Rajan, S (2009) Development and validation of In Vitro – In Vivo Correlations for the developed modified release formulations of selected drug candidates. Doctoral thesis, The Tamil Nadu Dr. M.G.R. Medical University, Chennai.
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Abstract
This thesis deals with the studies carried out by the writer for the past three years on the “Development and validation of in vitro-in vivo correlations for some modified release formulations”. Thesis begins with a brief account of the in vitro - in vivo correlations, biopharmaceutical classification systems, IVIVC models, in vitro dissolutions and estimation of drugs in biological medium. The methods used for the IVIVC model development, validation, the steps involved in bio analytical method development, in vitro dissolution methods and their importance have also been discussed. A review of literature on IVIVC model development available for the drugs in biological fluids is presented. Thesis deals with the scope and objective of the present investigation. The merits of IVIVC in the development of dosage forms and how IVIVC model development necessitates development of in vitro dissolution methods, bio analytical method development and validation are discussed. The objectives of the present study, namely, to optimize the chromatographic conditions, to develop and validate the methods to estimate the selected drugs in the biological fluids by HPLC, development of in vitro dissolution methods and IVIVC model development and validation have been described. Thesis also deals with the experimental procedures adopted. It describes in detail the procedures adopted for the bioequivalence study design & data handling, optimization and validation of the chromatographic conditions for the estimation of the drugs in plasma and selected modifies release (MR) formulations, IVIVC model development and validation. The results obtained are presented, supported by tables and figures and discussed in detail. In conclusion, it may be pointed out that the developed in vitro dissolution methods can replace absorption studies during the pre-approval process to develop a desirable formulation and to ensure batch-to-batch bioequivalence. It will also be very useful in performing possible post-approval changes in the formulation scale up or changes in the drug substance or excipients supplier. RECOMMENDATIONS: This In Vitro- In Vivo correlations (IVIVC) have been applied for setting biorelevant dissolution specifications, guiding new product development, supporting Scale-Up and Post Approval Changes (SUPAC), waiving bioequivalence study and more importantly, ensuring commercial product quality over the years. However, further investigations in human are required to prove the clinical usability of the experimental extended-release formulation.
| Item Type: | Thesis (Doctoral) |
|---|---|
| Uncontrolled Keywords: | In Vitro – In Vivo Correlations, modified release formulations, Development, Validation. |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Devi S |
| Date Deposited: | 27 Jun 2017 06:16 |
| Last Modified: | 17 Sep 2022 11:33 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/405 |
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