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- W3203930785 abstract "In the present work formaldehyde vapor treated (exposed for 1 and 2 hours) gelatin capsule body and untreated cap of size-1 were used. Formulations of propranolol HCl were developed with selected synthetic polymers PEO WSR-205, PEO WSR-N12K, PEO WSR-N60K and PEO WSR-301 using hand operated capsule filling machine with a batch size of 100 capsules. Bioanalytical method for estimation of propranolol HCl in rabbit plasma using RP-HPLC method was developed and validated as per ICH guidelines.The optimized formulation, M2PP43, containing PEO WSR 301 was evaluated for in vivo pharmacokinetic performance and various pharmacokinetic parameters were estimated using rabbits as animal model following CPCSEA-IAEC approved protocol. Statistical analysis and radiographic studies were conducted.The tests indicated that free formaldehyde content was less than the limit specified by USP and hence, the modified pulsincaps were considered safe for human consumption. The results confirmed that the drug release was varied based on drug-polymer ratio and the formaldehyde hardening time. The formulation, which has shown controlled release of drug over a period of 12 hours satisfying the USP dissolution criteria and released 100% drug at 12 hours along with confirming to the floating objectives of present investigation was considered as optimized formulation.All formulations followed zero order release kinetics with non-Fickian diffusion mechanism of drug release. Stability studies revealed that there were no considerable changes. The biopharmaceutical evaluation indicated the controlled release of drug from test formulation and also shown improvement in bioavailability. The results of the statistical analysis shown significant difference in Cmax, tmax, Ka, AUC0-t and MRT0-t values whereas, there was no significant difference in t1/2 and KE values of pure propranolol HCl and test formulation. Radiographic studies shown in vivo buoyancy up to 8 hours. Conclusion: Based on the present investigation and the obtained results, it was concluded that modified pulsincap technique can be successfully used in the development of non-effervescent gastric floating drug delivery systems for oral controlled release of propranolol HCl over a period of 12 hours using synthetic polymers." @default.
- W3203930785 created "2021-10-11" @default.
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- W3203930785 date "2020-02-03" @default.
- W3203930785 modified "2023-09-23" @default.
- W3203930785 title "Biopharmaceutical Evaluation of the Optimized Formulation of Anti-Hypertensive Drug Using a Novel Technique" @default.
- W3203930785 hasPublicationYear "2020" @default.
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