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Articles
METAL-COORDINATED PHARMACEUTICALS - Reducing Inter-Subject Variability With Metal-Coordinated Pharmaceuticals: A Case Study With Furosemide May 8, 2014
John D. Price, PhD, and Thomas Piccariello, PhD, use metal coordination chemistry to create a novel coordination complex of furosemide and magnesium that is absorbed more efficiently and consistently than furosemide itself.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Early-Stage Partnerships Are On The Rise April 2, 2014
Contributor Cindy H. Dubin asked leading CMOs and CDMOs to describe the value-added services they offer with respect to formulation and manufacturing. Solving challenges of insufficient solubility, poor stability, identifying excipient candidates, and particle design topped their list of offerings.
BIOAVAILABILITY ENHANCEMENT - Analysis of the Historical Use of Solubilization Technologies March 5, 2014
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.
EXECUTIVE INTERVIEW - Catalent Applied Drug Delivery Institute: Helping to Get Better Drugs to Waiting Patients, Encouraging the Adoption of Advanced Delivery Technologies November 19, 2013
Drug Development Executive: Kurt Nielsen, PhD, CTO & SVP, Innovation & Growth, and Founding Institute Board Member, discusses the Institute, its goals, structure, and activities.
BIOAVAILABILITY ENHANCEMENT - Navigating a Broad Spectrum of Solubilization Technologies: Part II of III October 15, 2013
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.
EXECUTIVE INTERVIEW - Ligand: Effective Drug Delivery Solutions With Captisol October 15, 2013
Drug Development Executive: Vincent D. Antle, PhD, Senior Director of Technical Operations, and James D. Pipkin, PhD, Senior Director, New Product Development talk about how the company works closely with pharmaceutical and biotechnology companies offering drug delivery solutions that significantly improve stability, solubility, bioavailability, safety, and dosing of APIs.
BIOAVAILABILITY ENHANCEMENT - Navigating a Broad Spectrum of Solubilization Technologies: Part I of III September 5, 2013
In the past two columns, The Second Quadrant focused on excipients and the roles they play in the quest to...BIOAVAILABILITY ENHANCEMENT - Out of the Shadows: Excipients Take the Spotlight; Part 1 of 2 June 10, 2013
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.
MARKET BRIEF - Controlled Release Technologies: Advancing Toward Targeting Therapeutics June 10, 2013
Frost & Sullivan Analyst Cecilia Van Cauwenberghe, MS, reviews a few recent innovative approaches to controlled release technologies with a focus on some of the therapeutic areas most relevant to the current pharmaceuticals market.
SPECIAL FEATURE - Excipients: Advanced Biologics Require Innovative Excipient Science March 29, 2024
Contributor Cindy H. Dubin speaks with several leading companies to discuss novel and functional excipients being developed, the role they will play in reformulations and new formulations, and their versatility in drug delivery.
LIPID-BASED EXCIPIENTS - Misconceptions About Lipid-Based Drug Delivery April 3, 2023
Rollie Fuller and Ron Permutt provide formulators confidence in using LBDDS as part of formulation development programs, by demonstrating their benefits and key functional mechanisms when used and addressing commonly misrepresented, misinterpreted, and misunderstood LBDDS topics.
SPECIAL FEATURE - Solubility & Bioavailability: Difficult Beasts to Tame March 1, 2023
Contributor Cindy H. Dubin highlights the services many of these outsourced providers offer to enhance solubility and bioavailability and get their clients’ projects to market faster and cost effectively – while maintaining critical quality attributes.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product June 1, 2022
Contributor Cindy H. Dubin speaks with industry leaders on how drug sponsors and CDMOs are collaborating earlier, and highlights how third-party contractors are navigating material shortages and how the industry is shifting to address different therapeutic targets and molecules, such as mRNA.
SPECIAL FEATURE - Solubility & Bioavailability: Utilizing Enabling Technologies March 1, 2022
Contributor Cindy H. Dubin interviews several leading companies on how they are using innovative technologies, such as lipid nanoparticles to achieve a high drug loading, combining anti-solvent continuous crystallization with micro-mixing technology to control crystallization and reduce crystal size, and how a robotic capsule can improve bioavailability in the range of 47% to 78%.
FORMULATION DEVELOPMENT - Impact of Excipients & Manufacturing Process on Solubility-Enhanced Ritonavir Tablet Size & Weight Reduction March 1, 2022
Gayatri Khanvilkar, MPharm, Ajit Bhagat, and Tejas Gunjikar, PhD, investigate bulking agents and disintegrants to develop efficacious Rotonavir tablets with improved in vitro release.
FORMULATION FORUM - Amorphous Nanoparticles for Drug Delivery of Poorly Water-Soluble Compounds November 30, 2021
Jim Huang, PhD, says a thorough understanding of their amorphous stabilization and nano colloidal properties in relationship to in-vitro and in-vivo performance will help advance this interesting dosage form into human clinical testing and commercialization.
SPECIAL FEATURE - Improving Bioavailability & Solubility: Each Molecule Is Unique March 1, 2021
Contributor Cindy H. Dubin speaks with several innovative companies to discuss novel approaches to improving bioavailability and solubility that have one commonality: they treat each molecule as an individual.
FORMULATION FORUM - Oral Controlled Delivery of Poorly Water-Soluble Drugs January 13, 2021
Jim Huang, PhD, discusses how understanding key biopharmaceutical properties in relationship to drug absorption and elimination plays a critical role in successful design of CR dosage forms from discovery to first-in-human with a shorter timeline and lower development costs.
OSD FORMULATIONS - Dissolving Bioavailability & Solubility Challenges in Formulation & Development September 30, 2020
Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.
FORMULATION FORUM - Rational Design of Oral Nanosuspensions for Insoluble Drugs June 3, 2020
Jim Huang, PhD, explains how nanosuspensions are an important class of pharmaceutical dosage forms, particularly for pharmaceutical compounds with solubility and bioavailability challenges.
WHITE PAPER: Selecting In-Vitro Dissolution Methodologies for Amorphous Solid Dispersions
Read about how achieving good in vivo performance is a key attribute for ensuring safety and efficacy of oral solid dosage (OSD) forms intended for systemic delivery.