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FORMULATION FORUM – Understanding of Amorphous Solid Dispersions & Their Downstream Development March 29, 2021
Jim Huang, PhD, discusses how understanding the properties of ASDs and their relationship to downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs in early development and commercialization in a timely and cost-effective manner.
FORMULATION DEVELOPMENT – Amorphous Dispersion Formulation Development: Phase-Appropriate Integrated Approaches to Optimizing Performance, Manufacturability, Stability & Dosage Form July 10, 2013
John Baumann, Dan Dobry, and Rod Ray, PhD, review the development and use of amorphous SDDs and the testing methodologies used to optimize the formulation and spray-drying process for performance, manufacturability, stability, and incorporation into final dosage forms.
FORMULATION DEVELOPMENT – Solving Tough Solubility Issues With Fewer Compromises & Better Outcomes March 28, 2024
Anshul Gupte, PhD, says fortunately, enhanced solubility can be achieved using a variety of approaches. For oral solid dosage forms, well-established approaches include micronization, nanoparticles, amorphous solid dispersions (ASDs), lipid-based formulations, salts, and co-crystals.
Apalutamide Study Again Demonstrates the Advantages of Nanoforming Over Traditional Cancer Treatment Formulations February 29, 2024
Nanoform Finland Plc recently announced it had received positive results from its own preclinical, in-vivo study of a nanocrystalline-enabled apalutamide...FORMULATION FORUM – Nanosuspensions – An Enabling Formulation for Improving Solubility & Bioavailability of Drugs December 4, 2023
Jim Huang, PhD, and Shaukat Ali, PhD, focus on the role of excipients and methods for preparation and application of nanosuspensions in injectable, ocular, topical, and oral drug delivery.
Ascendia Pharmaceuticals Develops Novel Nanoemulsion IV Formulation for Clopidogrel That Received IND Approval June 26, 2023
Ascendia Pharmaceuticals CEO Jim Huang, PhD, recently announced Ascendia’s patented Emulsol® nanotechnology has been used to develop a novel nanoemulsion IV formulation for….
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Putting Customers First June 5, 2023
Contributor Cindy H. Dubin speaks with several leading CDMOs from around the globe on their unique development and manufacturing capabilities and technologies, and presents real-world examples of how they have put these to use to produce innovative compounds, lower development costs, and shorten time to market.
FORMULATION FORUM – PLGA – A Versatile Copolymer for Design & Development of Nanoparticles for Drug Delivery June 5, 2023
Jim Huang, PhD, and Shaukat Ali, PhD, focus on the chemistry, properties, applications, and regulatory aspects of PLGA, and the future trends in the industry, especially those requiring the development of long-acting injectables for the treatment of a variety of rare diseases and for life cycle management.
FORMULATION FORUM – Tackling Challenging Molecules by Spray Drying: Making the Impossible Possible April 3, 2023
Jim Huang, PhD, and Shaukat Ali, PhD, focus on spray drying technology with special reference to polymers and solvents selection, processing conditions, and the challenges with downstream manufacturing, stability, and degradation of APIs in oral dosages.
ROUNDTABLE DISCUSSION – Which Trends Will Have the Most Impact on Drug Development in 2023? January 16, 2023
Contributor Cindy H. Dubin posed this question to life science leaders during a recent roundtable discussion, and one common theme is the focus on sustainability in pharmaceutical development.
FUNCTIONAL EXCIPIENTS – Improving the Water Solubility of Oral Drugs With Amorphous Solid Dispersions (ASDs) January 16, 2023
Liliana Miinea, PhD, says with certain polymers, it is possible for drug formulators to take full advantage of the benefits of ASDs, enabling them to overcome formulation challenges to deliver more effective novel drug products capable of transforming the lives of patients.
FORMULATION FORUM – Lipid Nanoparticles: Tackling Solubility Challenges With Lipid-Based Technologies for Oral & Injectable Formulations October 10, 2022
Jim Huang, PhD, and Shaukat Ali, PhD, believe as more hydrophobic or brick dust and/or lipophilic or waxy molecules come out of discovery, amorphous solid dispersions (ASDs) and lipid based self-emulsifying microemulsions, nanoemulsions, liposomes, and nanoparticles are ideal for oral and injectable formulations.
FORMULATION FORUM – Oral Formulation Approaches for Different Stages of Clinical Studies April 4, 2022
Jim Huang, PhD, says it is of the utmost important task to utilize a phase-appropriate formulation development approach for early and later-stage commercial development of oral dosage forms.
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.
Hovione Launches the Most Advanced Screening Service for Optimal Spray Dried Dispersions Formulation January 14, 2021
Hovione, the leader in Pharmaceutical Spray Drying, recently announced the launch of ASD-HIPROS, a proprietary screening service for spray dried dispersions…..
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 – Formulation Development Strategy for Early Phase Human Studies August 31, 2020
Jim Huang, PhD, says successful translation of discovery compounds into first-in-human and first-in-patient is one of the key challenges facing the pharmaceutical industry, and to achieve this, a rational formulation development strategy will be critical to avoid costly development failures, while speeding up the development timeline in a cost-effective manner.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules June 4, 2020
Contributor Cindy H. Dubin interviews key players in the CDMO market who present case studies about how they are helping pharmaceutical and biopharma companies overcome a variety of formulation and manufacturing challenges.
Outsourcing Drug Development & Production: Technology-Driven Drug Delivery Systems for Small Molecules at Losan Pharma
Due to the increasing demand for drug delivery systems that are able to improve the properties of low soluble, poor permeable, or highly dosed new and existing drug substances, technology-driven CDMOs can offer a wide range of technology platforms to overcome such challenges….