Advancing Lipid-Based Formulations and Softgels in Drug Development (Feb 2024)
February 22nd 2024Lipid-based formulations (LBFs) are complex mixtures of lipid, surfactant and solvent excipient, where the composition determines the potential impact of dispersion and digestion on drug solubilization. By carefully selecting fill formulations during the early stages of drug development, it is possible to meet the specific requirements for bioavailability and stability for clinical trial and supply.
Innovative Softgel Technologies to Deliver Poorly Soluble Molecules (Nov 2023)
November 15th 2023In this eBook learn more on how to expedite the development pathway for early phase compounds, and how lipid based formulations provide innovative approach to enhance bioavailability for challenging molecules. It also presents how the lipid-based delivery provides a tool for highly potent, poorly soluble, and unstable APIs.
Softgel Technology for Fast-Tracked Development Programs
November 15th 2023Download the article to learn how lipid-based formulation allows for the timely completion of early and late-phase development activities, and provides relatively straightforward scale-up dosage form manufacturing to meet the commercial volume demand requirements for newly launched products.
Exploring Pectin and the Advancement of Delayed Release Technology
November 15th 2023In this webinar, experts will provide an overview of why the properties and structure of pectin are well suited for site-specific delivery to the colon. In addition, experts will also provide insights into how softgel capsules, formed by the combination of both pectin and gelatin, are used in OptiGel® DR, a new delayed release delivery technology for pharmaceutical applications.
Optimizing Highly Potent API Drug Development and Manufacturing
October 11th 2023Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. Learn more about creating a safe, efficient and scalable drug development program with HPAPIs in this eBook.
White Paper - Formulation and Evaluation of Enteric Coated Aspirin Capsules
August 21st 2023Enteric polymer coatings play a crucial role in oral drug formulations, protecting the active pharmaceutical ingredient (API) from harsh gastric conditions and enabling targeted drug delivery with optimized release based on location. By selecting enteric coatings, formulators can ensure the protection of their acid-sensitive APIs and create a controlled release drug delivery system. With the latest polymer coatings technology, there's no limit to the precision and adaptability that can be achieved in drug formulations. This white paper provides valuable insights into the successful application of enteric polymer coatings for controlled drug delivery systems. Discover how this innovative technology can transform your oral drug formulations.
Executive Summary - Overcoming Manufacturing Challenges for Accelerated Drug Development
August 21st 2023New drugs receiving expedited approval have shorter timelines, which can create unique challenges for development and manufacturing. Learn how to leverage the drug development knowledge and build a strategy that maintains the integrity, quality, and timeliness of the manufacturing process. Download the executive summary to get expert insights on overcoming manufacturing challenges associated with expedited development programs.
eBook - Pharmaceutical Outsourcing for Oral Development and Manufacturing
August 21st 2023This eBook includes an overview of outsourcing trends in the oral solid dose market. Featured articles describe the robust market resulting from the demand for specialized dosage forms such as controlled release, pediatric and geriatric delivery vehicles.
Executive Summary - Strategies for the Optimal Scale-up & Tech Transfer of Oral Small Molecules
August 21st 2023The transition from early phase to late phase of a small molecule program plays a pivotal role in determining a program’s ultimate success. Early planning strategies can help minimize the burdens often faced in that transition. The implementation of modeling tools to analyze the relationships between material attributes, process parameters and product performance can provide an enhanced understanding of the drug product and improve manufacturing efficiency. In this executive summary, experts will demonstrate how Catalent’s (multivariate) modeling tools can help understand the relationship between material Critical Material Attributes (CMAs), unit operation Critical Process Parameters (CPPs) and their impact on the finished dosage. In addition, the experts will explain how these approaches can facilitate in the tech transfer of a program. Lastly, this executive summary includes an overview of Catalent’s oral solid dose turnkey solutions featuring advanced oral solid dosage (OSD) manufacturing technologies and expertise throughout an extensive global network.
Innovative Strategies to Maintain Product Integrity in Biologic and Biosimilar Clinical Studies
April 12th 2023For studies involving products such as biologics and biosimilars, maintaining reliability of clinical supply can be challenging. Explore how different cold chain strategies can be leveraged to maintain product integrity in transit and minimize disruptions to clinical supply.
Optimizing Cell Therapy Supply Chains for Success: Why Outsourcing Partner Expertise is Critical
April 12th 2023This eBook outlines how a CDMO specializing in advanced modalities can help sponsors to create a reliable and streamlined autologous cell therapy supply chain that maintains product quality, integrity, and compliance.
Catalent Potent Drug Handing Capabilities
April 11th 2023Catalent offers end-to-end solutions to accelerate drug development and market entry, with specialization in handling highly potent, hormonal, and cytotoxic compounds, integrating comprehensive risk assessment and controls for management and containment.