Journal of Drug Discovery and Therapeutics

Formulation and Evaluation of Sustained Release Pellets of Antihypertensive Drug

Jatin Dubey — 2026-05-10

Objective: The aim of the present study was to formulate sustained-release pellets of bosentan by eudragit RL 100 and RS 100, which are the polymers used in the pan coating technique.

Methods: The sustained release pellets of bosentan were formulated by pan coating method. The drug was coated on nonpareil seeds along with EudragitRL100 by solution layering technique. Drug-loaded pellets were coated with EudragitRS100. The prepared pellets were evaluated for moisture content, drug content, particle size, and in vitro drugrelease. Stability studies were carried out on the optimised formulations for a period of 6 mo.

Results: The drug content was in the range of 98.89±0.32. The mean particle size of the drug-loaded pellets was in the range of 835 μm. The drug release rate decreased as the concentration of eudragit increased in the pellet formulations.Among the prepared formulations, PC 4 showed

89.35±0.52 drug release in 12 h from a good linear relationship was established between model-independent approaches (T25%, T50%, and T100%) and weight gain in coating. This indicated the possibility of extending the drug release by increasing the weight gain in the coating, and hence, it was proposed to extend the drug release for 24 h. From the prepared pellets, the optimised formulation PC 12 showed a 100.02±0.03 drug release in 24 h. Furthermore, these pellets were filled into capsules and compared the dissolution studies. The compatibility between drugs and polymers in the drug-loaded pellets was confirmed by DSC and FTIR studies. Stability studies indicated that the pellets were stable.

Conclusion: The prepared pellets were capable of releasing the drug for 24 h to treat the Pulmonary ArterialHypertension.

Keywords: Pellets, Pan coating, Eudragit, Bosentan, Independent model.

Cubosomes in Transdermal Drug Delivery System

Shakya Ankush Singh Maury — 2026-05-13

Cubosomes are spherical, cubic particles characterized by an internal cubic lattice. Cubosomes possess an extensive interfacial area and feature two internal aqueous channels divided by honeycombed features. They exhibit thermodynamic stability. The cubic liquid crystalline particles are known as cubosomes. These particles consist of particular surfactants, which have a unique microstructure, making them useful and possessing an ideal water content ratio. The cubic liquid crystalline phase is transparent, highly viscous, and features a distinctive nanoscopic structure. "Bicontinuous" indicates a lipid bilayer assembled in a space-filling system separating two continuously existing but not overlapping aqueous regions. Cubosomes are usually created through hydration of either a polar lipid or a surfactant, generating the cubic phase and dispersing the solid-like phase into tiny particles. From the time of their discovery and naming, cubosomes self-assembled have attracted considerable attention as potent drug delivery systems. They have distinct drug-loading mechanisms and different cubic shapes and composition inside. Their properties include high internal surface area, cubic crystalline structures, lipids' biodegradability, encapsulation of hydrophobic, hydrophilic, and amphiphilic compounds, targeted delivery, and bioactive substance release. Cubosomes can be classified using several evaluation parameters and have broad applications in diverse fields. Cubosomes are consequently garnering heightened interest within the pharmaceutical sector.

Keywords: amphiphilic, hydrophilic, hydrophobic, drug-loading,

Hydrotropy: A Promising Solubilization Technique for Poorly Water-Soluble Drugs

Nikhil Tiwari — 2026-05-13

The low aqueous solubility has continued to be one of the greatest challenges in the current pharmaceutical sciences since a great percentage of the emerging therapeutic molecules are characterized by low water solubility and dissolution-limited absorption. Drugs that fall under Biopharmaceutics Classification System (BCS) Class II and IV are often characterized by poor dissolution properties, unpredictable oral bioavailability, slow absorption and unpredictable therapeutic effects. Traditional methods of solubility enhancement like micronization, salt formation, co-solvency, surfactant system, cyclodextrin complexation, solid dispersions and nanotechnology-based methods have demonstrated a lot of success but are also accompanied by some limitations like toxicity, solvent contamination, high cost of production, physical instability and complicated scale-up processes. Hydrotropy has become a cost-effective, environmentally friendly, and industrially viable alternative to enhance aqueous solubility of poorly water-soluble drugs. Hydrotropic agents, including sodium benzoate, sodium salicylate, sodium citrate, nicotinamide, and urea, enhance solubility and increase the wettability via self-aggregation, hydrogen bonding, π–π interactions, solvent structure alteration, and solubility enhancement. Recent developments in mixed hydrotropy also enhanced pharmaceutical applications by decreasing toxicity, and augmenting synergistic solubilization effects. Hydrotropic systems have proved to be widely applicable in oral, parenteral, topical, transdermal, ocular and analytical preparations. This review critically discusses the historical background, mechanisms, classifications, pharmaceutical applications, advantages, limitations, comparative evaluation, and future perspectives of hydrotropic solubilization. Mixed hydrotropy and green pharmaceutical manufacturing have been given a special focus.

Keywords: Hydrotropy, mixed hydrotropy, poorly water-soluble drugs, solubilization enhancement, bioavailability, hydrotropic agents, pharmaceutical formulation

Formulation, Development of Organogel Containing Dexamethasone and Diclofenac for the Treatment of Inflammation

Md Khalid Raza — 2026-05-01

The present study aimed to develop and evaluate an organogel formulation containing dexamethasone and diclofenac for topical drug delivery to enhance anti-inflammatory activity and improve patient compliance. Organogels were prepared using different polymers such as Carbopol 934, HPMC, and Tween 80 in varying concentrations. A total of nine formulations (F1–F9) were developed and evaluated for physicochemical parameters including pH, viscosity, spreadability, gel strength, drug content uniformity, and in vitro drug release. Pre-formulation studies confirmed the purity and compatibility of drugs using FTIR, UV spectroscopy, and melting point determination. The pH of all formulations was found within the acceptable range (6.1–6.7), indicating suitability for topical application. Viscosity and spreadability results showed that formulations exhibited good consistency and ease of application. Drug content uniformity ranged from 97.5% to 101%, confirming uniform distribution.

In vitro drug release studies revealed that formulation F7 showed the highest drug release (98.7% at 8 hours). Drug release kinetics followed the Higuchi model, indicating diffusion-controlled release. Thus, the developed organogel formulation can be considered a promising topical drug delivery system for effective management of inflammation.

Keywords: Organogel, Dexamethasone, Diclofenac, Topical drug delivery, Drug release kinetics.

Formulation, Development and Evaluation of Antifungal Shampoo of Itraconazole with Natural Extract

Jatin Yadav — 2026-05-01

The present study aimed to formulate and evaluate an antifungal shampoo containing itraconazole in combination with natural extracts such as neem, aloe vera, reetha, and shikakai for effective treatment of scalp fungal infections. A total of nine formulations (F1–F9) were developed using aqueous gel-based emulsion technique by varying concentrations of herbal components. Preformulation studies including DSC and FTIR confirmed the purity and compatibility of itraconazole with excipients. The prepared shampoos were evaluated for physicochemical parameters such as pH, viscosity, spreadability, foamability, stability, and drug content. The pH of all formulations ranged from 5.4 to 6.1, suitable for scalp application. Viscosity varied depending on xanthan gum concentration, with F3, F6, and F9 showing higher viscosity. Spreadability and foaming studies indicated good cleansing and application properties. Among all formulations, F6 exhibited optimal performance with balanced viscosity, stable foam, and good spreadability. In vitro drug release studies revealed sustained release of itraconazole up to 79% over 8 hours. Drug release kinetics followed first-order model (R² = 0.998), indicating concentration-dependent release. The formulation also showed significant antifungal activity against fungal strains. Thus, the developed antifungal shampoo represents a promising topical delivery system combining synthetic and herbal agents.

Keywords: Itraconazole, Antifungal shampoo, Herbal extract, Neem, Aloe vera, Drug release kinetics.

Analytical Method Development and Validation of Glimepiride in Tablet Dosage Form by New RP-HPLC

Hemraj Saini — 2026-05-07

A simple, precise, accurate, and stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative estimation of Glimepiride in tablet dosage form. Chromatographic separation was achieved using a C18 column (250 mm × 4.6 mm, 5 µm) with an isocratic mobile phase consisting of Acetonitrile: Phosphate Buffer (pH 3.0) in the ratio of 60:40 (v/v) at a flow rate of 1.0 mL/min. Detection was carried out at 230 nm using a UV/PDA detector. Under optimized chromatographic conditions, Glimepiride showed a sharp and symmetrical peak with a retention time of approximately 5.8 minutes.

The developed method was validated according to ICH Q2(R1) guidelines for parameters such as system suitability, linearity, accuracy, precision, robustness, limit of detection (LOD), and limit of quantification (LOQ). The method exhibited excellent linearity in the concentration range of 10–60 µg/mL with a correlation coefficient (r² = 0.9994). The %RSD values obtained for intraday and interday precision studies were 0.48% and 0.62%, respectively, indicating good repeatability and reproducibility of the method. Accuracy studies performed by recovery method at 80%, 100%, and 120% levels showed mean recovery of 99.73%, confirming the reliability of the developed method. The calculated LOD and LOQ values were found to be 0.85 µg/mL and 2.58 µg/mL, respectively, demonstrating good sensitivity of the method. Robustness studies revealed that small deliberate changes in chromatographic conditions such as flow rate and wavelength did not significantly affect analytical performance.

The developed RP-HPLC method was found to be simple, rapid, precise, accurate, economical, and suitable for routine quantitative analysis of Glimepiride in bulk drug and marketed tablet dosage forms. The method can also be effectively applied for quality control analysis and stability studies in pharmaceutical industries.

Keywords: Glimepiride, RP-HPLC, Method validation, Stability-indicating method, Tablet dosage form, ICH guidelines

Formulation and In Vitro Evaluation of Propranolol Hydrochloride Sublingual Films for Effective Hypertension Control

Dheeraj Bansiwal — 2026-05-08

The objective of the present investigation was the formulation and evaluation of an oral fast-dissolving sublingual film of Propranolol HCl. This study aimed to formulate a rapid dissolving sublingual film of propranolol HCl by employing HPMC E15 as a film-forming agent, propylene glycol as a plasticizer, and cross-povidone as a disintegration agent. A fast-dissolving film was fabricated using the solvent casting technique. The stability studies of the patch were conducted for the optimized batch in accordance with the ICH guidelines. The medication and excipients underwent characterization according to the Indian Pharmacopoeia (IP). Investigation of drugs and excipients using Fourier Transform Infrared Spectroscopy (FT-IR). The films underwent physicochemical characterization, including assessment of weight Variation, thickness, tack test, drug content homogeneity, surface pH, folding endurance, disintegration time, in vitro drug release, and stability testing. Out of all the formulas (F1 to F9) that were created, batches F4 and F5 exhibited the highest quality, with a release of 109.86% and 104.73%, respectively during a 10-minute timeframe. The statistically optimized formulation was assessed using FT-IR (Fourier transform-infrared spectroscopy) investigations, which revealed no chemical interactions between the medication and polymer. Therefore, the propranolol HCl quick-dissolving film may serve as a superior substitute for tablets and capsules in achieving better oral bioavailability for the management of hypertension.

Keywords: Fast dissolving sublingual film, Propranolol HCl, solvent casting method, Drug release, Fast onset of action.

Pharmaceutical Development and Analytical Method Validation of a Nicotine Polacrilex-Containing Pouch Formulation

Aakriti Raj — 2026-05-07

Nicotine Polacrilex is a most commonly used active pharmaceutical ingredient in the treatment of tobacco dependence as a nicotine replacement therapy (NRT) in adult patients. This paper demonstrates the pharmaceutical development and analytical method validation of a novel nicotine polacrilex-containing pouch formulation through buccal nicotine delivery. This formulation was designed to deliver 2 mg of nicotine per pouch through controlled buccal absorption, providing a smokeless, tar-free alternative to cigarettes.

Keywords: Nicotine polacrilex, nicotine replacement therapy, pouch formulation, buccal drug delivery, HPLC method validation, ICH Q2, smoking cessation, tobacco dependence.

Formulation and Evaluation of Extended-Release Glipizide Capsules Using Ethyl Cellulose and HPMC K100M for Once-Daily Oral Delivery

Manish Saini — 2026-05-11

Glipizide is a second-generation sulfonylurea used in the management of type 2 diabetes mellitus, but its short elimination half-life and poor aqueous solubility make it a suitable candidate for extended-release oral drug delivery. Hydrophilic-hydrophobic matrix systems based on hydroxypropyl methylcellulose (HPMC) and ethyl cellulose (EC) are widely used to modulate drug release through combined diffusion, swelling, and matrix relaxation mechanisms.

Objective: The study aimed to develop and evaluate extended-release matrix capsules of glipizide using different EC:HPMC K100M ratios and to identify an optimized formulation capable of sustained release over 24 hours.

Formulation and Evaluation of Gastro-Retentive Effervescent Floating Tablets of Ranitidine Hydrochloride Using HPMC K100M as a Rate-Controlling Polymer

Ajay Sharma — 2026-05-11

Background: Ranitidine hydrochloride (HCl), a Histamine H₂-receptor antagonist, exhibits pharmacokinetic limitations including a short biological half-life (2–3 h), narrow absorption window confined to the upper gastrointestinal tract, and low oral bioavailability (~50%), necessitating twice- daily conventional dosing. A gastro-retentive floating drug delivery system (GFDDS) offers a rational approach to prolong gastric residence, sustain drug release, and improve bioavailability.

Objective: To develop and evaluate effervescent floating matrix tablets of Ranitidine HCl using HPMC K100M as a hydrophilic rate-controlling polymer and sodium bicarbonate as a gas-generating agent, with the goal of achieving once-daily therapeutic delivery.

Methods: Six formulation batches (F1–F6) were prepared by direct compression with systematically varied HPMC K100M (30–50% w/w) and NaHCO₃ (10–17.5% w/w) concentrations at a fixed Ranitidine HCl dose of 150 mg. Tabletswere evaluated for preformulation characterisation (FTIR, DSC, UV spectrophotometry), pre-compression flow properties, post-compression pharmacopoeial parameters, in vitro buoyancy, in vitro drug release (USP Type II, 0.1N HCl, 24 h), drug release kinetic modelling, and accelerated stability (40°C/75% RH, 3 months, ICH Q1A(R2)).

Results: FTIR and DSC confirmed absence of drug–excipient interactions. Batch F3 (HPMC K100M 40%, NaHCO₃15%) was identified as the optimised formulation with floating lag time (FLT) of 1.9 ±

0.2 min, total floating time (TFT) of 19.4 ± 0.7 h, drug release of 19.8% at 1 h and 96.8% at 24 h, and anomalous (non-Fickian) drug transport (Korsmeyer–Peppas n = 0.543, R² = 0.9968). Stability testing confirmed drug content ≥ 97.9% with unchanged release profiles (f₂ > 50) over 3 months.

Conclusion: A once-daily effervescent floating tablet of Ranitidine HCl was successfully developed using directly compressible excipients. Batch F3 fulfilled all buoyancy, release, and stability criteria, demonstrating the feasibility of GFDDS for bioavailability enhancement of narrow-absorption-window drugs.

Keywords: Gastro-retentive drug delivery; floating tablets; Ranitidine hydrochloride; HPMC K100M; sodium bicarbonate; effervescent; controlled release; floating lag time.

Formulation and Evaluation of Controlled Release Microsphere of Rosuvastatin and Fenofibrate

Tanishka Rathore — 2026-05-12

The present study was aimed at the formulation and evaluation of microspheres containing Rosuvastatin and Fenofibrate for sustained and controlled drug delivery in the management of hyperlipidemia. Microspheres were prepared by the emulsion-polymerization method using polymers such as HPMC, chitosan, sodium alginate, and egg albumin. Preformulation studies including solubility analysis, melting point determination, FTIR spectroscopy, and UV spectroscopic analysis confirmed the purity, identity, and compatibility of the drugs with selected excipients. The prepared microspheres were evaluated for particle size, percentage yield, drug content, entrapment efficiency, and in-vitro dissolution behavior. Scanning Electron Microscopy revealed spherical microspheres with smooth surface morphology and uniform particle distribution. The percentage yield ranged from 70.27 ± 1.24% to 85.87 ± 1.86%, while drug content and entrapment efficiency were found to be in the range of 89.85 ± 1.43% to 96.23 ± 1.54% and 79.76 ± 1.45% to 86.34 ± 1.09%, respectively. In-vitro dissolution studies demonstrated sustained drug release for up to 12 hours, indicating effective controlled-release characteristics. Formulations containing higher polymer concentrations exhibited prolonged drug release due to enhanced matrix integrity and diffusional resistance. Among all formulations, F9 and F10 demonstrated superior performance in terms of entrapment efficiency, drug content, and sustained-release profile. The study concluded that microsphere-based delivery systems can effectively enhance drug release control, improve bioavailability, reduce dosing frequency, and potentially improve patient compliance in antihyperlipidemic therapy.

Keywords: Rosuvastatin; Fenofibrate; Microspheres; Sustained Drug Release; Emulsion Polymerization; Drug Entrapment Efficiency; Controlled Release; Hyperlipidemia; HPMC; Chitosan.

Formulation Development of Extended Release Pellets Of Venlafaxine HCL by Quality by Design (QBD) Approaches

Shiv Shanker Kumar — 2026-05-14

The present study was aimed to develop extended release pellet of Venlafaxine HCL (VEN) employing different tools of Quality by Design (QbD). VEN pellets were prepared by extrusion spheronization technique with the help of LHPC LH-31 and Hypromellose 15 cps. The pellets were further coated by extended release coating using different ratio of EC 45 cps and Hypromellose 6 cps by fluidized bed process. Based on former knowledge and preliminary experimental data, risk based assessment was done by FMEA and RPN score. For further optimization, 32 full factorial design (FFD) was used for choosing % EC and % coating as independent variables and % drug release at 2, 4, 8, 12 and 20 hrs as dependent variables. Results of DSC study revealed compatibility of VEN with proposed excipients. Statistical analysis and SEG revealed suitability of applied FFD. Results of physicochemical characterization of VEN pellets were in accordance with pharmacopoeia. Drug release from VEN pellets followed Weibull model. Final coating composition of VEN pellets was 8% coat and 84% EC in coating. SEM analysis showed spherical structure of pellets. Short term stability study exhibited stable features of VEN pellets. So, optimized VEN pellets were the promising approach for achieving desirable constant release upto 24 hrs and so choices of design for once a therapy.

Keywords: Venlafaxine HCL; Quality by design; Risk assessment; extended

Formulation and Evaluation of Transdermal Patches of Repaglinide and Metformin

Sankalp Gupta — 2026-05-14

Transdermal drug delivery systems (TDDS) offer a non-invasive and patient-compliant approach for the sustained delivery of therapeutic agents into systemic circulation. In this study, transdermal patches containing Repaglinide and Metformin were formulated using the solvent casting method. Various ratios of natural polymer (guar gum) and synthetic polymers (HPMC K-100 and ethyl cellulose) were incorporated, along with diethyl tartrate as a plasticizer and dimethyl sulfoxide as a permeation enhancer. Ten formulations (F1–F10) were prepared and evaluated for their physicochemical characteristics, drug content uniformity, and in vitro release performance. All the prepared patches exhibited smooth, uniform surfaces and consistent weight (approximately 728–737 mg). They also showed acceptable moisture content between 3.3% and 6.4%, while surface pH values ranging from 5.1 to 6.4 were found to be compatible with skin, suggesting low irritation potential. Drug content analysis demonstrated uniform drug distribution within the patches, with Repaglinide content ranging from 91.6% to 98.9% and Metformin from 92.4% to 99.1%, complying with pharmacopeial requirements. In vitro dissolution studies indicated that the polymer composition had a significant impact on drug release behavior. Formulations with an optimal balance of hydrophilic and hydrophobic polymers provided a more controlled and sustained release profile. Among all formulations, F8 showed the best performance, releasing 89.03% of Repaglinide and 96.01% of Metformin over a 24-hour period. The release kinetics followed a zero-order model with a non-Fickian diffusion mechanism. In conclusion, the developed dual-drug transdermal patches demonstrate potential for enhancing drug bioavailability, reducing dosing frequency, and improving therapeutic outcomes in the treatment of type 2 diabetes mellitus. Nevertheless, further in vivo studies are required to validate their clinical applicability and efficacy.

Keywords: Transdermal patches, drug delivery system, skin permeability, penetration enhancers, sustained release, microneedles, pharmaceutical innovation.

Formulation and Evaluation of Oral Thin Film of Simvastatin and Fenofibrate

Sakshi Kour — 2026-05-14

Cardiovascular disorders continue to represent a major global health burden, with elevated lipid levels recognized as one of the primary contributors to the development of atherosclerosis and related complications. Simvastatin and Fenofibrate are commonly utilized antihyperlipidemic agents for reducing cholesterol and triglyceride levels; however, their clinical performance is often restricted by poor water solubility, inadequate oral bioavailability, and the necessity for repeated administration. The present investigation focused on the development and evaluation of oral thin films (OTFs) incorporating Simvastatin and Fenofibrate through the solvent casting method using appropriate film-forming polymers and excipients. The prepared films were assessed for various physicochemical and mechanical parameters, including thickness uniformity, folding endurance, tensile strength, drug content, swelling behavior, disintegration time, and in-vitro drug release. The developed formulations exhibited smooth appearance, adequate flexibility, and rapid disintegration characteristics. Drug content uniformity was found within acceptable limits for both Simvastatin and Fenofibrate, indicating homogeneous distribution throughout the films. Dissolution studies demonstrated rapid and substantial release of both drugs within a short duration, suggesting improved dissolution behavior. Overall, the formulated oral thin films showed satisfactory mechanical properties, reproducible drug release, and formulation stability, indicating their suitability as an effective and patient-compliant alternative to conventional oral dosage forms for hyperlipidemia therapy.

Keywords: Simvastatin, Fenofibrate, Oral Thin Films, Hyperlipidemia, Solvent Casting, Fast-Dissolving Drug Delivery, Drug Release, Patient Compliance.

Formulation and Evaluation of Self-Nanoemulsifying Drug Delivery System (SNEDDS) of Pravastatin

Sadiya Khan — 2026-05-14

The present study was undertaken to develop and evaluate a Self-Nanoemulsifying Drug Delivery System (SNEDDS) of Pravastatin to enhance its intestinal permeability, dissolution rate, and oral bioavailability. Pravastatin, a BCS Class III drug, exhibits high aqueous solubility but poor permeability, leading to variable and limited oral absorption. To overcome this limitation, lipid-based SNEDDS formulations were designed using different combinations of oils, surfactants, and co-surfactants. Preformulation studies, including solubility analysis, melting point determination, UV spectroscopy, and FTIR, confirmed the physicochemical characteristics and compatibility of the drug with selected excipients. Nine SNEDDS formulations (F1–F9) were prepared and evaluated for droplet size, polydispersity index (PDI), zeta potential, self-emulsification efficiency, drug content, and in vitro dissolution behavior. The results indicated that all formulations formed stable nanoemulsions upon dilution. Among them, formulation F5 exhibited optimal characteristics with the smallest droplet size, low PDI, satisfactory zeta potential, and superior drug release profile. The in vitro dissolution study demonstrated significantly enhanced drug release compared to conventional systems, indicating improved solubilization and potential for enhanced absorption. Overall, the developed SNEDDS formulations successfully improved the biopharmaceutical performance of Pravastatin, suggesting that this approach can be an effective strategy for enhancing oral delivery of poorly permeable drugs.

Keywords: SNEDDS, Pravastatin, Nanoemulsion, Bioavailability enhancement, BCS Class III drug, Lipid-based drug delivery system, Oral drug delivery, Dissolution improvement.

Formulation and Evaluation of Transdermal Drug Delivery System of Nateglinide for Controlled Release Application

Kushal Pratap Singh — 2026-05-14

The present study aimed to develop and evaluate transdermal patches of Nateglinide for controlled and sustained drug delivery. Transdermal drug delivery systems (TDDS) offer a non-invasive alternative to conventional dosage forms by improving bioavailability and reducing dosing frequency through bypassing hepatic first-pass metabolism. In this study, various polymer-based matrix patches were formulated using agar, HPMC K-100, guar gum, ethyl cellulose, and Eudragit RS, along with suitable plasticizers. The prepared formulations were evaluated for physicochemical and mechanical properties including thickness uniformity, weight variation, moisture content, swelling behavior, tensile strength, folding endurance, surface pH, and drug content uniformity. In vitro drug release studies were performed using the paddle over disk method in phosphate buffer (pH 7.4) for 24 hours. The results demonstrated uniform film characteristics with thickness ranging from 0.401 to 0.631 mm and drug content between 94.95% and 102.32%, indicating uniform drug distribution. Swelling studies showed significant hydration capacity, while mechanical testing confirmed adequate tensile strength and excellent folding endurance across all formulations. Surface pH values remained within the skin-compatible range, ensuring safety for dermal application. In vitro release studies revealed sustained drug release up to 24 hours, with formulation F8 exhibiting the highest release (89.03%).Overall, the developed transdermal patches of Nateglinide showed promising results for controlled drug delivery, with optimized formulations providing sustained release, good mechanical strength, and acceptable skin compatibility, suggesting their potential for once-daily therapeutic application.

Keywords: Transdermal patches, drug delivery system, skin permeability, penetration enhancers, sustained release, microneedles, pharmaceutical innovation

Formulation and Evaluation of Self Nanoemulsifying Drug Delivery System of Sitagliptin and Metformin

Dinesh Kumar — 2026-05-14

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder requiring effective long-term glycemic control. Sitagliptin and Metformin Hydrochloride are widely used in combination therapy; however, both drugs exhibit limitations such as poor solubility and variable oral bioavailability, which can affect therapeutic efficacy. The present study aimed to develop and evaluate a liquid self-nanoemulsifying drug delivery system (SNEDDS) for the co-delivery of Sitagliptin and Metformin Hydrochloride to enhance their solubility, dissolution rate, and potential oral bioavailability. SNEDDS formulations were prepared using various combinations of oils, surfactants, and co-surfactants, followed by optimization based on emulsification efficiency, droplet size, polydispersity index (PDI), zeta potential, and drug content. Preformulation studies confirmed suitable excipients, with Garlic oil as the lipid phase and Cremophor EL and PEG 400 as effective surfactant and co-surfactant systems. The optimized formulations exhibited droplet sizes in the nanometric range (48–102 nm), acceptable PDI values, and zeta potential indicating moderate stability. Drug content analysis showed uniform incorporation of both drugs, and robustness to dilution confirmed formulation stability. In vitro diffusion studies demonstrated enhanced drug release, with cumulative release reaching up to 96.89% for Sitagliptin and 96.01% for Metformin over 12 hours. The results indicate that SNEDDS significantly improved the dissolution behavior of both drugs compared to conventional formulations. Overall, the developed SNEDDS presents a promising strategy for improving the oral delivery and therapeutic performance of Sitagliptin and Metformin Hydrochloride in T2DM management.

Keywords: Sitagliptin, Metformin, Self-Nanoemulsifying Drug Delivery System (SNEDDS), Droplet Size, Polydispersity Index, Zeta Potential, Solubility Enhancement, Cardiovascular Diseases, Oral Bioavailability, In Vitro Drug Release.

Formulation and Evaluation of Fast Dissolving Tablets of Ketoprofen Using Natural and Synthetic Superdisintegrants

Chaman Kumar Gupta — 2026-05-14

The present study was aimed at the formulation and evaluation of fast dissolving tablets (FDTs) of ketoprofen to improve its dissolution rate, bioavailability, and patient compliance. Ketoprofen, a non-steroidal anti-inflammatory drug (NSAID), exhibits poor aqueous solubility which limits its oral absorption. In the present work, fast dissolving tablets were prepared by direct compression method using synthetic superdisintegrants such as crospovidone and sodium starch glycolate along with Ocimum basilicum mucilage as a natural excipient. The prepared powder blends were evaluated for preformulation parameters including angle of repose, bulk density, tapped density, Carr’s index, and Hausner’s ratio to assess their flow properties. The formulated tablets were evaluated for various physicochemical parameters such as hardness, friability, weight variation, wetting time, water absorption ratio, drug content, in-vitro dispersion time, and in-vitro dissolution studies. FTIR studies confirmed the compatibility of ketoprofen with selected excipients. The prepared formulations exhibited satisfactory mechanical strength and rapid disintegration characteristics. Among all formulations, batch F11 showed the best performance with rapid dispersion time and maximum cumulative drug release of 98.31% within 20 min.The results demonstrated that the developed fast dissolving tablets of ketoprofen significantly improved the dissolution profile of the drug and may enhance its bioavailability and therapeutic efficacy. The study concluded that direct compression technique using suitable superdisintegrants and natural excipients is an effective approach for the development of ketoprofen fast dissolving tablets.

Keywords: Ketoprofen; Fast dissolving tablets; Direct compression; Superdisintegrants; Crospovidone; Sodium starch glycolate; Ocimum basilicum; In-vitro dissolution; Drug release; FTIR studies.

Formulation and Evaluation of Acyclovir Floating Matrix Tablets for Sustained Gastro-Retention

Annu Rajput — 2026-05-14

Acyclovir is a commonly prescribed antiviral drug; however, its therapeutic effectiveness after oral administration is restricted by poor bioavailability and rapid gastric emptying. The present investigation focused on the development and assessment of gastro-retentive floating matrix tablets of acyclovir designed to prolong gastric residence time and provide sustained drug delivery. The formulations were prepared using hydrophilic release-retarding polymers, namely HPMC K100M and xanthan gum, along with sodium bicarbonate as an effervescent agent to impart buoyancy. Pre-compression evaluation of the powder mixtures demonstrated satisfactory micromeritic properties, indicating good flow and compressibility characteristics. Parameters such as Hausner’s ratio (1.024–1.306), Carr’s compressibility index (9.27–11.84%), and angle of repose (26.24°–26.83°) confirmed the suitability of the blends for direct compression. Post-compression analysis showed that all prepared tablets complied with official pharmacopeial limits for physical quality attributes, including uniformity of weight, tablet hardness (4.2–4.7 kg/cm²), friability below 0.3%, swelling behavior, and drug content ranging from 96.79% to 99.57%. Buoyancy testing demonstrated floating lag times between 4.3 and 5.1 minutes, while most formulations remained buoyant for more than 10 hours, indicating effective gastro-retentive performance. In vitro dissolution studies confirmed prolonged drug release over a period of 12 hours, with formulations containing higher concentrations of HPMC K100M exhibiting a slower and more controlled release pattern. Compatibility and stability investigations using FTIR and UV spectroscopy revealed no significant interaction between acyclovir and the selected excipients. Overall, the developed floating matrix tablets demonstrated effective gastro-retentive and sustained-release characteristics, suggesting their potential to improve the oral bioavailability of acyclovir and enhance patient adherence through reduced dosing frequency.

Keywords: Acyclovir, floating matrix tablets, gastro-retentive drug delivery, HPMC K100M, xanthan gum, sustained release.

Formulation and Evaluation of Oral Thin Film of Drug for Gastroesophageal Reflux Disease (GERD)

Aman Kumar Gupta — 2026-05-14

The present investigation focused on the formulation and assessment of fast-dissolving oral thin films (OTFs) incorporating Famotidine and Domperidone for improved therapeutic management of gastroesophageal reflux disease (GERD). Comprehensive analytical evaluation of the drugs was carried out through organoleptic examination, Fourier Transform Infrared (FTIR) spectroscopy, ultraviolet spectrophotometry, melting point analysis, solubility studies, and HPLC analysis, confirming the authenticity, purity, and suitability of the drugs for formulation development. Compatibility studies indicated the absence of any significant interaction between the active pharmaceutical ingredients and selected excipients. The oral thin films were prepared using the solvent casting technique with Hypromellose and Polyvinyl Alcohol serving as film-forming agents, while Polyethylene Glycol 400 was utilized as a plasticizer to enhance flexibility and film integrity. The developed formulations were characterized for various quality control parameters including film thickness, uniformity of weight, folding endurance, surface pH, tensile strength, disintegration behavior, drug content, and in-vitro dissolution performance. The optimized batch demonstrated satisfactory mechanical properties, consistent film dimensions, excellent drug distribution, and rapid disintegration in less than 15 seconds. In-vitro release studies showed that both Famotidine and Domperidone were released rapidly, with cumulative drug release exceeding 97% within 25 minutes, and the release pattern predominantly followed first-order kinetics. The developed oral thin films exhibited desirable stability, ease of handling, and the advantage of administration without the need for water, making them particularly beneficial for patients experiencing swallowing difficulties or requiring convenient on-demand therapy. Overall, the study highlights the potential of Famotidine and Domperidone-loaded OTFs as an effective and patient-compliant alternative dosage form capable of delivering rapid symptomatic relief in GERD management, with promising prospects for future large-scale production and clinical utilization.

Keywords: Oral Thin Films (OTFs), Famotidine, Domperidone, Drug Delivery, Bioavailability, Rapid Disintegration, Drug Release.