Current Trends in Biotechnology and Pharmacy

Formulation and Assessment of Novel Ivabradine Hydrochloride Microspheres Using Synthetic Polymers

Lakshmana Rao Atmakuri — 2025-06-10

The research centers on developing Ivabradine hydrochloride microspheres through solvent evaporation with synthetic polymers including cellulose acetate, ethyl cellulose, and eudragit RS100. The research tries to make the drug more effective medicinally while managing its release pattern. Various features of manufactured microspheres underwent evaluation through tests for drug loading assessment and measurement of encapsulation efficiency exams as well as morphological examination and particle dimension assessments. Researchers evaluated Ivabradine HCl microsphere controlled drug release patterns through laboratory-based testing assessments. The development of Ivabradine HCl microspheres using the solvent evaporation method succeeded with the combination of cellulose acetate, ethyl cellulose, and eudragit RS100 in ratios of 1:1, 1:1.5, and 1:2. SEM results verified that the microspheres maintained consistent spherical shapes among uniformly distributed particles. The in vitro dissolution investigation showed Ivabradine HCl released at a greater rate when exposed to pH 7.4 solution than when placed in solutions of pH 1.2 & 5.5. The controlled release of drug process of microspheres reached 90% and continued throughout twelve hours of evaluation in phosphate buffer solution maintained at pH 7.4. Microspheres made using 1:2 ratio of cellulose acetate together with span 80 achieved optimal controlled release throughout a 12-hour period. All tests showed that drug-excipient reactions did not occur which points to the formulation's stable state. The research data suggests that Ivabradine HCl microsphere technology demonstrates capabilities as an efficient controlled-release delivery system and enhanced medication compliance platform.

A Quality by Design Driven RP-HPLC Method for the Assay of Lobeglitazone & Glimepiride and In-silico Admet Studies

Gangu Naidu Challa — 2025-06-10

A cost-effective, simple and accurate Quality by Design (QbD) based approach for the analysis of Lobeglitazone and Glimepiride in tablet dosage forms was developed. Insilico study was performed to investigate the pharmacokinetic and toxicological properties of the two drug products.The method was subjected to optimization using a central composite design, where column temperature, flow rate, and organic phase ratio in the mobile phase were optimally tuned as critical parameters to determine critical analytical parameters, i.e., resolution and theoretical plate number. Maximum separation was achieved on a C18 column using a mobile phase containing acetonitrile and 10 mM ammonium acetate buffer, 1.0 mL/min flow rate, and 40 °C column temperature. The statistical assessment was done using Design expert software and excel. pkCSM web server was used for Absorption, Distribution, Metabolism, Excretion and Toxicity (ADMET) studies. Glimepiride and Lobeglitazone retention times of 8.923 minutes and 10.529 minutes, respectively, were achieved. The drug product was found to be sensitive towards acidic, basic, neutral, oxidative, photolytic, and thermolytic conditions. Glimepiride’s potential for hepatotoxicity and Lobeglitazone’s possible cardiac risks due to hERG inhibition highlight the need for vigilant monitoring in patients.

Preformulation Analysis of Millet-Derived Starches: A Comparative Study

Eswara Gopala Krishna Murthy Talasila — 2025-06-10

Starch is a widely utilized excipient in the pharmaceutical industry, playing essential role as a multi functional adjuvant. While starches from rice, wheat, maize, corn and potato have traditionally been used, there is growing interest in alternative raw materials driven by sustainability and the demand for nutrient-rich options. Millets, small-seeded grains known for their high nutritional value and wide cultivation, present a promising alternative to conventional starch sources. This study aimed to isolate and evaluate starches from barnyard millet, finger millet, foxtail millet, kodo millet and little millet. The isolated starches were characterized for different parameters. The results revealed that the starch isolated from barnyard millet exhibited favorable rheological properties, indicating its suitability as an effective excipient. Granules were prepared using starch paste from the different millet species, and their micrometric properties were evaluated. Tablets were then formulated with these granules and subjected to various quality control tests. The results confirmed that barnyard millet starch demonstrated favorable rheological properties and served as an excellent binder, making it a promising alternative for pharmaceutical applications.

Hair Growth Stimulating and Antibacterial Activities of a Poly Herbal Hair Tonic

Karuna Sree Varicola — 2025-06-10

Healthy hair represents an individual's physical and emotional wellbeing. The scalp protectshair from regular wear and tear. Hair oiling protects the follicles and prevents dryness of hair by restoring moisture, sustains hair growth and gives relaxation. Herbal formulations have considerable attention because of less scope for side effects as compared to synthetic counterparts. This investigation intends to develop and assess the efficacy of hair tonicsand the antibacterial activity of a polyherbal formulation prepared from the selected medicinal plants. Roots and aerial roots of Ficus religiosa and seeds of Abrus precatorious which contain valuable therapeutic constituents are selected for this work. Abrus precatorius, also known as 'Kunnikuru' in Malayalam, Guruvindaginja in Telugu, and Kundumani in Tamil, has been utilized for millennia in supplementary medicine. Nearly fifty different conditions, such as asthma, diabetes, diarrhoea, epilepsy, stomach issues, inflammatory diseases, infectious disorders, and sexual disorders, are treated with Ficus religiosa in traditional medicine. This work is primarily intendedto provide a scientific base for the traditional uses of these selected plants. From this study, it is evident that the hair growth activity of 24 hours of application of poly herbal formulationon Male Wistar rats exhibited a more substantial effect compared to the standarddrug Minoxidil and control groups. Lastly, our research demonstrated that extracts from Ficus religiosa and Abrus precatorious can promote hair growth, making them useful for treating alopecia. The antibacterial potential of these extracts is on par with the industry benchmark. Research conducted by us showed that the primary components of aqueous extracts and alcohol are flavonoids, alkaloid compounds, carbohydrates, and tannins.

Innovative Formulation and Evaluation of Sumatriptan Fast Dissolving Tablets through 3² Factorial Design

Anusha Ravulapati — 2025-06-10

In this study, the objective aims to develop and analyse fast-dissolving tablets (FDTs) of sumatriptan using superdisintegrants primojel and crospovidone by direct compression technique. In each case tri concentrations of super disintegrant (3, 4 and 5 %) were used in the preparation of FDT’s. The tablets prepared were analysed for disintegration rate, disintegration time, hardness, friability, and drug concentration. The following conclusions are derived from the obtained results. A 3-level-2-factorial experimental design is chosen to specify the percentage of the independent variables primojel crospovidone that were included in the formulation of Sumatriptan Fast Dissolving Tablets. All FDTs prepared disintegrated within 34 sec. Among the nine formulations F9 gave 100 % drug release 6 min. All of the prepared FDTs led sumatriptan to dissociate rapidly. In each instance, the levels of super disintegrant increased along with the sumatriptan's rate of disintegration.A series of equations were generated for disintegration time (DT), percent drug disintegrated in 10 minutes (PD10).Y1= 74.00 – 7.83 X1 -22.67 X2-2.75 X1X2 +1.50X12 -6X22 (DT), Y2= 96.22 + 3.17X1 +5.33 X2 -2.50 X1X2 +1.71 X12 – 4.33 X22 (PD10m). The findings indicate that a higher concentration of Superdisintegrants results in a shorter disintegration time for the dosage form, and that a suitable selection of X1 and X2 levels can alter the drug release pattern.To check the validity of equation DT was selected for 40 sec and PD10 for 98.00. The Final Formula DT Values and PD10were found to be 39 sec and 98.64 % indicating the validity of equation. Thus sumatriptan tablets could be successfully prepared using primojel and Crospovidone using 3² Factorial Design.

A New Validated Stability Indicating RP-HPLC Method for Estimation of Vorasidenib in Bulk and in its Pharmaceutical Dosage Form

Giddaluri Ramya Sri — 2025-06-10

For the estimation of Vorasidenib in bulk and in its pharmaceutical dosage form, a reversed phase high-performance liquid chromatographic approach has been designed and validated in the current work. The separation of Vorasidenib was achieved on Waters Alliance-e2695, by using an XBridge Phenyl column (250x4.6mm, 5μ) by eluting with a mobile phase consisting of a mixture of acetonitrile and 0.1% Trifluoroacetic acid in the ratio of 40:60v/vat a flow rate of 1.0 mL/min; detection was carried out by absorption at 234 nm using a photodiode array detector at ambient temperature. The total run time set for the elution of the compound was 5 min. Under the optimised chromatographic conditions, the retention time was obtained at 2.855 min. The current analytical technique validation was conducted in accordance with ICH standards (ICH, Q2R1). The concentration range forVorasidenib in the linearity study was found to be 20–120 μg/mL and the coefficient of variance was found to be 0.9999. The percentage recovery was found to be 99.6-100.3%. LOD and LOQ were found to be 0.48 μg/mL and 1.6 μg/mL respectively. The developed method was also applied to monitor the forced degradation studies on the drug for testing for its ability to resolve the drug from their degradation products. The specificity of the developed method was evaluated by applying acid, base, oxidation, thermal, photolytic and neutral stress conditions to the drug. It was concluded that the estimation of Vorasidenib in bulk and its pharmaceutical dosage form was found to be successfully conducted by using the method.

Development and Validation of Bio-Analytical Method for Simultaneous Estimation of Metformin, Vildagliptin and Remogliflozin in Rabbit Plasma by using RP-HPLC

Prasanthi Thayi — 2025-06-10

The current investigation was intended to develop and validate bio-analytical RP-HPLC method for the simultaneous analysis of Metformin, Vildagliptin and Remogliflozin in rabbit plasma employing Saxagliptin as an internal standard. Protein precipitation method was used to extract the analytes from spiked plasma samples. Chromatographic separation of extracted analytes was achieved on X Bridge C18, (150 mm X 4.6 mm and 3.5 μm) column using the mobile phase consists of 0.01N KH2PO4: acetonitrile (70: 30 v/v, pH 5.4). Isobestic point of 235 nm wavelength was selected for quantification of drugs. The peaks eluted at 2.262 min, 3.850 min and 5.903 min were recognized as Metformin, Vildagliptin and Remogliflozin respectively. The present method showed desirable proportional response in the range of 25-2500 ng/mL for Metformin, 5-1000 ng/mL for Vildagliptin and 25-2500 ng/mL for Remogliflozin. Low variance was observed (%CV) in the results of precision and accuracy and excellent and reproducible recoveries were obtained with spiked plasma samples. Stability studies such as long term, short term and freeze thaw stability were performed and produced inconsistent results. The results revealed the proposed method can be appropriate for the simultaneous bio-analysis of Metformin, Vildagliptin and Remogliflozin in rabbit plasma and successfully employed for pharmacokinetic studies.

Impact of Fenugreek Oil on Sitagliptin's Pharmacokinetic and Pharmacodynamic Profile: A Computational Docking Study to Correlate Blood Glucose Level

Sukanya Manam — 2025-06-10

Sitagliptin, a DPP-4 inhibitor, performs by blocking the enzyme dipeptidyl peptidase-4 (DPP-4), which usually degrades incretin hormones that regulate blood glucose level. By inhibiting DPP-4, Sitagliptin enhances incretin levels, promoting insulin release and reducing liver glucose production. This study aimed to investigate the pharmacokinetic and pharmacodynamic interaction in between Sitagliptin, and fenugreek oil. The pharmacokinetic interactions were investigated with molecular docking studies and the results revealed that the absorption of Sitagliptin may be more in presence of fenugreek oil due to high binding energy of linoleic acid, linolenic acid and oleic acid present in fenugreek oil with PGlycoprotein (P-gp). The albumin binding capacity is less from the fatty acids of fenugreek oil compared to Sitagliptin. The metabolism of Sitagliptin caused by CYP3A4 is less in presence of fenugreek oil as the docking score is more with the components of fenugreek oil. This molecular docking study predicts an improvement of oral bioavailability of Sitagliptin in presence of fenugreek oil due to increased absorption and reduced metabolism. Pharmacodynamic studies were carried out by observing the blood glucose level in Streptozotacin induced diabetic rats. Higher percentage reduction in blood glucose was observed from the group treated with Sitagliptin and fenugreek oil compared to test group treated with Sitagliptin. Thus molecular docking studies are correlated with in-vivo experimental blood glucose data.

Development of Robust RP-HPLC Method for Concurrent Analysis of Aliskiren and Amlodipine in Combined Tablet Dosage Form

Lakshmana Rao Atmakuri — 2025-06-10

Present research focuses on development & validation of a robust RPHPLC method for the concurrent estimation of Aliskiren & Amlodipine in collective tablet dosage forms. The mixture of Aliskiren, selective renin inhibitor, & Amlodipine, calcium channel blocker, is commonly prescribed for the management of hypertension. The primary purpose of research was to establish a fast, accurate, & stability-indicating RP-HPLC method that can reliably quantify both active pharmaceutical ingredients (APIs) in a single analytical run. The method was validated as per ICH guidelines, confirming its precision, linearity, accuracy, & sensitivity. Optimized chromatographic conditions included an acetonitrile and hexane sulfonic acid mixture (55:45 v/v) as mobile phase, which provided adequate resolution & quick retention times for both compounds. Method demonstrated excellent linearity with Aliskiren concentration ranging from 15 to 225 μg/mL & Amlodipine from 1 to 15 μg/mL. Retention times for Aliskiren & Amlodipine were 2.716 minutes & 7.351 minutes, respectively. Method proved suitable for routine analysis & stability testing, offering high sensitivity & reliable results for the quantification of Aliskiren & Amlodipine in tablet formulations under stressed conditions.

A Novel RP-UPLC Technique for Quantification of Daunorubicin and Cytarabine Simultaneous in Combined Tablet Dosage Forms - Its Application in Monitoring Forced Degradation Studies

Vasudha Dadi — 2025-06-10

To establish and evaluate new reverse-phase ultra-performance liquid chromatography (RP-UPLC) technique to measure daunorubicin and cytarabine at the same time in combined tablet forms and to use this technique to monitor forced degradation studies. Using standardized testing, the authors identified a technique, reverse-phase ultraperformance liquid chromatography (RP-UPLC), on a piriform C18 column, 50mmx2.1mm OD core particle sizes, 1.7 micron. This approach used a changing mix of acetonitrile and a phosphate buffer with a pH level of 3.0. The liquid moved through the system at a rate of 0.3mL per minute, and UVlight detected substances at a wavelength of 254 nm. For the robustness of the method to be ensured, the scientific (research) community has used the ICH guidelines, has estimated the following functionalities, i.e., repeatability, reproducibility, accuracy, robustness and reliability. Moreover, the investigators also proved the protocol's versatility in various stress environments (acidic and basic stress, oxidative stress and thermal stress, light exposure and radiation). The method exhibited excellent linearity for both daunorubicin and cytarabine of concentration of 0.5–50μg/mL (R² > 0.999). Forced degradation studies demonstrated efficient separation of the analytes and degradation productsof the corresponding analytes, confirming the stability-indicating capability of this technique. Validation results indicated high precision, accuracy, and robustness, making the method suitable for routine quality control.Thus, this newly established RPUPLC techniqueis an efficient and reliable procedure for the quantification of both the drugs at the same timein combined formulation.It is also a strong stabilityindicating method forforced degradation studies ensuring the quality and purity of the pharmaceutical formulation.

Formulation and Evaluation of Tinospora Cordifolia - Cholesterol Phytophospholipid Complex for Enhanced Anti-Inflammatory Activity

Raveesha Peeriga — 2025-06-10

Tinospora cordifolia is widely recognized for its anti-inflammatory and immunomodulatory properties, offering therapeutic potential for managing inflammatory disorders such as arthritis and chronic autoimmune diseases. To develop and evaluate a Tinospora cordifoliacholesterol phytophospholipid complex to enhance entrapment efficiency and optimize drug release profiles, facilitating its application in inflammatory disorder management. To compare the drug entrapment efficiency and release profiles of nine formulations, identify the impact of cholesterol-to-extract ratios, and determine the most effective formulation. Nine formulations (F1–F9) of the Tinospora cordifolia-cholesterol phytophospholipid complex were prepared and evaluated for drug entrapment efficiency and in vitro release over eight hours. Burst and sustained release characteristics were analyzed, and the influence of varying cholesterol ratios was assessed to determine optimal formulation parameters. Formulation F7 showed the highest entrapment efficiency (92.91%), followed closely by F4 (92.31%), both indicating superior drug retention. F4 displayed an optimal release profile, with a burst release of 36.9% in the first hour and sustained release of 92.3% by the eighth hour. Higher cholesterol ratios, as seen in F4 and F2, enhanced stability and controlled release, while lower ratios in formulations such as F1 and F7 resulted in reduced performance. This research demonstrates the feasibility of a cholesterol-based phytophospholipid complex for enhancing the delivery of Tinospora cordifolia. Formulation F4 emerged as the most promising candidate due to its balanced burst and sustained release properties, offering potential for clinical applications in inflammatory disorder management. Future studies should validate its pharmacokinetic and in vivo therapeutic efficacy.

Bioanalytically Validated LC-UV Method for Estimation of Hypoxia-Inducible Factor-2 alpha (HIF-2α) Inhibitor in Spiked Human Plasma

Parimala Kolli — 2025-06-10

Belzutifan is a hypoxia-inducible factor- 2 alpha (HIF-2α) inhibitor used to treat von Hippel–Lindau disease-associated renal cell carcinoma. Simple, accurate, precise, and specific HPLC method was developed to estimate Belzutifan (BZT) in human plasma serving Emtricitabine (ETC) as reference (ISTD). The analyte and ISTD were separated on a Kromasil C18 (250x4.6mmx5μ) column using a mobile phase composition. The buffer was composed of Acetonitrile (60:40). The RTs of the analyte and ISTD were found to be 3.446 and 2.363 min, respectively with a flow of 1ml/min. Further, the reported method validated as per USFDA, and was found to be well within the acceptable range for all parameters with concentrations of LLOQ 0.075mcg/ml, LQC 0.225mcg/ml, MQC 1.5mcg/ml, HQC 2.4mcg/ml, and ULOQ 3.0 mcg/ml. The matrix effect at HQC and LQC was 100.19 and 99.83%; the sensitivity at LLOQ was 99.63%; the precision and accuracy at HQC, MQC, LQC, and LLOQ was between 98.56 and 100.11%. The linearity concentration is in the range of 0.75-3mcg/ml Belzutifan with a correlation coefficient of r2 = 0.999 with good stability. The proposed HPLC method as easy, fast, and particular for the calculation of Belzutifan in human plasma. Efficient sample preparation and rapid chromatographic analysis are crucial for high-throughput detection and quantification of target analytes in complex matrices such biological matrices. Thus, the reported HPLC method can be applied to the bioequivalence and pharmacokinetic studies of Belzutifan in human plasma samples and is appropriate for therapeutic drug monitoring in clinical laboratories.

Formulation and Assessment of Gliclazide Solid Dispersions

Rajani Vetapalem — 2025-06-10

Gliclazide, a sulfonylurea-class oral hypoglycemic agent, suffers from poor aqueous solubility, limiting its bioavailability and therapeutic efficacy. To enhance its solubility & dissolution rate, solid dispersions of Gliclazide were developed using PEG 6000 as hydrophilic carrier through physical mixing and kneading methods. Spectrophotometric analysis in pH 6.8 phosphate buffer confirmed linearity and reproducibility within a 2-10 μg/mL range. Flow property evaluations revealed good flow characteristics, with angle of repose (23.45– 25.88°), compressibility index (13.22– 14.11%), and Hausner’s ratio (1.10–1.25). Dissolution studies demonstrated significantly improved drug release from solid dispersions compared to pure Gliclazide. Among all formulations, GK2 (kneading method, 1:2 drug-to-polymer ratio) showed the fastest release, achieving 99.68% drug release within 45 minutes and exhibiting favorable kinetic parameters (T₅₀ = 2.5 min, T₉₀ = 20 min, R² = 0.999). Accelerated stability studies confirmed physical & chemical stability of optimized formulation (GK2), with consistent drug release profiles before and after storage. Overall, the kneading method with a higher polymer ratio proved most effective in enhancing Gliclazide's solubility and dissolution, offering a promising strategy to improve its bioavailability.

Green Synthesis of Zinc Oxide Nanoparticles Using Pterocarpus santalinus Leaf Extract: Antioxidant Potential and Antibacterial Efficacy Against Pseudomonas cichorii in Chrysanthemum

Shaik Babulla — 2025-06-10

The green manufacturing of nanoparticles utilising biological systems, particularly plant extracts, is a new field in nanotechnology. Zinc oxide nanoparticles were created in this work using an aqueous extract of Pterocarpus Santalinus leaves and zinc salt (zinc nitrate) as precursors. The green synthesised zinc oxide nanoparticles were assessed using a UV-visible spectrophotometer. Utilising SEM with EDAX, the shape of the zinc oxide nanoparticles was described. Research employing X-ray diffraction (XRD) equipment revealed that zinc oxide nanoparticles are crystalline and pure. Utilising FTIR spectroscopy, the specific functional groups in charge of the reduction, stabilisation, and capping agents seen in the nanoparticles were identified. Using the disc diffusion technique, the antibacterial activity of synthesised ZnO nanoparticles against a multihost bacterium (Pseudomonas cichorii) was evaluated. ZnO nanoparticles had superior antibacterial action. The findings of the antioxidant testing were positive. This work demonstrates that zinc oxide nanoparticles made through green synthesis have inherent anti-microbial and antioxidant qualities that might be used to make agricultural insecticides.

Bioanalytical Method Development and Validation for Quantification of an Anti-Neoplastic Agent - Glasdegib by using LC–MS/MS (ESI) in Human Plasma

Yamarthi Venkateswara Rao — 2025-06-10

Glasdegib is inhibitor of a Hedgehog signaling pathway used in the treatment of cancer associated with Sonic Hedgehog protein overexpression like breast, pancreatic, medulloblastoma, etc. Since this drug was recently approved by the food and drug administration the effectiveness of the treatment as well as the quality control of this drug need to be monitored. The highly sensitive and selective analytical technique like LC-MS/MS is necessary to monitor the quality and quantity of this drug in biological fluids. Hence this work aimed to develop an LC-MS/MS method to accurately quantify Glasdegib in biological fluids. Quantification of this drug was achieved by using a C18 symmetric column (150 mm x 4.6 mm, 3.5 μm) and isocratic elution, with a mobile phase containing Acetonitrile: 0.1% formic acid at a 30:70 ratios. The flow rate was set at 1 mL/min, and the mobile phase pH was adjusted to 4.0.The retention time for Glasdegib was found as 2.62 min, and a linear curve was established for concentrations between 6.00 and 120 ng/mL with regression coefficient of 0.999.Results showed that system suitability parameters, including theoretical plates, tailing factor, and resolution, within acceptable limits. Recovery testing indicated 99.94% extraction efficiency, while matrix effect studies revealed minimal interference (98.56%). Validation results of accuracy, linearity, and LOD/LOQ were found within acceptable ranges.The proposed LC-MS/MS method provides a sensitive, accurate, and reliable analytical approach for measuring Glasdegib in biological matrices, supporting its clinical applications in cancer treatment.