Purpose A pulsatile drug delivery system containing dexketoprofen trometamol was designed by combining immediate release and colon-targeted mini tablets into a capsule. Methods Both immediate release and colon-targeted mini tablets were prepared by wet granulation. Furthermore, colon-targeted mini tablets were coated with Eudragit L 100, Eudragit S 100, Eudragit RS 30D, and ethylcellulose (Surelease®)

Purpose The present work describes the systematic development of ganoderic acid (GA)–loaded solid lipid nanoparticles (SLNs) for the treatment of hepatocellular carcinoma (HCC). Methods A full factorial design was employed for optimization of the GA-loaded SLNs prepared by hot-homogenization method, where Capmul MCMC10 and soy lecithin were used as solid lipid and surfactant, while poloxamer 188 was

Purpose Light-induced fluorescence was evaluated as a process analytical tool in the development of quantitative models for the monitoring of a low-dose formulation manufacturing process. Method The system, equipped with a probe, was positioned in a tablet press feed-frame to monitor the active pharmaceutical ingredient content of the flowing powder before compression. Results Modeling errors of 1

Purpose Teriparatide (PTH(1–34)), as one of the FDA-approved anabolic medications for postmenopausal osteoporosis treatment, shows anabolic effects in intermittent administration. In the current study, a multilayer implantable device was developed by spin-coating and dip-coating techniques for providing pulsatile pattern release of teriparatide, composed of polymeric and hydrogel layers. Methods Copolymers

Purpose Tizanidine (TZN) is used for the management of muscle spasms. Oral TZN is liable to first-pass metabolism and interindividual variation. Transdermal drug delivery systems (TDDS) are gaining research attention as an alternative route. The aim of this study is the bioanalytical comparison of the oral route and two TDDS, bilosomes and aspasomes. Methods TZN-loaded bilosomes and aspasomes were

Purpose The current investigation explores the enhanced biopharmaceutical attributes of solid supersaturable self-microemulsifying drug delivery system (Solid SS SMEDDS) for poorly water soluble drug canagliflozin (CFZ). Methods Solid SS SMEDD formulation was prepared by spray drying using Neusilin US2 as an adsorbent. The developed SS SMEDDS were characterized for physicochemical and solid state characterizations

Purpose Due to the exceptionally high standards for accuracy and data integrity in scientific regulatory reporting, it is vital that any tool that aims to streamline this process is as efficient or more in gathering data as a team of scientists, without higher cost in terms of time or resources. For this reason, an artificial intelligence-based tool with parallel search, document creation, and data

Purpose This study was performed to explore the physicochemical and anti-biofilm properties of rifampin (Rif) and cis-2-decenoic acid (C2DA) co-entrapped in solid lipid nanoparticles, Rif-C2DA-SLN, against staphylococcal biofilm. Methods The formulation was prepared by high-shear homogenization and ultrasound methods and characterized for size, zeta potentials, encapsulation efficacy, drug lipid interaction

Purpose Loss-in-weight feeders play a vital role in assuring blend and content uniformity as well as lot-to-lot powder traceability in continuous manufacturing. Irregular flow from the feeders propagates through the system, potentially resulting in out-of-specification product. Powder properties such as density, cohesion, and adhesion can cause large variability in the flow rate of ingredients from

Purpose The present study focused on synthesis and characterization of polymeric nanocarrier for the hydrophobic drug, naringenin (Nar), using chitosan (CS) and dextran sulfate (DS). Method CSDS-Nar and blank CSDS nanoparticles were prepared by complex coacervation technique. The nanoparticles were characterized by scanning electron microscopy (SEM), Fourier transform-infrared spectroscopy (FTIR),

Purpose Conventional and novel drug delivery systems encompass therapeutic effects for treatment and management of various conditions like cancer, diabetes, and Alzheimer’s disease but mostly show side or adverse effects. To overcome such undesirable effects, new approaches like functionalized polymers, biocarriers, drug-free particles, and metallic nanocomposite display potential applications in healthcare

Purpose Roll compaction/dry granulation is established in manufacturing of solid oral dosage forms and, within the context of continuous manufacturing, it has sparked interest as material is fed, processed, and ejected continuously while also providing large possible throughputs. However, this amount of material has to be adequately controlled in real time to assure quality. Methods This research aimed

Purpose The current study entails the design, development, and optimization of nasal mucoadhesive microspheres of lercanidipine with improved systemic bioavailability for the management of hypertension. Methods Mucoadhesive microspheres of lercanidipine were prepared by solvent evaporation and polymerization method using bovine serum albumin (BSA) as the carrier and glutaraldehyde as the chelating

Purpose The objective of present work was to develop fibroin-sodium alginate floating microspheres of felodipine (FD) showing modified release. Method Binary polymer system of fibroin-sodium alginate was used to prepare microspheres by spray drying technique. Thus, FD loaded microspheres obtained were evaluated for % drug content, % entrapment efficacy, particle size, micromeritics, FT-IR, DSC, XRD

Purpose Glycine has been widely used as pharmaceutical excipients and synthesis reagents, and commercial glycine has a significant amount of aggregation and wide particle size distribution. A simple but reproducible process for generating uniform glycine crystals is always desired for both product quality and process efficiency purposes. Methods Continuous cooling crystallization of glycine has been

Purpose There is a growing interest in continuous biopharmaceutical processing due to the advantages of small footprint, increased productivity, consistent product quality, high process flexibility and robustness, facility cost-effectiveness, and reduced capital and operating cost. To support the decision making of biopharmaceutical manufacturing, comparisons between conventional batch and continuous

Purpose There is a continuous search for efficient optimization methods in the production of biopharmaceuticals, with a special focus on reducing production time and costs. Pharmaceutical production is currently dominated by batch production processes that have a relatively long downtime for cleaning and reconfiguration of the plant equipment when the product or its format size is changed. The geometry

Purpose The main objective of the present investigation was to develop transdermal films of ondansetron HCl (OS) with polyvinyl alcohol (PVA) using Box-Behnken design and to optimize them employing Derringer’s optimization tool. Methods Design-Expert software was used to investigate the effect of independent variables such as concentration (%, w/w) of glycerol and 1,8-cineole, and number of Freeze-Thaw

Purpose With the applications of more advanced manufacturing technologies being applied to the pharmaceutical industry, continuous processes are at the forefront of innovation. One area that is highly desired to be systematically investigated is material traceability in continuous manufacturing systems. By following federal guidelines already in place, the goal was to address the issue of material

Purpose This study is concerned with encapsulation of the anti-cancer drug (berberine hydrochloride (BH)) in nanocarriers as cubosomes, which is, then, formulated in solid form to ease its incorporation into different drug delivery systems, improve its solubility, and improve its anti-cancer activity. Methods BH cubosomes were prepared using glyceryl mono-oleate (GMO) and poloxamer 407 (PF127). Polyvinyl

Purpose Scholars often associate Operational Excellence (OPEX) enablers with high operational performance. Several studies have concluded that advancing OPEX enablers helps improve organizational performance. This paper aims to better understand the relation between OPEX enablers and a robust quality control lab. Integral to pharmaceutical quality systems, robust quality control labs ensure effective

Purpose Zoledronic acid (ZA) is one of the drugs used clinically for the treatment of osteoporosis, and its therapeutic effect is due to the inhibition of osteoclastic cells leading to bone resorption. The aim of this study is developing an optimization method for poly(lactide-co-glycolide) (PLGA) nanoparticles of ZA which is intended for local application to enable guided bone regeneration. Methods

Objective Solid lipid nanoparticles (SLN) mainly consist of lipids and surfactants. However, the toxicity of surfactant cannot be ignored, as the surfactant may cause unexpected side effect. This study established model SLN with different surfactants, Tween 80 (T80) and poloxamer 188 (P188). It was aimed to establish ultraviolet-visible (UV-Vis) spectroscopy methods for quantifying the contents of

Purpose Chromium species in higher oxidation states are toxic and carcinogenic. But lower oxidation state as Cr(III) microelement shows potential antimicrobial properties. Cefoperazone sodium is a parenteral bactericidal third-generation cephalosporin antibiotic effective in treating Pseudomonas bacterial infections. A new drug formed with the complexation of metal and drug. Hence, newer coordinated

Purpose Antimicrobial activity of drug products containing antibiotics is often measured using microbiological assays. However, the high values of measurement uncertainty associated with the analytical results obtained from microbiological assays may be an issue to conformity decisions. Methods The aim of this work was to estimate the risk of false decisions in conformity assessment due to measurement

Purpose The objective of this article is to review the critical material attributes of pharmaceutical excipients employed in solid dosage manufacturing and link them to critical quality attributes (CQAs). Material attributes can have a profound impact on CQAs of product. Methods The importance of particle size, particle morphology, density, moisture content, and polymorphism to product CQAs is discussed

Purpose A new Circulaire II (holding chamber) was designed to be used with VixOne nebulizer to increase the inhalable doses reaching the patient. The aim of this study was to evaluate the efficacy of this holding chamber with VixOne nebulizer and determine its usability with other nebulizers. Methods The aerodynamic characteristics of emitted dose of 2 ml salbutamol solution, 5000 μg/ml, were evaluated

Purpose Current in vitro disintegration methods for polymeric films are qualitative and introduce significant user bias. The goal of these studies is to develop a novel, quantitative disintegration technique which can be used to characterize polymeric films in vitro. Methods A method was developed using a Texture Analyzer instrument to evaluate film disintegration. Solvent casted, clinically advanced

Purpose The main objective of this present study was the investigation of potential novel transdermal patch technology (TEPI®) delivering ibuprofen as the active pharmaceutical ingredient (API) using a novel poly(ether-urethane)-silicone crosslinked pressure-sensitive adhesive (PSA) as the drug reservoir in a solvent-free manufacturing process. Methods The patch was synthesized utilizing the hot-melt

The sterility test described in pharmacopoeial compendia requires a 14-day incubation period to obtain a valid analytical result. Therefore, the use of alternative methods to evaluate the sterility of pharmaceuticals, such as the BacT/Alert® 3D system, is particularly interesting, because it allows a reduced incubation period and lower associated costs. Considering that the BacT/Alert® 3D system offers

PURPOSE 5-chloro-3-[phenylsulfonyl] indole-2-carboxamide (CSIC) is a highly potent non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1 which has been shown to have a more desirable resistance profile than other NNRTIs in development as HIV prevention strategies. This work involves generation of preformulation data for CSIC and systematic development of a cosolvent system to effectively

PURPOSE "Me-too" drugs are new pharmaceuticals with the mechanism of action of an existing drug and are considered less innovative than breakthrough drugs. The objective of this study was to evaluate whether the adoption patterns of the breakthrough drug sitagliptin and the "me-too" drug saxagliptin differed; and to assess whether the patterns differed between Medicare stand-alone (PDP) and Medicare-Advantage

Continuous processing in pharmaceutical manufacturing is a relatively new approach that has generated significant attention. While it has been used for decades in other industries, showing significant advantages, the pharmaceutical industry has been slow in its adoption of continuous processing, primarily due to regulatory uncertainty. This paper aims to help address these concerns by introducing methods

Small-interfering RNA (siRNA) is both a powerful tool in research and a promising therapeutic platform to modulate expression of disease-related genes. Malignant tumors are attractive disease targets for nucleic acid-based therapies. siRNA directed against oncogenes, and genes driving metastases or angiogenesis have been evaluated in animal models and in some cases, in humans. The outcomes of these

INTRODUCTION In previous studies carried out in our laboratory, a bile acid (BA) formulation exerted a hypoglycaemic effect in a rat model of type-1 diabetes (T1D). When the antidiabetic drug gliclazide (G) was added to the bile acid, it augmented the hypoglycaemic effect. In a recent study, we designed a new formulation of gliclazide-cholic acid (G-CA), with good structural properties, excipient compatibility

Terahertz pulsed spectroscopy was used to qualitatively detect ciprofloxacin hydrochloride monohydrate (CPFX·HCl·H(2)O) in tablets, and terahertz pulsed imaging (TPI) was used to scrutinize not only the coating state but also the density distribution of tablets produced by several manufacturers. TPI was also used to evaluate distinguishability among these tablets. The same waveform, which is a unique

Solid amorphous dispersions are frequently used to improve the solubility and, thus, the bioavailability of poorly soluble active pharmaceutical ingredients (APIs). Spray-drying, a well-characterized pharmaceutical unit operation, is ideally suited to producing solid amorphous dispersions due to its rapid drying kinetics. This paper describes a novel flowchart methodology based on fundamental engineering