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THE PHARMA REVIEW (JANUARY - FEBRUARY 2012)

Importance of Visual Observations in the Dissolution Testing

Singh Kavita1*, Marfatia Aditya2 and Bajaj Amrita3

Abstract: Dissolution testing is a critical methodology which is widely utilized in the development of a new pharmaceutical product. The test, in its simplest form, consists of placing the formulation in a dissolution apparatus containing suitable dissolution medium, allowing it to dissolve over a specified period of time and then assaying the resultant solution using appropriate analytical method to determine the amount of drug. Dissolution tests are relevant for an array of investigations like drug degradation profiles, stability and shelf life studies, physical and mechanical testing of dosage forms, incoming QC testing on raw materials etc

 
Introduction: The dissolution test is vital tool for formulation optimization, method development, formulation changes, manufacturing changes, process modifications to comply with regulatory requirement, USP compliance, in-vitro in-vivo correlation (IVIVC) and Scale Up and Post Approval Changes (SUPAC). As the drug moves into production, dissolution test becomes a QC test which helps to understand outcomes of process and manufacturing change on dissolution profile. When a new supplier for a certain excipient needs to be selected or when a new lot of excipient is used in the formulation the dissolution profile is investigated. Dissolution test helps in determining whether a drug lot passes or fails as per pharmacopeial standards. Finally as the drug moves into generic arena, dissolution test is one test which helps prove bio-equivalence of the generic drug with the patent protected innovative drug in the market. During all these stages, formulation scientists are always looking for ways to find a correlation between the in-vitro dissolution test and in-vivo drug concentration profile (IVIVC). Dissolution studies also provide a means to control the quality of many of the parameters of a solid oral dosage form for both batch release and stability testing. This test can provide a much greater amount of value, in addition to providing a metric for quality control and stability testing. The test can be used to investigate a number of critical processing and formulation properties, in order to develop and produce a more robust and better quality drug product. A number of metrics like disintegration time, time for 50% drug release, Q10, Q90 etc. are available to improve the information obtained from dissolution test.
One commonly overlooked metric that can provide a host of information about the dosage unit under study is a visual observation of façade of dosage form during dissolution process. The stature of the dosage form is a simple physical observation which may be followed by the notebook documentation of the photograph. A digital image captured to support the observation, or even live video obtained with a dedicated visual imaging system will enhance the value of the results.

 

 

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