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Amin, Saurin
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Medicine & Pharmacology

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Optimizing irbesartan spherical agglomerates through principal component analysis and experimental design Gorde, V. D.; Rachh, Punit R.; Mankar, S. D.; Amin, Saurin
Journal of Applied Pharmaceutical Research Vol. 12 No. 3 (2024)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v12i3.581

Abstract

Background: This study explores the amalgamation of crystallization and agglomeration through spherical crystallization, aiming to develop the spherical crystals of Irbesartan with improved micromeritic properties. The main objective is to use spherical crystallization techniques to improve the micromeritic characteristics of Irbesartan, which has poor flow and compressibility because of its crystal habit. Methodology: A solvent change approach was utilized to synthesize spherical agglomerates of Irbesartan. Several system parameters, including the amount of bridging liquid, the rate of stirring, and the concentration of the polymer, were tuned to enhance the particle size distribution and mechanical qualities. SEM, GC, PXRD, DSC, and FTIR analyses characterised the spherical crystals. Result and Discussion: The study demonstrated that spherical crystallization significantly enhanced Irbesartan's micromeritic properties. The angle of repose of optimized agglomerates was reduced by around 52%, indicating improved considerably flowability of irbesartan. The sphericity of the crystals was validated by SEM examination (shape factor: 0.996), and the solvent levels were found to be within allowable bounds by GC analysis. PXRD data showed no polymorphism alterations, and DSC/FTIR analyses confirmed that the excipients and drug were compatible. Conclusion: This process provides a feasible alternative to classic granulation and agglomeration procedures, resulting in better flow, compressibility, and spherical crystals. It streamlines the Irbesartan formulation, improving efficiency and uniformity, reducing manufacturing costs, higher tablet consistency, and enhancing patient compliance.
Formulation and development of bilayer tablet containing irbesartan and metformin hydrochloride for diabetic hypertensive patients Gorde, V D; Rachh, Punit R; Mankar, Someshwar; Amin, Saurin; Gorde, Prasad L
Journal of Applied Pharmaceutical Research Vol. 12 No. 4 (2024)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v12i4.589

Abstract

Background: Hypertension is a common complication of type II diabetes. The present research work aimed to develop bilayer tablets that would manage type II diabetes patients with hypertension. The prepared bilayer tablet has an immediate-release layer of anti-hypertensive irbesartan and a sustained-release (SR) layer of anti-diabetic metformin hydrochloride. The purpose of these bilayer tablets was to increase patient compliance by converting two separate monotherapy to single combination therapy. Methodology: Several ratios of polymers, including HPMC K100M, EC, Eudragit, and Guar gum, were employed to prolong the drug release for twelve hours. An immediate-release layer of irbesartan was prepared by spherical agglomeration. The physical properties, drug content, solubility profiles, release kinetics, and stability of prepared bilayer tablets were assessed. Results and Discussion: The examination of SR granules and bilayer tablets revealed outstanding packing qualities and excellent flow properties, with bulk and tapped densities ranging from 0.39-0.46 g/cm³ and 0.42-0.55 g/cm³, respectively. In vitro dissolution tests revealed that the immediate-release layer gave an initial burst of Irbesartan. Still, the sustained-release layer of metformin showed controlled drug release over 12 hours at greater polymer concentrations. According to stability testing, the bilayer tablets' physical properties, drug content, and dissolving profiles did not change significantly. Conclusion: The bilayer tablet combination of Irbesartan and Metformin exhibited desired physical features, controlled drug release, and stability. This formulation represents a viable treatment option for diabetic hypertensive patients, offering effective and consistent management of both disorders while improving patient compliance.
Optimization and evaluation of nebivolol hydrochloride loaded transferosomes using Box-Behnken experimental design Shelke, P V; Rachh, Punit R; Mankar, Someshwar; Amin, Saurin; Jain, Deepak
Journal of Applied Pharmaceutical Research Vol. 12 No. 4 (2024)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v12i4.590

Abstract

Background: This study optimizes and evaluates transferosomes containing Nebivolol Hydrochloride to enhance the drug's bioavailability and therapeutic efficacy. Ultra-deformable vesicles called transferosomes help to increase drug administration via the skin. Methodology: Using a thin-film hydration technique, beta-blocker Nebivolol Hydrochloride, which has antihypertensive properties, was added to transferosomes. To attain the ideal vesicle size (between 200 to 300 nm), entrapment efficiency, and deformability, the formulation was adjusted by adjusting the amounts of phosphatidylcholine, Span 80, and hydration time using a Box-Behnken experimental design. Particle size analysis, zeta potential measurement, and in vitro drug release tests were performed to characterize the transferosomes. Results and discussion: The optimized formulation demonstrated notable deformability, an entrapment effectiveness of 50%, and a vesicle size of 265 nm. The Box-Behnken design made it easier to evaluate the interactions between variables systematically. In vitro drug release studies showed a drug diffusion that persisted for a whole day, suggesting that transferosomes may have long-lasting therapeutic effects. Stability studies at room temperature and accelerated conditions over six months confirmed the formulation's robustness. Conclusion: The results imply that Nebivolol Hydrochloride transferosome-based delivery may be a viable strategy for improving the drug's bioavailability and effectiveness, as nearly 100% of drugs diffuse within 24 hr, perhaps leading to a breakthrough in the management of hypertension.
Co-Authors Gorde, Prasad L Gorde, V D Gorde, V. D. Jain, Deepak Mankar, S. D. Mankar, Someshwar Rachh, Punit R Rachh, Punit R. Shelke, P V