International Journal of Pharmaceutics and Drug Analysis

Formulation Optimisation and Evaluation of a Turmeric Extract–Incorporated Emulgel Using a Simplex Lattice Approach

Archana G L — 2026-01-08

Turmeric (Curcuma longa L.) possesses well-established anti-inflammatory, antioxidant, antimicrobial, and wound-healing properties; however, its topical application is limited by poor solubility, instability, and inadequate skin penetration. The present study aimed to develop and optimise a turmeric extract–incorporated emulgel using a simplex lattice experimental design to overcome these limitations and achieve an effective topical delivery system. Preformulation studies, including FTIR and DSC analyses, were carried out to characterise the extract and assess compatibility with formulation excipients. Solubility screening was performed to select suitable oil, surfactant, and co-surfactant for nanoemulsion development. Nanoemulsions were prepared and incorporated into an HPMC-based gel to form Nanoemulgels, which were optimised using Design-Expert® software with particle size and viscosity as response variables. The optimised formulation (F6) exhibited a mean particle size of approximately 379 nm with acceptable polydispersity and zeta potential, indicating good physical stability. The nanoemulgel showed skin-compatible pH, desirable rheological behaviour, uniform drug content, good spreadability, and sustained in-vitro drug release. Accelerated stability studies confirmed formulation stability over the study period. Overall, the findings demonstrate that simplex lattice-based optimisation is an effective approach for developing a stable and efficient turmeric extract nanoemulgel suitable for topical therapeutic and cosmetic applications.

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF VIMSELTINIB BY USING HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM.

Shaileshkumar Bhingaradiya — 2026-02-23

A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Vimseltinib in bulk and pharmaceutical dosage form. Chromatographic separation of Vimseltinib was achieved on Waters Alliance-e2695_,by using Waters Agilent Eclipse XDB (150x4.6 mm, 3.5µm) column and the mobile phase containing Acetonitrile and 0.1% Formic acid in the ratio of 20:80% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 221nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Vimseltinib were NLT 2000 and should not more than 2, respectively. % Relative standard deviation of peak areas of all measurements is always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be a simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Vimseltinib.

DESIGN, COMPARISON, AND EVALUATION OF LIDOCAINE HYDROCHLORIDE ORAL THIN FILMS USING NATURAL AND SYNTHETIC POLYMERS

Sushma K — 2026-02-23

Oral thin films (OTFs) have emerged as a promising alternative to conventional oral dosage forms due to their rapid disintegration, ease of administration, and improved patient compliance, particularly in pediatric and geriatric populations. The present study aimed to design, compare, and evaluate fast-dissolving oral thin films of Lidocaine Hydrochloride using natural and synthetic polymers. Lidocaine Hydrochloride, a widely used local anesthetic, was selected to achieve rapid onset of action and localized drug delivery in the oral cavity while bypassing first-pass metabolism. Oral thin films were prepared by the solvent casting method using hydroxypropyl methylcellulose (HPMC) as a synthetic polymer and sodium alginate as a natural polymer in different ratios. The prepared films were evaluated for physicochemical and mechanical properties including appearance, thickness, folding endurance, percentage elongation, surface pH, disintegration time, drug content uniformity, and in-vitro drug release. Preformulation studies confirmed the purity and compatibility of Lidocaine Hydrochloride with selected excipients. Among the various formulations, formulation F4 containing an optimized combination of HPMC (0.72 g) and sodium alginate (0.92 g) exhibited desirable mechanical strength, rapid disintegration, acceptable surface pH, and maximum drug release within a short duration. The study demonstrates that the combination of natural and synthetic polymers can effectively enhance film performance and drug release characteristics. Oral thin films of Lidocaine Hydrochloride prepared using optimized polymer combinations can serve as an efficient, patient-friendly dosage form for rapid local anesthetic action.

FORMULATION AND EVALUATION OF ETODOLAC-LOADED ETHOSOMAL GEL FOR DEEPER DERMAL DELIVERY IN THE MANAGEMENT OF CHRONIC INFLAMMATIONQ

Shaik Muhammad Soheb — 2026-03-13

Etodolac is a non-steroidal anti-inflammatory drug widely used in the treatment of pain and inflammation. Oral administration of Etodolac is often associated with gastrointestinal side effects and first-pass metabolism, while conventional topical formulations may show limited skin penetration.The present study aimed to formulate and evaluate an Etodolac-loaded ethosomal gel for enhanced topical drug delivery and sustained drug release.Etodolac-loaded Ethosomes were prepared by the cold method using ethanol, soya lecithin, propylene glycol, and distilled water. Nine formulations (F1–F9) were developed by varying the concentrations of lecithin and propylene glycol. The prepared ethosomes were evaluated for encapsulation efficiency and in vitro drug release. The optimized formulation was further characterised for particle size, polydispersity index (PDI), and zeta potential, and then incorporated into a Carbopol 940 gel base. The resulting ethosomal gel was evaluated for pH, spreadability, viscosity, drug content, and skin irritation. Drug release kinetics were analysed using zero-order, first-order, Higuchi, and Korsmeyer–Peppas models. Diffusion studies for both the prepared Etodolac ethosomal gel and the marketed Proxym (Etodolac) gelwere compared. Among all formulations, F9 was found to be the optimized formulation, showing the highest encapsulation efficiency of 95.72 ± 0.28% and maximum cumulative drug release of 96.67% at 12 h. The optimized formulation exhibited a particle size of 328.1 nm, PDI of 0.507, and zeta potential of -40.0 mV, indicating nanosized vesicles with good physical stability. The ethosomal gel showed satisfactory physicochemical properties, with pH 6.0, spreadability 6.65 g·cm/sec, drug content 99.52%, viscosity 48,750 ± 320 cps, and no signs of skin irritation. Release kinetic analysis revealed that the optimized formulation best followed zero-order kinetics.Drug diffusion from prepared Etodolac ethosomal gel found as 96.4%, and that of marketed preparation found as 82.6%. The developed Etodolac-loaded ethosomal gel demonstrated satisfactory formulation characteristics, high drug encapsulation, nanosized vesicle formation, good stability, and sustained drug release. The study suggests that ethosomal gel is a promising topical delivery system for Etodolac, with potential to improve therapeutic efficacy and better release from the marketed preparation.

STANDARDIZATION OF SIDDHA POLYHERBAL FORMULATION “INJI RASAYANAM”

Kowsalya S — 2026-03-31

Inji Rasayanam is a classical Siddha polyherbal formulation indicated for the management of Soothagavaayu, which is referred to as Polycystic Ovarian Disease (PCOD). Although its traditional efficacy is well documented, the lack of standardized quality control parameters poses a challenge to its global acceptance. The present study aimed to establish the standardization profile of Inji Rasayanam through physicochemical evaluation, phytochemical analysis, HPTLC fingerprinting, microbial load assessment, and aflatoxin analysis. The physicochemical parameters, such as total ash value, acid-insoluble ash, loss on drying, alcohol extractive value, and water extractive value, were analyzed according to standard protocols. Phytochemical screening revealed the presence of carbohydrates. The HPTLC fingerprinting profile showed 10 peaks at 254 nm and 6 peaks at 366 nm, indicating the presence of multiple phytoconstituents. Microbial load and aflatoxin levels were found to be within WHO permissible limits.These observations contribute to the scientific framework and confirm the quality and safety of Inji Rasayanam.

CARDIOPROTECTIVE EFFECT OF SEENTHIL CHOORANAM IN ISOPROTERENOL-INDUCED MYOCARDIAL INFARCTION IN WISTAR RATS

Sharmila M — 2026-03-31

Background: Oxidative stress-mediated myocardial damage is a key factor in the development of cardiovascular diseases. Seenthilchooranam, a classical Siddha formulation, is believed to possess antioxidant and cardioprotective properties. The present study aimed to evaluate the cardioprotective activity of Seenthilchooranam against isoproterenol-induced myocardial toxicity in wistar albino rats.

Aim: To evaluate the cardio protective activity of Seenthilchooranam Against isoproterenol -induced myocardial injury in wistar rats by assessing antioxidant status, heart/body weight ratio, biochemical markers and histopathological changes.

Materials and Methods: Wistar albino rats were allocated into five groups[n=6]: normal, isoproterenol control, vitamin E- treated standard group and two treatment groups receiving low and high doses of SC. Treatments were given orally for 28 days, followed by ISO injections for two consecutive days to induce myocardial injury. Serum cardiac marker enzymes [CK-MB, LDH, AST], heart weight/body weight ratio and cardiac antioxidant parameters such as malondialdehyde [MDA], superoxide dismutase [SOD], catalase [CAT] and reduced glutathione [GSH] were evaluated. Cardiac tissues were further examined histologically. Statistical analysis was performed using one-way ANOVA followed by Dunnett’s multiple comparison tests.

Result: Isoproterenol challenge resulted in significant damage in the myocardium, characterized by increased cardiac enzyme release, elevated lipid peroxidation, and decreased the levels of antioxidant enzymes and structural abnormalities in heart tissue. Treatment with Seenthilchooranam significantly improved these biochemical and tissue parameters in a dose-dependent manner with the higher dose showing effects comparable to the standard drug. Histopathological findings supported the biochemical results showing improved myocardial architecture and reduced cellular degeneration.

Conclusion: Seenthilchooranam demonstrated significant cardioprotective activity against isoproterenol- induced myocardial injury, possibly through antioxidant, membrane-stabilizing and free-radical scavenging mechanisms. These results support the potential role of Seenthilchooranam as a cardioprotective agent in oxidative stress-related cardiac disorders.

METHOD DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC ESTIMATION OF FINASTERIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Kesava Y — 2026-03-31

A simple, rapid, and cost-effective UV–Visible spectrophotometric method was developed and validated for the quantitative estimation of finasteride in bulk drug and pharmaceutical dosage forms. Finasteride, a selective inhibitor of type II 5?-reductase, is widely used in the management of benign prostatic hyperplasia and androgenic alopecia. The proposed method was based on measurement of absorbance at a wavelength of approximately 210 nm using methanol as solvent. The method exhibited good linearity over the concentration range of 2–10 µg/mL with a high correlation coefficient (r² ? 0.999), indicating adherence to Beer–Lambert’s law.Validation of the method was carried out in accordance with ICH guidelines, including parameters such as accuracy, precision, linearity, ruggedness, limit of detection (LOD), and limit of quantification (LOQ). The accuracy studies showed satisfactory recovery within 98–102%, while precision studies demonstrated low %RSD values (<2%), confirming reproducibility. The method also showed adequate sensitivity with acceptable LOD and LOQ values.Overall, the developed UV spectrophotometric method is reliable, economical, and suitable for routine quality control analysis of finasteride in pharmaceutical formulations.

PHARMACODYNAMIC EVALUATION OF USHNAVAAYUMENICHOORANAM IN A CARRAGEENAN-INDUCED PAW EDEMA MODEL IN WISTAR RATS

Saranya R — 2026-03-31

Background: Phytochemicals derived from medicinal plants continue to play a vital role in the development of anti-inflammatory drugs. UshnaVaayuMeniChooranam (UVMC), a traditional Siddha polyherbal formulation, is commonly used for the treatment of inflammatory disorders. However, there is limited scientific evidence supporting its anti-inflammatory efficacy. The present study aimed to evaluate the in vivo anti-inflammatory activity of UVMC in Wistar rats using the carrageenan-induced paw edema model.

Materials and Methods: Acute inflammation was induced by a subplantar injection of 1% carrageenan. The animals were divided into four groups (n = 6): disease control, indomethacin (10 mg/kg), UVMC (200 mg/kg), and UVMC (400 mg/kg). The percentage inhibition of paw edema was calculated. Histopathological examination of paw tissues and analysis of hematological parameters were also performed.

Results: UVMC produced a significant and dose-dependent reduction in paw edema compared to the disease control group (P < 0.05–0.001). At the fifth hour, the percentage inhibition was 25.18% (200 mg/kg) and 40.62% (400 mg/kg), which was comparable to indomethacin (36.74%). Histopathological findings revealed reduced inflammatory cell infiltration and restoration of normal tissue architecture, particularly in the high-dose group.

Conclusion: The findings demonstrate that UVMC possesses significant anti-inflammatory activity in an acute experimental model, thereby supporting its traditional use in Siddha medicine.

STANDARDIZATION OF SIDDHA POLYHERBAL FORMULATION “VALLARAI CHOORANAM”

Priyanka S — 2026-03-31

Standardization plays a crucial role in ensuring the authenticity, quality and safety of Siddha polyherbal formulations. Vallarai Chooranam is one among the Siddha herbal formulation which is traditionally prescribed in the management of urinary tract infection. The present study was carried out to standardize the formulation and to evaluate its microbial load and aflatoxin contamination in accordance with AYUSH protocols and WHO guidelines. The formulation showed characteristic physicochemical parameters and a well-defined HPTLC fingerprint profile, which may serve as a reference standard for identification and quality control. Preliminary phytochemical screening indicated the presence of important bioactive constituents such as carbohydrates, flavonoids, phenolic compounds, tannins, and phytosterols. Aflatoxinlevels were within the permissible limit and no pathogenic microbial contamination was detected. The findings of this study provide scientific baseline data for quality assessment and support the safe therapeutic use of Vallarai Chooranam.

EVALUATION OF ANTI-UROLITHIATIC AND ANTI-NEPHROLITHIATIC ACTIVITY OF COMBINED EXTRACTS OF PHYLLANTHUS FRATERNUS AND CORN SILK

Riyazullah M S — 2026-03-31

Urolithiasis is a prevalent urinary disorder characterized by the formation of calcium oxalate crystals in the urinary tract, leading to significant morbidity worldwide. The present study investigates the anti-urolithiatic and anti-nephrolithiatic potential of combined extracts of Phyllanthus fraternus and corn silk (Zea mays L.), both widely recognized in traditional medicine. The extracts were prepared using Soxhlet extraction and subjected to preliminary phytochemical screening, which revealed the presence of flavonoids, tannins, saponins, alkaloids, and terpenoids. HPTLC analysis further confirmed the presence of key phytoconstituents. The in vitro antiurolithiatic activity was evaluated using calcium oxalate crystal nucleation, aggregation, and growth inhibition assays at concentrations ranging from 250–5000 µg/mL, with sodium citrate as the standard. The combined extracts demonstrated significant concentration-dependent inhibition across all assays. At 5000 µg/mL, the formulation showed 87.21% inhibition of nucleation, 75.81% inhibition of aggregation, and 82.81% inhibition of crystal growth, comparable to the standard drug. Individual extracts showed moderate effects, indicating a synergistic interaction in combination. These findings highlight the potential of the combined extract as a promising natural therapeutic candidate for managing urolithiasis.

FORMULATION AND EVALUATION OF ROTENOIDS (BOERHAVIA DIFFUSA) NANOPARTICLES IN THE TREATMENT OF CHRONIC KIDNEY DISEASE

Mamatha Duggirala — 2026-03-31

Chronic Kidney Disease (CKD) is a progressive and irreversible condition that requires long-term therapeutic management to delay renal deterioration and associated complications. Limitations of conventional therapy, including poor patient compliance and systemic side effects, have encouraged the exploration of novel drug delivery systems using herbal therapeutics. Punarnava (Boerhavia diffusa Linn.), a traditionally acclaimed medicinal plant, exhibits significant nephroprotective, diuretic, antioxidant, and anti-inflammatory activities, making it a promising candidate for CKD management. The present study aims to formulate and evaluate Punarnava extract-loaded nanoparticles to enhance bioavailability, improve renal targeting, and achieve sustained drug release. Nanoparticles were designed using a suitable biodegradable polymer to protect active phytoconstituents such as punarnavoside and flavonoids from degradation while enabling controlled release. The formulated nanoparticles were characterized for particle size, surface morphology, entrapment efficiency, and in-vitro drug release behaviour. The nanoparticle-based delivery system is expected to maintain prolonged therapeutic concentrations, reduce dosing frequency, and minimize adverse effects. This approach demonstrates the potential of Punarnava nanoparticles as a novel, effective, and safer strategy for the management of Chronic Kidney Disease.

FORMULATION AND EVALUATION OF POLYHERBAL EMULGEL FOR RHEUMATOID ARTHRITIS

Pravallika P — 2026-03-31

Rheumatoid arthritis is a chronic inflammatory autoimmune disorder characterized by joint pain, swelling, stiffness, and progressive functional impairment, necessitating safer and more effective therapeutic approaches. The present study focuses on the formulation and evaluation of a polyherbal emulgel for the topical management of rheumatoid arthritis, aiming to enhance therapeutic efficacy while minimizing systemic side effects. The emulgel was formulated using ethanolic extracts of Rubia cordifolia, Vitex negundo, Piper nigrum, and Myristica fragrans, selected for their well-documented anti-inflammatory, analgesic, and antioxidant properties. The formulation combined the advantages of emulsions and gels to improve drug penetration and patient compliance. Various formulations were prepared using Carbopol 940 as a gelling agent and evaluated for physicochemical parameters including pH, viscosity, spreadability, extrudability, drug content, and in vitro drug release. All formulations exhibited acceptable characteristics suitable for topical application. Among them, formulation F3 demonstrated optimal performance with ideal viscosity, superior spreadability, uniform drug content (98.6%), and maximum drug release (89%) over 8 hours, along with good stability. The findings suggest that the developed polyherbal emulgel is a promising and effective alternative for the topical treatment of rheumatoid arthritis, offering sustained release, enhanced penetration, and improved patient compliance.

ROLE OF RESEARCH AND DEVELOPMENT IN NOVEL DRUG DELIVERY SYSTEM–A REVIEW

Sreelatha Gangu — 2026-02-09

The rising demand for improved therapeutic outcomes and decreased side effects in the pharmaceutical sector has spurred a new wave of innovation and research in novel drug delivery systems. These systems aim to overcome the limitations of traditional drug administration methods, such as short half-life, poor targeting, low solubility, and bioavailability. As the fields of pharmacy, materials science, and biomedicine advance and intersect, the focus on developing efficient and safe drug delivery systems, including biopharmaceutical formulations, has grown significantly both nationally and internationally. This article provides an overview of the latest advancements in drug delivery systems, categorized into four key areas: carrier-based and coupling-based targeted drug delivery systems, intelligent drug delivery systems, and drug delivery devices, according to their primary objectives and methodologies. Furthermore, it critically examines the technological barriers, current research challenges, and future trends in the application of novel drug delivery systems.

TRIPLE-NEGATIVE BREAST CANCER: A REVIEW OF EVOLVING STRATEGIES

Fathima Manaal — 2026-03-12

Triple-negative breast cancer (TNBC) is a heterogeneous and aggressive group of tumors that are defined by the absence of estrogen and progesterone receptors and lack of ERBB2 (formerly HER2 or HER2/neu) overexpression. TNBC accounts for 8%–13% of breast cancers. In addition, it accounts for a higher proportion of breast cancers in younger women compared with those in older women, and it disproportionately affects non-Hispanic Black women.The survival rate for TNBCis generally worse than other breast cancer subtypes. TNBC treatment has made significant advances, but certain limitations remain. Triple negative breast cancer has a negative expression of estrogen receptors (ER), progesterone receptors (PR), and human epidermal growth factor receptors (HER2). The survival rate for TNBCis generally worse than other breast cancer subtypes.Early TNBC outcomes have improved due to the intensification of therapies, including improvements in polychemotherapy and the addition of immunotherapy. Future efforts are needed to identify targetable aberrations for specific drug therapy, prevent immune evasion, and increase social-economic support. The non-availability of specific treatment options for TNBC is usually managedbyconventional therapy, which often leads to relapse.The focus of this review is to provide up-to-date information related to pathophysiology, prognosis, treatment, challenges, and future perspectives. The data presented in this paper may be helpful for researchers working in the field to obtain general and information to advance the understanding of TNBC and provide suitable disease management in the future.