Peter Langguth
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View article: Development of a Universal In Vivo Predictive Dissolution Method for a Borderline BCS III/IV Drug Guided by Modeling and Simulations─Acyclovir as a Case Study
Development of a Universal In Vivo Predictive Dissolution Method for a Borderline BCS III/IV Drug Guided by Modeling and Simulations─Acyclovir as a Case Study Open
Establishing in vivo predictive dissolution (IPD) conditions requires the consideration of biopredictive aspects during dissolution. For acyclovir, lower dose strengths (200 and 400 mg) can dissolve completely in the gastrointestinal fluid…
View article: Impact of Flow Restrictors on Aerosol Delivery of the Respimat® Soft Mist Inhaler
Impact of Flow Restrictors on Aerosol Delivery of the Respimat® Soft Mist Inhaler Open
View article: Simulating extractables and leachables in biopharmaceutical manufacturing to support safety assessment
Simulating extractables and leachables in biopharmaceutical manufacturing to support safety assessment Open
The use of single-use systems in the manufacturing of biopharmaceuticals raises concerns about the accumulation of process equipment-related leachables in their production and purification processes. However, this risk is mitigated by effe…
View article: AF4-to-SAXS: expanded characterization of nanoparticles and proteins at the P12 BioSAXS beamline
AF4-to-SAXS: expanded characterization of nanoparticles and proteins at the P12 BioSAXS beamline Open
Biological small-angle X-ray scattering (SAXS) is a versatile and powerful technique for investigating the structural and biophysical properties of biologically and pharmaceutically relevant macromolecules and nanoparticles. SAXS offers de…
View article: Direct structural investigation of pH responsiveness in mRNA lipid nanoparticles: Refining paradigms
Direct structural investigation of pH responsiveness in mRNA lipid nanoparticles: Refining paradigms Open
Using small angle X-ray scattering measurements, structural coherencies in lipid nanoparticle (LNP) formulations comprising messenger RNA (mRNA) were elucidated in response to pH changes and as a function of RNA to lipid ratio. Formulation…
View article: Utilizing an experimental design and scale up of a wet fluidized bed agglomeration process, to produce novel carbon agglomerates and tablets
Utilizing an experimental design and scale up of a wet fluidized bed agglomeration process, to produce novel carbon agglomerates and tablets Open
Wet granulation and agglomeration processes are widely used in the pharmaceutical industry. This study was performed, aimed at developing a systematic approach to scale up a carbon agglomeration process from 10 kg to 100 kg. The goal was t…
View article: Food Effect and Formulation: How Soluble Fillers Affect the Disintegration and Dissolution of Tablets in Viscous Simulated Fed State Media
Food Effect and Formulation: How Soluble Fillers Affect the Disintegration and Dissolution of Tablets in Viscous Simulated Fed State Media Open
The food-induced viscosity of the media can alter tablet disintegration and eventually the release of the drug it contains. The extent of this retardation depends on tablet formulation factors, such as the solubility of its excipients. Obj…
View article: Food Effect and Formulation: How Soluble Fillers Affect the Disintegration and Dissolution of Tablets in Viscous Simulated Fed State Media
Food Effect and Formulation: How Soluble Fillers Affect the Disintegration and Dissolution of Tablets in Viscous Simulated Fed State Media Open
The food-induced viscosity of the media can alter tablet disintegration and eventually the release of the drug. The extent of this retardation depends on tablet formulation factors such as the solubility of excipients. Objectives: This res…
View article: A new model for ionizable drug dissolution in intestinal bicarbonate buffer
A new model for ionizable drug dissolution in intestinal bicarbonate buffer Open
In order to achieve the desired effect in vivo, drugs taken orally must first be dissolved in the gastrointestinal tract. With the majority of the commercially available drugs having acidic and/or basic groups, ionization and intestinal bu…
View article: Utilizing an Experimental Design and Scale Up of a Wet Fluidized Bed Agglomeration Process, to Produce Novel Carbon Agglomerates and Tablets
Utilizing an Experimental Design and Scale Up of a Wet Fluidized Bed Agglomeration Process, to Produce Novel Carbon Agglomerates and Tablets Open
View article: Dissimilar ferric derisomaltose formulations – In vitro comparisons between an originator and its intended similars
Dissimilar ferric derisomaltose formulations – In vitro comparisons between an originator and its intended similars Open
Simple in vitro tests demonstrated that, aside from total iron content, the first intended similars of FDI bear little resemblance to their originator drug. It is clear that the efficacy and safety profile of Monofer® cannot be extrapolate…
View article: Microneedle-enhanced drug delivery: fabrication, characterization, and insights into release and permeation of nanocrystalline imiquimod
Microneedle-enhanced drug delivery: fabrication, characterization, and insights into release and permeation of nanocrystalline imiquimod Open
Transcutaneous delivery systems bear several advantages over conventional needle-based injections. Considering the low bioavailability and poor water-solubility of imiquimod, a manufacturing process has been developed to incorporate imiqui…
View article: On the Influence of Fabrication Methods and Materials for mRNA‐LNP Production: From Size and Morphology to Internal Structure and mRNA Delivery Performance In Vitro and In Vivo
On the Influence of Fabrication Methods and Materials for mRNA‐LNP Production: From Size and Morphology to Internal Structure and mRNA Delivery Performance In Vitro and In Vivo Open
Lipid nanoparticle (LNP) remains the most advanced platform for messenger RNA (mRNA) delivery. To date, mRNA LNPs synthesis is mostly performed by mixing lipids and mRNA with microfluidics. In this study, a cost‐effective microfluidic setu…
View article: Solubility vs Dissolution in Physiological Bicarbonate Buffer
Solubility vs Dissolution in Physiological Bicarbonate Buffer Open
Background Phosphate buffer is often used as a replacement for the physiological bicarbonate buffer in pharmaceutical dissolution testing, although there are some discrepancies in their properties making it complicated to extrapolate disso…
View article: Aerosol Plumes of Inhalers Used in COPD
Aerosol Plumes of Inhalers Used in COPD Open
View article: Optimization of product characteristics of porous carbon agglomerates using a design of experiments in fluidized bed agglomeration
Optimization of product characteristics of porous carbon agglomerates using a design of experiments in fluidized bed agglomeration Open
Spraying parameters during particle agglomeration processes can affect the agglomeration kinetics and particle growth. This study was conducted to better understand the influence of the spraying parameters in a fluidized bed wet agglomerat…
View article: Tumor-infiltrating CCR2+ inflammatory monocytes counteract specific immunotherapy
Tumor-infiltrating CCR2+ inflammatory monocytes counteract specific immunotherapy Open
Tumor development and progression is shaped by the tumor microenvironment (TME), a heterogeneous assembly of infiltrating and resident host cells, their secreted mediators and intercellular matrix. In this context, tumors are infiltrated b…
View article: Quantitative size-resolved characterization of mRNA nanoparticles by in-line coupling of asymmetrical-flow field-flow fractionation with small angle X-ray scattering
Quantitative size-resolved characterization of mRNA nanoparticles by in-line coupling of asymmetrical-flow field-flow fractionation with small angle X-ray scattering Open
We present a generically applicable approach to determine an extensive set of size-dependent critical quality attributes inside nanoparticulate pharmaceutical products. By coupling asymmetrical-flow field-flow fractionation (AF4) measureme…
View article: Optimized dithranol-imiquimod-based transcutaneous immunization enables tumor rejection
Optimized dithranol-imiquimod-based transcutaneous immunization enables tumor rejection Open
Introduction Transcutaneous immunization (TCI) is a non-invasive vaccination method promoting strong cellular immune responses, crucial for the immunological rejection of cancer. Previously, we reported on the combined application of the T…
View article: Polysarcosine-Functionalized mRNA Lipid Nanoparticles Tailored for Immunotherapy
Polysarcosine-Functionalized mRNA Lipid Nanoparticles Tailored for Immunotherapy Open
Lipid nanoparticles (LNPs) have gained great attention as carriers for mRNA-based therapeutics, finding applications in various indications, extending beyond their recent use in vaccines for infectious diseases. However, many aspects of LN…
View article: Quantitative size-resolved characterization of mRNA nanoparticles by in-line coupling of asymmetrical-flow field-flow fractionation with small angle X-ray scattering
Quantitative size-resolved characterization of mRNA nanoparticles by in-line coupling of asymmetrical-flow field-flow fractionation with small angle X-ray scattering Open
We present a generically applicable approach to determine an extensive set of size-dependent critical quality attributes inside nanoparticulate pharmaceutical products. By coupling asymmetrical-flow field-flow fractionation (AF4) measureme…
View article: Author Correction: Dithranol as novel co-adjuvant for non-invasive dermal vaccination
Author Correction: Dithranol as novel co-adjuvant for non-invasive dermal vaccination Open
View article: Quality by Design (QbD) Approach for a Nanoparticulate Imiquimod Formulation as an Investigational Medicinal Product
Quality by Design (QbD) Approach for a Nanoparticulate Imiquimod Formulation as an Investigational Medicinal Product Open
The present article exemplifies the application of the concept of quality by design (QbD) for the systematic development of a nanoparticulate imiquimod (IMQ) emulsion gel formulation as an investigational medicinal product (IMP) for evalua…
View article: Dithranol as novel co-adjuvant for non-invasive dermal vaccination
Dithranol as novel co-adjuvant for non-invasive dermal vaccination Open
View article: In Vitro Methodologies for Evaluating Colon-Targeted Pharmaceutical Products and Industry Perspectives for Their Applications
In Vitro Methodologies for Evaluating Colon-Targeted Pharmaceutical Products and Industry Perspectives for Their Applications Open
Several locally acting colon-targeted products to treat colonic diseases have been recently developed and marketed, taking advantage of gastrointestinal physiology to target delivery. Main mechanisms involve pH-dependent, time-controlled a…
View article: Level A IVIVC for immediate release tablets confirms in vivo predictive dissolution testing for ibuprofen
Level A IVIVC for immediate release tablets confirms in vivo predictive dissolution testing for ibuprofen Open
A bioequivalence study comparing two fixed dose combination tablets containing 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride showed bioequivalence for pseudoephedrine AUC and Cmax, but the reference product showed hig…
View article: Formulation and Characterization of an Effervescent Hydrogen-Generating Tablet
Formulation and Characterization of an Effervescent Hydrogen-Generating Tablet Open
Hydrogen, as a medical gas, is a promising emerging treatment for many diseases related to inflammation and oxidative stress. Molecular hydrogen can be generated through hydrogen ion reduction by a metal, and magnesium-containing effervesc…
View article: Optimized In Silico Modeling of Drug Absorption after Gastric Bypass: The Case of Metformin
Optimized In Silico Modeling of Drug Absorption after Gastric Bypass: The Case of Metformin Open
Bariatric surgery is an effective treatment for severe obesity and related comorbidities, such as type II diabetes. Gastric bypass surgery shortens the length of the intestine, possibly leading to altered drug absorption. Metformin, a firs…
View article: Predicting Pharmacokinetics of Multisource Acyclovir Oral Products Through Physiologically Based Biopharmaceutics Modeling
Predicting Pharmacokinetics of Multisource Acyclovir Oral Products Through Physiologically Based Biopharmaceutics Modeling Open
View article: Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin Phosphate Monohydrate Open