Newsletter | September 12, 2025

09.12.25 -- Avoiding Alcohol-Induced Dose Dumping In Oral Drug Formulation

SPONSOR

Explore the future of pharmaceutical packaging in this webinar from Adare Pharma Solutions. Discover how patient-centric designs, advanced safety systems, and sustainable materials are improving adherence and enabling innovative therapies. Learn how automation, digitalization, and regulatory guidance are reshaping packaging operations. Gain exclusive insights into trends, technologies, and partner selection strategies that will define the next decade—register today! Click here to learn more.

INDUSTRY INSIGHTS

The Art And Science Of Topical Formulations

Chief Scientific Officer Jon Lenn discusses the balance of art and science in topical formulation development, emphasizing advanced skin models for optimized delivery, activity, and product stability.

PBPK Modeling: Mitigating Absorption Risks In Early Drug Development

Discover how PBPK models combined with in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development.

What Is The Optimal Dosage Form For Your Specific Molecule?

Use this resource to decide whether tablets or liquid-filled, hard-shell capsules align seamlessly with the specific requirements of an active pharmaceutical ingredient and desired trial outcomes.

FEATURED EDITORIAL

The 15% Tariff: A Modest Jolt Or Deeper Disruption?

Regarding the U.S. / E.U. “agreement” to a blanket 15% tariff on pharmaceuticals entering the former from the latter, Chief Editor Louis Garguilo zeroes in on potential effects of outsourcing active pharmaceutical ingredients (API). A 2025 analysis indicates 43% of branded pharmaceutical APIs used in U.S. prescriptions come from the E.U. Learn from a case study and analysis.

Avoiding Alcohol-Induced Dose Dumping In Oral Drug Formulation

The FDA has become more vigilant about alcohol-induced dose dumping in extended-release oral dosages. Such dumping can result in anything from reduced therapeutic effects to dangerous toxicity. Let's take a closer look.

INDUSTRY INSIGHTS CONTINUED

Ensuring The Efficacy Of Probiotic Products

Without proper handling and packaging, the efficacy of probiotics can be compromised at any point in the packaging, storage, and transportation process, impacting shelf life and effectiveness.

Strategies For Optimal Scale-Up, Tech Transfer Of Oral Small Molecules

Learn about the identification of CMAs, CPPs, and CQAs of drug products and how to predict their impact on formulation and manufacturing processes.

Enhancing Precision In Personalized Medicine

Personalized medicine can often provide more accurate dosing that ensures efficacy and helps achieve optimal therapeutic outcomes. A new generation of dosing technologies are emerging.

Leveraging A Trusted Partner For Outsourcing Stability Storage

Gain insight into the benefits of outsourcing stability storage compared to handling in-house. By outsourcing stability storage, eliminate the need for maintaining in-house stability chambers or cabinets.

SPONSOR

Explore 20+ new CDMO presenters in quick 20-minute sessions during Outsourced Pharma’s October Partner Week. Sessions include Analytical Services, ADC, Large and Small Molecules, Cell and Gene Therapy, and Fill/Finish. Each session offers a quick, informative look at capabilities to help you find the best-fit partner. Registration, on-demand access, and interactive Q&A are all free.

SOLUTIONS

Emerging Trends In The CDMO Landscape

In this interview, Dr. Michael Grass discusses how the company is adapting to emerging trends in the CDMO landscape, driving innovation, and enhancing pharmaceutical product development.

IP Protection: A Culture Of Confidentiality

Bring your pharmaceutical product to market with peace of mind, knowing your Intellectual Property (IP) is protected by our robust CARE system.

Early Drug Development Made Easy With Small Quantities

Why take the risk of selecting individual components that may not work well together? Find a containment system with proven container closure integrity, providing risk mitigation and convenience.

The Link Between A Robust Company Culture And Quality

Integrity and transparent communication are fundamental to the interactions between a CDMO and its customers. They ensure efficient, effective, and phase-appropriate project management.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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