About Author: This article was Exclusively Written for Pharma Mirror Readers by Mohammad Dulal, Industrial Pharmacist licensed in MOH/Dubai, Senior Scientist, Product Development Lab, Julphar Gulf Pharmaceutical Ltd, Ras Al Khaimah, United Arab Emirates.
1.0 Introduction
Generic pharmaceutical products are clone of innovator products in the term of actives, strengths, dosage forms, dosage regimens and administrations. Actual fact is that innovator companies are very less in numbers in the world due to requirement of huge investment. Innovator companies are also not in good numbers enough to serve their medicines to all the worldwide patients. Reasonably, generic companies are established to serve their local patients with medicines at a manageable price. Generic companies cannot
change strengths, dosage forms, dosage regimens, administration of a drug substance which are already researched and proved safe & effective via clinical trial by Innovator Company, rather generic company can play with excipients and physical attributes (appearance, shape, size, color, etc) of dosage form only. [.......]
change strengths, dosage forms, dosage regimens, administration of a drug substance which are already researched and proved safe & effective via clinical trial by Innovator Company, rather generic company can play with excipients and physical attributes (appearance, shape, size, color, etc) of dosage form only. [.......]
3.0 Bioequivalence: why required
Bioequivalence ensures a generic product how much it is as close as reference product in term of bioavailability. Excipients used as well as physical attributes (particle size, process, physical parameters such as hardness for tablet) are release rate limiting factor for active ingredient from dosage form. In order to be bioequivalent (BE) with reference product, generic product should have in-vitro release rate of active ingredient from its dosage form as much closely as reference product. International drug regulatory authority urges to conduct Bioequivalence for ensuring to get better therapeutic activity from generic drug products. [.......]
5.0 In-vitro Dissolution Profile
In-vitro dissolution is a pre-assessment tool prior to conducting Bioequivalence study in order to see how much release of active drug of a generic product from its dosage form is as close as that of a reference product from its dosage form. This in-vitro dissolution will act as pre-assessment tool before conducting BE study. In-vitro dissolution profile is the % dissolution of active ingredient from its dosage form at sampling time interval in chemical laboratory. In-vitro dissolution profile is carried out for both generic product and reference product and their release is characterized by similarity factor (f2) and dissimilarity factor (f1). [.......]
5.2. Acceptance criteria for Similarity of dissolution profiles
The average dissolution rate of the test product (Generic product) is compared with the average dissolution rate of the reference product. If dissolution of the reference product or test product has a lag time, the dissolution curve can be adjusted with the dissolution lag time (Appendix 2). Criteria (1) to (3) below are applied after the lag time. However, when dissolution curves are corrected, the difference between the average dissolution lag times of the test product and reference product must be not more than 10 minutes. The time points for comparing dissolution rates when assessment is performed by the f2 function are specified in Appendix 1. 2.
When any of the criteria below are met under all the sets of dissolution test conditions, the dissolution behaviour is judged as similar. However, the average dissolution rate of the reference product must reach 85% or more within the designated test time under at least one set of dissolution test conditions. [.......]
Read the full article here and other related pharmaceutical articles here.
No comments:
Post a Comment