Aarthi, C K (2019) Formulation Development and In Vitro Characterization of Oral Floating In Situ Gelling Liquid System Of Rivastigmine Tartrate. Masters thesis, College of Pharmacy, Madras Medical College, Chennai.
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Abstract
The Rivastigmine tartrate oral In situ gel was developed using gelling agents such as Sodium Alginate, Gellan gum, Iota carrageenan and HPMC K4M. ❖ Physical compatibility study showed that the drug and excipients are physically compatible with each other. ❖ Chemical compatibility study was performed using FT-IR spectroscopy and FT-IR studies revealed that there was no change in major peaks, thus confirming no interaction between the drug and excipients. ❖ Calibration curve of Rivastigmine tartrate was constructed in Simulated Gastric Fluid (SGF) of pH 1.2 and it obeys Beer Lambert law. ❖ 10 formulations (F1, F2, F3, F4, F5, F6, F7, F8, F9, F10) of Rivastigmine tartrate In situ gel were prepared using varying concentrations of different polymers such as Sodium Alginate, Gellan Gum and Iota Carrageenan along with HPMC K4M (0.1 % w/v) as the release retardant. ❖ The prepared formulations (F1 - F10) were evaluated for Physical appearance, Pourability, pH, viscosity, In vitro gelation study, In vitro buoyancy study, Density, Gel strength, Percentage water uptake, Drug content and In vitro drug release. ❖ All the formulations had good physical appearance, free flowing and did not produce any gelation at room temperature. ❖ All the formulations except F4 exhibited good gelling capacity. In the formulation F4 containing only Iota carrageenan as the main polymer, the gel that was formed dispersed rapidly. ❖ All the formulations showed floating lag time of less than 2 minutes and duration of floating was greater than 12 hours. ❖ Formulation F9 and F10 exhibited lower density than the density of gastric fluid (~1.004 gcm−3) and higher gel strength when compared to other formulations. ❖ The percentage water uptake was higher for formulations F9 and F10 due to the presence of combination of 3 polymers i.e. Sodium alginate, Gellan gum and Iota carrageenan. ❖ The percentage drug content of all the formulations was in the range of 96.08-98.69 % indicating uniform distribution of drugs. ❖ In vitro drug release study showed that only the Formulations F9 and F10 released 99.91 % and 91.11% of drug respectively at the end of 12 hours, while the other formulations showed more than 90% of drug release even before the period of 12 hours. ❖ Based on the results of evaluation of In situ gel, the Formulations F9 and F10 was considered suitable for providing prolonged delivery of Rivastigmine tartrate. Since the Formulation F9 had lower viscosity and was easily pourable than the formulation F10 without significant differences in other parameters, Formulation F9 containing Sodium alginate (0.5 % w/v), Gellan gum (0.15 % w/v), Iota carrageenan (0.2 % w/v) and HPMC K4M (0.1%) was chosen as the optimized formulation. ❖ The In vitro release kinetic study of the optimized formulation F9 showed that the formulation followed Zero-order kinetics and Non-Fickian diffusion mechanism. ❖ The stability studies indicated that the optimized formulation F9 was stable and did not show any significant changes in the physical appearance, pH, gelling capacity, floating time, viscosity, drug content and In vitro drug release at the end of 1 month. The overall results indicate that formulation of Rivastigmine tartrate as oral floating In situ gel provides controlled release of the drug. This may improve the patient compliance due to ease of administration and reduction in dosing frequency. Hence, the developed formulation can be used as an alternative to the conventional dosage form for the treatment of Alzheimer’s disease in patients.
| Item Type: | Thesis (Masters) |
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| Additional Information: | 261711251 |
| Uncontrolled Keywords: | In Vitro Characterization, Oral Floating, In Situ Gelling Liquid System, Rivastigmine Tartrate |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ramakrishnan J |
| Date Deposited: | 18 May 2022 06:38 |
| Last Modified: | 18 May 2022 06:38 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/20100 |
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