Elangovan, S (2021) Formulation and Evaluation of Immediate Drug Release Containing Chenodeoxycholic Acid Hepatoprotective Drug. Masters thesis, Annai J.K.K. Sampoorani Ammal College of Pharmacy, Komarapalayam.
Full text not available from this repository.Abstract
Aim of the current research was to develop an Immediate Release Tablets, of robust quality equivalent to USP standard Reference Listed Drug (RLD), for the selected hepato-protective drug. The primary physico-chemical characterization (Physical description, Partition coefficient, pH, Spectral analysis) for the API were studied and confirmed. Further evaluation of RLD were performed for optimizing the standard reference values to be used while developing and optimizing various study formulations. The pre-formulation studies LOD, Solubility study, DEC, Flow and consolidation properties was performed for the API and excipients. The LOD was found to be in line with the standard LOD range of NMT 2%.The solubility studies indicated that the drug satisfactorily soluble in 0.08% polysorbate 80 (pH 6.8). DEC study performed for the physical mixture of drug and excipients showed that the API and excipients do not have any physical interactions amongst them. Retention time was observed to be at 22 min at 195 nm detected by UV Visible detector. The developed method was validated and found to be linear, accurate and reproducible. The flow and consolidation properties studied for the drug and excipient blend indicates that the blend has a Good flow property with an angle of repose value 32.15.Compressibility index (14%) and Hausner’s Ratio (1.16) was within the range of Good flow property, thus the blend was selected for tablet preparation by Direct compression method. After the initial pre-formulation studies, optimization process for the formulation variables were carried out by varying parameters involved in the formulation development. The drug-excipient concentration or ratio variation (Formulations F1 – F5), which has impact on dissolution and disintegration was studied for the formulation trials. Among the various formulations optimized, the F1 formulation with 8 mg Sodium starch glycolate and 1.6 mg Magnesium stearate exhibited the desired drug release profile. The disintegration study evaluation done using Paddle method for the formulations F1 – F5 was performed. Disintegration time for the F1 formulation (with 8 mg of SSG and 1.6 mg MS) was observed at 42 to 60 Sec which is much closer to the values of RLD (43 – 60 Sec). Dissolution profile for the study formulations F1-F5 performed exhibits release percentage falling within the limits at 45 min. based on the similarity factor for the formulations F1-F5 in comparison to RLD it was observed that formulations F2, F3, F4 & F5 exhibited a comparable amount of percentage release difference from the RLD value, whereas F1 formulation showed a much closer release profile value. Therefore, F1 was considered to be better formulation with 81% of similarity factor compared to RLD product. F5 was considered to optimized formulation 68% of similarity factor compared to RLD product. Thus, the optimized F1 formulation was further subjected to evaluate the content uniformity, assay and water content, to ascertain the stability of the formulation on storage, which were within the standard reference limit. Short-term Stability studies performed for the optimized F1 Formulation for a time period of one month at room temperature and 40°C/75%RH. The results were found to be satisfactory and within the specification limit for both the temperature conditions. Thus, on the basis of our research findings it could be concluded that the proposed design for the development of immediate release tablets of fluffy, low soluble molecule was extensively evaluated and the process was demonstrated to be flexible enough for improving the rate and extent of drug release. Additionally, a cost- effective quality product can be delivered to the patients, which is equivalent to the reference standard.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | 261910802 |
| Uncontrolled Keywords: | Formulation, Evaluation, Immediate Drug Release, Chenodeoxycholic Acid, Hepatoprotective Drug. |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ramakrishnan J |
| Date Deposited: | 12 Aug 2022 10:59 |
| Last Modified: | 12 Aug 2022 10:59 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/20751 |
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