Pranav Shah

Introduction: Candesartan Cilexetil (CC) is a non-peptide angiotensin II type 1 receptor antagonist widely used in the treatment of hypertension. However, CC has poor aqueous solubility (0.006 ± 0.002 mg/mL), low oral bioavailability (15%) and undergoes significant first-pass metabolism. Methods: Candesartan Cilexetil Solid Dispersion adsorbate (CC-SDAs) was formulated by the fusion method, employing polyethylene glycol (PEG) 4000 as a hydrophilic carrier and Neusilin® US2 as an adsorbent, to improve the solubility, dissolution, and oral bioavailability of CC. The formulation was optimized using a 3 ² factorial design. Results and Discussion: The optimized SDA formulation exhibited the following properties: Carr’s index (9.86 ± 0.09%), Hausner’s ratio (1.10 ± 0.16) and angle of repose (26.00 ± 0.19°), which shows improved flow property. DSC and XRD studies confirmed the conversion of the crystalline drug into an amorphous form. The optimized SDA formulation achieved %CDR of 90.41 ± 0.95% at Q30 min, demonstrating a marked improvement in in vitro dissolution compared to the pure drug (%CDR of 57.20 ± 3.78% at Q30 min). Furthermore, in vivo pharmacokinetic studies revealed a 2.02-fold enhanced oral bioavailability of CC from the SDA formulation compared to the CC suspension. Therefore, the SDA technique proves to be a promising approach for enhancing the solubility and dissolution of poorly water-soluble drugs.

This study aimed to develop lactoferrin-coated Brexpiprazole-loaded nanostructured lipid carriers (Lf-BXP-NLCs) using a Design of Experiments (DoE) approac

Amiodarone hydrochloride (AMH) is a potent anti-arrhythmic drug used for the treatment of ventricular tachycardia and ventricular fibrillation, but its cli

Background: The inherent limitation of ocular dosage forms is decreased precorneal residence time which affects the bioavailability and therapeutic efficacy. Objective: The objective of the current research was to sustain drug release and enhance precorneal drug residence time by formulating lipidic core-shell nanoparticles of Dexamethasone Sodium Phosphate and loading them in ion-sensitive in situ gel for corneal neovascularization. Methods: Polymeric nanoparticles were formulated using Eudragit L100-55 and PVA by twostep solvent diffusión nanoprecipitation method and coated by a lipidic film of Soya phosphatidylcholine with Cholesterol. The optimized lipidic core-shell nanoparticles were transformed into in situ gel using Gellan gum. The lipidic core-shell nanoparticles were evaluated for particle size, zeta potential, entrapment efficiency, in vitro reléase and in situ gel was evaluated for in vitro gelling time, pH, drug content, HETCAM studies, etc Results: The Core-shell lipid nanoparticles exhibited a particle size of 368.00±0.54 nm and zeta potential -13.3±2.0 mV respectively. The lipidic core-shell nanoparticles were found to show a sustained drug release when compared to the drug solution. The optimized in situ gel was found to show a gelation time of 39.59±2.49 seconds and was found to be non-irritant. Conclusion: A decline in ex vivo drug permeation was observed through an aqueous suspension of core-shell polymeric nanoparticles and core-shell LPN loaded in situ gel thus confirming sustained release for the drug Dexamethasone Sodium Phosphate.

Neurological disorders (ND) pose a major global health challenge, in large part due to the restrictive nature of the blood–brain barrier (BBB), which prevents most therapeutic agents from reaching the central nervous system (CNS). Intranasal delivery (IN) offers a non-invasive and patient-friendly route to bypass the BBB via the olfactory and trigeminal pathways, but its success requires advanced nanocarrier systems capable of enhancing drug retention, stability, and controlled release. In this study, a Quality by Design (QbD) framework was applied to systematically develop and optimize 1,2-distearoyl-sn-glycero-3-phosphoethanolamine (DSPE-PEG ₂₀₀₀ )-functionalized nanostructured lipid carriers (NLCs) using Donepezil (DPZ) as a model drug. Through sequential risk assessment, Plackett–Burman screening design (PBD), and Central Composite Design (CCD) optimization, the Critical Formulation Variables (CFVs) and Critical Process Parameters (CPPs) influencing particle size (PS) and entrapment efficiency (%EE) were identified. The optimized DSPE-PEG ₂₀₀₀ —NLCs exhibited nanoscale size (133.4 ± 2.91 nm), high %EE (89.5 ± 1.51%), strong mucin binding (84.6 ± 2.68%), and a distinct core–shell morphology. In vitro and ex vivo studies confirmed a biphasic and sustained drug release up to 60 h & 67 h, outperforming uncoated NLCs and conventional formulations. Stability studies demonstrated improved preservation under refrigerated conditions. Beyond DPZ, the QbD-guided strategy presented here provides a generalizable and regulatory-aligned platform for designing IN nanocarriers, paving the way for reproducible, scalable, and translational drug delivery systems targeting a wide range of ND. Graphical Abstract

The incidence of central nervous system (CNS) disorders is rising globally, particularly as the prevalence of neurodegenerative diseases increases. The primary challenge in such cases is limited transport of therapeutics through the blood-brain barrier (BBB). Statins, widely used for hypercholesterolemia, exhibit pleiotropic neuroprotective effects; however, their therapeutic potential in CNS disorders is restricted by poor brain bioavailability with conventional routes. Intranasal (IN) delivery has long been recognized as a plausible pathway for brain targeting. This narrative review critically examines preclinical literature on IN nanocarrier-based delivery systems developed specifically for statins, with emphasis on nose-to-brain transport, formulation strategies, pharmacokinetics (PK), and neuroprotective outcomes. Novelty and Contribution: This work uniquely integrates a formulation-centric comparison of IN nanocarriers for statins. It highlights the potential of IN delivery, discussing the influence of carrier type, physicochemical properties, and delivery strategy on brain targeting efficiency and therapeutic relevance across different neurological indications. IN nanocarrier systems display potential to enhance statin brain delivery by bypassing the BBB and first-pass metabolism. Nevertheless, current evidence is predominantly preclinical, with significant variability in study design, pharmacokinetic reporting, and safety evaluation. Translation to clinics will require standardized nose-to-brain metrics, long-term safety studies, scalable manufacturing processes, and early regulatory alignment.