Purpose D-tagatose is an alternative sweetener with superior properties for reducing overall sugar absorption, which is especially important in the diabetic population. Large-scale production of D-tagatose remains costly, thereby limiting its commercialization. Introducing the unit operation of spray-drying may reduce some of these costs. However, D-tagatose is challenging to spray-dry due to its hydrophilic

Purpose The study is inspired by the fact that intravenous administration of 2-hydroxypropyl-beta-cyclodextrins (HP-β-CD) in rats leads to a rapid decrease in plasma cholesterol levels. Further, HP-β-CD being more water soluble than native β-CD, HP-β-CD forms soluble complex with cholesterol and higher affinity of cholesterol towards HP-β-CD than native β-CD leads to increase sensitivity. Hence, present

Purpose This contribution is the first example of a small molecule pharmaceutical product development ontology. This ontology allows the portfolio-wide visualization of the small molecule pharmaceutical development business as a network of decisions and activities. This ontology was built not only to digitalize, rapidly access, and gain insights from prior decision-making but also to deliver input

Purpose In this study, a novel solubility enhancement excipient (Soluplus®) was investigated to improve the solubility and dissolution rate of Curcumin, a poorly water soluble drug. Methods Various methods were utilized for the fabrication of Curcumin-Soluplus® mixtures, including the physical mixture, co-grinding, milling physical mixture, and solid dispersion. The drug and polymer mixtures were prepared

Introduction Oral dispersible tablets (ODTs) are promising pharmaceutical dosage forms and, theoretically, could be used for many active pharmaceutical ingredients. The development of ODTs by direct compression with rapid disintegration and suitable hardness is a formulation challenge. The hypothesis of the present work is to prepare a single super-disintegrant multifunctional excipient for the production

Purpose The chromatography methods such as HPLC, HPTLC etc. were developed for simultaneous estimation of multiple fixed-dose combination products of metformin hydrochloride which need single chromatography condition to save solvent consumption. The method was developed by the implementation of analytical quality by design approach based on principles of quality risk management (QRM) and design of

Background Lithiasis is an agonizing disease that can be found all around the world. In Sri Lanka, the patients who are suffering from “lithiasis” are increasing gradually yearly. Uses of medicinal herbs as a cure for lithiasis are precious in folk and ayurvedic healing practices. Curing of ureteric calculi is still a challenge for modern medical practices; hence, the medicinal plants have become a

Purpose The purpose of this manuscript is to demonstrate that implementation of gravimetric measurements provides the same assurance of product quality and process control as spectroscopic measurements (1) for control of drug content in a fixed-dose combination (FDC) tablet and (2) for identification of non-conforming material. Methods A wet granulation continuous tableting line was used to make the

Nanocrystals (NCs) are the class of solid dosage forms which utilizes the concept of nanoscience together with crystal nature of drug to achieve advantages in terms of solubility, dissolution, and physicochemical properties. Comparing with other solid dosage forms, NC often comes with so many challenges in terms of physical stability as well as chemical stability during the manufacturing process and

Purpose The present study was aimed to develop and optimize linezolid loaded chitosan nanoparticles for pulmonary delivery. The objective was to achieve the mean particle size of nanoparticles less than 300 nm and the mass median aerodynamic diameter (MMAD) less than 5 μm and sustain the drug release up to 24 h. Methods Linezolid nanoparticles were prepared by ionic gelation technique employing chitosan

The original version of this article unfortunately contained a mistake.

Purpose Inflammation characterized by edema, redness, and pain predominantly symptomatizes in diseases like allergies, asthma, and arthritis. Anti-inflammatory drugs like NSAIDs have been used to treat inflammation but reportedly cause severe gastrointestinal problems; therefore, new and safer drugs are sought-after for better resolution of diseases. The metal-based drugs have been proved as promising

Purpose The present study reports synthesis, characterization and in vitro evaluation of physicochemical and biological properties of dendritic lipopeptide oligomers comprising L-glutamic acid dendrons and myristoyl tails such that termini of the molecules carry carboxylic ester, carboxylic acid or alcohol functions, which account for nonpolar neutral, polar anionic and polar neutral surfaces, respectively

Purpose Acceptable content uniformity is one of the major challenges in industrial pharmacy especially in low-dose drugs with narrow therapeutic index. Several methods have been proposed for solving this problem. Liquisolid technique is a new promising method that mainly has been used for enhancing solubility rate of drugs. It seems that this method could be able to obtain better distribution of drug

Purpose Anti-inflammatory drugs are in the spotlight of pharmaceutical investigations due to the involvement of this condition in different cancers and diseases. Non-steroidal anti-inflammatory drugs (NSAIDs) are considered to be the most widely used anti-inflammatory drugs. However, the inability of these molecules to distinguish between COX-1 and COX-2 results in concomitant side effects. In the

Purpose Paracetamol is a well-known OTC drug, and several combinations are available in the market. The numbers of chromatography methods were published for analysis of combined pharmaceutical dosage form of paracetamol. But every combination needs separate and dedicated chromatography condition for analysis. Hence, a chromatography method was developed for simultaneous estimation of some combined

Purpose This investigation was aimed to develop and evaluate lipid nanoemulsion-based gel of finasteride for topical administration, to increase drug availability into the skin for a long duration and to improve the in vivo potential of finasteride against alopecia. Methods Nanoemulsion was prepared by a high-speed homogenization method using Vit E oil, cholesterol, and soya lecithin, characterized

The original version of this article unfortunately contained a mistake. The name of the 3rd author was incorrectly presented. The correct name of the 3rd author is “Matheus Aparecido dos Santos Ramos.”

Objective Polysorbates 20 and 80 are the most used surfactants for the development of parenteral protein formulations, because of their beneficial safety and stabilisation profile. Although, showing excellent stabilisation properties, the stabilisation mechanism(s) of these surfactants for aqueous protein formulations are still unclear. Different stabilisation models have been discussed in the literature

Purpose Gastrointestinal hydrodynamics are poorly replicated in vitro and can significantly alter the release kinetics of drug products due to compressive forces in the stomach and peristaltic movement in the intestines. In this work, we describe the development and application of a predictive in vitro dissolution device that simulates gastrointestinal forces for the testing of oral drug products.

Purpose The number of studies utilizing the matrix-assisted laser desorption/ionization mass spectrometry (MALDI-MS) has significantly increased over the past years. This technique features excellent sensitivity and speed of analysis for ionic compounds such as proteins, peptides, nucleic acids and small metabolites. Detection of small metabolites by MALDI-MS is essential for early diagnosis and monitoring

Purpose In situ-forming gels (semi-solid state) (ISFGs) are widely used as sustained drug delivery, but they show a high burst release as well. The purpose of the current study is to make triblock that can make a quick gel on injection with a minimum burst release. Methods In this study, to control the release of levothyroxine from ISFG, PLGA-PEG-PLGA (triblock) polymer was used. The melting method

Purpose This study aims to design oily-core nanocapsules for poorly water-soluble antihypertensive drug olmesartan medoxomil (OM) and optimize systematically the in-vitro characteristics of prepared nanosystems. The study represents an organized methodology for screening and studying significant parameters affecting polymeric nanocapsule formulation and characterization. Method A full two-level (23)

Purpose The present study was focused on the synthesis and characterization of cerium with hydroxyapatite for biomedical applications. Method Hydroxyapatite (HAp) substituted with variable concentration (0.075, 0.150, 0.225%) of cerium (Ce) was synthesized by sol–gel method. The structural and morphological properties were characterized by X-ray diffraction (XRD), scanning electron microscopy (SEM)

Objective One of the main problems with NSAIDs is the dosing frequency, which leads to patients’ noncompliance. To overcome this, fabrication of sustained release formulation of the drug is considered a well-reputed technique. The present study aimed to develop sustained release formulation of a model drug aceclofenac through the new liquisolid technique. Methods Liquisolid powder prepared using glycerin

Purpose The study was aimed at exploring the feasibility of LIPOID SPC-3 as a coprecipitate carrier to enhance the aqueous solubility and permeability of ranolazine, a BCS class II drug. Methods LIPOID SPC-3-based coprecipitates of ranolazine (RNZ-SPC-CP) were developed using the solvent method. The developed formulation was physico-chemically characterized using scanning electron microscopy (SEM)

Purpose The active ingredient recovery from the vegetable is a very attractive research field for the development of a sustainable economy; to revalue the jujube fruit (Zizyphus lotus) polysaccharide (ZLPS), an optimized green microwave-assisted method was used for the recovery and enrichment of the antioxidants present in a distilled water extract. Methods A series of 17 experiments including microwave

Purpose The size was a key factor influencing the drug loading, release, and delivery efficacies of poly (lactic-co-glycolic) acid (PLGA) microspheres (MS). The purpose of the study was to explore a novel and simple method to prepare uniform-sized PLGA MS for drug delivery. Methods Different from routine homogenizer, a vortex shaker was employed for emulsification during the preparation of PLGA MS

Purpose The purpose of the study was to develop a model to predict the critical quality attribute (CQA) of tablets during continuous and batch manufacturing using only critical material attributes (CMAs). Methods Experiments were performed using ethenzamide as the active pharmaceutical ingredient processed with batch and continuous high-shear granulators. The disintegration time of tablets was defined

Abstract The design of multiparticulate systems is a high-impact technological strategy in the formulation of immunomodulators for oral administration, fluid bed coating being a technique used due to its versatility and relatively low cost. Purpose The objective of this work was to cover a solid support (Suglets® of Colorcon®) with an extract of cell wall of Saccharomyces cerevisiae through a fluidized

Purpose Less local availability and higher skin permeation restrict wide application of silver sulfadiazine (SSD) formulations against infectious burn wound. Aim We aimed to develop β-cyclodextrin inclusion complex-based in situ pluronic gel of SSD (β-CD-ssd P-Gel). Methods Formation of inclusion complex was confirmed by FT-IR, DSC, SEM, and XRD and checked for improved solubility. Results and Discussion

Purpose The purpose of this paper is to unveil two novel statistical strategies to decide on the acceptability of an analytical and bioanalytical method transfer. These new approaches, namely the uncertainty assessment approach and the risk-based approach, are based on the measurement uncertainty as a decision-making tool. Methods At first, we illustrate step by step all the calculations required to

Background and Introduction Piroxicam is an NSAID (non-steroidal anti-inflammatory drug) persisting antipyretic and analgesic effects and being usually implied in managing and treating osteoarthritis, rheumatoid arthritis, soft tissue disorders, ankylosing spondylitis, and acute gout and also in post-operative pain management. Aim The present research was undertaken aiming to formulate Piroxicam encompassing

Purpose Clofazimine displays high intersubject variability in absorption after oral administration because of its extremely low water solubility and high lipophilicity. The present investigation was aimed to prepare self micro emulsifying drug delivery system (SMEDDS) of clofazimine for improving its dissolution properties by using design of experiment (DoE) approach. Methods Various lipid, surfactant

Purpose Lean stability is a science- and risk-based initiative which utilizes the enhanced understanding of drug substance and drug product physical and chemical characteristics to (1) reduce and optimize the design of standard stability protocols; (2) expedite the generation of stability data without impact to safety, efficacy, or quality of the product; and (3) decrease time to market for innovative

Purpose Infectious diseases caused by Candida sp. have high drug resistance due to the uncontrolled use of antibiotics. Among the natural products, ursolic acid (UA), a triterpene, has been increasing interest due to its antimicrobial effects. However, the physicochemical properties of UA, such as its low aqueous solubility, lead to failure of therapeutic application. Because of this, drug release

Purpose The present study explored biochemical transformation and optimization of fermentation method for enhanced content of flavonoids in a composite extract of Syzygium cumini seed, Mangifera indica seed, Momordica charantia fruit, and Gymnema sylvestre leaf along with the fermentation kinetics. Methods The herbs were mixed and extracted in hot water. The extract was fermented using Wickerhamomyces

Background Topical drug delivery offers improved therapeutic effect and reduced systemic adverse effects of the administered compounds. Objective The present work was aimed at developing and comparing levocetirizine loaded polymeric nanoparticles and niosomal formulation(s), respectively, against dinitrochlorobenzene-induced atopic dermatitis animal model. Methods The niosome and chitosan nanoparticle

Purpose The aim of this work is to study the metal–drug–amino acid ternary complex formation kinetically, thermodynamically and computationally and explore the possibility of developing some potent new drugs for biological applications. Methods Metal(II)–ciprofloxacin–glycine ternary complexes (metal = MnII, CuII, ZnII) were synthesized. The slow kinetics and thermodynamics of imine formation were

Purpose Objective of present work was to develop microfluidic-based technique for continuous production of drug (luliconazole)-loaded microemulsion. Methods Pseudo-ternary phase diagrams were constructed, and optimization of concentration of selected formulation components like Capmul MCM, Tween 20 and Transcutol P was done using the Box-Behnken design (BBD). Batch process and microfluidic process

The original version of this article unfortunately contained a mistake.

Purpose The present study was aimed to formulate and evaluate fast-disintegrating tablets (FDTs) having Flurbiprofen (FP) and Metoclopramide HCl (MHCl) in combination. Method Direct compression was used to formulate FDTs of FP and MHCl as a combination regimen in six formulations. FDTs are defined as solid oral dosage form that disintegrates rapidly within seconds when placed in the oral cavity. FDT-1

Purpose The study was aimed to formulate eugenol-loaded polymeric microsponges using eugenyl methacrylate (Eg-MA) incorporated in situ gelling system for the treatment of periodontitis. Method Eg-MA monomer was first synthesized by reacting eugenol with methacryloyl chloride, which acted as a monomer and cross-linking agent for preparing microsponges of Eg-MA using suspension polymerization method

Purpose The prevalence of rheumatic disease patients was estimated at 25% of the population. Rheumatic diseases are the leading cause of disability. The main objective of the study was to investigate the kinetic drug release characteristics of aceclofenac sustained-release (SR) matrix tablets for the management of rheumatic diseases. Methods The novel formulation of aceclofenac was prepared by using

Purpose Implementation of Process Analytical Technologies (PAT) is an important consideration to increase process knowledge during pharmaceutical manufacturing. Currently used batch sampling methods, however, are limited in terms of temporal resolution when compared with continuous process sampling. Here, we show the importance of fluid dynamic characterization when repurposing available batch sampling

Drug delivery through the skin by transdermal patches has a long history. Subsequent growth of transdermal science proved prominent utility of transdermal systems meant for passive diffusion of the drug. It was followed by the development of iontophoresis- and sonophoresis-based transdermal delivery systems. Microneedle array has now caught attention of the investigators owing to its immense utility

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