Release Kinetic Studies Research Articles

Dynamic pH‐Responsive Release and Biological Impact of In‐Situ Quercetin‐Modified MIL‐101(Fe)‐NH2

A successful investigation was conducted on the in‐situ modification of MIL‐101(Fe)‐NH2 with quercetin and its controlled release under various pH conditions. MIL‐101(Fe)‐NH2 was synthesized using an electrochemical method at room temperature (15 volts, 30 minutes). The formation of the material was confirmed through comprehensive analyses, including PXRD, FTIR, and TGA. Nitrogen sorption isotherm measurements revealed that Qu@MIL‐101(Fe)‐NH2 exhibited a smaller surface area compared to MIL‐101(Fe)‐NH2, with both materials classified as mesoporous. Transmission electron microscopy (TEM) clearly depicted the materials' octahedral microspindle morphology. The cumulative percent release (CPR) of quercetin from Qu@MIL‐101(Fe)‐NH2 over 72 hours was determined to be 53.45% at pH 1.2, 19.48% at pH 4.8, and 5.87% at pH 7.4. Notably, quercetin release in the acidic microenvironment representative of cancer cells (pH 4.8) was nearly four times higher than under physiological conditions (pH 7.4). Kinetic release studies indicated that quercetin release from Qu@MIL‐101(Fe)‐NH2 followed the Ritger‐Peppas kinetic model, suggesting non‐Fickian diffusion. The MIL‐101(Fe)‐NH2 nanocarriers, with in‐situ‐loaded quercetin, demonstrated promising potential for pH‐triggered drug release. Additionally, the safety of MIL‐101(Fe)‐NH2 in biological models and the anticancer efficacy of quercetin were evaluated in vitro using two liver cancer cell lines.

5-Fluorouracil adsorption on graphene oxide-amine modified graphene oxide/hydroxyapatite composite for drug delivery applications: Optimization and release kinetics studies

The present study focused on investigation of graphene oxide/hydroxyapatite (GO/HAp) and amine modified graphene oxide/hydroxyapatite (GO-NH2/HAp) composites as potential drug carrier agents for 5-Fluorouracil (5-FU). Incorporation of 5-Fluorouracil drug was performed via adsorption through π-π interactions and electrostatic attractions. Modification of graphene oxide was performed for the production of amine modified graphene oxide/hydroxyapatite composite with the intention of enhancing adsorption performance. The X-Ray Diffraction (XRD), Fourier Transform Infrared Spectroscopy (FTIR), Thermogravimetric Analysis (TGA) and zeta potential/particle size analysis were performed for particle characterization while Scanning Electron Microscopy (SEM) and Transmission Electron Microscopy (TEM) analysis were used to analyze detailed morphological properties. Experimental design studies were followed out in order to determine the effect of adsorption parameters including graphene oxide amount, pH and initial drug concentration on 5-Fluorouracil adsorption behavior. Adsorption isotherms of both composites with unmodified and modified GO were best fitted to Freundlich model with R2 values of 0.9616 and 0.9682 respectively. The maximum adsorption capacities (qm) were calculated as 47.3 mg/g and 18.4 for graphene oxide/hydroxyapatite and amine modified graphene oxide/hydroxyapatite composites respectively at pH 2.0. The highest adsorption percentage was obtained for amine modified graphene oxide/hydroxyapatite composite as 40.87 % at pH 2.0 condition. In vitro release kinetic studies revealed that compliance with Higuchi and Korsmeyer-Peppas kinetic models were observed for graphene oxide/hydroxyapatite, whereas zero order and Korsmeyer-Peppas kinetic models pointed out as the well-fitted model for amine modified graphene oxide/hydroxyapatite composite. The release period of 5-FU drug from all composites were continued up to 8–10 h in physiological conditions (pH 7.4, 37 °C) indicating an achieved controlled release. Based on the overall findings, graphene oxide/hydroxyapatite and amine modified graphene oxide/hydroxyapatite composites could be suggested as a potential drug delivery agent for 5-FU in clinical applications.

Synergistic enhancement of chlorophenols removal using eco-friendly alginate@montmorillonite hybrid bio-capsules: insights from encapsulation and kinetic release studies

This study investigates the synergistic effects of alginate@montmorillonite (Alg@Mt) hybrid microcapsules for enhancing water purification, focusing on improving the encapsulation of hydrophobic contaminants. Alg@Mt microcapsules were prepared through ionotropic gelation. Characterisation was performed using SEM-EDX, FTIR, XRD, and TGA. Encapsulation efficiency (EE), loading capacity (LC), and release behaviour were also examined. Alg@Mt microcapsules effectively removed phenol and its chlorinated derivatives from water. Incorporating Na-Mt improved structural and thermal properties, EE, and LC. Increasing the clay content to 60% (w/w) raised the EE of phenol and its more hydrophobic derivative, 2,4,6-trichlorophenol, from 39.74 ± 3.1% (w/w) and 63.91 ± 2% (w/w) to 60.56 ± 1.6% (w/w) and 82.28 ± 2.3% (w/w), respectively, with more controlled release rates, following Fickian diffusion mechanism. EE increased with phenolic substances hydrophobicity, while LC and release rates were inversely related. This approach is promising for removing hydrophobic contaminants from water.

Characterization of caseinate-pectin complex coacervates as a carrier for delivery and controlled-release of saffron extract

In this work, microcapsules were developed by the complex coacervation of sodium caseinate and pectin as a carrier for saffron extract. Parameters such as Zeta potential, dynamic light scattering, and microscopic techniques were investigated for their influence on the formation of these complexes. Furthermore, Fourier transform infrared (FTIR) analysis confirmed the reaction mechanism between the protein and tannic acid or saffron extract. The study revealed that core/shell and protein/polysaccharide (Pr/Ps) ratios play a role in the encapsulation efficiency (EE) and loading capacity (LC) of saffron extract, with EE and LC ranging from 48.36 to 89.38% and 1.14 to 5.55%, respectively. Thermal gravimetric analysis revealed that the degradation temperature of saffron increased significantly with microencapsulation. The use of tannic acid for hardening the microcapsules led to an increase in size from 13 μm to 27 μm. Rheological findings indicated that shear-thinning behavior in the coacervates, with cross-linking, has a minor effect on the interconnected elastic gel structures. However, cross-linking improved the microcapsules' thermal and structural properties. The increase in polymer chain length due to cross-linking and the presence of the guest molecule (saffron extract) resulted in higher rheological moduli, reflecting enhanced entanglements and correlating well with the thermal, structural, and microstructural properties of the coacervates. Kinetic release studies showed a slower release in the gastric phase compared to the intestinal phase, with the Ritger–Peppas model effectively describing saffron extract release, highlighting a dominant swelling and dissolution release mechanism. Therefore, the NaCas/HMP coacervate wall materials made saffron stable in the gastric stage and sustainably release. It in the intestinal stage, promoting excellent absorption of saffron in simulated digestion.Graphical

A Comparative Study of Using Poly (D, L, Lactide-co-Glycolic Acid) and Chitosan Nanoparticle as Vaccine Delivery System for a Recombinant Fusion Protein of Newcastle Disease Virus

Introduction: The more effective method of preventing many infectious diseases is vaccination. Numerous infectious diseases that affect both humans and animals have significantly decreased as a result of routine immunization. Aim: The present study aimed to compare the efficacy of in-house built chitosan and Polylactide coglycolic acid (PLGA) nanoparticles coupled with Pichia pastoris expressed immunogenic fusion (F) protein of Newcastle disease (ND). Objectives: Synthesis of biodegradable nanoparticles such as PLGA and chitosan offers a promising opportunity as a vaccine delivery system. Methods: Chitosan nanoparticles and PLGA nanoparticles were synthesized by ionic gelation, and double emulsion solvent evaporation, respectively, and the size was 38.6± 0.84 nm and 320 ±1.5nm, respectively. They demonstrated good epitope integrity of recombinant fusion protein and in vitro release kinetics studies have proved consistent release profile of protein Results: In vivo pathogenicity assay of separately injected nanoparticles has proved no abnormal signs and mortality in chickens. Specific pathogen-free (SPF) chicks were vaccinated with chitosan and PLGA nanoparticles and a recombinant fusion protein of the ND virus. It was demonstrated that PLGA nanoparticles coupled with a fusion protein of Newcastle disease virus conferred a marginally better immune response than chitosan nanoparticles. Comparative study-based results showed that PLGA-based nanoparticles proved a better vaccine delivery vehicle and generated an effective immune response without needing further adjuvants. Conclusion: The present study is a scientific platform for developing the PLGA-based vaccine delivery vehicle to improve immune responses against many infectious diseases.

Release kinetic study of microplastics from N95 face masks and consequent effects on freshwater alga Scenedesmus obliquus

The uncontrolled disposal of N95 face masks, widely used during the recent COVID-19 pandemic can release significant amounts of microplastics and other additives into aquatic bodies. This study aimed to: (i) to quantify and analyze the released microplastics and heavy metals from N95 face masks weathered for various time periods (24, 48, 72, 96, 120, and 144 h) and (ii) to assess the cytotoxicity potential of the leachates on a model organism, freshwater alga Scenedesmus obliquus. The mask leachates contained microplastics, polypropylene in different shapes and sizes, and heavy metals like Cu, Cd, and Zn. The leachates significantly reduced cell viability and increased reactive oxygen species (ROS) generation, antioxidant enzyme activity, and membrane damage. The effects were also accompanied by a significant drop in the photosynthetic yield. All of the examined parameters indicated a dose-response relationship, with longer leaching periods resulting in higher microplastic concentrations. Mask leachates severely damaged the structural integrity of the algal cells, as seen in scanning electron microscopy images. The findings of our study confirm that the releases from disposable N95 face masks pose a severe threat to freshwater microalgae, and the cascading effects would harm the aquatic ecosystems.

Antiproliferative activity of syringic acid-loaded nanostructured lipid carriers against MCF-7 human breast carcinoma cells

Syringic acid (SA) is a phenolic herbal compound known to exert antiproliferative properties. However, its poor aqueous solubility and low bioavailability lead to limited therapeutic efficacy in treating breast cancer. Hence, to overcome the above problems, the current study aims to explore the quality by design (QbD) optimized syringic acid loaded nanostructured lipid carriers (SA-NLCs) to treat breast cancer. Here, SA-NLCs were formulated via the hot-melt emulsification method and optimized using the Box-Behnken design. The SA-NLCs exhibited spherical shapes with a particle size and zeta potential of 142.7 ± 4 nm and −14.5 ± 3.6 mV, respectively. The differential scanning calorimetry and powder XRD analyses showed the conversion of crystalline to amorphous form of SA after entrapping into NLCs. Also, the optimized SA-NLCs showed sustained drug release of 75.5 % and 97.6 % in pH 5.5 acetate buffer solution and pH 7.4 phosphate buffer saline respectively. The drug release kinetics study revealed that the optimized SA-NLCs exhibit the Weibull model with the Fickian drug release mechanism. Further, a significantly improved cytotoxicity of the optimized SA-NLCs (IC50: 3.8 ± 0.2 μg/mL) was observed as compared to free SA (IC50: 14.5 ± 1.2 μg/mL) on MCF-7 human breast carcinoma cell lines. Thus, the improved cytotoxicity of SA-NLCs on MCF-7 cell lines can be a suitable strategy for breast cancer treatment.

Hyaluronic acid-based multifunctional bio-active coating integrated with cinnamaldehyde/hydroxypropyl-β-cyclodextrin inclusion complex for fruit preservation

Natural preservatives such as cinnamaldehyde (CIN) are garnering increasing interest to replace their synthetic counterparts in maintaining fruit freshness and safety. However, their long-term effectiveness and widespread application have been greatly limited due to high volatility and potent aroma. To address these challenges, we developed a viable and simple strategy to prepare a multifunctional active coating for fruit preservation by incorporating host-guest inclusion complex of CIN and 2-hydroxypropyl-β-cyclodextrin (HP-β-CD) CIN@HP-β-CD into hyaluronic acid (HA), a natural polysaccharide with exceptional film-forming properties. The as-prepared HA/CIN@HP-β-CD coatings exhibited universal surface affinity, excellent antimicrobial performance, and satisfactory antioxidant properties with no potential toxicity. Release kinetic studies have demonstrated that CIN in the coating is continuously and slowly released. Furthermore, freshness preservation experiments on bananas and fresh-cut apples demonstrated that the developed coating is effective in preserving the color of fruit, decreasing the weight loss rate, preventing the microorganism's growth, and significantly extending the period of freshness, exhibiting the potential for application in fruit preservation.

Folate-conjugated organic CO prodrugs: Synthesis and CO release kinetic studies

Folate-conjugated organic CO prodrugs: Synthesis and CO release kinetic studies

Drug-loaded polymer-coated silver nanoparticles for lung cancer theranostics.

Lung cancer is the leading cause of death in cancer across the globe. To minimize these deaths, the replacement of traditional chemotherapy with novel strategies is significant. We have developed a nanotheranostic approach using silver nanoparticles for imaging and treatment. Silver nanoparticles (AgNPs) are fabricated by chemical reduction method. The formulation of AgNPs was confirmed by different characterization techniques like stability test, UV-Visible spectroscopy, Confocal Raman Spectroscopy, and Energy-Dispersive X-ray analysis. Further, AgNPs are coated with poly lactic-co-glycolic acid (PLGA) and then loaded with paclitaxel(Pac). Then the drug-loaded PLGA-coated AgNPs were characterized for size and zeta potential measurement by zetasizer, surface morphology study by atomic force microscopy, Fourier transform infrared spectroscopy, and release kinetics study. The imaging and anticancer properties of these nanoformulations are investigated using lung cancer cell lines. The results proved that the particles are in the nanometer range with smooth surface morphology. Moreover, the drug-loaded NPs showed a sustained release of the drug for a longer period of time. Further the formulations showed imaging property with greater anticancer efficacy. Thus, the results suggest the effective use of these nanoformulation in both lung cancer imaging and treatment using a simple and efficient approach.

Exploring the Potential of Momordica charantia Fruits Mucilage as a Novel Pharmaceutical Excipient

Background: The discovery and developments of new drug formulations are inspired by medicinal plants. Polysaccharides, such as mucilage or gum from medicinal plants, have a variety of physicochemical properties and are commonly used in pharmaceutical applications. Objectives: The current study's objectives are to construct and assess Metformin HCl tablets employing Momordica charantia (MC) natural mucilage as a binder and release modifier. Methods: The mucilage was isolated from the fruits of MC. The tablet was made using a wet granulation process, and the formulation included several mucilage ratios (1%, 2.5%, 5%, and 10%). Results: It was found that the granules and tablets had good flow qualities based on results of the pre- and post-compression parameters. The release kinetic study showed that F4 showed the first order release kinetics and F8 showed the zero and the higuchi’s release kinetics. In low concentration of mucilage tablets showed good binding properties with immediate release properties. As the concentration was increased, tablets showed good binding properties with sustained release properties. Conclusion: The isolated mucilage from Momordica charantias has the potential to be used as a tablet binder and as an intermediary in the development of a sustained-release drug

Preparation and release of antibacterial Na-mica-4/chlorhexidine nanocomposites

High charge swelling micas are layered silicates used in adsorption of several inorganic and organic species. In this study, we evaluated the adsorption of chlorhexidine digluconate on highly charge mica Na-mica-4. Drug release and antibacterial action against Staphylococcus aureus (S. aureus) and Escherichia coli (E. coli) using the direct contact test for mica/chlorhexidine hybrids were evaluated. The hybrids were characterized using X-ray diffraction, Fourier transform infrared spectroscopy, zeta potential measurements, CHN elemental analysis, and scanning electron microscopy. Chlorhexidine interacts successfully with the mica surface. The maximum amount of chlorhexidine incorporated was 583 mg g−1, and the characterizations indicated that electrostatic attraction between the protonated amino group of the drug and the negative surface of clay was predominant in the formation of hybrids. Release kinetics study indicated that 80% of the drug release occurred in the first 12 h. The antibacterial test proved to be dependent on the time of chlorhexidine release, reaching 100% inhibition against S. aureus and E. coli after 0.5 h and 6 h, respectively.

Effect of mango butter on the physicochemical properties of beeswax-Moringa seed oil-based oleogels for topical application

Objective The purpose of this research was to determine any connections between the characteristics of oleogels made of beeswax and the impact of mango butter. Methods Oleogel was prepared through inverted tube methods, and optimized through oil binding capacity. Other evaluations like bright field and polarized microscopy, Fourier-transform infrared (FTIR) spectroscopy, crystallization kinetics, mechanical study, and X-ray diffractometry (XRD). The drug release kinetic studies and in vitro antibacterial studies were performed. Results FTIR study reveals that the gelation process does not significantly alter the chemical composition of the individual components. Prepared gel exhibiting fluid-like behavior or composed of brittle networks is particularly vulnerable to disruptions in their network design. The incorporation of mango butter increases the drug permeation. In-vitro microbial efficacy study was found to be excellent. Conclusion The studies revealed that mango butter can be used to modify the physico-chemical properties of the oleogels.

Fabrication and Synthesis of Thiococlchicoside Loaded Matrix Type Transdermal Patch.

The goal of this work was to synthesize and fabricate matrix type transdermal patches based on a combination of polymers (Eudragit L100, HPMC and PVP K30), plasticizer and crosslinking agents (propylene glycol and triethyl citrate) and adhesives (Dura Tak 87-6908) to increase Thiocolchicoside (THC) absorption via topical route. This method allows avoidance of first-pass metabolism along with a consistent and extended duration of therapeutic activity. Fabrication and casting of polymeric solutions containing THC was done either in petri plates or through lab coater to get transdermal patches. Finally, the formulated patches were studied for their physicochemical and biological evaluation using scanning electron microscopy, FTIR, DSC, XRD and ex-vivo permeation studies using pig ear skin. FTIR studies confirm that the THC characteristics peaks (carbonyl (Amide I) at 1525.5 cm-1, C=O stretching (tropane ring) at 1664.4 cm-1, Amide II band (N-H stretching) at 3325.9 cm-1, thioether band at 2360.7 cm-1, and OH group stretching band at 3400.2 cm-1) are still present in the polymer mixture even after formulation as a transdermal patch, indicating compatibility among all excipients. While on the other hand, DSC studies confirm endothermic peaks for all the polymers along with THC with the highest enthalpy of 65.979 J/g, which is an indicator of sharp endothermic peak at 198°C, leading to the melting of THC. The percentage drug content and percentage moisture uptake of all the formulation was found in the range of 96 ± 2.04 to 98.56 ± 1.34% and 4.13 ± 1.16 to 8.23 ± 0.90%, respectively. Drug release and release kinetics studies confirm that it is dependent on the composition of individual formulation. All these findings support the possibility of using suitable polymeric composition, as well as proper formulation and manufacturing circumstances, to create a one-of-a-kind technology platform for transdermal drug administration.

Development and Assessment of Hydroxypropyl Methylcellulose-Based Floating Tablets for Ciprofloxacin HCL Using Direct Compression Technique

The key findings and conclusions include: such as formulation approaches as aim and objective Development of floating tablets using sodium bicarbonate and HPMC aimed at enhancing gastric residence time for improved drug bioavailability. Physicochemical Compliances The formulated tablets met compliance standards for various physicochemical parameters, including dimensions, floating time, tablet density, and drug content. Method of Formulations F2, F5, and F6 displayed favorable drug release profiles, with the F7 formulation exhibiting excellent release characteristics. in the evaluation the drug release kinetics studies show Kinetic analysis revealed that F2, F5, F6, and F7 formulations followed the Korsmeyer–Peppas model, indicating non-Fickian diffusion with 'n' values ranging from 0.521 to 0.633 and the stability indicates the Optimal storage conditions for stability were determined as 2-8°C for 60 days. Formulations F2, F5, F6, and F7 demonstrated stability at room temperature, 40°C, and 2-8°C for 30 days, with refrigerated storage maintaining stability throughout the 60 days. In conclusion, the developed hydrodynamically balanced tablets of Ciprofloxacin HCl exhibit promising physicochemical characteristics, dissolution profiles, and stability. These tablets hold the potential for enhancing drug bioavailability, making them a viable option for localized drug delivery in the upper gastrointestinal tract.

Spray-Dried Chitosan Hydrogel Particles as a Potential Delivery System for Benzydamine Hydrochloride.

Chitosan, being a biocompatible and mucoadhesive polysaccharide, is one of the most preferred hydrogel-forming materials for drug delivery. The objectives of the present study are to obtain spray-dried microparticles based on low-molecular-weight chitosan and study their potential application as cargo systems for the orally active drug benzydamine hydrochloride. Three types of particles are obtained: raw chitosan particles (at three different concentrations), cross-linked with sodium tripolyphosphate (NaTPP) particles (at three different chitosan:NaTPP ratios), and particles coated with mannitol (at three different chitosan:mannitol ratios), all of them in the size range between 1 and 10 µm. Based on the loading efficiency and the yields of the formulated hydrogel particles, one model of each type is chosen for further investigation of the effect of the cross-linker or the excipient on the properties of the gel structures. The morphology of both empty and benzydamine hydrochloride-loaded chitosan particles was examined by scanning electron microscopy, and it was quite regular and spherical. Interactions and composition in the samples are investigated by Fourier-transformed infrared spectroscopy. The thermal stability and phase state of the drug and drug-containing polymer matrixes were tested by differential scanning calorimetry and X-ray powdered diffraction, revealing that the drug underwent a phase transition. A drug release kinetics study of the chosen gel-based structures in simulated saliva buffer (pH = 6.8) and mathematical modeling of the process were performed, indicating the Weibull model as the most appropriate one.

Formulation and Characterization of Self-Microemulsifying Drug Delivery System (SMEDDS) of Sertraline Hydrochloride.

Sertraline hydrochloride is the most widely used selective serotonin reuptake inhibitor (SSRI) for the treatment of several depressive disorders. Its applicability is limited due to extensive metabolism and poor oral bioavailability of 44 %. The current research focused on improving the solubility and oral bioavailability of Sertraline by using microemulsions developed by a self-micro emulsifying drug delivery system (SMEDDS) for significant antidepressant action. SMEDDS were developed by selecting appropriate proportions of oil, surfactant, and co-solvents and out of them isopropyl myristate, tween 80 and propylene glycol were identified as best. The emulsification zone was demonstrated by a ternary phase diagram, and compatibility was confirmed with Fourier-transformed infrared spectroscopy (FT-IR). The formulated SMEDDS were characterized for robustness to dilution, globule size (GS), polydispersity index (PDI), viscosity, in-vitro dissolution and diffusion study, and drug release kinetics study. All the batches (A1-A9) passes the test and A3 was selected as an optimized batch that doesn't show phase separation, precipitation with globule size (101 nm), PDI (0.319), drug content (99.14±0.35 %), viscosity (10.71±0.02 mPa), self-emulsification time (46 sec), in-vitro drug release (98.25±0.22 %) within 8 h, release kinetics (Higuchi) and effective antidepressant in in-vitro diffusion studies. An optimized batch A3 observed circular in shape estimated by Transmission electron microscopy (TEM) and passes all the thermodynamic stability testing with loss of 0.271 mg of the drug after 90 days and showed marked antidepressant action with higher stability.

Design of Hydrogel for the Drug Delivery of Less Permeable Ursolic Acid Isolated from Rhododendron arboreum Flower in Animal Skin Membrane

Ursolic acid (UA) is a pentacyclic triterpene that has antioxidant, anticancer, and anti-inflammatory properties. As it belongs to the biopharmaceutical classification system IV due to its poor water solubility and permeability restricts its use in clinical application. So, the research is focused on the development of hydrogel containing encapsulated liposomes of ursolic acid to increase its permeability. The ursolic acid liposomal gel was prepared with a 0.5%, 1%, and 1.5% mixture of carbopol 934P and HPMC K4M as gelling agents. The pH and spreadability of liposomal gel were found to be in the range of (6.93±0.035 to 7.12±0.03) and (15.41±0.36 to 24.47±0.90) g.cm/sec respectively. The drug content was found to be in (19.77±0.02 to 20.11±0.02)%. The study of drug release kinetics showed Higuchi release followed by a non-Fickian diffusion mechanism. The result of the permeation study by Franz diffusion cell showed 1.55 times higher compared to the plain gel at the 5th hour of the study with a flux value of 0.455(mg/cm2/hr). It resolved the fast and enhanced delivery of liposomal ursolic acid through the skin membrane.

Comprehensive strategy of white analytical chemistry and analytical quality by design to sensitive spectrofluorimetric method for in-vitro drug release kinetic study of Ibrutinib-loaded nanostructured lipid carriers for leukemia via lymphatic targeting

Ibrutinib (IBR) is a drug classified as BCS class II, characterized by low solubility and high permeability. However, its oral bioavailability is limited to a mere 2.9% due to significant first-pass metabolism. To address this challenge, researchers developed IBR-NLCs (Nanostructured Lipid Carriers) using a DoE-based hot melted ultrasonication method to enhance its bioavailability and drug release profile. While various methods exist for IBR analysis in pharmaceutical formulations, human plasma, and rat plasma, a sensitive spectrofluorimetric method has not been reported for estimating IBR. To facilitate in-vitro drug release kinetic studies of IBR-NLCs, a sensitive and green spectrofluorimetric method was developed, combining principles of white analytical chemistry and analytical quality by design. This approach included a fractional factorial design for screening of method variables and a Box-Behnken design for method optimization. The developed method underwent rigorous validation following ICH guidelines. The developed method was applied to assess the in-vitro drug release kinetic study of IBR-NLCs in comparison to marketed formulations. Remarkably, the optimized IBR-NLCs exhibited sustained release of IBR which helps to decrease dose and dose frequency. The whiteness and greenness profiles of published and proposed method have been assessed using analytical greenness calculator, green analytical procedure index software, national environmental method index standards, and eco-scale assessment tool. The results confirmed that the proposed method is sensitive, eco-friendly, cost-effective, speedy, and user-friendly, making it an excellent choice for IBR estimation in NLCs. In summary, the developed method for drug release kinetic study of BR-NLCs, utilizing principles of white analytical chemistry and analytical quality by design, has not only improved drug release profile but also resulted in an efficient and environmentally friendly analytical approach.

Formulation and Evaluation of Teneligliptin Nanosuspension

In this present study, the drug Teneligliptin is selected for the management of Type-2 Diabetes mellitus. The drug-excipient compatibility study results showed that there is no chemical change occur between the drug and the excipients and there was no functional group change observed. Teneligliptin is poorly water-soluble drug and it was fabricated as nanosuspension of Nine formulations by using nano precipitation technique. In this method, nano size particle size of Teneligliptin was obtained by using different type of various proportions of stabilizers along with other ingredient at different stirring speed. For the prepared formulation (F1-F9) the particle size, polydispersibility index and zeta potential were done. Among nine formulations, formulation 8(F8) results revealed that the values are desirable and stable. The total drug content of all the formulation ranges from 81% to 99%, The average particle size of F1 to F9 batches was found to be in the range of 0.211 nm to 0.486 nm The scanning electron microspore study stated that the nano size particles were spherical in shape. Among all the formulations (F8) was optimized which showed maximum highest percentage of drug release at 24 hours. The cumulative percentage of drug release of formulation 8 (F8) increase with the optimum concentration of stabilizers and tween 80. The release rate of optimized formulation 8(F8) was fitted with various release kinetic studies and the selected formulation followed zero order kinetics. The results of stability study was confirmed that the prepared Teneligliptin nanosuspension is stable during the stability study. Thus, it can be concluded that the nanosuspension method was commercially feasible and cost effective.