Abstract

USP APPARATUS-3 (RECIPROCATING CYLINDER) – A PREDICTIVE TOOL FOR BIORELEVANT DISSOLUTION TESTING OF MODIFIED RELEASE SOLID ORAL DOSAGE FORMS

Dr. Devi Thamizhanban* and Dr. Raja Subburayalu

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Abstract

Biorelevant dissolution method has become an integral part of formulation development and life cycle management of pharmaceutical products. Bioavailability and therapeutic efficacy of drug product is mainly depends on the targeted amount of drug available to the systemic circulation. Bio relevant dissolution method is aimed to use as predictive tool for assessing the in-vivo behaviour of drug product after oral administration. Human gastro intestinal system was simulated with respect to pH and residence time of individual segment of human body. For modified release products, where the release of drug was extended for the period of twelve hours, the reciprocating cylinder is more appropriate for changing the dissolution in certain stipulated period of time. Having the scope to operate the dissolution media volume of 100ml to 350ml, can simulate much closure the volume available for product exposure at various gastro intestinal segments. Dissolution is very important critical quality attribute, since the drug concentration available in single dose modified release dosage form is more than therapeutic concentration required. The dissolution methods adopted for quality control testing are generally using regular buffers with the target of achieving maximum extent of drug release. Biorelevant dissolution testing are based on the dosage form might be exposed to after oral administration, which interprets the dissolution data with regard to in-vivo behaviour of the finished product.

Keywords: biorelevant, predictive tool, reciprocating cylinder, deconvolution.