Process Development and Optimization of Zolpidem Tartrate Tablets by Moisture Activated Dry Granulation Technique.

Nusum, Srinivasa Reddy (2012) Process Development and Optimization of Zolpidem Tartrate Tablets by Moisture Activated Dry Granulation Technique. Masters thesis, Adhiparasakthi College of Pharmacy, Melmaruvathur, Tamil Nadu, India.


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The treatment of a disease or for prophylactic purpose. An Active Pharmaceutical Ingredient (API) may exist in solid, liquid or semisolid form. They are rarely prescribed to the patients as such i.e. without adding excipients, since the desired effect may not be obtained. Earlier, it was thought that excipients are inert in nature but, in recent time it is well known that excipients can greatly modify the intended effect of a drug. The API and excipients are suitably processed in pharmaceutical industry to convert them into dosage forms such as tablet, capsule, suspension, solution, etc. The selection of excipients and processing of drug excipients mixture is as important as API itself. The process development and optimization of Zolpidem Tartrate tablets by moisture activated dry granulation (MADG) technique was performed in the present study. The process development and optimization Zolpidem Tartrate tablets were performed by using different percentages (%) of water in all the formulations. Preformulation study was carried out for powder blends, it was evaluated to determine the flow characteristics by angle of repose, bulk density, tapped density, carr’s index and hausner’s ratio. The data obtained from these studies indicated that the powder blends some had good flow, some had moderate flow properties. The tablets were prepared using with different percentages of water by Moisture activated dry granulation technique. The formulated tablets were evaluated for physical characterization like thickness, hardness, friability, weight variation and drug content. All the physical parameters of prepared tablets compiles with and without IP specifications. Evaluation studies of all formulations showed that the drug content, weight variation and friability as per the standards given in IP. The hardness of all formulations was within the limits. The in-vitro dissolution studies closely indicate that among nine formulations the formulation F5 was found to be the best with high percentage of drug release (99.50%). From the stability data, it can be concluded that there was no significant changes in any parameters. Hence the formulation F5 is considered to be highly stable formulation. The overall studies indicate that 5% of water up taken showed satisfactory properties. Among the nine formulations the formulation F5 exhibited optimum drug release profile.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Development; Optimization; Zolpidem Tartrate Tablets; Moisture Activated; Dry Granulation Technique
Subjects: PHARMACY > Pharmaceutics
Depositing User: Ravindran C
Date Deposited: 06 Jul 2017 08:46
Last Modified: 14 Jul 2017 06:40

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