Combining excipients with active compounds can improve their solubility, bioavailability and more. But which excipients will work best with your candidate compounds? Excipient screening can provide the answer.
At Pion, we run high-throughput screening that will identify the most appropriate excipients to improve the bioavailability properties of your compound. Depending on your API, we’ll screen it with a range of polymers (precipitation inhibitors), lipid excipients, including oily vehicles, water-insoluble surfactants, water dispersible surfactants, water soluble surfactants and hydrophilic cosolvents. We can also screen a range of diluents, disintegrants, glidants and lubricants.
Determining compound solubility is an essential tool for understanding drug compound behaviour. Solubility studies in the presence of excipients are used to understand the capacity of APIs (Active Pharmaceutical Ingredients) to be solubilised by ingredients commonly used in the pharmaceutical industry and is an important consideration for poorly soluble drugs. Solubility enhancing ingredients can lead to higher drug concentrations in the gastrointestinal tract for solubility limited BCS Class II drugs and can lead to increased flux across biological membranes and increase overall drug absorption. These solubility-excipient studies are used to understand the impact of common pharmaceutical excipients on compound solubility behaviour and can guide early development efforts as part of a solubility enhancement strategy.
A minimal accurately weighable quantity of dry compound (~20 mg) is required for this assay per excipient level.
The equilibrium solubility is determined for each compound in the presence of different levels of various excipients. A full study report is provided showing the impact of excipient on the solubility behaviour of the drug.
The shake flask protocol is used to determine the solubility of a compound in the presence of various pharmaceutical grade excipients. Typical assay conditions will involve a prolonged incubation period in assay media containing different levels of excipient, followed by a sedimentation period prior to vacuum filtration and quantitation. The assay is run in duplicates for each excipient condition and quantitation is performed using a Waters Acquity HPLC.
These experiments will determine the equilibrium solubility in the presence of selected pharmaceutical excipients. Please contact Pion for more details on the types of excipients that can be used.
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Multiwavelength spectrophotometric determination of acid dissociation constants of ionisable drugs
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Multiwavelength spectrophotometric determination of acid dissociation constants. Part IV. Water-insoluble pyridine derivatives
Multiwavelength spectrophotometric determination of acid dissociation constants Part III. Resolution of multi-protic ionization systems
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N-substituted analogues of S-nitroso-N-acetypenicillamine: chemical stability and prolonged nitric oxide mediated vasodilation in isolated rat femoral arteries
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Ionization constants and distribution coefficients of phenothiazines and calcium channel antagonists determined by a pH-metric method and correlation with calculated partition coefficients
BUFMAKE: a computer program to calculate the compositions of buffers of defined buffer capacity and ionic strength for ultra-violet spectrophotometry
Structure-lipophilicity relationships of neutral and protonated-blockers, part I: intra and intermolecular effects in isotropic solvent systems
Multiwavelength spectrophotometric determination of acid dissociation constants Part VI. Deconvolution of binary mixtures of ionizable compounds
Study of equilibrium solubility measurement by saturation shake-flask method using hydrochlorothiazide as a model compound
Multiwavelength spectrophotometric determination of acid dissociation constants Part V. Tautomerization microcontstants
Physicochemical characterization of sildenafil: Ionization, lipophilicity behaviour, and ionic-partition diagram studied by two-phase titration and electrochemistry
Rapid Physicochemical Profiling as an Aid to Drug Candidate Selection
Solubility challenge: can you predict solubilities of 32 molecules using a database of 100 reliable measurements?
Multiwavelength Spectrophotometric Resolution of the Micro- equilibria of a Triprotic Amphoteric Drug: Methacycline
Multiwavelength Spectrophotometric Determination of Acid Dissociation Constants: A Validation Study
Concomitant hydrate polymorphism in the precipitation of sparfloxacin from aqueous solution.
Multiwavelength Spectrophotometric Resolution of the Micro-Equilibria of Cetirizine
A new method for the reproducible generation of polymorphs: two forms of sulindac with very different solubilities.
Lipophilicity behaviour of the zwitterionic antihistamine cetirizine in phospatidylcholine liposomes/water systems
Evaluation of human intestinal absorption data and subsequent derivation of a quantitative structure-activity relationship (QSAR) with the Abraham descriptors
High throughput physicochemical profiling for drug discovery
Lipophilicity Profiles: Theory and Measurement
Diclofenac Solubility: Independent Determination of the Intrinsic Solubility of Three Crystal Forms
Physicochemical Properties of a New Multicomponent Cosolvent System for the pKa Determination of Poorly Soluble Pharmaceutical Compounds.
Potentiometric and spectrophotometric pKa determination of water-insoluble compounds: Validation study in a new cosolvent system. Anal. Chim
Transport characteristics of L-carnosine and the anticancer derivative 4-toluenesulfonylureido-carnosine in a human epithelial cell line
Presentation of a Structurally Diverse and Commercially Available Drug Data Set for Correlation and Benchmarking Studies
Calculation of Abraham Descriptors from solvent-water partition coefficients in four different systems; evaluation of different methods of calculation
A new multi-wavelength spectrophotometric method for the determination of the molar absorption coefficients of ionisable drugs
Application of hydrogen bonding calculations in property based drug design
Equilibrium vs. kinetic measurements of aqueous solubility, and the ability of compounds to supersaturate in solution - a validation study
New findings on the synthesis of the centrally acting muscle relaxant chlormezanone and its resolution of a gram scale using a Chiralcel OD column
Hydantoin-Substituted 4,6-Dichloroindole-2- carboxylic Acids as Ligands with High Affinity for the Glycine Binding Site of the NMDA Receptor
Ionization Constants and Ionization profiles
Hydroxychloroquine is much less active than chloroquine against chloroquine-resistant Plasmodium falciparum, in agreement with its physicochemical properties
A potentially simpler approach to measure aqueous pKa of insoluble basic drugs containing amino groups
Physical and molecular properties of agrochemicals: an analysis of screen inputs, hits, leads and products
Ionization, Lipophilicity and solubility properties of repaglinide
Chasing equilibrium: measuring the intrinsic solubility of weak acids and bases.
High Throughput Measurement of pKa values in a mixed-buffer linear pH gradient system
High Throughput measurement of drug pKa values for ADME screening
A modification of the Hammett equation for predicting ionization constants of p-vinyl phenols.
High throughput measurement of logD and pKa In Drug Bioavailability. Estimation of Solubility, Permeability and Bioavailability
Permeability through DOPC/dodecane membranes: measurement and LFER modelling
Using pH Gradient Dissolution with In-Situ Flux Measurement to Evaluate Bioavailability and DDI for Formulated Poorly Soluble Drug Products
Direct imaging of the dissolution of salt forms of a carboxylic acid drug
Ranking Itraconazole Formulations Based on the Flux through Artificial Lipophilic Membrane
In vitro model for predicting bioavailability of subcutaneously injected monoclonal antibodies
Glatiramer acetate persists at the injection site and draining lymph nodes via electrostatically-induced aggregation
A comparison of the in vitro permeation of niacinamide in mammalian skin and in the Parallel Artificial Membrane Permeation Assay (PAMPA) model
Video: Use of Flux Measurements in Lieu of In Vitro Dissolution to Assess the Complex Interplay Between Solubility, Permeability and Formulation Effects
Scissor subcutaneous poster
Subcutaneously administered biopharmaceuticals
MacroFLUX Generics
Measuring Physiochemical Properties 2
4‐case chart to classify supersaturation and precipitation behavior
Measuring pKa values in 2-propanol to gain process understanding
Ionization Constants of Isoniazid and Benzimidazole
pH-metric titration to characterize aci-nitro tautomerism
Effects of solubility enhancing excipients
A DoE study to understand partition rate in a biphasic system
Evaluation of in vitro tests to reduce animal testing in drug toxicology studies
Faster Dissolution Methods
Low Volume Dissolution Assays
The effect of dissolution media, torque and flow speed
Controlled supersaturation by the solvent quench method, with UV monitoring of precipitation
Supersaturation time with CheqSol using different excipients AZ
Supersaturation, phase separation and measurement of precipitation rates
AAPS 2017 Supersaturation excipients poster KBox
AAPS 2017 Supersaturation modelling poster KBox
Biorelevant dissolution - the quest for simple in-vitro experiments
AAPS Understanding drug release mechanisms of metformin using complementary in vitro dissolution tools
AAPS 2017 Flo-Vitro poster KBox
A pH stat method to measure the dissolution rate of nano- and microparticle suspensions
Visualising the release patterns of promethazine across microparticulate systems
Biphasic dissolution studies of Felodipine
Dissolution & precipitation studies of carbamazepine cocrystals with small scale assays
Dissolution of a drug in the presence of additives and biorelevant media
Dissolution in presence of lipid to mimic absorption
Dissolution Experiments in Lipid Layers
Small scale assays for studying dissolution of cocrystals
Small volume dissolution of a poorly soluble drug as solid dispersions
In-situ pH change on a biphasic dissolution model in the presence of SIFs
Use of SDI to assess dissolution characteristics - John Comer (Pion)
Application of the SDI in Pharmaceuticals - Mei Wong (Pfizer)
Dissolution Imaging Symposium 2013 - Book of Abstracts
Solubility of drugs in the presence of excipients in lipid based formulations
Supersaturation & precipitation of ionizable drugs with cellulose polymers
Physicochemical Studies of Triclosan
Simulated Lung Fluid media
Solubility measurement by extrapolation
Solubilities of morphine analogs
Biphasic dissolution studies: Impact of concentration and particle size on partition rate
Improvements in biphasic dissolution
Biphasic dissolution studies of Aripiprazole
Robert Taylor: Automated Measurements of Lipolysis, Supersaturation & Biphasic Dissolution
Automated Measurements of Precipitation, Supersaturation and Biphasic Dissolution
Characteristics of Felodipine ‐ HPMCAS Solid Dispersions
Dissolution Performance of Inhaled Products in Simulated Lung Fluid
In-situ Solubility Measurements of Ionizable Drugs
Determination of Aqueous Solubility by Extrapolation
A low volume method for screening Plasdone® polymers
Assay Expert Flyer
SDi Digest
Biphasic Dissolution Case Study of Carvedilol
Salts Dissolution
A pH stat method to measure the dissolution rate of nano- and microparticle suspensions
Biphasic Dissolution Studies
BCS Class IV formulation: case study
Triclosan: a PhysChem study
AN405 Controlled supersaturation by solvent-quench
AN404 Biorelevant dissolution with gradient pH adjustment
AN403 GI lipolysis of lipid based drug formulations
AN402 Controlled supersaturation assays for modelling intestinal precipitation
AN401 Biphasic Dissolution
Pion inForm Intrinsic Dissolution Rate of Ibuprofen and its Sodium Salt
AN410 Measuring the isoelectric point pf peptides by potentiometric titration
AN15 Determination of pKa Measurement or Prediction?
AN14 Using NaOH and NaCL instead of KOM and KCI
AN13 Measuring Solubility What’s Best for You?
AN12 Introduction to logP and logD Measurement Using SiriusT3
AN11 Evaluating Solid Dispersion using Small-Scale Dissolution Testing
AN10 Measuring LogP of Samples that are Hard to Dissolve in Water and Octanol
AN09 The Determination of Solubility - Pion CheqSol Explained
AN08 Solubility and Supersaturation - A Brief Introduction
AN07 the Pion GI Dissolution Assay
AN06 The use of cosolvent pKa assays for poorly soluble compounds
AN05 Measurement of extreme pKas
AN04 Insights into BCS classification using Pion assays
AN03 Blank Titrations Using the SiriusT3
AN02 PKa measurements in 15 minutes - the SiriusT3 Fast UV pKa method
AN01 High quality measurements for small sample amounts
AN503 Investigation of subcutaneous monoclonal antibody formulations
AN502 IN vitro studt of subcutaneous injection of two insulin formulations
AN501 A novel in vitro model for subcutaneous injection
AN418 Using Scissor as a platform to analyze non-protein subcutaneous formulations
Pion SDi2 and Raman spectroscopy - study of diclofenac sodium salt
Understanding drug release mechanisms from diclofenac tablets using the SDi2
Degree and Extent of Supersaturation of Amorphous Pharmaceuticals and Their Flux through Lipophilic Membrane
Behavior of Basic Compounds in the Presence of Plasdone Polymers
Differentiating Itraconazole Formulations Based on the Flux through Artificial Lipophilic Membrane
Effect of Simulated Mucus Environment on the Supersaturation of Carvedilol and Its Flux through Artificial Lipophilic Membranes
Study of Danazol Cocrystal Using Trans-Membrane Flux Measurements
Application of MacroFLUX™ Apparatus for Screening Formulations before Bioequivalence Studies
Using Integrated Absorption Chamber with USP II Dissolution Apparatus to Predict Risk of Drug‐Drug Interaction from pH‐Modifying Agents: Application Notes
Estimating Food Effect on Drug Absorption using Flux Experiments through Artificial Lipophilic membranes
Validation of the SDi2 intrinsic dissolution rate measurement
Using SDi2 to characterise swelling and drug release profiles
Determination of pKa values and Solubility pH Profiles of Selected ß blockers
Supersaturation in additives and GI fluids
Validation of titrimetric measurement of pKa, logP and solubility
The intrinsic solubility of indomethacin
Measuring the solubility of salts of basic drugs
Potentiometric techniques for measuring solubility at 37°C
Karl Box Sunrise Presentation
Determination of Polymer Effectiveness
Utilization of pH-Metric Titration
FLUX Measurements using Pion µFLUX™ and MacroFLUX™ Devices
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Studying transdermal patches using Skin PAMPA
Studying semi-solid formulations of diclofenac using Skin PAMPA
Fast pKa UV Titrations using PULSE™ Instrument
Measuring Solubility of Nanoparticles by Zero Intercept Method
Application of MacroFLUX™ Apparatus for Screening Formulations before Bioequivalent Studies
Application of Skin Pampa™ to Cosmetic Solvent Screening
Differentiating itraconazole formulations based on the flux through artificial lipophilic membranes
Biorelevant drug release of Metformin dosage forms using complementary in vitro tools
Using Integrated Absorption Chamber with USP II Dissolution Apparatus to Predict Risk of Drug-Drug Interaction from pH Modifying Agents: Poster
Application of simultaneous dissolution-absorption apparatus for screening formulations before bioequivalence studies
Using flux experiments through artificial lipophilic membranes for predicting food effect for BCS Class 2 Compounds
Progress in pKa Determination Technology: Case Studies in Low and High Soluble Flavonoids
Degree and Extent of Supersaturation of Amorphous Pharmaceuticals and Their Flux through Lipophilic Membranes
Using Skin-PAMPA For Transdermal Patch Testing
In Situ Method for Monitoring Free Drug Concentration Released from Nanoparticles
Novel HT Method for Parallel Excipient/Vehicle Formulation Studies
Dissolution-Permeability Apparatus with Integrated In Situ Concentration Monitoring of both Donor and Receiver Compartments
Real Time Monitoring of Dissolution, Supersaturation and Precipitation Processes in Dynamically Changing Biorelevant Media
Universal Potentiometric Sensors: Application for Real Time Concentration Monitoring in Complex Biorelevant Media
Assessment of Transdermal Penetration Enhancement by Topical Pharmaceutical Excipients Using Skin PAMPA Method
Dissolution and Precipitation Monitoring of Crystalline Salts
Soluplus® Maintains the Supersaturation of Carbamazepine from Amorphous Solid Dispersions
Application of Skin PAMPA to Differentiate Between Topical Pharmaceutical Formulations of Ibuprofen
Comparison of Naproxen Release from Nano- and Microsuspensions with Its Dissolution from Untreated and Micronized Powder
In Situ Monitoring of Supersaturation State for Solid Dispersions of Low Soluble Compounds
Monitoring Supersaturation State of Solid Dispersions of Low Solubility Compounds
Skin-PAMPA: Fast Prediction of Skin Penetration
Skin-PAMPA: A New Method for Fast Prediction of Skin Penetration
Preparation, Physical Characterization and Solubility-Dissolution Testing of Loratidine Hot Melt Extrudates Prepared on a Laboratory Mixing Extruder
Evaluating Drug Salt Dissolution and Precipitation Processes for Rational Formulation Strategies
Developing Skin PAMPA for Transdermal Patches
Univ Potentiometric Sensors Food Matrixes
Supersaturation and Transmembrane Flux of Meloxicam
Evaluation of Optimized Caco-2 Permeability Measurements
Novel Device and Method for in situ UV Dissolution and Precipitation Monitoring in 96-well Plate
Human Jejunal Permeability Predicted from Caco-2 Assay - A Biophysical Model Applied to Fluoroquinolone Antimicrobials
In Vitro-In Vivo Correlation (IVIVC): Prediction of pK a at 37°C, From the Measured Value at 25°C
Univ Potentiometric Sensors Protein Binding
Nanoparticle Formulation of Gresiofulvin
Very Thin PAMPA Membranes Indicate Higher Antipyrene Permeability but are Fragile and Contain Leaky Water Pores
Prediction of in situ Blood-Brain Barrier Permeability using BBB PAMPA Model
Miniaturization of Powder Dissolution Measurement and Estimation of Particle Size
Impact of Biorelevant Media on Apparent Solubility and Biopharmaceutical Classification of Poorly Soluble Compounds
Powder Intrinsic Dissolution Rate Measurement: When is it Possible?
In Situ Solubility and Dissolution of Concentrated Solutions
Drug Permeation in Skin PAMPA and Franz Cell Model
Penetration Enhancer Effect of Sucrose Esters
Novel in vitro PK (non-animal PK) Assay for Excipient/Vehicle Formulation Studies
Comparison of Miniaturized Intrinsic Dissolution Rate Measurement to Traditional Wood’s Apparatus
Prediction of Caco-2 pH-Dependent Permeability based on High Quality in vitro Training Set
Determination of the Intrinsic Dissolution Rate (IDR) from a Powder and using a Miniaturized Wood’s Apparatus
Dissolution Rate and Apparent Solubility of Poorly Soluble Compounds in Biorelevant Fluids
Universal Potentiometric Sensors: Application for Real Time Concentration Monitoring in Surfactant Containing
Universal Potentiometric Sensors Fast Determination of Free Ionized Drug Concentration in Micellar Solutions
MacroFLUX An Integration of Absorption Chamber with USP II Dissolution Apparatus
Real Time Dissolution Monitoring of Dual Component Drug Product Using Fiber Optic System
Application of In Situ Potentiometric Sensors to Study Dissolution-Precipitation Behavior of Electrospray-Generated Loperamide Nanoparticles
Cyclodextrin-Based Orally Fast Dissolving Drug Delivery System of Aripiprazole and Its In Vitro Dissolution-Permeation Testing Using µFLUX
Dissolution, Free Drug Concentration and Permeability of Crystalline Nanoparticle Formulation Study Using In Situ Fiber Optic and Potentiometric Techniques
Interplay between Ketoconazole Cocrystal Supersaturation and Trans-membrane Flux Behavior In Simulated Intestinal Fluids
Effect of simulated mucus environment on the supersaturation of carvedilol and its flux through artificial lipophilic membranes
Study of Danazol Cocrystal using Trans-membrane Flux Measurements
Estimating food effect on drug absorption using flux experiments through artificial lipophilic membranes
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