Sheni Obel, D (2021) Formulation Development and In Vitro Characterization of Oral Floating in Situ Gelling Liquid System of Losartan Potassium. Masters thesis, College of Pharmacy, Madras Medical College, Chennai.
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Abstract
The Losartan potassium oral In situ gel F1.F2.F3.F4.F5.F6.F7 and F8 was developed using gelling agents such as 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 its studies revealed that there was no change in major peaks, thus confirming no interaction between the drug and excipients. • Calibration curve of Losartan potassium was constructed in simulated gastric fluid of pH 1.2 and it obeys Beer Lambert’s law. • 8 formulations of Losartan potassium In situ gel was prepared using varying concentrations of different polymers such as Gellan gum, Iota carrageenan along with HPMC K4M as the release retardants. • The prepared formulations (F1- F8) 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. • All the formulations except F3 exhibited good gelling capacity. The gel that was formed dispersed rapidly in the formulation F3 containing only Iota carrageenan as the main polymer. • All the formulations showed floating lag time of less than 1 minute and duration of floating are greater than 12 hours. • All the formulation exhibited lower density than the density of gastric fluid (⁓ 1.004 gcmˉ3). • Formulations F7 and F8 showed higher gel strength when compared to the other formulations. • The percentage water uptake was higher for formulations F7 and F8 due to the presence of combination of polymers Gellan gum and Iota carrageenan. • The percentage drug content of all the formulations was in the range of 87.5 – 92.74 % indicating uniform distribution of drugs. • In vitro drug release study showed that only the formulations F7 and F8 released 98.24 % and 98.64 % 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. • The In vitro release kinetics study of the optimized formulation F8 showed that the formulation followed Zero order kinetics and Non- fickian diffusion mechanism. • The stability studies indicated that the optimized formulation F8 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 3 months. The overall results indicate that the formulation of Losartan potassium 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 Hypertension in patients. FUTURE PLANS: ❖ Scale-up studies of the optimized formulation ❖ In vivo and In vitro- In vivo correlation studies ❖ To perform Bioequivalence studies
| Item Type: | Thesis (Masters) |
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| Additional Information: | 261911259 |
| Uncontrolled Keywords: | Formulation, Development, In Vitro Characterization, Oral Floating, Situ Gelling Liquid System, Losartan Potassium. |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Subramani R |
| Date Deposited: | 01 Nov 2022 17:15 |
| Last Modified: | 01 Nov 2022 17:15 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/20892 |
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