Avéma Pharma Solutions & PLD Gummies
Bringing Gummy Manufacturing Expertise to Rx and OTC Drugs

Gummies are one of the most popular new dosage forms in the nutritional supplement market as they offer a convenient and enjoyable way to consume supplements, especially for pediatric and geriatric populations who have difficulty swallowing pills. As pharmaceutical companies consider gummies for OTC and Rx drugs, it’s important to choose a company that offers the right expertise, a robust formulation and development process, and access to state-of-the-art facilities because, unlike nutritional supplements, where an exact dosage is not critical, for OTC and Rx drugs, the gummies must do more than taste good; dose accuracy, dose consistency and bioavailability of the drug are paramount.

As a fully-owned subsidiary of PLD Developments and PLD Gummies, Avéma Pharma Solutions is in a strong position to help pharma companies enter this market as the company has a unique combination of confectionary experience and drug development capabilities. The CDMO focuses on Rx development and manufacturing of oral and solid-dose drugs. The company’s R&D scientists have experience working with a range of APIs in a variety of delivery systems, so they already have experience with the actives in another matrix and can leverage that knowledge in the development of a gummy.

“Our ability to develop perfectly formulated gummies in bulk stems from the combination of our confectionery expertise and know-how of prescription (Rx) and overthe- counter (OTC) drug production,” says Mitchell Slade, chief operating officer at PL Developments and president of the PLD Gummy Co. “We have a sophisticated drug development facility with a dedicated R&D department that adheres to the stringent standards of the Rx and OTC industries.”

To support gummy development, PL Developments purchased a fully-operational CFR 211 and CFR 111-compliant gummy- and gum facility in Copiague, NY, which means it is compliant with making drug products. Most gummy manufacturers are only certified for confectionary or supplement manufacturing. The facility has four manufacturing lines with the capacity to produce approximately 1.2 billion starchless gummies annually.

Avéma’s Miami R&D lab plays a crucial role in formulation development. Among the critical parameters that need to be specified in a starchless gummy manufacturing process include the consistency of the liquid slurry, the actives level in the product, the pH of the product, and the ability of the formulation to react and solidify when deposited.

The R&D lab focuses first on the dosage requirements of the active ingredient before considering aspects like flavor, color, and shape. Generally, the API represents 10-15% of the weight of a gummy as higher levels of actives could adversely impact taste and could prevent the formulation from solidifying when deposited. The lab also conducts flavor masking and mouth feel tests. Many active ingredients have unpleasant tastes – some are sour, others are bitter. Avéma masks flavors by using a combination of sweeteners and flavors and or by encapsulating actives using coated bead technologies.

Our ability to develop perfectly formulated gummies in bulk stems from the combination of our confectionery expertise and know-how of prescription (Rx) and over-the-counter (OTC) drug production. We have a sophisticated drug development facility with a dedicated R&D department that adheres to the stringent standards of the Rx and OTC industries

“In our effort to create perfectly formulated gummy products, we harmonize three important aspects—flavor, mouth feel, and accurate dosing. The successful interplay of these elements is essential for the overall effectiveness of the manufacturing process,” says Slade.

The company is currently conducting commercial trials as part of its full-scale production process, manufacturing a wide range of sugar-free gummies for testing and market evaluation. These items include vitamin C, vitamin D, and melatonin, as well as products focused on sleep and immunity support. Trials like these allow the company to assess the viability and market demand for these formulations before proceeding with full commercial production.

As Avéma works with companies to develop the first OTC and Rx gummies, another critical benefit is the company’s experience with regulatory approvals. Avéma’s team works with the FDA on new drug applications (NDAs), abbreviated drug applications (ANDAs), and more – something few supplement manufacturers can bring to the table. The company also has packaging capabilities, which will be important when developing drugs for the pediatric market as they will involve using child-resistant packaging such as CRCs and childresistant blister cards.

With its decades of experience, a fully-certified facility, and experience commercializing oral and solid dose drugs, PLD/Avéma Pharma Solutions is positioned to become a leader in the development of gummies as a delivery source for the next generation of Rx and OTC drugs.