In the rapidly evolving digital ecosystem of pharmaceutical development, there is a growing importance for the integration and management of diverse data to help drive affordable success. This presentation will delve into the realm of big data and how comprehensive data management impacts parameter prediction and refinement for scale-up models and provides valuable forecast insight to support a more cost-effective manufacturing campaign. How can we harness technological solutions to optimize data utilization across the process development data space and create transformative impact within the pharmaceutical industry, to drive efficiency and foster innovation? Join us as we explore the transformative potential of data-driven strategies in shaping the future of biopharmaceutical manufacturing.

The global gummy vitamin market is expected to reach 10.6 billion by 2025 and gummies are gaining traction as a drug delivery system -- especially for children and seniors who resist taking pills, capsules and liquids. Mitchell Slade, who brings more than 20 years of gummy manufacturing experience at Nature’s Bounty to the table, will address the challenges of developing gummies beyond supplements, such ensuring consistent dosage, production and taste. Avéma/PLD has a world-class GDUFA facility that is CFR 211 and CFR 111 certified, uses a starchless gummy manufacturing process and brings 40+ years of formulating experience to the development of innovative drug delivery systems.

Common high-performance lipids and surfactants were used to improve the dissolution rate of furosemide as a model compound for BCS Class II and Class IV active pharmaceutical ingredients. Furosemide equilibrium solubility was measured throughout an HLB range (1-16) of liquid lipids and surfactants. Furosemide tablets were then manufactured using high shear granulation to absorb the solubilized and suspended furosemide onto microcrystalline cellulose (Avicel PH101).

The granulations were then compressed using a rotary tablet press and standard tablet tooling. Finished tablets were analyzed to compare dissolution rates using 0.1 N HCl media and USP Apparatus II. Higher equilibrium solubility yielded increased dissolution rates for furosemide tablets compared to directly compressed furosemide tablets.