Pharmacometrics to Evaluate Dosing of the Patient-Friendly Ivermectin CHILD-IVITAB in Children ≥ 15 kg and <15 kg
Abstract
The antiparasitic drug ivermectin is approved for persons > 15 kg in the US and EU. A pharmacometric (PMX) population model with clinical PK data was developed (i) to characterize the effect of the patient-friendly ivermectin formulation CHILD-IVITAB on the absorption process and (ii) to evaluate dosing for studies in children < 15…
Drug Product Characterization of High Concentration Non-Aqueous Protein Powder Suspensions
High concentration protein formulations for subcutaneous injection represent a substantial number of development projects in the pharmaceutical industry. Such concentrated aqueous protein solutions face some specific challenges such as…
Fabrication of bilayer tablets using hot melt extrusion-based dual-nozzle fused deposition modeling…
The objective of this study was to fabricate bilayer tablets using hot-melt extrusion (HME)-based dual-nozzle fused deposition modeling (FDM) three-dimensional (3D) printing techniques. Acetaminophen (APAP) and caffeine citrate (CC) were…
Roquette Expands PEARLITOL® SD Mannitol Range for Highly Sensitive Active Pharmaceutical…
Roquette, a global leader in plant-based ingredients and a leading provider of pharmaceutical excipients, today announces the addition of a new grade to its PEARLITOL® SD mannitol range for direct compression – PEARLITOL® 150 SD. Developed…
Microneedle-based two-step transdermal delivery of Langerhans cell-targeting immunoliposomes induces…
Novel Coronavirus is affecting human's life globally and vaccines are one of the most effective ways to combat the epidemic. Transcutaneous immunization based on microneedle (MN) has attracted much attention because of its painlessness,…
Mucus-penetrating nanoparticles based on chitosan grafted with various non-ionic polymers:…
Transmucosal administration offers numerous advantages for drug delivery as it usually helps to avoid first pass metabolism, provides rapid onset of action, and is a non-invasive route. Mucosal surfaces are covered by a viscoelastic mucus…
Multifunctional active ingredient-based delivery systems for skincare formulations: A review
Nowadays, there is a growing demand for effective cosmetic skincare products that can address the specific skin problems of consumers. Delivery systems play an important role in the effective action of cosmetic skincare formulations.…
Kollidon® VA 64 and Soluplus® as modern polymeric carriers for amorphous solid dispersions
As the number of new drug candidates that are poorly soluble in water grows, new technologies that enable the enhancement of their solubility are needed. This is the case with amorphous solid dispersions (ASDs) that, nowadays, not only…
Preparation of Terbinafin-Encapsulated Solid Lipid Nanoparticles Containing Antifungal Carbopol®…
The present research was aimed to develop a terbinafin hydrochloride (TH)-encapsulated solid lipid nanoparticles (SLNs) hydrogel for improved antifungal efficacy. TH-loaded SLNs were obtained from glyceryl monostearate (lipid) and Pluronic®…
Cyclodextrin Inclusion Complexes with Antibiotics and Antibacterial Agents as Drug-Delivery…
Cyclodextrins (CDs) are a family of cyclic oligosaccharides, consisting of a macrocyclic ring of glucose subunits linked by α-1,4 glycosidic bonds. The shape of CD molecules is similar to a truncated cone with a hydrophobic inner cavity and…
Downstream Processing of Itraconazole:HPMCAS Amorphous Solid Dispersion: From Hot-Melt Extrudate to…
The downstream processing of hot-melt extruded amorphous solid dispersions (ASDs) into tablets is challenging due to the low tabletability of milled ASDs. Typically, the extrudate strand is sized before milling, as the strand cannot be fed…
Risk Assessment and QbD-Based Optimization of Sorafenib Tosylate Colon Targeted Bilayer Tablet: In…
The employment of site-specific administration in colon is a promising technique to improve efficacy and reduce systemic side effects of anticancer medications used in colorectal cancer. However, the physiology of the gastrointestinal tract…
Celecoxib-Loaded Solid Lipid Nanoparticles for Colon Delivery: Formulation Optimization and In Vitro…
This work aimed to optimize a celecoxib (CXB)-loaded solid lipid nanoparticles (SLN) colon delivery system for the enhancement of anticancer activity. An ultrasonic melt-emulsification method was employed in this work for the preparation of…
Controlling drug release by introducing lipase inhibitor within a lipid formulation
Drug overdose connected to marketed pharmaceutical products, particularly opioids, occurs at an alarming rate. Novel strategies through innovative formulation approaches that reduce the likelihood of overdose while allowing safe therapeutic…
Customized 3D-printed hollow capsular device filled with norfloxacin-loaded micropellets for…
Pharmacotherapy has become more focused on the personalized treatment of patients with various diseases. This field of pharmacology and pharmacogenomics focuses on developing drug delivery systems designed to address the unique…
Product-Property Guided Scale-Up of a Fluidized Bed Spray Granulation Process Using the CFD-DEM…
In this work, a method to predict the surface structures of particles produced by fluidized bed spray layering granulation using the CFD-DEM method was developed. A simple state-variable/event tracking approach was implemented to capture…
Formulation and Optimization of Diclofenac Sodium Loaded Ethylcellulose Nanoparticles
Design of experiment (DoE) is a useful time and cost-effective tool for analyzing the effect of independent variables on the formulation characteristics. The aim of this study is to evaluate the effect of the process variables on the…
Research progress of poly(methyl methacrylate) microspheres: Preparation, functionalization and…
Poly(methyl methacrylate) (PMMA) microsphere is a kind of spherical polymer particles, which is polymerized from methyl methacrylate (MMA) monomer by initiator. Monodisperse diameter, excellent biocompatibility, superior transparency and…
A Oral Fast Dissolving Films Containing Lyophilized Labetalol HCL with Hydroxy Propyl…
Introduction: Labetalol HCL is an antihypertensive drug used to treat high blood pressure in the long term management of angina. Labetalol HCL is readily absorbed after oral administration. Labetalol HCl undergoes considerable hepatic…
Rational and practical considerations to guide a target product profile for patient-centric drug…
The APV presents the scientific paper recently published by the APV Task Force Patient Centric Medicine (PaCeMe):
Abstract
The increasing awareness of acceptability and usability of pharmaceutical drug products by the patient as a key…
Using the Intranasal Route to Administer Drugs to Treat Neurological and Psychiatric Illnesses:…
While the intranasal administration of drugs to the brain has been gaining both research attention and regulatory success over the past several years, key fundamental and translational challenges remain to fully leveraging the promise of…
Pickering Emulsions: A Novel Tool for Cosmetic Formulators
The manufacturing of stable emulsion is a very important challenge for the cosmetic industry, which has motivated intense research activity for replacing conventional molecular stabilizers with colloidal particles. These allow minimizing…
Prediction of tablet weight variability from bulk flow properties by sparse modeling
Die filling is a critical step in the pharmaceutical tableting process as it determines the uniformity in tablet weight, which affects the drug content uniformity and appearance of tablets. With the progress in powder flow characterization,…
A fundamental step in your tablet development – MEDELPHARM brochure
Formulation development and technical transfer from lab to production can be challenging and requires a deep knowledge of your formulation.
The integrated and intuitive data analysis features drive formulators and scientists in their…
Transdermal delivery of inflammatory factors regulated drugs for rheumatoid arthritis
Rheumatoid arthritis is a chronic autoimmune disease, with the features of recurrent chronic inflammation of synovial tissue, destruction of cartilage, and bone erosion, which further affects joints tissue, organs, and systems, and…
Near Elimination of In Vitro Predicted Extrathoracic Aerosol Deposition in Children Using a…
Purpose
This study evaluated the in vitro aerosol performance of a dry powder antibiotic product that combined a highly dispersible tobramycin powder with a previously optimized pediatric air-jet dry powder inhaler (DPI) across a subject…
Optimization of screw design for continuous wet granulation: A case study of metoprolol succinate ER…
This study aimed at understanding the effect of screw design on the critical characteristics of granules and tablets of an extended-release (ER) formulation for twin screw granulation process. The screw design parameters assessed included…
Spray freeze drying for protein encapsulation: Impact of the formulation to morphology and stability
Proteins, the building blocks of life, are increasingly being used as therapeutics for treating several diseases. Yet, there are challenges in the delivery of highly labile materials like proteins, which is often circumvented with the help…
Compounding Tailored Veterinary Chewable Tablets Close to the Point-of-Care by Means of 3D Printing
Certain patient populations receive insufficient medicinal treatment due to a lack of commercially available products. The number of approved veterinary products is limited, making animals a patient population with suboptimal medicinal…
Poly(3-hydroxybutyrate): A potential biodegradable excipient for direct 3D printing of…
During the past decades, 3D printing has revolutionised different areas of research. Despite the considerable progress achieved in 3D printing of pharmaceuticals, the limited choice of suitable materials remains a challenge to overcome. The…
Milk Oral Lyophilizates with Loratadine: Screening for New Excipients for Pediatric Use
The development of suitable formulations for the pediatric population remains a challenging field with great advances reported every year in terms of excipients and technology. When developing pediatric formulations, the acceptability of…
Formulation development of loratadine immediate-release tablets using hot-melt extrusion and 3D…
The main goal of this study was to develop immediate release Fused Deposition Modeling (FDM) 3D printed loratadine tablets using hot-melt extrusion (HME) filaments. Loratadine was used as a model drug with 10% (w/w) drug loading. Ten…
A multivariate formulation and process development platform for direct compression
The efficient development of robust tableting processes is challenging due to the lack of mechanistic understanding on the impact of raw material properties and process parameters on tablet quality. The experimental determination of the…
Charge reduction assisted production of diminutive fluid bed granules for high drug load minitablets
Micronized drug powders are generally unsuitable as tableting feed to produce minitablets due to their cohesivity and poor flow. The silicification of fine paracetamol powder (PCMF) with an optimal concentration range of fumed silica (fSi)…
Soft sensor for content prediction in an integrated continuous pharmaceutical formulation line based…
In this study, a concentration predicting soft sensor was achieved based on the Residence Time Distribution (RTD) of an integrated, three-step pharmaceutical formulation line. The RTD was investigated with color-based tracer experiments…