procedure for a dissolution involves a liquid known as Dissolution Medium which is placed in the vessels of a dissolution unit. The medium can range from degassed or sonicated deionized water to pH adjusted chemically-prepared solutions and mediums that are prepared with surfactants.