Search Results for: COMBINATION PRODUCTS 6 Guidelines to
Sanjay Konagurthu, PhD, and Alexander McVey, MS, present a case study in which a model BCS Class II compound, dipyridamole, was evaluated as an amorphous dispersion using molecular modeling combined with experimental data.
- SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Early-Stage Partnerships Are On The Rise
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.
- CONTROLLED RELEASE – Informed Selection of Modified-Release Technologies Provides Simpler Oral Dose Regimens
Ronak Savla, PhD, reviews some of the physicochemical and biopharmaceutical characteristics of drugs and how they influence creation of a controlled drug delivery formulation.
- PREFILLABLE SYRINGE TECHNOLOGY – BD Neopak – Delivering the Next Generation in Glass Prefillable Syringes
Justin M. Wright, PhD, and Herve Soukiassian highlight significant development and commercial manufacturing investments in glass PFS container technology for the biotech industry with three key areas of focus: reducing overall variability, reducing SbVPs, and increasing glass strength and durability performance.
Contributor Cindy H. Dubin spoke with several testing providers to find out what services they offer, trends they identify, and how they have specifically addressed clients’ needs throughout the past year.
Pierre Carlotti, Vice-President of Marketing and Communication for Aptar Pharma Prescription Division, talks about the market for auto-injectors and some relevant market trends, and explains how his company went about designing and developing a novel auto-injector.
Winston Brown explains how companies can reduce the risk and impact that regulatory uncertainty can play by, in advance of pursuing development, understanding the regulatory landscape and then developing a regulatory compliance strategy that is appropriate and suitable for the combination product as a system.
- SPECIAL FEATURE – Injection Devices: Manufacturers Focus on 21st Century Technology While Still Tackling Traditional Challenges
Contributor Cindy H. Dubin highlights some of the key companies in the injectable delivery market that are focusing on advanced technology as well as the more traditional challenges related to breakage, leaching, and needlestick prevention.
- SPECIAL FEATURE – Excipients: Manufacturers Look to Co-Processing as a Way of Improving Functionality
Contributor Cindy H. Dubin reports how leading excipient manufacturers are overcoming their own R&D challenges to deliver innovative excipients that address problems associated with both large and small molecules.
Executive Summary: Martin Driscoll, CEO of Asmacure, talks about his company’s unique, yet practical approach to treating asthma and its core symptoms.
- SPECIAL FEATURE – Analytical Testing: Using More Sophisticated Tools to Support Small & Large Molecule Projects
Contributor Cindy H. Dubin recently spoke with leading analytical testing providers to find out what services they offer and what equipment they use to handle both small and large molecules for their pharma clients.
Contributor Cindy H. Dubin highlights many of the latest techniques to enhance bioavailability and solubility, how to determine the right technique for your compound, and how some companies are realizing faster time to market as a result.
- SYRINGE SYSTEM – The Credence Companion Syringe System Delivers on Safety & Usability Using Human Factors Studies
John A. Merhige, MEM, and Lisa Caparra, RN, explain how development of the Companion product line has been driven by these two constituents, the innovation driven by the end-users’ needs and the avoidance of change driven by needs of the drug manufacturer.
Johannes BartholomÃ¤us, PhD; Judy Ashworth, MD; Hans-Jürgen Stahlberg, MD; Eric Galia, PhD; and Kai Strothmann, PhD; examine an innovative drug delivery platform that can significantly raise the hurdle for misuse or abuse of tablets by routes of administration that require the product to first be crushed.
Suniket Fulzele, PhD, and Sarah Rieschl present an overview and current status of the industrial approaches and platforms used for taste-masking in oral dosage forms.
- DRUG DELIVERY – Hyaluronic Acid: An Ideal Ingredient for Slow-Release Formulations for Osteoarthritis Treatment
Morten J. Maltesen, PhD; and Ole M. Dall, MSc; believe that in addition to its physiological and biological effects in the joints, HA exhibits significant structural and rheological properties that make it an attractive carrier for drug delivery applications.
- PACKAGING – Trends in Pharmaceutical Primary Packaging for Injectables – Solutions for New Challenges
Claudia Petersen forecasts that primary packaging suppliers will assume an increasing number of production steps relating to closure preparation for the fill & finish process, and as a result, they will evolve from component providers to system suppliers and product development project partners.
Contributor Cindy H. Dubin interviews several excipient manufacturers who share their insights about the role excipients play in formulating and manufacturing drugs for improved bioavailability, solubility, and delivery.
- SPECIAL FEATURE – Prefilled Syringes & Parenteral Contract Manufacturing: Anticipating the Needs of the Future
Contributor Cindy H. Dubin speaks with several companies in the prefilled syringe and parenteral manufacturing market that are offering a range of services and systems that cater to today’s issues as well as anticipating the needs of the future.
Contributor Cindy H. Dubin interviews several industry experts who believe there is intense competition to develop cutting-edge therapies and get them through development quickly to take advantage of patent exclusivity. And one of the critical elements in the drug development process is analytical testing.
Contributor Cindy H. Dubin speaks with some of the leading companies operating in the injectables arena, and discovers this ever-evolving sector is witnessing some very specific and eye-opening trends that are affecting the market’s growth.
- MARKET BRIEF – Financial Performance Benchmarking & Competitive Landscape Assessment of Leading CROs
Adam M. Dion, MS, summarizes GlobalData’s recent CRO Benchmark Report and believes the dynamics of pharmaceutical outsourcing and location decisions in emerging markets are changing. Cost reduction is being augmented and will gradually be eclipsed by footprint growth as a major factor shaping decisions, and CROs are realizing that the ability to be on the ground closer to their customers is a key building block to establishing sustainable, long-term relationships with clients.
Richard Featherstone explains how manufacturers of combination products are being asked to provide rigorous data on the safety of product when intended users use them. These challenges are not going to diminish, but with a focused approach and some sound HF principles, manufacturers can navigate the challenges successfully.
- STANDARDIZATION TECHNOLOGY – Innovative Temperature Standardization Technology Supports Cell Therapy Clinical Trials
Rolf O. Ehrhardt, MD, PhD, and Maria Thompson, PhD, discuss a unique proprietary temperature standardization technology that is practical for all stages of cell processing and handling. It is currently supporting a Phase IIb clinical trial investigating the efficacy of an immunotherapy treatment for patients with moderate-to-severe refractory Crohn’s disease.