Purpose Role of omega-3 fatty acid (ω-3 FA) in human health and negative impact of altered omega-6 to 3 ratio is well documented. Hence, food fortification with ω-3 FA is need of the day. Functional foods containing ω-3 FA are gaining a lot of importance. However, long-term stability of ω-3 FA is a major obstacle with respect to the consumer acceptability and industrial exploitation of such functional

Cancer is one of the fatal diseases that cause many deaths around the world. Lung cancer has the highest incidence and mortality rates among cancer-related death worldwide. Lung cancer is a common malignant tumor that poses a severe threat to human life due to its high prevalence and mortality. There are no early screening biomarkers for lung cancer. Patients with lung cancer are often diagnosed in

Purpose Ointments and creams used in burn treatments have limitations that compromise their effectiveness since they dry on the skin, their removal/replacement is traumatic and the half-life of the active ingredient is short requiring more applications during treatment. In this context, the objective was to develop a biofilm with potential biotherapeutics for differential treatment of burns. Methods

Solid lipid nanoparticles (SLN) have been intensively exploited as nanocarriers for pulmonary drug delivery. However, no consensus on the underlying mechanisms between particle sizes and cell uptake behaviors was attained owing to their unclear in vivo fate after inhalation, which hindered the further development of a novel nanoparticle delivery system. Recently, aggregation-caused quenching (ACQ)

Purpose To propose a statistical methodology for quantitative analysis of the quality management system (QMS) of pharmaceutical manufacturing. Methods (1) Based on the manufacturing data from two established active pharmaceutical ingredient (API) manufacturers in China from 2010 to 2019, the linear regression with Pearson correlation coefficient is used to find the correlations between the proposed

Purposes The present study was aimed to formulate dual-release reconstitutable oral suspension (DRROS) of cefpodoxime proxetil (CPDP) for pediatric patients using the Quality by Design (QbD) approach. Methods CPDP pellets were prepared using the extrusion–spheronization technique. Sustained-release pellets (SRPs) of CPDP were prepared using HPMCK100M, Eudragit RSPO, and KollidonSR as release retardant

Purpose Long-acting solid lipid microparticles of tetracycline hydrochloride (TH) were prepared using solvent-free twin screw hot melt dispersion technique utilizing biocompatible lipids. Design of experiments was employed to assess the formulation and process parameters followed by statistical analysis. Methods Plackett–Burman design generated 12 experiments containing varying ratios of lipids and

Purpose In the pharmaceutical industry, there has been a growing interest in continuous manufacturing in recent years. Many efforts have been made to implement new process equipment for various production steps. One step which is not yet covered well is the continuous drying of the active pharmaceutical ingredient (API) after it has been crystallized with the desired particle properties. The dryer

Purpose Exosomes have the potential to create new therapeutics as drug loading carriers. Their important inherent roles are stem from structures (also known natural liposomes) and strong biological stability in many cellular processes. The formation of a new drug delivery system in cervical cancer by loading a chemotherapeutic agent docetaxel into exosomes obtained from HELA cells is intended. Methods

Purpose The presence of the impurity N-nitrosodimethylamine (NDMA) has been a reason for recent drug product recalls in 2019–2020. Methods This document reviews the timing of ranitidine and valsartan recalls due to NDMA; the numerical values reported in the available literature are compared, while the proposed mechanisms and influencing factors are discussed in detail. The liability of other histamine

The emergence of lipid nanovesicles (LNVs), like liposomes, transferosomes, and ethosomes, strengthens transdermal drug delivery. The composition of lipid vesicles is similar to that of skin, so these can easily penetrate through the skin. Modifications in the design of lipid vesicles help enhance skin permeation; therefore, dose reduction is possible. Ultradeformable vesicles are superior to conventional

Coaxial electrospinning is a robust technique to prepare core-shell nanofibers for various biomedical applications such as tissue engineering. In this study, the coaxial electrospinning method was used to prepare two different core-shell nanofibers based on polycaprolactone/polyvinyl alcohol (PCL/PVA) and polycaprolactone/collagen (PCL/Col). The mechanical (e.g., shear viscosity and surface tension)

Purpose Quality assurance in oral solid dose (OSD) manufacturing is essential for therapeutic efficacy and patient safety. This study uses multivariate analysis (MVA) to correlate process and material inputs vs. dissolution behaviour to enhance process understanding and elucidate potential control improvements in a commercial tabletting line for an extended release (ER) OSD product. Methods Partial

Purpose The aim of this study was to develop liposomes loaded with (-)- epigallocatechin gallate (EGCG) by using the Quality by Design (QbD) approach. Methods The risk assessment tools (Ishikawa diagram and Risk Estimation Matrix) highlighted three formulation factors, namely phospholipid concentration, phospholipid to cholesterol molar ratio and EGCG concentration that are likely to influence the

Purpose Microcarriers have been extensively explored for culturing anchorage-dependent mammalian cells for various applications. While numerous polymers have been explored for fabricating the microcarriers, both natural and synthetic polymers have their shortcomings. Thus, a synthetic, biocompatible polymer, exhibiting good cell adhesion properties, is the most suitable material for such applications

Purpose This paper summarizes results from a recent pharmaceutical industry survey to understand the adoption status of science- and risk-based approaches in pharmaceutical stability (lean stability) in regulatory submissions across the full pharmaceutical product life cycle and to ascertain whether companies are deriving their stability strategies based on scientific risk or applying generic strategies

Purpose The objective of this work was to develop a new nanostructured lipid carrier (NLC) formulation for the oral delivery of quetiapine fumarate (QTF) and assess the drug’s in vitro release mechanism through gastric and intestinal conditions. Methods A preformulation study was conducted to select the most suitable components and solid-to-liquid lipid ratio for the formulation of nanoparticles. Then

Purpose This study investigated surface-modified dual-responsive (bio-responsive and thermo-sensitive) micellar microgels as a novel vaginal drug delivery system (VDDS) for enhanced administration and prolonged localized efficacy. Methods Lipid matrices (LMs) consisting of Softisan® 154 and super-refined sunseed oil with or without PEG-4000 were prepared by fusion, loaded with a model topical vaginal

Purpose The main objective of the research was to formulate an effervescent floating matrix tablet (EFMT) of a potential anticancer drug neratinib employed in breast cancer therapy. The drug shows poor aqueous solubility at higher pH leading to reduce therapeutic efficacy, thereby resulting in poor bioavailability. Hence, an EFMT is designed to extend the gastric residence time (GRT) of drugs, which

Bioavailability of oral drug formulations is strongly dependent on the composition of the gastric and intestinal fluids and hydrodynamic conditions in the gastrointestinal tract. These affect the dissolution behavior of oral formulations and their subsequent absorption to the bloodstream. A detailed characterization of all these factors is almost impossible in an in vivo setting, which necessitates

This perspective article provides historical background and current considerations of the regulation of rare diseases and orphan drugs in China, presenting the ongoing reform of the orphan drug assessment system in the context of a maze of seemingly convoluted government agencies and regulatory policies that are unique to the fast developing China.

Purpose Liqui-Tablet is a dosage form derived from Liqui-Mass technology. It has proven to be a promising approach to improve drug dissolution rate of poorly water-soluble drugs. So far, Liqui-Tablet is feasible for low-dose drugs. In this study, an attempt was made to produce high-dose Liqui-Tablet, whilst maintaining ideal physicochemical properties for ease of manufacturing. Methods Liqui-Tablets

A correction to this paper has been published: https://doi.org/10.1007/s12247-021-09558-1

Purpose Research has shown that co-administration of preparations containing HQ and azelaic acid (AZ) or vitamin C (vit C) may be more effective than HQ alone. The aim of this study was to evaluate the stability of HQ in the presence of AZ and vit C as active ingredients in the extemporaneous preparations prepared with different techniques. Methods Topical preparations containing HQ, vit C, and AZ

Purpose In this work, we investigate the effect of adding polyvinylpyrrolidone (PVP K30) to the binary solid dispersion (indomethacin/kaolin) on the formation of physically stable amorphous drug. This aims to profit more effectively from the therapeutic effect of kaolin in the solid dosage forms of indomethacin. Methods Binary mixtures (indomethacin/kaolin) were ball milled at room temperature (≈ 25 °C)

Purpose The present study is focused on designing an automated jet nebulizer that possesses the capability of dynamic flow regulation. In the case of existing equipment, 50% of the aerosol is lost to the atmosphere through the vent, during the exhalation phase of respiration. Desired effects of nebulization may not be achieved by neglecting this poor administration technique. There may be adverse effects

Purpose Risperidone is an important antipsychotic agent used for treatment of both acute and chronic schizophrenia. The drug has been effective in resolving the disease’s signs while keeping extrapyramidal side effects as low as possible. To achieve a sustained and gradual release of risperidone from PLGA microspheres, we utilized an emulsifying agent; PLGA-PEG-PLGA triblock (M-triblock), instead of

Purpose Fat from Capra hircus (goat fat) has been widely used for drug delivery. Methods In this work, 1:1, 1:2, and 2:1 of goat fat and Softisan® 142 were melted together, cooled at room temperature, and the resultant matrix further modified with Phospholipon 90G (4:1) to obtain solidified reverse micellar solutions (SRMS). SRMS were used to prepare solid lipid microparticles (SLMs) loaded with or

Purpose Malignant glioma cells are generally insensitive to TRAIL (tumor necrosis factor-related apoptosis-inducing ligand)-induced apoptosis. In this research, we designed a system containing mitoxantrone (MTX) which is loaded into poly lactic-co-glycolic acid (PLGA) nanoparticles (NPs) in order to increase sensitivity of glioblastoma cancer cell to TRAIL plasmid. Methods PLGA NPs were prepared using

Nanoarchitectonics is an emerging multidisciplinary field that has the potential to offer trailblazing solutions to various challenging therapies by facilitating precise and tailored control of physicochemical properties, morphology, and also the biological effects of nano-sized drugs. In this review, various examples of drug delivery based on the nanoarchitectonic approach are discussed. The article

Purpose The present work aims to prepare a controlled release matrix, using biodegradable materials containing different active ingredients (AI) in order to deliver only the necessary dose for a specific time and a well-defined target. Methods The matrix is a manual sheet, composed of lignocellulosic fibers. The membrane, which regulates the release, is obtained by immersing the sheet in an emulsion

Purpose The aim of this study was to develop transferrin-conjugated nanoemulsions utilizing hydrophobic ion pairing for a targeted cellular uptake. Methods In the lipophilic phase of nanoemulsion composed of 60% oleic acid, 30% Capmul MCM EP and 10% Span 85, 1% cetyltrimethylammonium bromide (CTAB) and 3% phosphatidic acid (PA) were incorporated. After emulsification, the resulting droplets were decorated

Purpose To formulate multiparticulate controlled-release alginate-gelatin (AL-GL) beads in order to modify gliclazide (GLZ) release rate. Methods AL-GL beads were prepared using different glutaraldehyde concentrations and dried using either air or freeze-drying method. For comparison, calcium alginate beads (AL-beads) were prepared at different temperatures. Drug incorporation efficiency, beads swelling%

Purpose Trichosporon inkin is recognized as one of the vital causative organisms of white piedra in humans. Very few herbal treatments are available against white piedra. Muntingia calabura (MC) leaf extract and silver (Ag) nanoparticles are identified for their numerous therapeutic applications which is the main purpose of this research work. Methods In this work, we synthesized, characterized, and

Purposes Reactive oxygen species production is harmful to human’s health. The presence of antioxidants in the body may help to diminish reactive oxygen species. Trans-ferulic acid is a good antioxidant, but its low water solubility excludes its utilization. The study aims to explore whether a vesicular drug delivery could be a way to overcome the poor absorption of trans-ferulic acid hence improving

Purpose Methotrexate is one of the widely used agents to treat various solid tumors, although its usage brings some challenges because of its poor bioavailability and/or dose-dependent side effects. Increasing the solubility, permeability, and consequently bioavailability in company with minimizing side effects are always desired to formulate such these drugs. In this paper, we concentrated on formulation

Purpose Letrozole (LTZ), an aromatase inhibitor with poor aqueous solubility, is used as the first line treatment for hormonal sensitive breast cancer in postmenopausal women. The purpose of the current study is to develop hyaluronic acid (HA)/chitosan (Cs)-coated poly(d,l-lactide-co-glycolide) (PLGA) nanoparticles for the delivery of LTZ to improve therapeutic efficacy, control release and minimize

Purpose The pace of the COVID-19 vaccine development process is unprecedented and is challenging the traditional paradigm of vaccinology science. The main pressure comes from the pandemic situation, but what makes it possible is a complex set of factors and innovative environments built along the times, which this manuscript aims to study. Methods Through an exploratory study within the scope of innovation

Purpose Oral delivery of peptide/protein is quite difficult due to physiological barriers. Encapsulation of these drugs in the suitable biopolymeric matrix could protect the drug as well as increase the residence time of the formulation. Mucoadhesive biopolymers are being widely investigated for this purpose. Methods We have fabricated insulin-loaded chemically crosslinked chitosan-alginate macrobeads

Purpose The objective of the present study was to screen oils and suspending agents for the formulation of novel progesterone (PGT) suspension, demonstrating improved solubility, drug release, stability, and non-allergenicity. Presumably, formulated novel PGT suspensions could supersede clinically available peanut oil and lecithin based formulations (PL). Method The PGT suspensions were formulated

In pharmaceutical research and development, various new chemical entities (NCE) are found to be poorly water-soluble. Therefore, solubility enhancement, a key factor for higher bioavailability, is a major challenge in pharmaceutical industries. Particle size reduction is one such method that increases the surface area of the pharmaceutical compounds and subsequently leads to a higher dissolution rate

Purpose The development of pH-independent drugs is difficult because it involves improvements in their solubility and dissolution (%) in solubilizer. In the present study, the pH-independent cilostazol (CLT) was formulated for enhanced solubility and dissolution (%) and for maintaining stability with meglumine by the solid dispersion (SD) technique. Methods The CLT formulations were prepared with weak

Purpose Macromolecules are important in polymer-based drug delivery systems as they help in specific targeting. This study explores the use of guggul gum (GG) and chitosan (Ch) in encapsulating boswellic acid (BA) which has high first-pass metabolism and low aqueous solubility for possible uses in inflammatory conditions. Methods Ionic complexation was used for nanoparticle formulation. The contents

Purpose Evaluating the potential of gross Linum usitatissimum L. seed mucilage to be used as a drug release retardant. In order to do so, seeds were subjected to a simple and scalable extractive process comprising few stages, without alcohol-based precipitation. Matrix tablets based on hydrophilic polymers are one of the simplest forms of developing modified release systems. Methods Flaxseeds were

Purpose Particle size control is of vital importance to the performance and manufacturability of a solid drug substance used in an oral dosage pharmaceutical product. Numerous options for control are available to engineers and scientists engaged in process design; this study seeks to demonstrate the steps taken to define the optimal solution. Method Wet milling, terminal size control though crystallisation

Purpose Direct compression (DC) remains the most preferred technique to produce tablets, and its effectiveness is directly influenced by raw material attributes. Therefore, the selection of specific grades of excipients to achieve desirable powder flow and compression properties is of importance. Shifting toward continuous manufacturing requires even more enhanced performance, quality, and consistency

Purpose In continuous manufacturing of pharmaceuticals, dry granulation is of interest because of its large throughput capacity and energy efficiency. In order to manufacture solid oral dosage forms continuously, valid control strategies for critical quality attributes should be established. To this date, there are no published control strategies for granule size distribution in continuous dry granulation

A Correction to this paper has been published: https://doi.org/10.1007/s12247-020-09528-z.