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.

A Correction to this paper has been published: https://doi.org/10.1007/s12247-020-09522-5

Twin-screw extruder (TSE), originally built and developed for plastic and rubber industries approximately 100 years ago, is now slowly but steadily gaining popularity in the pharmaceutical industry for manufacturing various dosage forms. TSE has proven to be a robust, multi-purpose, and environment-friendly instrument that has displayed the potential to revolutionize the manufacturing processes in

Purpose To develop a bilayer tablet containing sustained-release (SR) nicorandil and immediate-release (IR) atorvastatin components in separate layers for the effective treatment of angina accompanied by hyperlipidemia with less dosing frequency and improved patient compliance. Methods Sustained-release nicorandil layer was formulated using HPMC K100M with or without Eudragit RS PO and Ethyl Cellulose

Purpose The study aimed to formulate hydrocolloid dressings incorporated with nano calcium oxide for effective wound healing. Hydrocolloid dressings create an insulated, moist environment in the wound bed for controlling the exudate and promoting autolytic debridement. Calcium ions play an important role in wound response and are considered to be an initial trigger in our immune response to healing

This study aimed to develop and characterize a novel microemulsion-based intranasal diazepam for treating acute repetitive seizures (ARS). The solubility of diazepam was obtained in different solvents. An oil in water microemulsion was prepared with castor oil as oil phase, polyethylene glycol monostearate as surfactant, ethanol as cosurfactant, and water. The formulation was further evaluated for

Purpose Being hydrophobic, paraffin wax is potentially useful for developing taste-masked or sustained release drug formulations. However, its high hydrophobicity also makes it challenging to achieve good embedment of a hydrophilic drug (e.g. paracetamol) due to the significant interfacial tension experienced. While spray congealing is an efficient technique of producing microparticles for pharmaceutical

Purpose The industrial applications of lipases are hampered by their sensitive nature to processing and storage conditions. In this context, this study presents a simple statistical modeling approach using Nano Spray Dryer BÜCHI B-90 as an ideal technique for the production of stable lipase nano-powder (LNP). Methods In this study, factorial design is employed to optimize the spray drying process for

Purpose The present work was aimed at formulating solidified reverse micellar microparticles (SRMMs) using templated lipids (Softisan 154, stearic acid, and Phospholipon ®90H) for improved biopharmaceutical performance, dissolution of miconazole nitrate. Methods SRMMs containing miconazole nitrate (MN) (1, 2, and 3% w/w) were formulated using Softisan® 154 (SOFT) and stearic acid (ST) and their combinations

Purpose In this study, the preparation of self-assembled polymer-free in situ forming nanovesicles (ISNs) based on non-ionic surfactants (NISs) is presented. Methods A 22·41 full factorial experimental design was adopted for the development of novel polymer-free ISNs loaded with tenoxicam utilizing the emulsion method. The type of NIS (Brij® 52 or Span® 60), the cholesterol percentage (30, 50, or 60

Hot melt extrusion (HME) is emerging as a continuous, single-step, scalable, and industrially feasible process for the production of cocrystals. HME has gained momentum as a continuous and solvent-free process in the manufacturing of cocrystals. The incorporation of the matrix and the use of process analytical tool (PAT) for real-time monitoring further facilitate the process. The advantages and disadvantages

Purpose Dextromethorphan (DXM) is exceptionally bitter, yet the most widely used antitussive agents worldwide. It belongs to BCS class-II of pharmaceutical agents because of its poor water solubility; this is why it is only available in its hydrobromide salt form either in liquid or in solid formulations in the market. This water-soluble salt of the drug releases its content to a greater extent in

Purpose Microencapsulation is a technique employed in the development of controlled drug delivery systems. It is beneficial in reducing dosing frequency, ensuring targeted drug delivery, and improving drug bioavailability. The objective of this study was to evaluate the effectiveness of Cyperus esculentus starch and its derivative in the development of microbeads for sustained delivery of ibuprofen

Purpose In this work, a new water-soluble Pt(II) complex was synthesized with aliphatic glycine ligand with a formula of cis-[Pt(NH3)2(isopentylgly)]NO3, as an anti-cancer drug, and characterized. To determine the binding constant of the human serum albumin (HSA, the most abundant carrier proteins in the human circulatory system) to this complex and the binding site of the complex on HSA, the melting

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