Long-term commercial success for novel pharmaceutical development hinges on more than just a drug’s efficacy. It requires a strategic approach to formulation that addresses bioavailability, patient experience, and market longevity.
Fergus Binnie, Formulation Development Team Leader at Douglas CDMO
Softgel capsules represent a superior oral dosage form that delivers a compelling and sustained commercial advantage in the medium to long term life of a drug’s lifecycle.
Partnering with a specialized contract development and manufacturing organization (CDMO) to leverage this advanced technology is a key decision for securing a product’s market position.
We sat down with Fergus Binnie, Formulation Development Team Leader at Douglas CDMO to ask him about the commercial viability of softgels and uncover the five most significant commercial reasons why his customers choose softgels in their pharmaceutical development projects.
1. Enhanced bioavailability: the foundation of efficacy and market differentiation
A key reason for developing softgel capsules is their exceptional ability to enhance the bioavailability of poorly soluble or lipophilic APIs. The liquid or semi-solid fill matrix allows the drug to be delivered in a pre-solubilized state, enabling faster and more complete absorption. This is a critical factor for challenging compounds, as it can lead to improved therapeutic outcomes and allow for a lower effective dose. A product with superior bioavailability is inherently more valuable, providing a significant competitive edge and a strong basis for market differentiation.
“Softgels are not just a simple delivery system. They unlock the true potential of challenging APIs by optimizing their bioavailability for superior patient outcomes.”
Fergus Binnie, Formulation Development Team Leader at Douglas CDMO
2. Superior stability for reduced risk and extended shelf life
The hermetically sealed, one-piece shell of a softgel capsule provides an unparalleled barrier against oxygen, light, and moisture. This protection is vital for maintaining the chemical stability of sensitive APIs, preventing degradation and extending a product’s shelf life. For products that might otherwise be prone to instability, softgels can reduce the risk of recalls and ensure a longer, more reliable presence on the market. This robust stability translates directly into long-term commercial viability and builds a reputation for quality and reliability.
“At Douglas CDMO, we utilize advanced formulation science to protect sensitive compounds, ensuring a robust and reliable product with a shelf life that secures long-term market presence and minimizes risk. An extra year or more of shelf life makes a huge difference to the profitability for a marketed drug.”
Fergus Binnie
3. Patient-centric design for improved compliance and brand loyalty
Patient acceptance and compliance are paramount for a drug’s commercial success. The smooth, easy-to-swallow nature of softgels significantly improves the patient experience, particularly for individuals who struggle with tablets or hard capsules. The gelatin shell also effectively masks unpleasant tastes or odors. A product that is easier and more pleasant to take fosters greater patient adherence, leading to better clinical outcomes and increased brand loyalty. This focus on the end-user experience is a powerful lever for maintaining a strong market position.
“The patient experience is paramount. By designing a dosage form that is both easy to swallow and taste-masked, we’re not just creating a superior product; we’re actively improving patient compliance, which is a powerful driver of brand loyalty and market success.”
Fergus Binnie
4. Flexibility and versatility for product innovation
Softgel technology offers remarkable flexibility and sets the standard in novel formulation development. They can encapsulate a wide range of APIs, including liquids, semi-solids, and suspensions, as well as multiple active ingredients in a single capsule. This versatility allows drug developers to create unique combination products or reformulate existing ones to improve performance.
“Softgels are an ideal choice for life cycle management strategies, enabling companies to breathe new life into older products and expand their market reach.”
Fergus Binnie
Adopting softgel technology is not just a formulation choice, but a strategic business decision that offers a clear path to long-term commercial success. By addressing critical challenges like bioavailability and stability while simultaneously creating a superior patient experience, softgels provide a distinct competitive advantage.
This versatility, combined with the high barrier to entry for competitors and a clear pathway for lifecycle management, positions softgels as a powerful tool for drug developers seeking to maximize a product’s market potential and secure its enduring profitability.
Douglas CDMO: Your partner in unlocking the commercial advantage of softgels
Choosing to develop a drug in a softgel format is a strategic move, but its success depends on the right manufacturing partner. Douglas CDMO, a proven leader in softgel technology, is uniquely positioned to help you realize these commercial advantages. As the first company to produce a generic isotretinoin softgel for severe acne and with a 30% share of the U.S. retinoid sector, Douglas has a long-standing reputation for manufacturing excellence and quality.
The complex and specialized nature of softgel production, which Douglas has mastered over decades, creates a significant barrier to entry for generics, protecting your intellectual property and market share. Partner with Douglas CDMO to leverage our dual expertise in both generic and novel softgel development, ensuring your product benefits from superior bioavailability, enhanced stability, and a high-quality, defensible market position.
Contact us to talk about your next development project.