A case study on distributed manufacturing of 3D printed medicines
Pharmaceutical 3D printing (3DP) is one of the emerging enabling technologies of personalised medicines as it affords the ability to fabricate highly versatile dosage forms. In the past 2 years, national medicines regulatory authorities have held consultations with external stakeholders to adapt regulatory frameworks to embrace point-of-care…
Exploiting common ion addition to accelerate zolpidem hemitartrate release from Eudragit EPO…
The current study aimed at optimizing a previously developed non-clinical formulation for use in zolpidem deprescribing. The formulation under investigation consists of extruded zolpidem hemitartrate (30% w/w) and Eudragit EPO (70% w/w)…
Thiolated α-cyclodextrin: The likely smallest drug carrier providing enhanced cellular uptake and…
This study aimed to evaluate the effect of thiolated α-cyclodextrin (α-CD-SH) on the cellular uptake of its payload.
For this purpose, α-CD was thiolated using phosphorous pentasulfide. Thiolated α-CD was characterized by FT-IR and 1H NMR…
A Data-Driven Approach to Predicting Tablet Properties after Accelerated Test Using Raw Material…
The purpose of this study was to develop a model for predicting tablet properties after an accelerated test and to determine whether molecular descriptors affect tablet properties. Tablets were prepared using 81 types of active…
Tablet coating in lab-scale drum coaters: Combining DEM simulations and spray experiments to predict…
In pharmaceutical industry the coating of granulates or tablets is an essential production step, which is often realised in a rotating drum moving the tablet bed and a number of spray nozzles installed above this bed. The nozzles atomise…
Revolutionizing pediatric HIV therapy: The latest breakthroughs in drug delivery techniques
Human Immunodeficiency Virus (HIV) is the root cause of acquired immunodeficiency syndrome (AIDS), which destroys the body's immune cells, thereby rendering the body unable to fight any infections. It is a sexually transmitted disease (STD)…
3D printing of hollow capsular body & sealing pin by fused filament fabrication (FFF) technique…
Additive manufacturing (AM) is an emerging pharmaceutical manufacturing technique feasible for patient-centric personalised medicine with tailored pharmacotherapy. Fused filament fabrication (FFF) is a highly emphasised 3D printing…
Thiolated polymers: An overview of mucoadhesive properties and their potential in drug delivery via…
Abstract
Thiolated polymers, or thiomers, are a class of polymers that exhibit unique mucoadhesive properties, allowing them to form strong covalent bonds with cysteine-rich subdomains of mucus glycoproteins. This property makes them ideal…
Gin & tonic – the first bittersweet antimalarial
During the 1700s, antimalarial properties of quinine were first unleashed. British soldiers stationed in India began drinking tonic water to prevent and combat the disease. However, quinine has a pronounced bitter taste; in the 1800s, gin…
Impact of Amylose-Amylopectin Ratio of Starches on the Mechanical Strength and Stability of…
The two main components of starch — amylose and amylopectin, are responsible for its interaction with moisture. This study investigated how moisture sorption properties of the starches with different amylose-amylopectin ratio impacted…
A systematic review of commercial high concentration antibody drug products approved in the US:…
Three critical aspects that define high concentration antibody products (HCAPs) are as follows: 1) formulation composition, 2) dosage form, and 3) primary packaging configuration. HCAPs have become successful in the therapeutic sector due…
Eudragit® FS Microparticles Containing Bacteriophages, Prepared by Spray-Drying for Oral…
Phage therapy is recognized to be a promising alternative to fight antibiotic-resistant infections. In the quest for oral dosage forms containing bacteriophages, the utilization of colonic-release Eudragit® derivatives has shown potential…
Reviewing the Impact of Powder Cohesion on Continuous Direct Compression (CDC) Performance
Abstract
The pharmaceutical industry is undergoing a paradigm shift towards continuous processing from batch, where continuous direct compression (CDC) is considered to offer the most straightforward implementation amongst powder processes…
Parenteral Drugs: Ensuring Sterility and Minimizing Risks During Manufacturing
THE IMPORTANCE OF PARENTERAL DRUGS
Parenteral drugs are infused or injected either intravenously, intramuscularly, or subcutaneously into the body to treat a wide range of diseases and conditions. Injectables are the second fastest growing…
Layer by layer self-assembly for coating a nanosuspension to modify drug release and stability for…
Layer-by-layer (LbL) modification is an effective way to tune the properties of particles. However, the traditional LbL process involves repeated washing steps which are not compatible with nanoparticles with a partial solubility. In this…
Parteck® TA (Calcium Carbonate): Enhanced opacity with ideal particle properties
Titanium dioxide is extensively used in solid dosage forms as an opacifier and colorant. Due to regulatory developments and restrictions by authorities, formulators are increasingly interested in titanium dioxide-free solutions for both…
Ranking mAb–excipient interactions in biologics formulations by NMR spectroscopy and computational…
ABSTRACT
Excipients are added to biopharmaceutical formulations to enhance protein stability and enable the development of robust formulations with acceptable physicochemical properties, but the mechanism by which they confer stability is…
Preliminary Study on the Development of Caffeine Oral Solid Form 3D Printed by Semi-Solid Extrusion…
Apnea of prematurity can be treated with a body-weight-adjusted dosage of caffeine. Semi-solid extrusion (SSE) 3D printing represents an interesting approach to finely tailor personalized doses of active ingredients. To improve compliance…
Parteck® MXP: two polymers, unparalleled value – Polyvinyl alcohol for hot melt extrusion
With two specifically engineered grades of polyvinyl alcohol, Merck´s Parteck® MXP polymers are optimal for generating high performing, solubility enhanced formulations via hot melt extrusion.
Enhancing drug solubility
Parteck® MXP…
Investigation of the impact of Kollicoat® Smartseal formulation concepts on their taste masking…
Introduction
Taste-masking is typically considered to overcome the bitter or unpleasant taste of an active pharmaceutical ingredient, leading to a higher patient compliance and acceptability.
Different techniques are available to obtain…
Development and evaluation of niacinamide transdermal formulation by artificial membrane…
Despite many efforts to improve the transdermal permeability of drugs, most of them are blocked by the skin barrier. Niacinamide (NAC) is a Biopharmaceutics Classification System class I drug with high aqueous solubility and intestinal…
Size-optimized simvastatin TPGS modified lipid nanocapsules for targeting epithelial-to-mesenchymal…
ABSTRACT
Objectives
Novel D-α-tocopherol polyethylene glycol 1000 succinate (TPGS) modified lipid nanocapsules (LNC) were prepared with the aim of improving the effectiveness of simvastatin (SIM) in hepatocellular carcinoma (HCC).…
Core-Shell Structured PLGA Particles Having Highly Controllable Ketoprofen Drug Release
The non-steroid anti-inflammatory drug ketoprofen (KP) as a model molecule is encapsulated in different poly(lactide-co-glycolide) (PLGA) nanostructured particles, using Tween20 (TWEEN) and Pluronic F127 (PLUR) as stabilizers to demonstrate…
Self-emulsifying drug delivery systems (SEDDS): In vivo-proof of concept for oral delivery of…
In spite of recent progress made in the field of peptide and protein delivery, oral administration of insulin and similar drugs remains a challenge. In this study, lipophilicity of insulin glargine (IG) was successfully increased via…
Influence of Pore Size and Surface Functionalization of Mesoporous Silica Nanoparticles on the…
Coenzyme Q10 is a potent antioxidant that plays an important role in the maintenance of various biochemical pathways of the body and has a wide range of therapeutic applications. However, it has low aqueous solubility and oral…
The application of Near-Infrared Spatially Resolved Spectroscopy in scope of achieving continuous…
In scope of achieving real-time release of tablets, quality attributes need to be monitored and controlled through Process Analytical Technology tools such as near-infrared spectroscopy (NIRS). The authors evaluated the suitability of…
Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol…
Guidance for Industry
This guidance is for immediate implementation.
This guidance is intended to alert pharmaceutical manufacturers, compounders, repackers, and suppliers to the potential public health hazard of glycerin and other…
Calcium Phosphate Microcapsules as Multifunctional Drug Delivery Devices
Abstract
More challenging active pharmaceutical ingredients are entering the market, spurring the introduction of novel drug delivery strategies that necessitate a paradigm shift from exhausted excipients to materials with combined actions…
Comparative Study of Selected Excipients’ Influence on Carvedilol Release from Hypromellose Matrix…
Solid dosage forms based on hypromellose (HPMC) with prolonged/extended drug release are very important from the research and industrial viewpoint. In the present research, the influence of selected excipients on carvedilol release…
Comparison of Ceolus™ Grades – Continuous Manufacturing System “Granuformer® Gf-2050”
Comparison of Ceolus™ Grades in Continuous Manufacturing (Wet Granulation) - Continuous Manufacturing System “Granuformer® Gf-2050”
Introduction
Until now, batch manufacturing has been the main mode of pharmaceutical manufacture: raw…
Microfluidic mixing as platform technology for production of chitosan nanoparticles loaded with…
In recent decades, biotechnological drugs have emerged as relevant therapeutic tools. However, therapeutic molecules can exert their activity only if properly formulated and delivered into the body. In this regard, nano-sized drug delivery…
The future of mRNA delivery: Advancements in engineering lipid nanoparticles for enhanced…
Messenger RNA (mRNA) has played a crucial role in recent vaccine developments and is at the forefront of much current medical research. Traditionally. the delivery of mRNA systemically via lipid nanoparticles (LNPs) innately results in LNP…
Investigating structural attributes of drug encapsulated microspheres with quantitative X-ray…
The intra-sphere and inter-sphere structural attributes of controlled release microsphere drug products can greatly impact their release profile and clinical performance. In developing a robust and efficient method to characterize the…
Mesoporous Silica Nanoparticles as a Gene Delivery Platform for Cancer Therapy
Cancer remains a major global health challenge. Traditional chemotherapy often results in side effects and drug resistance, necessitating the development of alternative treatment strategies such as gene therapy. Mesoporous silica…
Parenteral Process Guide – Formulation by Merck
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