Overcoming the Challenges of Gummies as a Drug Delivery System

PL Developments (PLD) has brought its contract services division, Avéma Pharma Solutions, under the PLD brand as PLD Pharma Services. With this move, PLD aims to reduce confusion in the market by presenting a unified identity that reflects PLD’s commitment to developing and manufacturing high quality, liquid and solid dose OTC and Rx products to its customers.

Lessons Learned: Choosing & Managing a CDMOAvéma Pharma Solutions, a division of PL Developments (PLD), is in the unique position being both a consumer and supplier of global CDMO services for both OTC and rX products. In this presentation, we’ll explore the lessons we have learned from managing our own CMOs that have allowed us to build a better CDMO model for our Avéma customers. We’ll address the areas that can help speed up your time-to-market, keep development costs under control, and smooth the FDA approval and commercial launch process. Watch our webinar at https://app.webinar.net/K2OlZE6JLx9?mcc=WebsitePost

PL Developments (PLD) has reached a major milestone with the FDA approval of its Omeprazole Magnesium Tablet, a product comparable to Prilosec® OTC. This achievement makes PLD the only provider of OTC Omeprazole manufactured in the United States, solidifying the company’s position as a leader in complex pharmaceutical manufacturing.

Bringing this product to market required several years of development, including bioequivalence (BE) studies and the application of Multi-Unit Pellet System (MUPS) technology, a highly advanced oral drug delivery system. This approval highlights PLD’s ability to develop, produce, and commercialize intricate pharmaceutical formulations that meet the rigorous standards of the U.S. healthcare market. PL Developments (PLD) has reached a major milestone with the FDA approval of its Omeprazole Magnesium Tablet, a product comparable to Prilosec® OTC. This achievement makes PLD the only provider of OTC Omeprazole manufactured in the United States,...

In this session, Aaron Dely, Vice President of R&D at PLD Pharma Services, explores the opportunities and challenges of developing over-the-counter (OTC) and Rx gummies. Dely explains why consumer demand for gummies—driven by improved compliance—is fueling rapid growth and premium pricing in this dosage form. He highlights key technical and regulatory hurdles, from API suitability and heat stability to taste masking, texture, and FDA expectations. Drawing on real-world examples, Dely showcases how PLD leverages decades of formulation and manufacturing expertise, a dedicated R&D lab, and its state-of-the-art gummy facility in New York. The presentation details PLD’s proprietary solutions, including a custom 4-way blending process for exceptional product uniformity, precise pH and viscosity controls, and deposit accuracy in the single digits—far exceeding typical confectionery standards. Attendees will gain practical insights into overcoming formulation challenges and responsibly commercializing safe, high-quality gummies.

This presentation provides an overview of Avéma Pharma Solution's capabilities.

Welcome to PLD Pharma Services. This short video provides an overview of our capabilities.

Taste is one of the most important parameters in developing an Rx or OTC drug. Unpleasant, bitter-tasting components can make a product unpalatable which will impact patient compliance, marketability and, ultimately, product sales and profitability. If a product doesn’t taste good, it’s not going to sell well. Learn how PLD Pharma Services brings its expertise into the development of new products.

One of the best ways to determine whether a company and a contractor manufacturer are a good match is through a rigorous RFQ process where every element of a potential project is discussed. When an RFQ is vague, the chance of success decreases significantly, so the RFQ should include as many details as possible about the excipients, drug substances, process flow, the parameters of the product/formulation development and the scope of the regulatory requirements. It should also include a forecast and competitive assessment to evaluate whether there is a need for the product or whether there are already well-established competitive products that have saturated the market.

Aaron Dely, PLD's VP of Global Research, gives a tour of PLD's R&D facilities and discusses how the company's focus on small batches with short turn times around allows for more characterization of the process through design of experiments to support the FDA’s mandate on quality by design. This approach can lead to reductions in review time by the FDA and lead to fewer information requests or a faster approval cycle.

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.

Avéma is leveraging its OTC and Rx drug development expertise into using gummies as a novel delivery system. This White Paper describes what it takes to succeed in this expanding market.

Looking at the supplement industry as a barometer for drug delivery systems, it’s apparent that gummies are gaining traction as a preferred delivery system. In 2019, the sales of non-pill formats, including gummies, powders and shots, exceeded the sales of pill formats and that gap between the pill and non-pill market share continues to grow.

Avéma Pharma Solutions is building an enhanced, state-of-the-art R&D center that is almost three times larger than the existing space and will help the company respond to increased customer demand for formulation and analytical development.

Avéma Pharma Solutions has made significant investments to enable new capabilities and expand its service offerings going into 2023.

This presentation touches on how Avéma Pharma Solutions helps to eliminate lost time while transitioning from R&D to commercial launch.