Hot melt extruded High-Dose amorphous solid dispersions containing lumefantrine and Soluplus
Abstract
Over the last 15 years, a small number of paediatric artemisinin-based combination therapy products have been marketed. These included Riamet® and Coartem® dispersible tablets, a combination of artemether and lumefantrine, co-developed by the Medicines for Malaria Venture and Novartis. Disappointingly, patient compliance, requirement for…
Chinese Excipient Registration (Master File) And Chinese Pharmacopeia (ChP 2020) Compliance…
Excipients used in a drug product for the Chinese market need to be registered in China. The specific setup of such a dossier and the translation in Chinese is a critical part of the success of such a registration. A solid collaboration of…
Quality-by-design in hot melt extrusion based amorphous solid dispersions: An industrial perspective…
An industrially feasible approach to overcome the solubility and bioavailability limitations of poorly soluble active pharmaceutical ingredients is the development of amorphous solid dispersions (ASDs) using hot-melt extrusion (HME)…
The role of excipient molecular weight in drug release by fibrous dosage forms with close packing…
In this work, drug release by highly drug-loaded, densely-packed fibrous dosage forms is investigated. The formulations consisted of 87wt% ibuprofen drug and 13wt% hydroxypropyl methyl cellulose (HPMC) excipient of molecular weights 10, 26,…
Functional 3D printing: Approaches and bioapplications
3D printing technology has become a mature manufacturing technique, widely used for its advantages over the traditional methods, such as the end-user customization and rapid prototyping, useful in different application fields, including the…
Novel Technique for Coating of Fine Particles Using Fluidized Bed and Aerosol Atomizer
Fine particles are widely used in many industrial fields, and there are many techniques applied for these particles, like electroplating, and chemical and physical vapor deposition. However, in the food and pharmaceutical industries, most…
Molecular Dynamics Simulations Reveal Membrane Interactions for Poorly Water-Soluble Drugs: Impact…
Molecular transport mechanisms of poorly soluble hydrophobic drug compounds to lipid membranes were investigated using molecular dynamics (MD) simulations. The model compound danazol was used to investigate the mechanism(s) by which bile…
Towards functional characterization of excipients for oral solid dosage forms using UV-Vis imaging.…
The purpose of this study was to investigate whole-dosage form UV-Vis imaging as a potential tool for functional characterization of excipients used in solid oral dosage forms. To this end, tablets (average mass 260.0 mg, 224.5 mg and 222.1…
Automation and data-driven design of polymer therapeutics
Polymers are uniquely suited for drug delivery and biomaterials applications due to tunable structural parameters such as length, composition, architecture, and valency. To facilitate designs, researchers may explore combinatorial libraries…
A Fast release tablet containing Herbal extracts (Ginger, Cinnamon, Turmeric, Long pepper and…
The aim of the present work is to formulate a fast release tablet containing herbal extracts (ginger, cinnamon, turmeric, long pepper and punarnava) as drug, by direct compression method. Tablets contain super-disintegrant which…
Novel Coating Uniformity Models for Tablet Pan Coaters
Novel mathematical models were developed to predict inter-tablet coating uniformity in terms of coefficients of variation (CV) and acceptance values (AV) for cylindrical tablet pan coaters, operating in batch and continuous modes. The…
Empty mesoporous silica particles significantly delay disease progression and extend survival in a…
Amyotrophic lateral sclerosis (ALS) is a devastating incurable neurological disorder characterized by motor neuron (MN) death and muscle dysfunction leading to mean survival time after diagnosis of only 2–5 years. A potential ALS treatment…
Transdermal Delivery of Salmon Calcitonin Using a Dissolving Microneedle Array: Characterization,…
Salmon calcitonin (sCT) is a polypeptide drug, possessing the ability to inhibit osteoclast-mediated bone resorption. Just like other bioactive macromolecules, sCT is generally administered to the patients by either injection for poor…
An innovative sampling interface for monitoring flowing pharmaceutical powder mixtures
A chute was designed following the principles of the Theory of Sampling to minimize the variations in powder flow and provide all particles in the flowing blends with the same opportunity of being selected as a sample. The design also…
Friday’s Top 5 by pharmaexcipients
Story of the week
First Product Presentation by pharma excipients
We had the chance to interview Filip Francqui from Granutools on the new Granupack - High Temperature. The influence of temperature on the packing dynamics can now be…
On the particle formation of leucine in spray drying of inhalable microparticles
The particle formation of L-leucine, a dispersibility-enhancing amino acid used in the spray drying of inhalable pharmaceutical aerosols, was extensively studied using three experimental methods, and the results were interpreted with the…
Spray drying of naproxen and naproxen sodium for improved tableting and dissolution –…
In this work the tabletability and dissolution of spray-dried forms of naproxen and its sodium salt were compared with those of unprocessed drugs. Solutions of naproxen or naproxen sodium alone or with HPMC (5% w/w of drug content) were…
Hopper design for piezo-actuated granular flow in powder bed 3D food printing
The flow properties of powders in hoppers are studied in order to make a design procedure for piezo-actuated hoppers that are used to deposit powder layers in multi-material 3D (food) printing. A commercial ring shear tester and an…
Chitosan as a machine for biomolecule delivery: A review
The major role of biomolecules in treatment of different diseases has been proven by several studies. However, the main drawback in successful treatment by these molecules is designing of efficient delivery systems to fulfill all of the…
Self-Nanoemulsifying System Loaded with Sildenafil Citrate and Incorporated within Oral Lyophilized…
Sildenafil citrate is a drug used throughout the world primarily to treat erectile dysfunction. Several problems with the commercially available product decrease its efficacy, such as limited solubility, delayed onset of action, and low…
High Temperature GranuPack – See the newest development from Granutools
Numerous industrial processes involve powder heating which leads to major modification of the powder packing properties. For example, the setting of solid bridges due to pre-sintering will have drastic consequences on the packing behavior…
3D screen printing – An innovative technology for large-scale manufacturing of pharmaceutical dosage…
Three-dimensional (3D) screen printing was used to fabricate oral dosage forms of different geometry and size. The paste required as starting material for the 3D screen printing process was designed for delayed release and contained the…
Nanocarriers based on vitamin E-TPGS: Design principle and molecular insights into improving the…
α-Tocopheryl polyethylene glycol succinate (Vitamin E-TPGS or TPGS) is a nonionic amphiphile synthesized by the esterification of vitamin E succinate. It has been categorized as a safe excipient by US-FDA and EMA. Like other polyethylene…
Disintegrant Selection in Hydrophobic Tablet Formulations
The hydrophobicity of poorly soluble drugs can delay tablets disintegration. We probed here the influence of different disintegrants on the disintegration of challenging hydrophobic formulations. Tablets containing diluents, hydrogenated…
Process Design of Continuous Powder Blending Using Residence Time Distribution and Feeding Models
The present paper reports a thorough continuous powder blending process design of acetylsalicylic acid (ASA) and microcrystalline cellulose (MCC) based on the Process Analytical Technology (PAT) guideline. A NIR-based method was applied…
Comparison of Compressibility, Compactability and Lubricant Sensitivity of Two Partially…
Modified starches are widely employed excipients in tablets compression. The ability of materials to deform under pressure (compressibility) and create strong compacts (compactability) is then important for tablet manufacture. This study…
The Use of a Three-Fluid Atomising Nozzle in the Production of Spray-Dried Theophylline/Salbutamol…
The aim of this study was to investigate the use of a three-fluid atomising nozzle in a lab-scale spray dryer for the production of dry powders intended for pulmonary delivery. Powders were composed of salbutamol sulphate and theophylline…
Tableting of mini-tablets in comparison with conventionally sized tablets: A comparison of tableting…
Mini-tablets are solid dosage forms with increasing interest for pharmaceutical industry due to clinical and biopharmaceutical benefits. But technological aspects on mini-tableting are not fully investigated. Therefore, the impact of…
Raman monitoring of semi-continuously manufactured orodispersible films for individualized dosing
Orodispersible films are promising oral dosage forms for special populations. To enable continuous manufacturing of orodispersible films, monitoring of the active pharmaceutical ingredient contained in the final product is essential.…
Comparing Different Moisture Protective Instant Release Coatings for Solid Oral Dosage Forms
Introduction: Drug stability and shelf life are main targets of current pharmaceutical development as many active ingredients are highly moisture sensitive. Instead of using impermeable and expensive packaging materials it appears advisable…
Overview of Extensively Employed Polymeric Carriers in Solid Dispersion Technology
Solid dispersion is the preferred technology to prepare efficacious forms of BCS class-II/IV APIs. To prepare solid dispersions, there exist a wide variety of polymeric carriers with interesting physicochemical and thermochemical…
Advanced design and development of nanoparticle/microparticle dual-drug combination lactose…
Lactose is the only FDA-approved carrier for dry powder inhaler (DPI) formulations in the US. Lactose carrier-based DPI products are contraindicated in patients with a known lactose allergy. Hence, inhaler formulations without lactose will…
Potential of solid dispersions to enhance solubility, bioavailability, and therapeutic efficacy of…
In the last few decades, solid dispersion (SD) technology had been studied as an approach to produce an amorphous carrier to enhance the solubility, dissolution rate, and bioavailability of poorly water-soluble drugs. The use of suitable…
Solubility and Stability Enhanced Oral Formulations for the Anti-Infective Corallopyronin A
Novel-antibiotics are urgently needed to combat an increase in morbidity and mortality due to resistant bacteria. The preclinical candidate corallopyronin A (CorA) is a potent antibiotic against Gram-positive and some Gram-negative…
The Influence of Solidification on the in vitro Solubilisation of Blonanserin Loaded Supersaturated…
Supersaturated silica-lipid hybrids have previously demonstrated improved in vitro solubilisation and in vivo oral bioavailability of poorly water-soluble drugs, however were only fabricated using a single lipid (LFCS type I formulations)…